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Clinical Trial Results:
A Phase 1b/2, Multicenter, Open-label, Dose-escalation Study of Elotuzumab (Humanized Anti-CS1 Monoclonal IgG1 Antibody) in Combination With Lenalidomide and Dexamethasone in Subjects With Relapsed Multiple Myeloma

Summary
EudraCT number	2007-006677-83
Trial protocol	DE GB
Global end of trial date	20 Oct 2016

Results information
Results version number	v1(current)
This version publication date	27 Oct 2017
First version publication date	27 Oct 2017
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

HuLuc63‐1703

ISRCTN number

US NCT number

NCT00742560

WHO universal trial number (UTN)

Sponsor organisation name

AbbVie Deutschland GmbH & Co. KG

Sponsor organisation address

AbbVie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, United Kingdom, SL6-4UB

Public contact

Global Medical Services, AbbVie, 001 800-633-9110,

Scientific contact

Nilou Mobashery, MD, AbbVie, Nilou.mobashery@abbvie.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

20 Oct 2016

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

20 Oct 2016

Was the trial ended prematurely?

Main objective of the trial

the purpose of this study is to evaluate the combination of elotuzumab, lenalidomide, and dexamethasone in subjects with relapsed relapsed multiple myeloma.

Protection of trial subjects

Subject read and understood the information provided about the study and gave written permission.

Background therapy

Evidence for comparator

Actual start date of recruitment

22 Aug 2008

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Canada: 10

Country: Number of subjects enrolled

France: 24

Country: Number of subjects enrolled

Germany: 8

Country: Number of subjects enrolled

United States: 60

Worldwide total number of subjects

102

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Screening details

A total of 101 participants were randomized (intent-to-treat [ITT] population); 1 subject did not receive study drug and is excluded from the analyses.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Non-randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1)

Arm description

Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.

Arm type

Experimental

Investigational medicinal product name

elotuzumab

Investigational medicinal product code

Other name

HuLuc63

Pharmaceutical forms

Powder for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Humanized Anti-CS1 Monoclonal IgG1 Antibody (HuLuc63) administered as an intravenous infusion once a week during Cycles 1 and 2, and every other week beginning with Cycle 3.

Investigational medicinal product name

lenalidomide

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Lenalidomide 25 mg administered orally once daily on Days 1 to 21 of each 28-day cycle

Investigational medicinal product name

dexamethasone oral

Investigational medicinal product code

Other name

Pharmaceutical forms

Oral solution

Routes of administration

Oral use

Dosage and administration details

Dexamethasone 40 mg administered orally once weekly; during weeks when elotuzumab is also administered, dexamethasone was administered as a split dose (28 mg orally and 8 mg intravenously)

Investigational medicinal product name

dexamethasone injection

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intravenous use

Dosage and administration details

Dexamethasone 40 mg administered orally once weekly; during weeks when elotuzumab is also administered, dexamethasone was administered as a split dose (28 mg orally and 8 mg intravenously)

Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1)

Arm description

Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.

Arm type

Experimental

Investigational medicinal product name

elotuzumab

Investigational medicinal product code

Other name

HuLuc63

Pharmaceutical forms

Powder for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Humanized Anti-CS1 Monoclonal IgG1 Antibody (HuLuc63) administered as an intravenous infusion once a week during Cycles 1 and 2, and every other week beginning with Cycle 3.

Investigational medicinal product name

lenalidomide

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Lenalidomide 25 mg administered orally once daily on Days 1 to 21 of each 28-day cycle

Investigational medicinal product name

dexamethasone oral

Investigational medicinal product code

Other name

Pharmaceutical forms

Oral solution

Routes of administration

Oral use

Dosage and administration details

Dexamethasone 40 mg administered orally once weekly; during weeks when elotuzumab is also administered, dexamethasone was administered as a split dose (28 mg orally and 8 mg intravenously)

Investigational medicinal product name

dexamethasone injection

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intravenous use

Dosage and administration details

Dexamethasone 40 mg administered orally once weekly; during weeks when elotuzumab is also administered, dexamethasone was administered as a split dose (28 mg orally and 8 mg intravenously)

Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1)

Arm description

Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.

Arm type

Experimental

Investigational medicinal product name

elotuzumab

Investigational medicinal product code

Other name

HuLuc63

Pharmaceutical forms

Powder for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Humanized Anti-CS1 Monoclonal IgG1 Antibody (HuLuc63) administered as an intravenous infusion once a week during Cycles 1 and 2, and every other week beginning with Cycle 3.

Investigational medicinal product name

lenalidomide

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Lenalidomide 25 mg administered orally once daily on Days 1 to 21 of each 28-day cycle

Investigational medicinal product name

dexamethasone oral

Investigational medicinal product code

Other name

Pharmaceutical forms

Oral solution

Routes of administration

Oral use

Dosage and administration details

Dexamethasone 40 mg administered orally once weekly; during weeks when elotuzumab is also administered, dexamethasone was administered as a split dose (28 mg orally and 8 mg intravenously)

Investigational medicinal product name

dexamethasone injection

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intravenous use

Dosage and administration details

Dexamethasone 40 mg administered orally once weekly; during weeks when elotuzumab is also administered, dexamethasone was administered as a split dose (28 mg orally and 8 mg intravenously)

Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2)

Arm description

Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.

Arm type

Experimental

Investigational medicinal product name

elotuzumab

Investigational medicinal product code

Other name

HuLuc63

Pharmaceutical forms

Powder for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Humanized Anti-CS1 Monoclonal IgG1 Antibody (HuLuc63) administered as an intravenous infusion once a week during Cycles 1 and 2, and every other week beginning with Cycle 3.

Investigational medicinal product name

lenalidomide

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Lenalidomide 25 mg administered orally once daily on Days 1 to 21 of each 28-day cycle

Investigational medicinal product name

dexamethasone oral

Investigational medicinal product code

Other name

Pharmaceutical forms

Oral solution

Routes of administration

Oral use

Dosage and administration details

Dexamethasone 40 mg administered orally once weekly; during weeks when elotuzumab is also administered, dexamethasone was administered as a split dose (28 mg orally and 8 mg intravenously)

Investigational medicinal product name

dexamethasone injection

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intravenous use

Dosage and administration details

Dexamethasone 40 mg administered orally once weekly; during weeks when elotuzumab is also administered, dexamethasone was administered as a split dose (28 mg orally and 8 mg intravenously)

Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2)

Arm description

Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.

Arm type

Experimental

Investigational medicinal product name

elotuzumab

Investigational medicinal product code

Other name

HuLuc63

Pharmaceutical forms

Powder for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Humanized Anti-CS1 Monoclonal IgG1 Antibody (HuLuc63) administered as an intravenous infusion once a week during Cycles 1 and 2, and every other week beginning with Cycle 3.

Investigational medicinal product name

lenalidomide

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Lenalidomide 25 mg administered orally once daily on Days 1 to 21 of each 28-day cycle

Investigational medicinal product name

dexamethasone oral

Investigational medicinal product code

Other name

Pharmaceutical forms

Oral solution

Routes of administration

Oral use

Dosage and administration details

Dexamethasone 40 mg administered orally once weekly; during weeks when elotuzumab is also administered, dexamethasone was administered as a split dose (28 mg orally and 8 mg intravenously)

Investigational medicinal product name

dexamethasone injection

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intravenous use

Dosage and administration details

Dexamethasone 40 mg administered orally once weekly; during weeks when elotuzumab is also administered, dexamethasone was administered as a split dose (28 mg orally and 8 mg intravenously)

Number of subjects in period 1 ^[1]	Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1)	Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1)	Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1)	Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2)	Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2)
Started	3	3	22	36	37
Completed	0	0	0	0	0
Not completed	3	3	22	36	37
Investigator's decision	-	-	4	1	-
Disease progression	1	-	5	17	16
Death	-	2	-	2	3
Not specified	-	1	8	9	9
Subject's decision	1	-	2	3	3
New multiple myeloma therapy	1	-	2	3	4
Adverse event	-	-	1	1	1
Missing	-	-	-	-	1

Notes
[1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
Justification: A total of 101 participants were randomized (intent-to-treat [ITT] population); 1 subject did not receive study drug and is excluded from the analyses.

Baseline characteristics

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Reporting group title

Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1)

Reporting group description

Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.

Reporting group title

Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1)

Reporting group description

Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.

Reporting group title

Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1)

Reporting group description

Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.

Reporting group title

Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2)

Reporting group description

Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.

Reporting group title

Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2)

Reporting group description

Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.

Reporting group values	Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1)	Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1)	Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1)	Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2)	Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2)	Total
Number of subjects	3	3	22	36	37	101
Age categorical
Units: Subjects
Age continuous
Units: years
arithmetic mean (standard deviation)	68.3 ( 7.23 )	64.7 ( 6.94 )	59.3 ( 10.87 )	60.6 ( 9.7 )	63.3 ( 9.76 )	-
Gender categorical
Units: Subjects
Female	2	1	10	19	24	56
Male	1	2	12	17	13	45

End points

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Reporting group title

Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1)

Reporting group description

Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.

Reporting group title

Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1)

Reporting group description

Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.

Reporting group title

Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1)

Reporting group description

Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.

Reporting group title

Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2)

Reporting group description

Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.

Reporting group title

Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2)

Reporting group description

Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.

Subject analysis set title

Phase 1 Elotuzumab + Lenalidomide and Dexamethasone

Subject analysis set type

Intention-to-treat

Subject analysis set description

Elotuzumab 5, 10, or 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.

Subject analysis set title

Total (Phase 2)

Subject analysis set type

Intention-to-treat

Subject analysis set description

Elotuzumab (10 or 20 mg/kg) administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.

Subject analysis set title

Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone

Subject analysis set type

Intention-to-treat

Subject analysis set description

Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally in Phase 1 and Phase 2.

Subject analysis set title

Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone

Subject analysis set type

Intention-to-treat

Subject analysis set description

Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally in Phase 1 and Phase 2.

Subject analysis set title

Total (Phase 1)

Subject analysis set type

Intention-to-treat

Subject analysis set description

Elotuzumab (5, 10, or 20 mg/kg) administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.

Primary: Maximum Tolerated Dose (MTD) of Elotuzumab in Combination With Lenalidomide and Dexamethasone (Phase 1)

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End point title

Maximum Tolerated Dose (MTD) of Elotuzumab in Combination With Lenalidomide and Dexamethasone (Phase 1) ^[1]

End point description

MTD was determined by testing increasing doses up to 20 mg/kg once daily dose escalation cohorts 1 to 3 with 3 patients each. MTD reflects highest dose of drug that did not cause an unacceptable side effect (dose limiting toxicity [DLT]) in more than 30% of patients; e.g., hematologic toxicities like Common Toxicity Criteria for Adverse Events (CTCAE) Grade 4 neutropenia in specific conditions, platelets < 10,000 cells/mm^3 that do not recover to 25,000 cells/mm^3; and specific non-hematologic/biochemical toxicities CTCAE Grade 3 or 4 (except fatigue and Grade 3 infections); CTCAE version 3.0 were used.

End point type

Primary

End point timeframe

4 weeks

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive data are summarized for this end point per protocol.

End point values	Phase 1 Elotuzumab + Lenalidomide and Dexamethasone
Number of subjects analysed	28 ^[2]
Units: mg/kg
number (not applicable)	20

Notes
[2] - All randomized participants who received at least 1 dose of study drug in phase 1 escalation cohorts

No statistical analyses for this end point

Primary: Objective Response Rate (ORR) According to the International Myeloma Working Group Uniform Response Criteria (Phase 2)

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End point title

Objective Response Rate (ORR) According to the International Myeloma Working Group Uniform Response Criteria (Phase 2) ^[3] ^[4]

End point description

ORR: Percentage of participants with confirmed complete response (CR; negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and ≤5% plasma cells in bone marrow), partial response (PR; ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to ≤200 mg per 24 hour; if serum and urine M-protein are unmeasurable, a ≥50% decrease in the difference between involved and uninvolved free light chain (FLC] levels is required in place of the M-protein criteria; if serum and urine M-protein are unmeasurable, and serum FLC is also unmeasurable, a ≥50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma cell percentage was ≥30%; and, if present at baseline, a ≥50% reduction in the size of soft tissue plasmacytomas), very good PR (VGPR; normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence), or stringent CR (sCR; CR plus VGPR).

End point type

Primary

End point timeframe

From date of randomization until 60 days following the last infusion (or before initiation of new therapy), up to 101 months

Notes
[3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Descriptive data are summarized for this end point per protocol.
[4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The primary end point included subjects enrolled in Phase 2 only.

End point values	Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2)	Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2)	Total (Phase 2)
Number of subjects analysed	36 ^[5]	37 ^[6]	73 ^[7]
Units: percentage of participants
number (confidence interval 95%)	91.7 (77.5 to 98.2)	75.7 (58.8 to 88.2)	83.6 (73 to 91.2)

Notes
[5] - Safety population: All randomized participants who received at least 1 dose of study drug
[6] - Safety population: All randomized participants who received at least 1 dose of study drug
[7] - Safety population: All randomized participants who received at least 1 dose of study drug

No statistical analyses for this end point

Secondary: Objective Response Rate (ORR) According to the International Myeloma Working Group Uniform Response Criteria (Phase 1)

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End point title

Objective Response Rate (ORR) According to the International Myeloma Working Group Uniform Response Criteria (Phase 1) ^[8]

End point description

End point type

Secondary

End point timeframe

From first dose of elotuzumab until 60 days following the last infusion (or before initiation of new therapy), up to 100.5 months

Notes
[8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The secondary end point included subjects enrolled in Phase 1 only.

End point values	Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1)	Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1)	Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1)	Total (Phase 1)
Number of subjects analysed	3 ^[9]	3 ^[10]	22 ^[11]	28 ^[12]
Units: percentage of participants
number (confidence interval 95%)	100 (29.2 to 100)	100 (29.2 to 100)	77.3 (54.6 to 92.2)	82.1 (63.1 to 93.9)

Notes
[9] - Safety population: All randomized participants who received at least 1 dose of study drug
[10] - Safety population: All randomized participants who received at least 1 dose of study drug
[11] - Safety population: All randomized participants who received at least 1 dose of study drug
[12] - Safety population: All randomized participants who received at least 1 dose of study drug

No statistical analyses for this end point

Secondary: Number of Participants With Treatment-emergent Adverse Events (TEAEs)

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End point title

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

End point description

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either definitely related, probably related, possibly related or unrelated. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.

End point type

Secondary

End point timeframe

Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 60 days after the last dose of study drug (up to 95 months)

End point values	Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1)	Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1)	Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1)	Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2)	Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2)
Number of subjects analysed	3 ^[13]	3 ^[14]	22 ^[15]	36 ^[16]	37 ^[17]
Units: participants
number (not applicable)
Any TEAE	3	3	22	36	37
Any TESAE	0	3	12	21	21
TEAEs ≥ Grade 3	2	3	19	32	25
TEAEs related to study drug	3	3	16	29	26
TESAEs related to study drug	0	0	2	2	5

Notes
[13] - Safety population: All randomized participants who received at least 1 dose of study drug
[14] - Safety population: All randomized participants who received at least 1 dose of study drug
[15] - Safety population: All randomized participants who received at least 1 dose of study drug
[16] - Safety population: All randomized participants who received at least 1 dose of study drug
[17] - Safety population: All randomized participants who received at least 1 dose of study drug

No statistical analyses for this end point

Secondary: Number of Participants With Infusion Reactions

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End point title

Number of Participants With Infusion Reactions

End point description

During Phase 1, a list of 118 pre-defined MedDRA preferred terms that had been adjudicated to be clinically relevant to infusion reactions by a safety committee was used to search for TEAEs that could potentially be associated with an infusion reaction following elotuzumab administration. Examples of these terms included angioedema, bronchospasm, chills, flushing, pyrexia, rash and urticaria. During Phase 2, the method for capturing TEAEs associated with an infusion reaction was modified to include investigators' designation of AEs judged as clinically relevant infusion reactions. The number of participants infusion reactions are provided overall and by highest toxicity grade (CTCAE v 3.0).

End point type

Secondary

End point timeframe

Cycles 1 and 2: Days 1, 8, 15, and 22 (day of infusion of elotuzumab) and Days 2, 9, 16, and 23 (day following infusion); and Cycles 3 and greater: Days 1 and 15 (day of infusion) and Days 2 and 16 (day after infusion) (up to 95 months)

End point values	Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1)	Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1)	Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1)	Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2)	Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2)
Number of subjects analysed	3 ^[18]	3 ^[19]	22 ^[20]	36 ^[21]	37 ^[22]
Units: participants
number (not applicable)
Any reaction	2	3	20	5	3
Grade 5	0	0	0	0	0
Grade 4	0	0	1	0	0
Grade 3	0	0	2	1	0
Grade 2	0	1	5	1	1
Grade 1	2	2	12	3	2

Notes
[18] - Safety population: All randomized participants who received at least 1 dose of study drug
[19] - Safety population: All randomized participants who received at least 1 dose of study drug
[20] - Safety population: All randomized participants who received at least 1 dose of study drug
[21] - Safety population: All randomized participants who received at least 1 dose of study drug
[22] - Safety population: All randomized participants who received at least 1 dose of study drug

No statistical analyses for this end point

Secondary: Mean Serum Concentrations of Elotuzumab During Cycle 1

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End point title

Mean Serum Concentrations of Elotuzumab During Cycle 1 ^[23]

End point description

Blood samples were collected during Phase 1, Cycle 1, prior to elotuzumab infusion (time 0 hours) and 30 minutes (0.5 hours) and 4 hours post-infusion (Day 1), 30 minutes (0.5 hours) post-infusion (Day 8 and Day 15), or 30 minutes (0.5 hours), 2 hours, and 4 hours post-infusion (Day 15). Blood samples were collected during Phase 2, Cycle 1, prior to elotuzumab infusion (time 0 hours) and 30 minutes (0.5 hours), 2 hours, and 4 hours post-infusion (Day 1), 30 minutes (0.5 hours) and 2 hours post-infusion (Day 8 and Day 15), or 30 minutes (0.5 hours), 2 hours, and 4 hours post-infusion (Day 15). The samples were analyzed for the concentration of elotuzumab using validated analytical methods. Mean serum concentrations on Cycle 1, Days 1, 8, 15, and 22 (measured in μg/mL) are reported overall (across Phase 1 and Phase 2) by dose. 55555=The estimated standard deviation of one sample is undefined. 88888=Blood samples not collected at given timepoint.

End point type

Secondary

End point timeframe

Cycle 1: Days 1 (pre-infusion and 0.5, 2 and 4 hours post-infusion), 8 (pre-infusion and 0.5 and 2 hours post-infusion), 15 (pre-infusion and 0.5 hours and 2 hours post-infusion), and 22 (pre-infusion and 0.5, 2, and 4 hours post-infusion)

Notes
[23] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The end point is analyzed by dose (5, 10, and 20 mg/kg).

End point values	Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1)	Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone	Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone
Number of subjects analysed	3 ^[24]	39 ^[25]	58 ^[26]
Units: μg/mL
arithmetic mean (standard deviation)
Day 1: 0.5 hours (N=3,39,58)	0 ( 0 )	0 ( 0 )	0 ( 0 )
Day 1: 0.5 hours (N=3,39,57)	78.48 ( 21.33 )	217.9 ( 99.31 )	434.2 ( 202.74 )
Day 1: 2 hours (N=0,36,43)	88888 ( 88888 )	213.31 ( 91.3 )	388.58 ( 112.94 )
Day 1: 4 hours (N=3,3,12)	85.56 ( 23.54 )	251.34 ( 31.92 )	525.98 ( 188.46 )
Day 8: 0 hours (N=3,37,55)	32.44 ( 8.91 )	92.47 ( 61.16 )	168.55 ( 56.43 )
Day 8: 0.5 hours(N=3,22,44)	133.37 ( 40.87 )	281.53 ( 117.35 )	593.8 ( 192.7 )
Day 8: 2 hours (N=0,12,9)	88888 ( 88888 )	268.35 ( 107.44 )	520.97 ( 207.28 )
Day 15: 0 hours (N=3,37,58)	49.84 ( 28.28 )	111.11 ( 56.36 )	298.82 ( 231.17 )
Day 15: 0.5 hours (N=3,36,55)	140.09 ( 32.28 )	282.29 ( 100.29 )	661.91 ( 251.08 )
Day 22: 0 hours (N=3,38,54)	61.93 ( 53.66 )	135.92 ( 106.83 )	308.02 ( 144.61 )
Day 22: 0.5 hours (N=3,38,54)	168.61 ( 59.31 )	310.03 ( 165.14 )	699.7 ( 230.41 )
Day 22: 2 hours (N=1,35,40)	268.53 ( 55555 )	298.85 ( 114.35 )	704.48 ( 234.98 )
Day 22: 4 hours (N=2,3,10)	128.94 ( 42.04 )	538.88 ( 195.35 )	981.16 ( 280.28 )

Notes
[24] - All participants in the safety population with evaluable data at given timepoint
[25] - All participants in the safety population with evaluable data at given timepoint
[26] - All participants in the safety population with evaluable data at given timepoint

No statistical analyses for this end point

Secondary: Maximum Serum Concentration (Cmax) of Elotuzumab

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End point title

Maximum Serum Concentration (Cmax) of Elotuzumab ^[27]

End point description

The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the blood after administration in a dosing interval. The Cmax of elotuzumab was to be estimated using non-compartmental methods and data reported as the mean ± standard deviation. No noncompartmental pharmacokinetic parameters (e.g., AUC, CL, V, t 1/2) were estimated due to sparse serum concentration collections.

End point type

Secondary

End point timeframe

Cycle 1: Days 1, 8, and 15; Cycle 2: Days 1 and 22; Cycle 3 and beyond: Day 1

Notes
[27] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The end point was to be analyzed by dose (5, 10, and 20 mg/kg).

End point values	Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1)	Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone	Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone
Number of subjects analysed	0 ^[28]	0 ^[29]	0 ^[30]
Units: ng/mL
arithmetic mean (standard deviation)	( )	( )	( )

Notes
[28] - No pharmacokinetic parameters were estimated due to sparse serum concentration collections
[29] - No pharmacokinetic parameters were estimated due to sparse serum concentration collections
[30] - No pharmacokinetic parameters were estimated due to sparse serum concentration collections

No statistical analyses for this end point

Secondary: Area Under the Concentration-time Curve From 0 to Infinity (AUC0-inf) of Elotuzumab

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End point title

Area Under the Concentration-time Curve From 0 to Infinity (AUC0-inf) of Elotuzumab ^[31]

End point description

The area under the plasma concentration-time curve (AUC; measured in ng*hr/mL) is a method of measurement to determine the total exposure of a drug in blood plasma. The AUC24 of elotuzumab was to be estimated using non-compartmental methods and data reported as the mean ± standard deviation. No noncompartmental pharmacokinetic parameters (e.g., AUC, CL, V, t 1/2) were estimated due to sparse serum concentration collections.

End point type

Secondary

End point timeframe

Cycle 1: Days 1, 8, and 15; Cycle 2: Days 1 and 22; Cycle 3 and beyond: Day 1

Notes
[31] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The end point was to be analyzed by dose (5, 10, and 20 mg/kg).

End point values	Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1)	Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone	Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone
Number of subjects analysed	0 ^[32]	0 ^[33]	0 ^[34]
Units: ng*hr/mL
arithmetic mean (standard deviation)	( )	( )	( )

Notes
[32] - No pharmacokinetic parameters were estimated due to sparse serum concentration collections
[33] - No pharmacokinetic parameters were estimated due to sparse serum concentration collections
[34] - No pharmacokinetic parameters were estimated due to sparse serum concentration collections

No statistical analyses for this end point

Secondary: Systemic Clearance (CL) of Elotuzumab

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End point title

Systemic Clearance (CL) of Elotuzumab ^[35]

End point description

Systemic clearance (CL, measured in mL/kg/hr) is a measure of the efficiency with which a drug is irreversibly removed from the body. The CL of elotuzumab was to be estimated using non-compartmental methods and data reported as the mean ± standard deviation. No noncompartmental pharmacokinetic parameters (e.g., AUC, CL, V, t 1/2) were estimated due to sparse serum concentration collections.

End point type

Secondary

End point timeframe

Cycle 1: Days 1, 8, and 15; Cycle 2: Days 1 and 22; Cycle 3 and beyond: Day 1

Notes
[35] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The end point was to be analyzed by dose (5, 10, and 20 mg/kg).

End point values	Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1)	Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone	Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone
Number of subjects analysed	0 ^[36]	0 ^[37]	0 ^[38]
Units: mL/kg/hr
arithmetic mean (standard deviation)	( )	( )	( )

Notes
[36] - No pharmacokinetic parameters were estimated due to sparse serum concentration collections
[37] - No pharmacokinetic parameters were estimated due to sparse serum concentration collections
[38] - No pharmacokinetic parameters were estimated due to sparse serum concentration collections

No statistical analyses for this end point

Secondary: Volume of Distribution (V) of Elotuzumab

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End point title

Volume of Distribution (V) of Elotuzumab ^[39]

End point description

Volume of distribution (V, measured in L/kg) is the hypothetical volume of body fluid that would be required to dissolve the amount of drug needed to achieve the same concentration in the blood. The V of elotuzumab was to be estimated using non-compartmental methods and data reported as the mean ± standard deviation. No noncompartmental pharmacokinetic parameters (e.g., AUC, CL, V, t 1/2) were estimated due to sparse serum concentration collections.

End point type

Secondary

End point timeframe

Cycle 1: Days 1, 8, and 15; Cycle 2: Days 1 and 22; Cycle 3 and beyond: Day 1

Notes
[39] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The end point was to be analyzed by dose (5, 10, and 20 mg/kg).

End point values	Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1)	Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone	Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone
Number of subjects analysed	0 ^[40]	0 ^[41]	0 ^[42]
Units: L/kg
arithmetic mean (standard deviation)	( )	( )	( )

Notes
[40] - No pharmacokinetic parameters were estimated due to sparse serum concentration collections
[41] - No pharmacokinetic parameters were estimated due to sparse serum concentration collections
[42] - No pharmacokinetic parameters were estimated due to sparse serum concentration collections

No statistical analyses for this end point

Secondary: Serum Half-life (t1/2) of Elotuzumab

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End point title

Serum Half-life (t1/2) of Elotuzumab ^[43]

End point description

The serum half-life of a drug (t1/2, measured in hours) is the time necessary to reduce the plasma concentration by half. The t1/2 of elotuzumab was to be estimated using non-compartmental methods and data reported as the mean ± standard deviation. No noncompartmental pharmacokinetic parameters (e.g., AUC, CL, V, t 1/2) were estimated due to sparse serum concentration collections.

End point type

Secondary

End point timeframe

Cycle 1: Days 1, 8, and 15; Cycle 2: Days 1 and 22; Cycle 3 and beyond: Day 1

Notes
[43] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The end point was to be analyzed by dose (5, 10, and 20 mg/kg).

End point values	Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1)	Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone	Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone
Number of subjects analysed	0 ^[44]	0 ^[45]	0 ^[46]
Units: hours
arithmetic mean (standard deviation)	( )	( )	( )

Notes
[44] - No pharmacokinetic parameters were estimated due to sparse serum concentration collections
[45] - No pharmacokinetic parameters were estimated due to sparse serum concentration collections
[46] - No pharmacokinetic parameters were estimated due to sparse serum concentration collections

No statistical analyses for this end point

Secondary: Duration of Response

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End point title

Duration of Response

End point description

Duration of response is defined as the time from the initial objective response to disease progression or death, whichever occurs first. The distribution of duration of response was estimated for each treatment group using Kaplan-Meier methodology. Point estimates and 95% CIs for the median for the duration of response distribution are provided. 77777=Median was not reached (max value was 58.22). 11111=Lower limit not calculable due to insufficient progression events. 99999=upper limit not calculable due to insufficient progression events.

End point type

Secondary

End point timeframe

From first dose of elotuzumab (phase 1) or randomization (phase 2) until 60 days following the last infusion (or before initiation of new therapy), up to 101 months

End point values	Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1)	Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1)	Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1)	Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2)	Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2)	Total (Phase 2)	Total (Phase 1)
Number of subjects analysed	3 ^[47]	3 ^[48]	22 ^[49]	36 ^[50]	37 ^[51]	73 ^[52]	28 ^[53]
Units: months
median (confidence interval 95%)	4.47 (1.45 to 4.47)	9.92 (0 to 99999)	77777 (11111 to 99999)	34.83 (14.6 to 99999)	29.01 (15.0 to 99999)	29.24 (18.2 to 99999)	77777 (11111 to 99999)

Notes
[47] - Safety population: All randomized participants who received at least 1 dose of study drug
[48] - Safety population: All randomized participants who received at least 1 dose of study drug
[49] - Safety population: All randomized participants who received at least 1 dose of study drug
[50] - Safety population: All randomized participants who received at least 1 dose of study drug
[51] - Safety population: All randomized participants who received at least 1 dose of study drug
[52] - Safety population: All randomized participants who received at least 1 dose of study drug
[53] - Safety population: All randomized participants who received at least 1 dose of study drug

No statistical analyses for this end point

Secondary: Time to Progression (TTP)

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End point title

Time to Progression (TTP)

End point description

TTP is defined as the time from first dose (phase 1) or time from randomization (phase 2) to disease progression. The distribution of TTP was estimated for each treatment group using Kaplan-Meier methodology. Point estimates and 95% CIs for the median for the TTP distribution are provided. 11.111=Lower limit not calculable due to insufficient progression events. 99999=upper limit not calculable due to insufficient progression events

End point type

Secondary

End point timeframe

From first dose of elotuzumab (phase 1) or randomization (phase 2) until 60 days following the last infusion (or before initiation of new therapy), up to 101 months

End point values	Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1)	Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1)	Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1)	Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2)	Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2)	Total (Phase 2)	Total (Phase 1)
Number of subjects analysed	3 ^[54]	3 ^[55]	22 ^[56]	36 ^[57]	37 ^[58]	73 ^[59]	28 ^[60]
Units: months
median (confidence interval 95%)	6.08 (6.05 to 6.08)	11.53 (11.111 to 99999)	52.93 (7.43 to 99999)	32.49 (14.9 to 99999)	19.94 (12.9 to 35.7)	28.16 (15.4 to 35.8)	52.93 (7.43 to 99999)

Notes
[54] - Safety population: All randomized participants who received at least 1 dose of study drug
[55] - Safety population: All randomized participants who received at least 1 dose of study drug
[56] - Safety population: All randomized participants who received at least 1 dose of study drug
[57] - Safety population: All randomized participants who received at least 1 dose of study drug
[58] - Safety population: All randomized participants who received at least 1 dose of study drug
[59] - Safety population: All randomized participants who received at least 1 dose of study drug
[60] - Safety population: All randomized participants who received at least 1 dose of study drug

No statistical analyses for this end point

Secondary: Percentage of Participants With Treatment-emergent Anti-elotuzumab Antibody (ADA)

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End point title

Percentage of Participants With Treatment-emergent Anti-elotuzumab Antibody (ADA) ^[61]

End point description

Treatment-emergent (post-dose) positive elotuzumab-specific ADA is differentiated from pre-existing (positive at the predose time point) positive elotuzumab-specific ADA. The percentage of participants with confirmed treatment-emergent ADA overall by dose is provided.

End point type

Secondary

End point timeframe

From screening through 60-day follow up period (up to 101 months)

Notes
[61] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The end point is analyzed by dose (5, 10, and 20 mg/kg).

End point values	Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1)	Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone	Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone
Number of subjects analysed	3 ^[62]	39 ^[63]	57 ^[64]
Units: participants
number (not applicable)	0	6	5

Notes
[62] - All participants who received ≥ 1 dose of study drug and ≥ 1 evaluable post-dose sample
[63] - All participants who received ≥ 1 dose of study drug and ≥ 1 evaluable post-dose sample
[64] - All participants who received ≥ 1 dose of study drug and ≥ 1 evaluable post-dose sample

No statistical analyses for this end point

Secondary: Plasma Cell Myeloma Cytogenetic Subtype

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End point title

Plasma Cell Myeloma Cytogenetic Subtype

End point description

Plasma cell myeloma cytogenetic subtype was assessed at the screening visit using standard karyotyping and/or fluorescence in situ hybridization. The number of participants in each cytogenetic risk category are provided: High Risk (International Staging System [ISS] stage II or III and t(4;14) or del(17p) abnormality); Standard Risk (not high or low risk); and Low Risk (ISS stage I or II and absence of t(4;14), del(17p) and 1q21 abnormalities AND age < 55).

End point type

Secondary

End point timeframe

Screening (up to 14 days prior to dosing)

End point values	Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1)	Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1)	Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1)	Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2)	Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2)
Number of subjects analysed	3 ^[65]	3 ^[66]	22 ^[67]	36 ^[68]	37 ^[69]
Units: participants
number (not applicable)
High Risk	1	0	0	1	3
Standard Risk	2	3	17	30	24
Low Risk	0	0	3	2	3
Not Reported	0	0	2	3	7

Notes
[65] - Safety population: All randomized participants who received at least 1 dose of study drug
[66] - Safety population: All randomized participants who received at least 1 dose of study drug
[67] - Safety population: All randomized participants who received at least 1 dose of study drug
[68] - Safety population: All randomized participants who received at least 1 dose of study drug
[69] - Safety population: All randomized participants who received at least 1 dose of study drug

No statistical analyses for this end point

Secondary: Progression-free Survival (PFS)

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End point title

Progression-free Survival (PFS)

End point description

PFS is defined as the time from first dose (phase 1) or time from randomization (phase 2) to disease progression or death. The distribution of PFS was estimated for each treatment group using Kaplan-Meier methodology. Point estimates and 95% CIs for the median for the PFS distribution are provided. 77777=Median was not reached (max value was 58.91). 11111=Lower limit not calculable due to insufficient progression events. 99999=upper limit not calculable due to insufficient progression events.

End point type

Secondary

End point timeframe

From first dose of elotuzumab (phase 1) or randomization (phase 2) until 60 days following the last infusion (or before initiation of new therapy), up to 101 months

End point values	Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1)	Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1)	Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1)	Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2)	Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2)	Total (Phase 2)	Total (Phase 1)
Number of subjects analysed	3 ^[70]	3 ^[71]	22 ^[72]	36 ^[73]	37 ^[74]	73 ^[75]	28 ^[76]
Units: months
median (confidence interval 95%)	6.08 (6.05 to 6.08)	22.23 (11.5 to 32.9)	77777 (11111 to 99999)	32.49 (14.9 to 99999)	25.00 (14.0 to 35.7)	28.62 (16.6 to 43.1)	32.92 (7.43 to 99999)

Notes
[70] - Safety population: All randomized participants who received at least 1 dose of study drug
[71] - Safety population: All randomized participants who received at least 1 dose of study drug
[72] - Safety population: All randomized participants who received at least 1 dose of study drug
[73] - Safety population: All randomized participants who received at least 1 dose of study drug
[74] - Safety population: All randomized participants who received at least 1 dose of study drug
[75] - Safety population: All randomized participants who received at least 1 dose of study drug
[76] - Safety population: All randomized participants who received at least 1 dose of study drug

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 60 days after the last dose of study drug (up to 95 months).

Adverse event reporting additional description

TEAEs and TESAEs are defined as any adverse event or serious adverse event that begins or worsens in severity after initiation of study drug until 30 days after the last dose of study drug.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

19.1

Reporting group title

Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1)

Reporting group description

Elotuzumab 5 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.

Reporting group title

Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1)

Reporting group description

Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.

Reporting group title

Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1)

Reporting group description

Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.

Reporting group title

Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2)

Reporting group description

Elotuzumab 10 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.

Reporting group title

Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2)

Reporting group description

Elotuzumab 20 mg/kg administered as an IV infusion in combination with lenalidomide 25 mg and dexamethasone 40 mg administered orally.

Serious adverse events	Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1)	Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1)	Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1)	Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2)	Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2)
Total subjects affected by serious adverse events
subjects affected / exposed	0 / 3 (0.00%)	3 / 3 (100.00%)	12 / 22 (54.55%)	21 / 36 (58.33%)	21 / 37 (56.76%)
number of deaths (all causes)	0	2	0	1	2
number of deaths resulting from adverse events
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BLADDER TRANSITIONAL CELL CARCINOMA
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	0 / 36 (0.00%)	1 / 37 (2.70%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
LOBULAR BREAST CARCINOMA IN SITU
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	0 / 36 (0.00%)	1 / 37 (2.70%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
MALIGNANT MELANOMA
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	1 / 36 (2.78%)	0 / 37 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
MYELODYSPLASTIC SYNDROME
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	1 / 36 (2.78%)	1 / 37 (2.70%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
PROSTATE CANCER
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	0 / 36 (0.00%)	1 / 37 (2.70%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
SQUAMOUS CELL CARCINOMA
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	1 / 36 (2.78%)	0 / 37 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
SQUAMOUS CELL CARCINOMA OF SKIN
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	1 / 36 (2.78%)	1 / 37 (2.70%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Vascular disorders
ACCELERATED HYPERTENSION
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	1 / 36 (2.78%)	0 / 37 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
DEEP VEIN THROMBOSIS
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 22 (4.55%)	0 / 36 (0.00%)	1 / 37 (2.70%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
PHLEBITIS
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	0 / 36 (0.00%)	1 / 37 (2.70%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
PHLEBITIS SUPERFICIAL
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	1 / 36 (2.78%)	0 / 37 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
CHEST PAIN
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 22 (4.55%)	0 / 36 (0.00%)	1 / 37 (2.70%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
MULTIPLE ORGAN DYSFUNCTION SYNDROME
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	0 / 36 (0.00%)	1 / 37 (2.70%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
PYREXIA
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	0 / 36 (0.00%)	2 / 37 (5.41%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Immune system disorders
ANAPHYLACTIC REACTION
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 22 (4.55%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Reproductive system and breast disorders
BENIGN PROSTATIC HYPERPLASIA
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	0 / 36 (0.00%)	1 / 37 (2.70%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
PROSTATITIS
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	0 / 36 (0.00%)	1 / 37 (2.70%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	0 / 36 (0.00%)	1 / 37 (2.70%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
ASTHMA
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	1 / 36 (2.78%)	0 / 37 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
LUNG DISORDER
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 22 (9.09%)	1 / 36 (2.78%)	0 / 37 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 3	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
PNEUMONITIS
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	0 / 36 (0.00%)	1 / 37 (2.70%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
PULMONARY EMBOLISM
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 22 (4.55%)	1 / 36 (2.78%)	1 / 37 (2.70%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
STRIDOR
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 22 (4.55%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	2 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Psychiatric disorders
CONFUSIONAL STATE
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	0 / 36 (0.00%)	2 / 37 (5.41%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
GASTROENTERITIS RADIATION
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 22 (4.55%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
ANGINA PECTORIS
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	0 / 36 (0.00%)	1 / 37 (2.70%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
ATRIAL FIBRILLATION
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	1 / 22 (4.55%)	0 / 36 (0.00%)	1 / 37 (2.70%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
BRADYCARDIA
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	1 / 36 (2.78%)	0 / 37 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
TACHYCARDIA
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	1 / 36 (2.78%)	0 / 37 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
CEREBROVASCULAR ACCIDENT
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	1 / 36 (2.78%)	0 / 37 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
GENERALISED TONIC-CLONIC SEIZURE
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	1 / 36 (2.78%)	0 / 37 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
SYNCOPE
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	2 / 36 (5.56%)	0 / 37 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
TRANSIENT GLOBAL AMNESIA
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	0 / 36 (0.00%)	1 / 37 (2.70%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
TRANSIENT ISCHAEMIC ATTACK
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	1 / 36 (2.78%)	1 / 37 (2.70%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	1 / 22 (4.55%)	1 / 36 (2.78%)	2 / 37 (5.41%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 1	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
LYMPHOPENIA
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	0 / 36 (0.00%)	1 / 37 (2.70%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
NEUTROPENIA
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	1 / 36 (2.78%)	1 / 37 (2.70%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
PANCYTOPENIA
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	0 / 36 (0.00%)	1 / 37 (2.70%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
CONSTIPATION
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	1 / 36 (2.78%)	0 / 37 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
DIARRHOEA
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 22 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
DIVERTICULAR PERFORATION
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 22 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
GASTROINTESTINAL HAEMORRHAGE
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 22 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
GASTROINTESTINAL PERFORATION
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 22 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
HAEMATEMESIS
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 22 (4.55%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
NAUSEA
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	0 / 36 (0.00%)	1 / 37 (2.70%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
VARICES OESOPHAGEAL
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	0 / 36 (0.00%)	1 / 37 (2.70%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
VOMITING
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	0 / 36 (0.00%)	1 / 37 (2.70%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
CHOLECYSTITIS
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	0 / 36 (0.00%)	1 / 37 (2.70%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
RASH
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	1 / 36 (2.78%)	0 / 37 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
ACUTE KIDNEY INJURY
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 22 (0.00%)	1 / 36 (2.78%)	0 / 37 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
RENAL COLIC
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	1 / 36 (2.78%)	0 / 37 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
RENAL FAILURE
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	0 / 36 (0.00%)	2 / 37 (5.41%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
Musculoskeletal and connective tissue disorders
ARTHRALGIA
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 22 (4.55%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
BACK PAIN
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	1 / 36 (2.78%)	0 / 37 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
BONE PAIN
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	1 / 36 (2.78%)	0 / 37 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
MUSCULOSKELETAL PAIN
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	1 / 36 (2.78%)	0 / 37 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
PAIN IN EXTREMITY
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	1 / 36 (2.78%)	0 / 37 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
ASPERGILLUS INFECTION
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 22 (4.55%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
BRONCHITIS
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	2 / 36 (5.56%)	1 / 37 (2.70%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
CELLULITIS
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	2 / 36 (5.56%)	1 / 37 (2.70%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
CLOSTRIDIUM DIFFICILE COLITIS
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	1 / 36 (2.78%)	0 / 37 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
H1N1 INFLUENZA
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	1 / 36 (2.78%)	0 / 37 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
HERPES ZOSTER
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	1 / 36 (2.78%)	0 / 37 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
INFLUENZA
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	1 / 36 (2.78%)	0 / 37 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
LOCALISED INFECTION
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	1 / 36 (2.78%)	0 / 37 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
LUNG INFECTION
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	0 / 36 (0.00%)	1 / 37 (2.70%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
MENINGITIS
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	0 / 36 (0.00%)	1 / 37 (2.70%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
PNEUMONIA
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 22 (4.55%)	4 / 36 (11.11%)	5 / 37 (13.51%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 5	1 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
PNEUMONIA KLEBSIELLA
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	0 / 36 (0.00%)	1 / 37 (2.70%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
PNEUMONIA VIRAL
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	1 / 36 (2.78%)	0 / 37 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
POSTOPERATIVE WOUND INFECTION
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	1 / 36 (2.78%)	0 / 37 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
PYELONEPHRITIS
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	0 / 36 (0.00%)	1 / 37 (2.70%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
SEPSIS
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 22 (4.55%)	3 / 36 (8.33%)	2 / 37 (5.41%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 3	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 1
URINARY TRACT INFECTION
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 22 (4.55%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
VISCERAL LEISHMANIASIS
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	0 / 36 (0.00%)	1 / 37 (2.70%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
ELECTROLYTE IMBALANCE
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	0 / 36 (0.00%)	1 / 37 (2.70%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
HYPERCALCAEMIA
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	0 / 36 (0.00%)	1 / 37 (2.70%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
HYPOKALAEMIA
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	1 / 36 (2.78%)	0 / 37 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
METABOLIC ACIDOSIS
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 22 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1)	Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1)	Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1)	Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2)	Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2)
Total subjects affected by non serious adverse events
subjects affected / exposed	3 / 3 (100.00%)	3 / 3 (100.00%)	22 / 22 (100.00%)	36 / 36 (100.00%)	37 / 37 (100.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	1 / 36 (2.78%)	2 / 37 (5.41%)
occurrences all number	0	0	0	1	2
Vascular disorders
DEEP VEIN THROMBOSIS
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	3 / 22 (13.64%)	2 / 36 (5.56%)	2 / 37 (5.41%)
occurrences all number	1	0	4	2	2
FLUSHING
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 22 (4.55%)	4 / 36 (11.11%)	2 / 37 (5.41%)
occurrences all number	0	0	1	5	3
HOT FLUSH
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	2 / 22 (9.09%)	2 / 36 (5.56%)	2 / 37 (5.41%)
occurrences all number	0	1	2	3	3
HYPERTENSION
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 22 (9.09%)	2 / 36 (5.56%)	2 / 37 (5.41%)
occurrences all number	0	0	2	2	5
HYPOTENSION
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	3 / 22 (13.64%)	4 / 36 (11.11%)	4 / 37 (10.81%)
occurrences all number	0	0	4	5	8
PHLEBITIS SUPERFICIAL
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	2 / 36 (5.56%)	0 / 37 (0.00%)
occurrences all number	0	0	0	2	0
THROMBOPHLEBITIS SUPERFICIAL
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	2 / 36 (5.56%)	0 / 37 (0.00%)
occurrences all number	0	0	0	2	0
General disorders and administration site conditions
ASTHENIA
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	6 / 22 (27.27%)	7 / 36 (19.44%)	12 / 37 (32.43%)
occurrences all number	0	1	12	10	22
CHEST DISCOMFORT
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 22 (4.55%)	1 / 36 (2.78%)	2 / 37 (5.41%)
occurrences all number	0	0	1	2	2
CHEST PAIN
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 22 (4.55%)	0 / 36 (0.00%)	3 / 37 (8.11%)
occurrences all number	0	0	1	0	3
CHILLS
subjects affected / exposed	2 / 3 (66.67%)	2 / 3 (66.67%)	1 / 22 (4.55%)	6 / 36 (16.67%)	2 / 37 (5.41%)
occurrences all number	2	3	1	8	4
FATIGUE
subjects affected / exposed	1 / 3 (33.33%)	2 / 3 (66.67%)	15 / 22 (68.18%)	24 / 36 (66.67%)	18 / 37 (48.65%)
occurrences all number	1	2	21	36	24
FEELING HOT
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	2 / 36 (5.56%)	0 / 37 (0.00%)
occurrences all number	0	0	0	2	0
GAIT DISTURBANCE
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 22 (4.55%)	2 / 36 (5.56%)	2 / 37 (5.41%)
occurrences all number	0	0	1	2	2
INFLAMMATION
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	2 / 36 (5.56%)	0 / 37 (0.00%)
occurrences all number	0	0	0	2	0
INFLUENZA LIKE ILLNESS
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 22 (9.09%)	2 / 36 (5.56%)	0 / 37 (0.00%)
occurrences all number	0	0	2	2	0
IRRITABILITY
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	2 / 36 (5.56%)	1 / 37 (2.70%)
occurrences all number	0	0	0	3	1
NON-CARDIAC CHEST PAIN
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 22 (4.55%)	5 / 36 (13.89%)	2 / 37 (5.41%)
occurrences all number	0	0	1	5	2
OEDEMA
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	5 / 36 (13.89%)	1 / 37 (2.70%)
occurrences all number	0	0	0	8	1
OEDEMA PERIPHERAL
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	6 / 22 (27.27%)	14 / 36 (38.89%)	9 / 37 (24.32%)
occurrences all number	0	2	15	23	14
PAIN
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	4 / 22 (18.18%)	1 / 36 (2.78%)	5 / 37 (13.51%)
occurrences all number	0	0	4	1	5
PERIPHERAL SWELLING
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 22 (9.09%)	5 / 36 (13.89%)	7 / 37 (18.92%)
occurrences all number	0	0	2	14	9
PYREXIA
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	10 / 22 (45.45%)	14 / 36 (38.89%)	17 / 37 (45.95%)
occurrences all number	0	0	21	22	23
Immune system disorders
DRUG HYPERSENSITIVITY
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	2 / 36 (5.56%)	1 / 37 (2.70%)
occurrences all number	0	0	0	2	1
SEASONAL ALLERGY
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	1 / 22 (4.55%)	3 / 36 (8.33%)	0 / 37 (0.00%)
occurrences all number	0	1	2	3	0
Reproductive system and breast disorders
BENIGN PROSTATIC HYPERPLASIA
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	0 / 36 (0.00%)	3 / 37 (8.11%)
occurrences all number	0	0	0	0	3
VULVOVAGINAL PRURITUS
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	2 / 36 (5.56%)	0 / 37 (0.00%)
occurrences all number	0	0	0	2	0
Respiratory, thoracic and mediastinal disorders
ASTHMA
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	2 / 36 (5.56%)	0 / 37 (0.00%)
occurrences all number	0	0	0	2	0
COUGH
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	7 / 22 (31.82%)	12 / 36 (33.33%)	13 / 37 (35.14%)
occurrences all number	0	0	11	20	20
DYSPHONIA
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 22 (4.55%)	6 / 36 (16.67%)	3 / 37 (8.11%)
occurrences all number	0	0	1	7	4
DYSPNOEA
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	5 / 22 (22.73%)	11 / 36 (30.56%)	10 / 37 (27.03%)
occurrences all number	0	0	7	15	15
DYSPNOEA EXERTIONAL
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 22 (9.09%)	9 / 36 (25.00%)	5 / 37 (13.51%)
occurrences all number	0	0	2	11	6
EPISTAXIS
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 22 (4.55%)	6 / 36 (16.67%)	6 / 37 (16.22%)
occurrences all number	0	0	1	6	8
HICCUPS
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	1 / 36 (2.78%)	3 / 37 (8.11%)
occurrences all number	0	0	0	1	3
LUNG DISORDER
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 22 (9.09%)	1 / 36 (2.78%)	2 / 37 (5.41%)
occurrences all number	0	0	3	1	2
NASAL CONGESTION
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 22 (9.09%)	2 / 36 (5.56%)	5 / 37 (13.51%)
occurrences all number	0	0	2	2	6
OROPHARYNGEAL PAIN
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 22 (9.09%)	5 / 36 (13.89%)	4 / 37 (10.81%)
occurrences all number	0	0	2	8	5
PARANASAL SINUS HYPERSECRETION
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 22 (4.55%)	2 / 36 (5.56%)	1 / 37 (2.70%)
occurrences all number	0	0	2	2	1
PRODUCTIVE COUGH
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 22 (0.00%)	5 / 36 (13.89%)	2 / 37 (5.41%)
occurrences all number	0	1	0	5	3
PULMONARY EMBOLISM
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 22 (4.55%)	2 / 36 (5.56%)	2 / 37 (5.41%)
occurrences all number	0	0	1	2	2
RALES
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	2 / 36 (5.56%)	0 / 37 (0.00%)
occurrences all number	0	0	0	2	0
RHINORRHOEA
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	4 / 22 (18.18%)	4 / 36 (11.11%)	5 / 37 (13.51%)
occurrences all number	0	0	5	4	7
SINUS CONGESTION
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 22 (4.55%)	4 / 36 (11.11%)	2 / 37 (5.41%)
occurrences all number	0	0	1	4	2
THROAT IRRITATION
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 22 (9.09%)	0 / 36 (0.00%)	1 / 37 (2.70%)
occurrences all number	0	0	2	0	1
UPPER-AIRWAY COUGH SYNDROME
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 22 (9.09%)	2 / 36 (5.56%)	1 / 37 (2.70%)
occurrences all number	0	0	2	2	1
Psychiatric disorders
AGGRESSION
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	2 / 36 (5.56%)	0 / 37 (0.00%)
occurrences all number	0	0	0	2	0
ANXIETY
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	4 / 22 (18.18%)	5 / 36 (13.89%)	1 / 37 (2.70%)
occurrences all number	0	0	4	5	1
CONFUSIONAL STATE
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	1 / 36 (2.78%)	3 / 37 (8.11%)
occurrences all number	0	0	0	1	3
DEPRESSED MOOD
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	2 / 36 (5.56%)	1 / 37 (2.70%)
occurrences all number	0	0	0	2	1
DEPRESSION
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	2 / 22 (9.09%)	4 / 36 (11.11%)	3 / 37 (8.11%)
occurrences all number	1	0	2	4	4
INSOMNIA
subjects affected / exposed	2 / 3 (66.67%)	1 / 3 (33.33%)	7 / 22 (31.82%)	10 / 36 (27.78%)	15 / 37 (40.54%)
occurrences all number	2	1	9	12	16
MOOD SWINGS
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 22 (9.09%)	1 / 36 (2.78%)	2 / 37 (5.41%)
occurrences all number	0	0	2	1	2
Investigations
ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	2 / 36 (5.56%)	1 / 37 (2.70%)
occurrences all number	0	0	0	2	1
ALANINE AMINOTRANSFERASE INCREASED
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 22 (4.55%)	5 / 36 (13.89%)	4 / 37 (10.81%)
occurrences all number	0	0	1	8	8
ASPARTATE AMINOTRANSFERASE INCREASED
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	3 / 36 (8.33%)	4 / 37 (10.81%)
occurrences all number	0	0	0	4	6
BLOOD ALKALINE PHOSPHATASE INCREASED
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 22 (9.09%)	3 / 36 (8.33%)	1 / 37 (2.70%)
occurrences all number	0	0	2	3	2
BLOOD BICARBONATE DECREASED
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	7 / 36 (19.44%)	4 / 37 (10.81%)
occurrences all number	0	0	0	13	9
BLOOD CREATININE INCREASED
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 22 (9.09%)	5 / 36 (13.89%)	4 / 37 (10.81%)
occurrences all number	0	0	2	8	10
BLOOD LACTATE DEHYDROGENASE INCREASED
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	4 / 36 (11.11%)	1 / 37 (2.70%)
occurrences all number	0	0	0	7	4
BLOOD MAGNESIUM DECREASED
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 22 (4.55%)	2 / 36 (5.56%)	0 / 37 (0.00%)
occurrences all number	0	0	1	2	0
BLOOD PHOSPHORUS DECREASED
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	1 / 22 (4.55%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	1	1	0	0
BLOOD POTASSIUM DECREASED
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	1 / 22 (4.55%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	1	1	0	0
BLOOD UREA INCREASED
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	2 / 36 (5.56%)	2 / 37 (5.41%)
occurrences all number	0	0	0	2	3
CARDIAC MURMUR
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	3 / 36 (8.33%)	1 / 37 (2.70%)
occurrences all number	0	0	0	3	1
EJECTION FRACTION DECREASED
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	2 / 36 (5.56%)	0 / 37 (0.00%)
occurrences all number	0	0	0	2	0
IMMUNOGLOBULINS DECREASED
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 22 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	1	0	0	0
INTERNATIONAL NORMALISED RATIO INCREASED
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	3 / 36 (8.33%)	1 / 37 (2.70%)
occurrences all number	0	0	0	7	1
NEUTROPHIL COUNT INCREASED
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	3 / 36 (8.33%)	1 / 37 (2.70%)
occurrences all number	0	0	0	3	2
PROTEIN TOTAL INCREASED
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	2 / 36 (5.56%)	0 / 37 (0.00%)
occurrences all number	0	0	0	2	0
PROTHROMBIN TIME PROLONGED
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	2 / 36 (5.56%)	1 / 37 (2.70%)
occurrences all number	0	0	0	3	3
WEIGHT DECREASED
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	3 / 22 (13.64%)	7 / 36 (19.44%)	4 / 37 (10.81%)
occurrences all number	0	0	3	9	4
WEIGHT INCREASED
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 22 (9.09%)	1 / 36 (2.78%)	3 / 37 (8.11%)
occurrences all number	0	0	2	1	3
WHITE BLOOD CELL COUNT DECREASED
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 22 (4.55%)	2 / 36 (5.56%)	2 / 37 (5.41%)
occurrences all number	0	0	2	2	3
Injury, poisoning and procedural complications
ARTHROPOD BITE
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	0 / 36 (0.00%)	2 / 37 (5.41%)
occurrences all number	0	0	0	0	2
CONTUSION
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 22 (4.55%)	4 / 36 (11.11%)	4 / 37 (10.81%)
occurrences all number	0	0	1	4	5
FALL
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	3 / 22 (13.64%)	5 / 36 (13.89%)	4 / 37 (10.81%)
occurrences all number	0	0	6	5	4
JOINT DISLOCATION
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	2 / 36 (5.56%)	0 / 37 (0.00%)
occurrences all number	0	0	0	2	0
LIGAMENT SPRAIN
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 22 (0.00%)	1 / 36 (2.78%)	0 / 37 (0.00%)
occurrences all number	0	1	0	1	0
SKIN ABRASION
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 22 (4.55%)	0 / 36 (0.00%)	2 / 37 (5.41%)
occurrences all number	0	0	1	0	2
STOMA SITE PAIN
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 22 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	1	0	0	0
SUNBURN
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 22 (4.55%)	2 / 36 (5.56%)	0 / 37 (0.00%)
occurrences all number	0	0	1	2	0
Cardiac disorders
ATRIAL FIBRILLATION
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	1 / 22 (4.55%)	1 / 36 (2.78%)	3 / 37 (8.11%)
occurrences all number	0	1	1	1	3
PALPITATIONS
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 22 (9.09%)	2 / 36 (5.56%)	2 / 37 (5.41%)
occurrences all number	0	0	2	3	2
Nervous system disorders
AMNESIA
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 22 (4.55%)	0 / 36 (0.00%)	2 / 37 (5.41%)
occurrences all number	0	0	1	0	2
BALANCE DISORDER
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 22 (0.00%)	1 / 36 (2.78%)	1 / 37 (2.70%)
occurrences all number	1	0	0	2	1
CARPAL TUNNEL SYNDROME
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 22 (9.09%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	2	0	0
DISTURBANCE IN ATTENTION
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 22 (9.09%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	2	0	0
DIZZINESS
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	4 / 22 (18.18%)	12 / 36 (33.33%)	7 / 37 (18.92%)
occurrences all number	0	0	6	16	12
DYSGEUSIA
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 22 (9.09%)	9 / 36 (25.00%)	6 / 37 (16.22%)
occurrences all number	0	0	2	10	7
HEADACHE
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	5 / 22 (22.73%)	14 / 36 (38.89%)	7 / 37 (18.92%)
occurrences all number	1	0	8	20	8
HYPOAESTHESIA
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 22 (4.55%)	5 / 36 (13.89%)	3 / 37 (8.11%)
occurrences all number	0	0	1	5	3
HYPOGEUSIA
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	2 / 36 (5.56%)	0 / 37 (0.00%)
occurrences all number	0	0	0	2	0
MEMORY IMPAIRMENT
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 22 (9.09%)	2 / 36 (5.56%)	2 / 37 (5.41%)
occurrences all number	0	0	2	2	2
NEURALGIA
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	2 / 36 (5.56%)	1 / 37 (2.70%)
occurrences all number	0	0	0	2	1
NEUROPATHY PERIPHERAL
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	7 / 22 (31.82%)	8 / 36 (22.22%)	7 / 37 (18.92%)
occurrences all number	0	0	10	11	8
PARAESTHESIA
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	3 / 22 (13.64%)	6 / 36 (16.67%)	3 / 37 (8.11%)
occurrences all number	1	0	3	7	3
PERIPHERAL SENSORY NEUROPATHY
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 22 (4.55%)	3 / 36 (8.33%)	5 / 37 (13.51%)
occurrences all number	0	0	1	3	5
PSYCHOMOTOR HYPERACTIVITY
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	3 / 36 (8.33%)	0 / 37 (0.00%)
occurrences all number	0	0	0	3	0
SCIATICA
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	2 / 36 (5.56%)	0 / 37 (0.00%)
occurrences all number	0	0	0	2	0
SINUS HEADACHE
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 22 (4.55%)	3 / 36 (8.33%)	1 / 37 (2.70%)
occurrences all number	0	0	1	3	1
SOMNOLENCE
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	2 / 36 (5.56%)	1 / 37 (2.70%)
occurrences all number	0	0	0	2	1
SYNCOPE
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 22 (4.55%)	6 / 36 (16.67%)	1 / 37 (2.70%)
occurrences all number	0	0	1	7	1
TREMOR
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	3 / 36 (8.33%)	5 / 37 (13.51%)
occurrences all number	0	0	0	3	6
Blood and lymphatic system disorders
ANAEMIA
subjects affected / exposed	2 / 3 (66.67%)	2 / 3 (66.67%)	10 / 22 (45.45%)	17 / 36 (47.22%)	13 / 37 (35.14%)
occurrences all number	2	3	17	29	24
FEBRILE NEUTROPENIA
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	1 / 22 (4.55%)	2 / 36 (5.56%)	3 / 37 (8.11%)
occurrences all number	0	1	2	2	3
HAEMOGLOBINAEMIA
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 22 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	1	0	0	0
INCREASED TENDENCY TO BRUISE
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	2 / 36 (5.56%)	0 / 37 (0.00%)
occurrences all number	0	0	0	2	0
IRON DEFICIENCY ANAEMIA
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	2 / 36 (5.56%)	0 / 37 (0.00%)
occurrences all number	0	0	0	2	0
LEUKOPENIA
subjects affected / exposed	1 / 3 (33.33%)	1 / 3 (33.33%)	2 / 22 (9.09%)	8 / 36 (22.22%)	6 / 37 (16.22%)
occurrences all number	1	3	2	13	8
LYMPHADENOPATHY
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	2 / 36 (5.56%)	2 / 37 (5.41%)
occurrences all number	0	0	0	3	3
LYMPHOPENIA
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	1 / 22 (4.55%)	12 / 36 (33.33%)	8 / 37 (21.62%)
occurrences all number	0	2	1	23	11
NEUTROPENIA
subjects affected / exposed	2 / 3 (66.67%)	3 / 3 (100.00%)	7 / 22 (31.82%)	12 / 36 (33.33%)	9 / 37 (24.32%)
occurrences all number	3	8	11	25	17
PANCYTOPENIA
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	0 / 36 (0.00%)	3 / 37 (8.11%)
occurrences all number	0	0	0	0	3
THROMBOCYTOPENIA
subjects affected / exposed	1 / 3 (33.33%)	2 / 3 (66.67%)	5 / 22 (22.73%)	12 / 36 (33.33%)	10 / 37 (27.03%)
occurrences all number	3	3	5	21	18
Ear and labyrinth disorders
HYPOACUSIS
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 22 (4.55%)	1 / 36 (2.78%)	3 / 37 (8.11%)
occurrences all number	0	0	1	1	3
TINNITUS
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	1 / 22 (4.55%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	1	0	1	0	0
VERTIGO
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 22 (0.00%)	3 / 36 (8.33%)	3 / 37 (8.11%)
occurrences all number	2	0	0	3	4
Eye disorders
CATARACT
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 22 (9.09%)	4 / 36 (11.11%)	6 / 37 (16.22%)
occurrences all number	0	0	2	4	7
DRY EYE
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 22 (4.55%)	0 / 36 (0.00%)	2 / 37 (5.41%)
occurrences all number	0	0	1	0	2
EYE IRRITATION
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 22 (4.55%)	3 / 36 (8.33%)	3 / 37 (8.11%)
occurrences all number	0	0	1	3	3
OCULAR HYPERAEMIA
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	1 / 36 (2.78%)	3 / 37 (8.11%)
occurrences all number	0	0	0	1	4
VISION BLURRED
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	4 / 22 (18.18%)	9 / 36 (25.00%)	5 / 37 (13.51%)
occurrences all number	0	0	4	14	5
VISUAL ACUITY REDUCED
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	3 / 36 (8.33%)	1 / 37 (2.70%)
occurrences all number	0	0	0	3	1
VITREOUS FLOATERS
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 22 (4.55%)	0 / 36 (0.00%)	2 / 37 (5.41%)
occurrences all number	0	0	1	0	2
Gastrointestinal disorders
ABDOMINAL DISTENSION
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 22 (4.55%)	4 / 36 (11.11%)	2 / 37 (5.41%)
occurrences all number	0	0	1	7	2
ABDOMINAL PAIN
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 22 (4.55%)	7 / 36 (19.44%)	7 / 37 (18.92%)
occurrences all number	0	0	1	9	8
ABDOMINAL PAIN UPPER
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	5 / 36 (13.89%)	4 / 37 (10.81%)
occurrences all number	0	0	0	6	6
CONSTIPATION
subjects affected / exposed	1 / 3 (33.33%)	2 / 3 (66.67%)	11 / 22 (50.00%)	18 / 36 (50.00%)	19 / 37 (51.35%)
occurrences all number	2	2	13	25	22
DIARRHOEA
subjects affected / exposed	1 / 3 (33.33%)	2 / 3 (66.67%)	14 / 22 (63.64%)	24 / 36 (66.67%)	25 / 37 (67.57%)
occurrences all number	1	3	29	71	56
DIVERTICULAR PERFORATION
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 22 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	1	0	0	0
DRY MOUTH
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	3 / 36 (8.33%)	2 / 37 (5.41%)
occurrences all number	0	0	0	3	2
DYSPEPSIA
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 22 (4.55%)	8 / 36 (22.22%)	2 / 37 (5.41%)
occurrences all number	0	0	1	10	2
FLATULENCE
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 22 (9.09%)	2 / 36 (5.56%)	1 / 37 (2.70%)
occurrences all number	0	0	2	2	1
GASTROINTESTINAL HAEMORRHAGE
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 22 (0.00%)	0 / 36 (0.00%)	1 / 37 (2.70%)
occurrences all number	0	1	0	0	1
GASTROINTESTINAL MOTILITY DISORDER
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 22 (9.09%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	3	0	0
GASTROINTESTINAL PERFORATION
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 22 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	1	0	0	0
GASTROOESOPHAGEAL REFLUX DISEASE
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 22 (4.55%)	3 / 36 (8.33%)	4 / 37 (10.81%)
occurrences all number	0	0	1	3	5
HAEMATOCHEZIA
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	3 / 36 (8.33%)	0 / 37 (0.00%)
occurrences all number	0	0	0	5	0
HAEMORRHOIDS
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	2 / 22 (9.09%)	2 / 36 (5.56%)	1 / 37 (2.70%)
occurrences all number	0	1	2	2	1
NAUSEA
subjects affected / exposed	0 / 3 (0.00%)	3 / 3 (100.00%)	11 / 22 (50.00%)	18 / 36 (50.00%)	17 / 37 (45.95%)
occurrences all number	0	4	13	35	27
PARAESTHESIA ORAL
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	3 / 36 (8.33%)	0 / 37 (0.00%)
occurrences all number	0	0	0	3	0
STOMATITIS
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	1 / 22 (4.55%)	3 / 36 (8.33%)	1 / 37 (2.70%)
occurrences all number	0	1	1	5	1
TOOTH DISORDER
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	2 / 36 (5.56%)	0 / 37 (0.00%)
occurrences all number	0	0	0	2	0
TOOTHACHE
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 22 (9.09%)	3 / 36 (8.33%)	0 / 37 (0.00%)
occurrences all number	0	0	2	3	0
VOMITING
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	6 / 22 (27.27%)	11 / 36 (30.56%)	6 / 37 (16.22%)
occurrences all number	0	0	6	18	8
Hepatobiliary disorders
HYPERBILIRUBINAEMIA
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 22 (4.55%)	2 / 36 (5.56%)	0 / 37 (0.00%)
occurrences all number	0	0	1	3	0
Skin and subcutaneous tissue disorders
ALOPECIA
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	3 / 36 (8.33%)	0 / 37 (0.00%)
occurrences all number	0	0	0	3	0
BLISTER
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	0 / 36 (0.00%)	2 / 37 (5.41%)
occurrences all number	0	0	0	0	2
DRY SKIN
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 22 (9.09%)	1 / 36 (2.78%)	1 / 37 (2.70%)
occurrences all number	0	0	2	1	3
ECCHYMOSIS
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 22 (4.55%)	3 / 36 (8.33%)	3 / 37 (8.11%)
occurrences all number	0	0	1	3	3
ERYTHEMA
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 22 (9.09%)	3 / 36 (8.33%)	4 / 37 (10.81%)
occurrences all number	0	0	2	3	5
HYPERHIDROSIS
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	3 / 22 (13.64%)	4 / 36 (11.11%)	5 / 37 (13.51%)
occurrences all number	0	0	5	5	5
INGROWING NAIL
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 22 (9.09%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	0	3	0	0
NIGHT SWEATS
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 22 (4.55%)	8 / 36 (22.22%)	10 / 37 (27.03%)
occurrences all number	0	0	1	12	12
PRURITUS
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	2 / 22 (9.09%)	2 / 36 (5.56%)	2 / 37 (5.41%)
occurrences all number	1	0	2	2	2
RASH
subjects affected / exposed	1 / 3 (33.33%)	1 / 3 (33.33%)	3 / 22 (13.64%)	9 / 36 (25.00%)	9 / 37 (24.32%)
occurrences all number	1	1	7	16	15
RASH GENERALISED
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	1 / 22 (4.55%)	2 / 36 (5.56%)	2 / 37 (5.41%)
occurrences all number	1	0	1	2	3
RASH MACULAR
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 22 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	1	0	0	0
RASH MACULO-PAPULAR
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 22 (4.55%)	2 / 36 (5.56%)	1 / 37 (2.70%)
occurrences all number	0	0	1	3	1
SCAB
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	0 / 36 (0.00%)	2 / 37 (5.41%)
occurrences all number	0	0	0	0	2
SKIN DISCOLOURATION
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	0 / 36 (0.00%)	2 / 37 (5.41%)
occurrences all number	0	0	0	0	2
SKIN LESION
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 22 (9.09%)	0 / 36 (0.00%)	1 / 37 (2.70%)
occurrences all number	0	0	2	0	2
URTICARIA
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 22 (9.09%)	1 / 36 (2.78%)	0 / 37 (0.00%)
occurrences all number	0	0	3	1	0
Renal and urinary disorders
ACUTE KIDNEY INJURY
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 22 (0.00%)	1 / 36 (2.78%)	0 / 37 (0.00%)
occurrences all number	0	1	0	1	0
DYSURIA
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 22 (4.55%)	4 / 36 (11.11%)	2 / 37 (5.41%)
occurrences all number	0	0	1	4	2
HAEMATURIA
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	1 / 36 (2.78%)	2 / 37 (5.41%)
occurrences all number	0	0	0	1	2
POLLAKIURIA
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	0 / 36 (0.00%)	2 / 37 (5.41%)
occurrences all number	0	0	0	0	2
RENAL FAILURE
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	1 / 36 (2.78%)	2 / 37 (5.41%)
occurrences all number	0	0	0	1	3
Musculoskeletal and connective tissue disorders
ARTHRALGIA
subjects affected / exposed	0 / 3 (0.00%)	2 / 3 (66.67%)	7 / 22 (31.82%)	12 / 36 (33.33%)	8 / 37 (21.62%)
occurrences all number	0	2	12	13	9
BACK PAIN
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	7 / 22 (31.82%)	17 / 36 (47.22%)	14 / 37 (37.84%)
occurrences all number	0	1	11	27	15
BONE PAIN
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 22 (9.09%)	4 / 36 (11.11%)	8 / 37 (21.62%)
occurrences all number	0	0	3	5	12
MUSCLE SPASMS
subjects affected / exposed	1 / 3 (33.33%)	1 / 3 (33.33%)	10 / 22 (45.45%)	22 / 36 (61.11%)	23 / 37 (62.16%)
occurrences all number	2	1	12	28	32
MUSCULAR WEAKNESS
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 22 (4.55%)	2 / 36 (5.56%)	1 / 37 (2.70%)
occurrences all number	0	0	1	2	1
MUSCULOSKELETAL CHEST PAIN
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	5 / 22 (22.73%)	4 / 36 (11.11%)	3 / 37 (8.11%)
occurrences all number	0	0	8	7	3
MUSCULOSKELETAL DISCOMFORT
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	2 / 36 (5.56%)	1 / 37 (2.70%)
occurrences all number	0	0	0	2	1
MUSCULOSKELETAL PAIN
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	3 / 22 (13.64%)	6 / 36 (16.67%)	4 / 37 (10.81%)
occurrences all number	0	0	3	8	4
MUSCULOSKELETAL STIFFNESS
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	2 / 36 (5.56%)	1 / 37 (2.70%)
occurrences all number	0	0	0	3	1
MYALGIA
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	3 / 22 (13.64%)	6 / 36 (16.67%)	1 / 37 (2.70%)
occurrences all number	0	0	3	8	1
NECK PAIN
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 22 (4.55%)	4 / 36 (11.11%)	3 / 37 (8.11%)
occurrences all number	0	0	1	4	4
OSTEONECROSIS OF JAW
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	0 / 36 (0.00%)	2 / 37 (5.41%)
occurrences all number	0	0	0	0	2
PAIN IN EXTREMITY
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	5 / 22 (22.73%)	10 / 36 (27.78%)	13 / 37 (35.14%)
occurrences all number	0	1	6	10	16
PAIN IN JAW
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	1 / 22 (4.55%)	0 / 36 (0.00%)	1 / 37 (2.70%)
occurrences all number	1	0	2	0	1
Infections and infestations
BRONCHITIS
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	5 / 22 (22.73%)	8 / 36 (22.22%)	10 / 37 (27.03%)
occurrences all number	0	0	14	10	15
CELLULITIS
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	4 / 36 (11.11%)	4 / 37 (10.81%)
occurrences all number	0	0	0	8	5
CONJUNCTIVITIS
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	4 / 22 (18.18%)	1 / 36 (2.78%)	2 / 37 (5.41%)
occurrences all number	0	0	4	2	2
EAR INFECTION
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	2 / 36 (5.56%)	0 / 37 (0.00%)
occurrences all number	0	0	0	4	0
FUNGAL INFECTION
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 22 (0.00%)	1 / 36 (2.78%)	0 / 37 (0.00%)
occurrences all number	0	1	0	1	0
GASTROENTERITIS
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	2 / 36 (5.56%)	3 / 37 (8.11%)
occurrences all number	0	0	0	4	4
GASTROENTERITIS VIRAL
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 22 (4.55%)	2 / 36 (5.56%)	0 / 37 (0.00%)
occurrences all number	0	0	1	4	0
GINGIVITIS
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 22 (9.09%)	1 / 36 (2.78%)	0 / 37 (0.00%)
occurrences all number	0	0	2	2	0
HERPES ZOSTER
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	4 / 36 (11.11%)	0 / 37 (0.00%)
occurrences all number	0	0	0	4	0
INFLUENZA
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 22 (4.55%)	8 / 36 (22.22%)	3 / 37 (8.11%)
occurrences all number	0	0	1	9	4
LOCALISED INFECTION
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 22 (4.55%)	2 / 36 (5.56%)	2 / 37 (5.41%)
occurrences all number	0	0	1	2	2
LUNG INFECTION
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	0 / 36 (0.00%)	3 / 37 (8.11%)
occurrences all number	0	0	0	0	3
NASOPHARYNGITIS
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	3 / 22 (13.64%)	10 / 36 (27.78%)	9 / 37 (24.32%)
occurrences all number	0	0	4	21	15
ORAL CANDIDIASIS
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	1 / 22 (4.55%)	1 / 36 (2.78%)	5 / 37 (13.51%)
occurrences all number	0	1	2	1	6
ORAL HERPES
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	2 / 36 (5.56%)	1 / 37 (2.70%)
occurrences all number	0	0	0	2	1
PHARYNGITIS
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	1 / 36 (2.78%)	2 / 37 (5.41%)
occurrences all number	0	0	0	1	2
PNEUMONIA
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	4 / 22 (18.18%)	7 / 36 (19.44%)	9 / 37 (24.32%)
occurrences all number	0	0	5	10	11
PNEUMONIA VIRAL
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	2 / 36 (5.56%)	0 / 37 (0.00%)
occurrences all number	0	0	0	2	0
RHINITIS
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	1 / 22 (4.55%)	5 / 36 (13.89%)	8 / 37 (21.62%)
occurrences all number	1	0	1	8	10
SEPSIS
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 22 (4.55%)	3 / 36 (8.33%)	2 / 37 (5.41%)
occurrences all number	0	0	1	3	2
SINUSITIS
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	3 / 22 (13.64%)	5 / 36 (13.89%)	3 / 37 (8.11%)
occurrences all number	1	0	8	6	11
UPPER RESPIRATORY TRACT INFECTION
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	7 / 22 (31.82%)	19 / 36 (52.78%)	15 / 37 (40.54%)
occurrences all number	0	2	44	46	54
UPPER RESPIRATORY TRACT INFECTION BACTERIAL
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 22 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	1	0	0	0
URINARY TRACT INFECTION
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	4 / 22 (18.18%)	6 / 36 (16.67%)	5 / 37 (13.51%)
occurrences all number	0	0	19	13	5
VIRAL INFECTION
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	1 / 22 (4.55%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	1	1	0	0
VIRAL UPPER RESPIRATORY TRACT INFECTION
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 22 (4.55%)	0 / 36 (0.00%)	2 / 37 (5.41%)
occurrences all number	0	0	1	0	2
Metabolism and nutrition disorders
DECREASED APPETITE
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	3 / 22 (13.64%)	10 / 36 (27.78%)	8 / 37 (21.62%)
occurrences all number	0	0	3	12	11
DEHYDRATION
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 22 (4.55%)	3 / 36 (8.33%)	2 / 37 (5.41%)
occurrences all number	0	0	1	4	2
DIABETES MELLITUS
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	1 / 36 (2.78%)	2 / 37 (5.41%)
occurrences all number	0	0	0	1	2
GOUT
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 22 (4.55%)	0 / 36 (0.00%)	2 / 37 (5.41%)
occurrences all number	0	0	1	0	2
HYPERCALCAEMIA
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	1 / 36 (2.78%)	3 / 37 (8.11%)
occurrences all number	0	0	0	1	3
HYPERGLYCAEMIA
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	3 / 22 (13.64%)	9 / 36 (25.00%)	12 / 37 (32.43%)
occurrences all number	0	0	4	24	24
HYPERKALAEMIA
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 22 (4.55%)	3 / 36 (8.33%)	1 / 37 (2.70%)
occurrences all number	0	0	1	3	1
HYPERNATRAEMIA
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	3 / 36 (8.33%)	0 / 37 (0.00%)
occurrences all number	0	0	0	3	0
HYPOALBUMINAEMIA
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	5 / 36 (13.89%)	3 / 37 (8.11%)
occurrences all number	0	0	0	6	8
HYPOCALCAEMIA
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	3 / 36 (8.33%)	3 / 37 (8.11%)
occurrences all number	0	0	0	3	3
HYPOKALAEMIA
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	6 / 22 (27.27%)	7 / 36 (19.44%)	7 / 37 (18.92%)
occurrences all number	0	2	13	21	12
HYPOMAGNESAEMIA
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	2 / 36 (5.56%)	2 / 37 (5.41%)
occurrences all number	0	0	0	4	4
HYPONATRAEMIA
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 22 (4.55%)	3 / 36 (8.33%)	2 / 37 (5.41%)
occurrences all number	0	0	1	3	2
HYPOPHOSPHATAEMIA
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 22 (0.00%)	2 / 36 (5.56%)	5 / 37 (13.51%)
occurrences all number	0	0	0	2	6
METABOLIC ACIDOSIS
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 22 (0.00%)	0 / 36 (0.00%)	0 / 37 (0.00%)
occurrences all number	0	2	0	0	0
VITAMIN D DEFICIENCY
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 22 (4.55%)	0 / 36 (0.00%)	3 / 37 (8.11%)
occurrences all number	0	0	1	0	3

More information

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Were there any global substantial amendments to the protocol? Yes

29 Aug 2008

The primary purpose of this amendment was to add pretreatment with an antihistamine and acetaminophen before or during study drug infusion and to slow the infusion rate of the elotuzumab dose.

23 Apr 2009

The primary purpose of this amendment was to reduce the maximum number of subjects in phase 1 treated at the maximum tolerated dose (MTD) from 36 to 33 subjects because no dose-limiting toxicities (DLTs) were observed; extend the duration of the treatment period beyond 6 cycles to allow treatment to continue until the subject experienced disease progression or unacceptable toxicity; and increase the flow rate of elotuzumab infusion as the subject was able to tolerate (the rate remained capped at 2 mL/min).

30 Sep 2009

The primary purpose of this amendment was to expand the study design from phase 1b to phase 1b/2 and to enroll an additional 60 subjects; include pretreatment with IV methylprednisolone, diphenhydramine and acetaminophen before every elotuzumab infusion; and specify that the weekly dose of dexamethasone was to be administered 12 hours before all elotuzumab infusions.

19 Mar 2010

The primary purpose of this amendment was to revise predosing instructions (change the first weekly 40 mg oral dexamethasone administration from 2 to 4 hours to 1 to 3 hours prior to elotuzumab, and to allow split dosing of dexamethasone prior to the second dose and all subsequent doses of elotuzumab)

29 Jul 2010

The primary purpose of this amendment was to enroll and additional 10 subjects; update the predose of dexamethasone to a split dose of 28 mg orally (between 3 – 24 hours prior to elotuzumab infusion) and 8 mg IV (at least 45 minutes prior to infusion), and dexamethasone 28 mg orally was given on elotuzumab dosing days to reducing total dexamethasone dosing to a total biologic equivalent dose of 40 mg oral dexamethasone, the standard of care with a maximum 40 mg; and increase the maximum allowable elotuzumab infusion rate to 5 mL/min for subjects who had completed at least 4 cycles without an infusion reaction.

28 Jan 2011

The primary purpose of this amendment was to allow reduction to 20 mg weekly dexamethasone dose for subjects who developed intolerance to dexamethasone.

23 May 2012

The primary purpose of this amendment was to decrease the frequency of vital sign measurements and blood tests; and to discontinue DMC oversight (safety to be monitored by Bristol-Myers Squibb and Abbott).

20 Nov 2012

The primary purpose of this amendment was to remove serum soluble SLAMF7 and cytokines at the last cycle Day 28/early termination visit and the 30- and 60-day follow-up visits; and to incorporate changes related to Sponsor changing from Abbott to AbbVie (Abbott separated into 2 publicly traded companies, Abbott and AbbVie).

21 Nov 2013

The primary purpose of this amendment was to reduce the burden of assessments during treatment and the burden of long-term follow-up.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results: A Phase 1b/2, Multicenter, Open-label, Dose-escalation Study of Elotuzumab (Humanized Anti-CS1 Monoclonal IgG1 Antibody) in Combination With Lenalidomide and Dexamethasone in Subjects With Relapsed Multiple Myeloma

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Maximum Tolerated Dose (MTD) of Elotuzumab in Combination With Lenalidomide and Dexamethasone (Phase 1)

Primary: Maximum Tolerated Dose (MTD) of Elotuzumab in Combination With Lenalidomide and Dexamethasone (Phase 1)

Primary: Objective Response Rate (ORR) According to the International Myeloma Working Group Uniform Response Criteria (Phase 2)

Primary: Objective Response Rate (ORR) According to the International Myeloma Working Group Uniform Response Criteria (Phase 2)

Secondary: Objective Response Rate (ORR) According to the International Myeloma Working Group Uniform Response Criteria (Phase 1)

Secondary: Objective Response Rate (ORR) According to the International Myeloma Working Group Uniform Response Criteria (Phase 1)

Secondary: Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Secondary: Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Secondary: Number of Participants With Infusion Reactions

Secondary: Number of Participants With Infusion Reactions

Secondary: Mean Serum Concentrations of Elotuzumab During Cycle 1

Secondary: Mean Serum Concentrations of Elotuzumab During Cycle 1

Secondary: Maximum Serum Concentration (Cmax) of Elotuzumab

Secondary: Maximum Serum Concentration (Cmax) of Elotuzumab

Secondary: Area Under the Concentration-time Curve From 0 to Infinity (AUC0-inf) of Elotuzumab

Secondary: Area Under the Concentration-time Curve From 0 to Infinity (AUC0-inf) of Elotuzumab

Secondary: Systemic Clearance (CL) of Elotuzumab

Secondary: Systemic Clearance (CL) of Elotuzumab

Secondary: Volume of Distribution (V) of Elotuzumab

Secondary: Volume of Distribution (V) of Elotuzumab

Secondary: Serum Half-life (t1/2) of Elotuzumab

Secondary: Serum Half-life (t1/2) of Elotuzumab

Secondary: Duration of Response

Secondary: Duration of Response

Secondary: Time to Progression (TTP)

Secondary: Time to Progression (TTP)

Secondary: Percentage of Participants With Treatment-emergent Anti-elotuzumab Antibody (ADA)

Secondary: Percentage of Participants With Treatment-emergent Anti-elotuzumab Antibody (ADA)

Secondary: Plasma Cell Myeloma Cytogenetic Subtype

Secondary: Plasma Cell Myeloma Cytogenetic Subtype

Secondary: Progression-free Survival (PFS)

Secondary: Progression-free Survival (PFS)

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Phase 1b/2, Multicenter, Open-label, Dose-escalation Study of Elotuzumab (Humanized Anti-CS1 Monoclonal IgG1 Antibody) in Combination With Lenalidomide and Dexamethasone in Subjects With Relapsed Multiple Myeloma