Download PDF

Clinical Trial Results:
A Phase 2, Randomized Study of Bortezomib/Dexamethasone With or Without Elotuzumab in subjects with Relapsed/Refractory Multiple Myeloma

Summary
EudraCT number	2011-002695-16
Trial protocol	ES IT
Global end of trial date	21 Apr 2017

Results information
Results version number	v1(current)
This version publication date	06 May 2018
First version publication date	06 May 2018
Other versions

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

Collapse all Expand all

Trial information

Top of page

Sponsor protocol code

ca204-009

ISRCTN number

US NCT number

WHO universal trial number (UTN)

Sponsor organisation name

Bristol-Myers Squibb

Sponsor organisation address

Chaussée de la Hulpe 185, Brussels, Belgium, 1170

Public contact

EU Study Start-Up Unit, Bristol-Myers Squibb International Corporation, Clinical.Trials@bms.com

Scientific contact

Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, Clinical.Trials@bms.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

21 Apr 2017

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

21 Apr 2017

Was the trial ended prematurely?

Main objective of the trial

The purpose of study CA204-009 was to evaluate the effect of elotuzumab in combination with bortezomib and dexamethasone, (E-Bd; investigational arm) compared with bortezomib and dexamethasone alone (Bd; control group) in subjects with relapsed/refractory multiple myeloma.

Protection of trial subjects

The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization Good Clinical Practice Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.

Background therapy

Evidence for comparator

Actual start date of recruitment

31 Jan 2012

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Spain: 26

Country: Number of subjects enrolled

France: 23

Country: Number of subjects enrolled

Italy: 75

Country: Number of subjects enrolled

United States: 61

Worldwide total number of subjects

185

EEA total number of subjects

124

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

101

85 years and over

Subject disposition

Top of page

Recruitment details

Screening details

185 subjects were enrolled, 152 subjects were randomized. Reasons not randomized: 23 no longer met study criteria, 5 withdrew consent, 2 died, 3 had poor/non-compliance. 150 were treated with study drug. 2 subjects were not treated: 1 withdrawal by subject and 1 physician decision.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Elotuzumab + Bortezomib + Dexamethasone

Arm description

Elotuzumab: Solution; Intravenous (IV); 10 mg/kg; (Cycles 1 & 2: Days 1, 8 & 15; Cycles 3-8: Days 1 & 11; Cycle 9+: Days 1 & 15); Until subject meets criteria for discontinuation of drug Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of drug. Days of Elotuzumab infusion: Dexamethasone (8mg IV + 8mg Oral) administered. Other days Dexamethasone 20 mg Oral administered Dexamethasone: Tablets; 20 mg; (Cycles 1& 2: once daily on Days 2, 4, 5, 8, 9, 11; Cycles 3-8: once daily on Days 2, 4, 5, 9, 12; Cycles 9+: once daily on Days 2, 8, 9, 16); Until criteria met for discontinuation. Dexamethasone: Tablets; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation of drug. Dexamethasone: Solution; IV; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation

Arm type

Experimental

Investigational medicinal product name

Bortezomib

Investigational medicinal product code

Other name

Velcade

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use, Intravenous use

Dosage and administration details

1.3 mg/m2 IV (intravenously) or subcutaneously (SQ)

Investigational medicinal product name

Dexamethasone

Investigational medicinal product code

Other name

Pharmaceutical forms

Oral liquid, Solution for injection

Routes of administration

Oral use, Intravenous use

Dosage and administration details

Intravenous and po dexamethasone doses are calculated to provide a total dose that is bioequivalent to the 20 mg oral dose (Dexamethasone 8 mg IV is approximately bioequivalent to 11 mg po).

Investigational medicinal product name

Elotuzumab

Investigational medicinal product code

Other name

EMPLICITI

Pharmaceutical forms

Powder for concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

10 mg/kg IV

Bortezomib + Dexamethasone

Arm description

Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of study drug. Dexamethasone: Tablets; 20 mg; (Cycles 1-8 once daily on Days 1, 2, 4, 5, 8, 9, 11, 12; Cycles 9+ once daily on Days 1, 2, 8, 9, 15, 16); Until criteria is met for discontinuation of study drug

Arm type

Active comparator

Investigational medicinal product name

Dexamethasone

Investigational medicinal product code

Other name

Pharmaceutical forms

Oral liquid, Solution for injection

Routes of administration

Oral use, Intravenous use

Dosage and administration details

Intravenous and po dexamethasone doses are calculated to provide a total dose that is bioequivalent to the 20 mg oral dose (Dexamethasone 8 mg IV is approximately bioequivalent to 11 mg po).

Investigational medicinal product name

Bortezomib

Investigational medicinal product code

Other name

Velcade

Pharmaceutical forms

Solution for injection

Routes of administration

Intravenous use, Subcutaneous use

Dosage and administration details

1.3 mg/m2 IV (intravenously) or subcutaneously (SQ)

Number of subjects in period 1 ^[1]	Elotuzumab + Bortezomib + Dexamethasone	Bortezomib + Dexamethasone
Started	77	75
Received Treatment	76	74
Completed	0	0
Not completed	77	75
Consent withdrawn by subject	2	5
poor/non-compliance	-	1
Adverse event, non-fatal	2	11
subject request to discontinue treatment	3	5
study drug toxicity	11	14
non-specified	6	4
no longer meets study criteria	1	-
Disease Progression	52	35

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: 185 participants were enrolled, 152 participants were randomized. Reasons not randomized: 23 no longer met study criteria, 5 withdrew consent, 2 died, 3 had poor/non-compliance. 150 were treated with study drug. 2 participants were not treated: 1 withdrawal by subject and 1 physician decision.

Baseline characteristics

Top of page

Reporting group title

Elotuzumab + Bortezomib + Dexamethasone

Reporting group description

Reporting group title

Bortezomib + Dexamethasone

Reporting group description

Reporting group values	Elotuzumab + Bortezomib + Dexamethasone	Bortezomib + Dexamethasone	Total
Number of subjects	77	75	152
Age, Customized
Less than (<); Greater than, equal to (≥).
Units: Subjects
< 65 years\|	34	33	67
≥65 and <75 years\|	28	28	56
>= 75 years\|	15	14	29
Age Continuous
Units: years
arithmetic mean (standard deviation)	65.4 ( 9.48 )	65.1 ( 10.34 )	-
Gender, Male/Female
Units: Subjects
Female	35	38	73
Male	42	37	79
Region of Enrollment
Number of subjects enrolled, by country, were summarized.
Units: Subjects
United States\|	25	23	48
Italy\|	34	32	66
France\|	10	11	21
Spain\|	8	9	17
Prior Protease Inhibitor Use
Categories presented as they were at randomization based on information collected via the Interactive Voice Recognition System (IVRS) system.
Units: Subjects
Yes\|	38	37	75
No\|	39	38	77
Presence of At Least 1 FcγRIIIa V allele
An allele is any one of a series of 2 or more different genes that may be on a specific chromosome. Categories presented as they were at randomization based on information collected via the Interactive Voice Recognition System (IVRS) system.
Units: Subjects
Yes\|	55	54	109
No\|	22	21	43
Number of Prior Lines of Therapy
Categories presented as they were at randomization based on information collected via the Interactive Voice Recognition System (IVRS) system.
Units: Subjects
1 line of prior therapy\|	55	51	106
2 or 3 lines of prior therapy\|	22	24	46

End points

Top of page

Reporting group title

Elotuzumab + Bortezomib + Dexamethasone

Reporting group description

Reporting group title

Bortezomib + Dexamethasone

Reporting group description

Primary: Median Investigator-Assessed Progression-free survival (PFS) Time (Months) from Randomization to Date of First Tumor Progression or Death due to any Cause - Randomized Participants

Top of page

End point title

Median Investigator-Assessed Progression-free survival (PFS) Time (Months) from Randomization to Date of First Tumor Progression or Death due to any Cause - Randomized Participants

End point description

PE was planned for after at least 103 events; it was analyzed after 111 events. Response was assessed: Day 1 (± 7 days) of each cycle per modified International Myeloma Working Group (IMWG) criteria; assessed using adequate tumor assessment (ATA) (ie, serum and urine M-protein tests performed within 14 days of each other; imaging if baseline measurable extramedullary plasmacytoma existed). Progression: Any of following: Increase of 25% from lowest response in 1 or more: serum and/or urine M-component; in those without measurable serum and urine M-protein levels, difference between involved and uninvolved free light chain (FLC) levels (absolute increase > 100 mg/L); Bone marrow plasma cell percentage (≥10%). Definite new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing lesions or plasmacytomas. Development of hypercalcemia attributed solely to the plasma cell proliferative disorder.

End point type

Primary

End point timeframe

Randomization until 111 events (disease progression or death), up to May 2014, approximately 2 years

End point values	Elotuzumab + Bortezomib + Dexamethasone	Bortezomib + Dexamethasone
Number of subjects analysed	77	75
Units: Months
median (confidence interval 95%)	9.7 (7.4 to 12.2)	6.9 (5.1 to 10.2)

Median Progression-free survival

Comparison groups

Elotuzumab + Bortezomib + Dexamethasone v Bortezomib + Dexamethasone

Number of subjects included in analysis

152

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0923 ^[1]

Method

Logrank

Parameter type

Hazard ratio (HR)

Point estimate

0.72

Confidence interval

level

95%

sides

2-sided

lower limit

0.49

upper limit

1.06

Notes
[1] - Log Rank test was stratified by prior proteasome inhibitor use (Yes versus No), presence of at least 1 FcγRIIIa V allele (Yes versus No) and number of prior lines of therapy (1 versus 2 or 3) at randomization

Primary: Number of Investigator-Assessed Progression-free survival Events from Randomization to Date of First Tumor Progression or Death Due to Any Cause - All Randomized Participants

Top of page

End point title

Number of Investigator-Assessed Progression-free survival Events from Randomization to Date of First Tumor Progression or Death Due to Any Cause - All Randomized Participants ^[2]

End point description

PE planned for after at least 103 events (progression/death); analyzed at 111 events. Those who neither progressed nor died were censored on the date of last adequate tumor assessment (ATA), which requires both serum and urine M-protein tests. If no post-baseline tumor assessments/no death, then censored on randomization day. Response assessed: Day 1 (± 7 days) each cycle; 30 and 60 days post treatment. Modified IMWG criteria used. Progression: Any of following: Increase of 25% in serum and/or urine M-component; if no measurable serum, urine M-protein levels, then difference between involved and uninvolved free light chain (FLC) levels (absolute increase > 100 mg/L) ; Bone marrow plasma cell percentage (≥10%). New bone lesions or soft tissue plasmacytomas or increase in size of existing lesions, plasmacytomas. Development of hypercalcemia attributed solely to plasma cell proliferative disorder. First dose occurs within 3 days of randomization.

End point type

Primary

End point timeframe

Randomization until 111 events, up to May 2014, approximately 2 years

Notes
[2] - 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: Only summary statistics were planned for this endpoint

End point values	Elotuzumab + Bortezomib + Dexamethasone	Bortezomib + Dexamethasone
Number of subjects analysed	77	75
Units: Events (progression or death)	52	59

No statistical analyses for this end point

Primary: 1 Year Progression-Free Survival Rate - Randomized Participants

Top of page

End point title

1 Year Progression-Free Survival Rate - Randomized Participants ^[3]

End point description

PFS rate=Percentage probability of participants experiencing no progression or death up to 1 year, estimated using the Kaplan-Meier method. Response assessed by the investigator: Day 1 (± 7 days) of each cycle per modified IMWG criteria; assessed using ATA (ie, serum and urine M-protein tests performed within 14 days of each other; imaging done if baseline measurable extramedullary plasmacytoma existed). Progression: Any of the following: Increase of 25% from lowest response in 1 or more: serum and/or urine M-component; in those without measurable serum and urine M-protein levels, difference between involved and uninvolved FLC levels (absolute increase > 100 mg/L) ; Bone marrow plasma cell percentage (≥10%). Definite new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing lesions or plasmacytomas. Development of hypercalcemia attributed solely to the plasma cell proliferative disorder.

End point type

Primary

End point timeframe

Year 1 after last participant was randomized

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: Only summary statistics were planned for this endpoint

End point values	Elotuzumab + Bortezomib + Dexamethasone	Bortezomib + Dexamethasone
Number of subjects analysed	77	75
Units: percentage probability
number (confidence interval 95%)	0.39 (0.28 to 0.50)	0.33 (0.22 to 0.44)

No statistical analyses for this end point

Secondary: Median Progression-free survival Time (Months) from Randomization to Date of First Tumor Progression or Death due to any cause, in Randomized Participants With at Least One FcγRIIIa V allele

Top of page

End point title

Median Progression-free survival Time (Months) from Randomization to Date of First Tumor Progression or Death due to any cause, in Randomized Participants With at Least One FcγRIIIa V allele

End point description

PE was planned for after at least 103 events; it was analyzed after 111 events. Response was assessed: Day 1 (± 7 days) of each cycle per modified IMWG criteria; assessed using adequate tumor assessment (ATA) (ie, serum and urine M-protein tests performed within 14 days of each other; imaging if baseline measurable extramedullary plasmacytoma existed). Progression: Any of following: Increase of 25% from lowest response in 1 or more: serum and/or urine M-component; in those without measurable serum and urine M-protein levels, difference between involved and uninvolved FLC levels (absolute increase > 100 mg/L); Bone marrow plasma cell percentage (≥10%). Definite new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing lesions or plasmacytomas. Development of hypercalcemia attributed solely to the plasma cell proliferative disorder. Randomized participants with at least 1 FcγRIIIa V allele were a sub-set of all randomized participants.

End point type

Secondary

End point timeframe

Randomization until 111 events, up to May 2014, approximately 2 years

End point values	Elotuzumab + Bortezomib + Dexamethasone	Bortezomib + Dexamethasone
Number of subjects analysed	55	54
Units: Months
median (confidence interval 95%)	9.9 (6.1 to 13.9)	8.1 (5.0 to 11.1)

No statistical analyses for this end point

Secondary: Investigator-Assessed Objective Response Rate (ORR) - All Randomized Participants

Top of page

End point title

Investigator-Assessed Objective Response Rate (ORR) - All Randomized Participants

End point description

ORR was calculated for participants with a best overall response (BOR) of partial response (PR) or better, including stringent complete response (sCR), complete response (CR), and very good partial response (VGPR). BOR was determined by the investigator based on myeloma tumor assessments using IMWG criteria: CR=Negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas, and < 5% plasma cells in bone marrow; sCR= CR + normal FLC ratio and absence of clonal cells in bone marrow; VGPR=Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein level + urine M-protein level < 100 mg per 24 hour; PR= ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥ 90% or to < 200 mg per 24 hour. ORR= number of participants responding divided by total number of participants randomized, measured as a percentage.

End point type

Secondary

End point timeframe

Randomization until 111 events, up to May 2014, approximately 2 years

End point values	Elotuzumab + Bortezomib + Dexamethasone	Bortezomib + Dexamethasone
Number of subjects analysed	77	75
Units: percentage of participants
number (confidence interval 95%)	64.9 (53.2 to 75.5)	62.7 (50.7 to 73.6)

Objective Response Rate

Comparison groups

Elotuzumab + Bortezomib + Dexamethasone v Bortezomib + Dexamethasone

Number of subjects included in analysis

152

Analysis specification

Pre-specified

Analysis type

Method

Parameter type

Difference using Chan-Zhang method

Point estimate

2.3

Confidence interval

level

95%

sides

2-sided

lower limit

-13.2

upper limit

17.8

Secondary: Investigator-Assessed Objective Response Rate in Randomized Participants With at Least One FcγRIIIa V Allele

Top of page

End point title

Investigator-Assessed Objective Response Rate in Randomized Participants With at Least One FcγRIIIa V Allele

End point description

ORR was calculated for participants with a BOR of PR or better, sCR, CR, and VGPR. BOR was determined by the investigator based on myeloma tumor assessments using IMWG criteria: CR=Negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas, and < 5% plasma cells in bone marrow; sCR= CR + normal FLC ratio and absence of clonal cells in bone marrow; VGPR=Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein level + urine M-protein level < 100 mg per 24 hour; PR= ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥ 90% or to < 200 mg per 24 hour. ORR= number of participants responding divided by total number of participants randomized, measured as a percentage. Randomized participants with at least 1 FcγRIIIa V allele were a sub-set of all randomized participants.

End point type

Secondary

End point timeframe

Randomization until 111 events, up to May 2014, approximately 2 years

End point values	Elotuzumab + Bortezomib + Dexamethasone	Bortezomib + Dexamethasone
Number of subjects analysed	55	54
Units: percentage of participants
number (confidence interval 95%)	60.0 (45.9 to 73.0)	61.1 (46.9 to 74.1)

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

All Serious Adverse Events were reported from screening period to 60 days from last dose. All Non-Serious Adverse Events were reported from first dose to end of study treatment.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

20.0

Reporting group title

Elotuzumab + Bortezomib + Dexamethasone

Reporting group description

Subjects received treatment of Elotuzumab 10 milligram per kilogram (mg/kg) intravenously (IV) with Bortezomib 1.3 mg/meter square (mg/m2) IV or subcutaneously (SQ). Dexamethasone 20 mg orally in tablet form was given on days when Elotuzumab is not administered, and 8 mg orally in tablet form + 8 mg IV on days when Elotuzumab is administered up to 62 cycles (each cycle is of 21 days for 1-8 cycles and of 28 days for 9-62 cycles).

Reporting group title

Bortezomib + Dexamethasone

Reporting group description

Subjects received treatment of Bortezomib 1.3 mg/m2 IV or SQ and Dexamethasone 20 mg orally in tablet form to 55 cycles (each cycle is of 21 days for 1-8 cycles and of 28 days for 9-55 cycles).

Serious adverse events	Elotuzumab + Bortezomib + Dexamethasone	Bortezomib + Dexamethasone
Total subjects affected by serious adverse events
subjects affected / exposed	39 / 75 (52.00%)	31 / 75 (41.33%)
number of deaths (all causes)	2	6
number of deaths resulting from adverse events	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
subjects affected / exposed	2 / 75 (2.67%)	0 / 75 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Malignant neoplasm progression
subjects affected / exposed	2 / 75 (2.67%)	1 / 75 (1.33%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Plasma cell myeloma
subjects affected / exposed	1 / 75 (1.33%)	1 / 75 (1.33%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Plasmacytoma
subjects affected / exposed	0 / 75 (0.00%)	1 / 75 (1.33%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Squamous cell carcinoma
subjects affected / exposed	0 / 75 (0.00%)	1 / 75 (1.33%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular disorders
Orthostatic hypotension
subjects affected / exposed	0 / 75 (0.00%)	1 / 75 (1.33%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
General disorders and administration site conditions
Asthenia
subjects affected / exposed	0 / 75 (0.00%)	1 / 75 (1.33%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gait disturbance
subjects affected / exposed	0 / 75 (0.00%)	1 / 75 (1.33%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
General physical health deterioration
subjects affected / exposed	1 / 75 (1.33%)	0 / 75 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Non-Cardiac chest pain
subjects affected / exposed	0 / 75 (0.00%)	1 / 75 (1.33%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oedema peripheral
subjects affected / exposed	2 / 75 (2.67%)	0 / 75 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Performance status decreased
subjects affected / exposed	1 / 75 (1.33%)	0 / 75 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	1 / 1	0 / 0
Pyrexia
subjects affected / exposed	1 / 75 (1.33%)	3 / 75 (4.00%)
occurrences causally related to treatment / all	0 / 1	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0
Reproductive system and breast disorders
Genital prolapse
subjects affected / exposed	1 / 75 (1.33%)	0 / 75 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
subjects affected / exposed	0 / 75 (0.00%)	1 / 75 (1.33%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Dyspnoea
subjects affected / exposed	1 / 75 (1.33%)	0 / 75 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haemothorax
subjects affected / exposed	0 / 75 (0.00%)	1 / 75 (1.33%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Interstitial lung disease
subjects affected / exposed	1 / 75 (1.33%)	0 / 75 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Organising pneumonia
subjects affected / exposed	1 / 75 (1.33%)	0 / 75 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pleural effusion
subjects affected / exposed	1 / 75 (1.33%)	0 / 75 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonitis
subjects affected / exposed	0 / 75 (0.00%)	1 / 75 (1.33%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary hypertension
subjects affected / exposed	0 / 75 (0.00%)	1 / 75 (1.33%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory failure
subjects affected / exposed	1 / 75 (1.33%)	0 / 75 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Investigations
Blood creatinine increased
subjects affected / exposed	1 / 75 (1.33%)	0 / 75 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Platelet count decreased
subjects affected / exposed	1 / 75 (1.33%)	1 / 75 (1.33%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Injury, poisoning and procedural complications
Femur fracture
subjects affected / exposed	0 / 75 (0.00%)	1 / 75 (1.33%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Humerus fracture
subjects affected / exposed	1 / 75 (1.33%)	0 / 75 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Limb injury
subjects affected / exposed	0 / 75 (0.00%)	1 / 75 (1.33%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural haemorrhage
subjects affected / exposed	1 / 75 (1.33%)	0 / 75 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rib fracture
subjects affected / exposed	0 / 75 (0.00%)	1 / 75 (1.33%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sternal fracture
subjects affected / exposed	0 / 75 (0.00%)	1 / 75 (1.33%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Subdural haematoma
subjects affected / exposed	1 / 75 (1.33%)	1 / 75 (1.33%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Wrist fracture
subjects affected / exposed	0 / 75 (0.00%)	1 / 75 (1.33%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac disorders
Angina pectoris
subjects affected / exposed	0 / 75 (0.00%)	1 / 75 (1.33%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Atrial fibrillation
subjects affected / exposed	1 / 75 (1.33%)	0 / 75 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Atrial flutter
subjects affected / exposed	0 / 75 (0.00%)	1 / 75 (1.33%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardio-Respiratory arrest
subjects affected / exposed	0 / 75 (0.00%)	2 / 75 (2.67%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 2
Coronary artery disease
subjects affected / exposed	1 / 75 (1.33%)	0 / 75 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Myocardial infarction
subjects affected / exposed	0 / 75 (0.00%)	1 / 75 (1.33%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Sinus tachycardia
subjects affected / exposed	0 / 75 (0.00%)	1 / 75 (1.33%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Tachycardia
subjects affected / exposed	0 / 75 (0.00%)	1 / 75 (1.33%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nervous system disorders
Dizziness
subjects affected / exposed	0 / 75 (0.00%)	1 / 75 (1.33%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Syncope
subjects affected / exposed	3 / 75 (4.00%)	1 / 75 (1.33%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Blood and lymphatic system disorders
Thrombocytopenia
subjects affected / exposed	1 / 75 (1.33%)	0 / 75 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Eye disorders
Cataract
subjects affected / exposed	2 / 75 (2.67%)	0 / 75 (0.00%)
occurrences causally related to treatment / all	2 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diplopia
subjects affected / exposed	1 / 75 (1.33%)	0 / 75 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
Abdominal pain
subjects affected / exposed	2 / 75 (2.67%)	1 / 75 (1.33%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Colitis
subjects affected / exposed	2 / 75 (2.67%)	0 / 75 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Constipation
subjects affected / exposed	1 / 75 (1.33%)	1 / 75 (1.33%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Diarrhoea
subjects affected / exposed	4 / 75 (5.33%)	1 / 75 (1.33%)
occurrences causally related to treatment / all	3 / 5	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastritis
subjects affected / exposed	0 / 75 (0.00%)	1 / 75 (1.33%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal haemorrhage
subjects affected / exposed	0 / 75 (0.00%)	1 / 75 (1.33%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ileus
subjects affected / exposed	1 / 75 (1.33%)	0 / 75 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ileus paralytic
subjects affected / exposed	0 / 75 (0.00%)	1 / 75 (1.33%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Impaired gastric emptying
subjects affected / exposed	0 / 75 (0.00%)	1 / 75 (1.33%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nausea
subjects affected / exposed	2 / 75 (2.67%)	1 / 75 (1.33%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oesophagitis
subjects affected / exposed	0 / 75 (0.00%)	1 / 75 (1.33%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pancreatitis
subjects affected / exposed	1 / 75 (1.33%)	0 / 75 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Small intestinal obstruction
subjects affected / exposed	0 / 75 (0.00%)	2 / 75 (2.67%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Vomiting
subjects affected / exposed	1 / 75 (1.33%)	2 / 75 (2.67%)
occurrences causally related to treatment / all	0 / 1	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatobiliary disorders
Hepatitis
subjects affected / exposed	1 / 75 (1.33%)	0 / 75 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal and urinary disorders
Acute kidney injury
subjects affected / exposed	0 / 75 (0.00%)	2 / 75 (2.67%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Renal failure
subjects affected / exposed	2 / 75 (2.67%)	1 / 75 (1.33%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Arthritis
subjects affected / exposed	1 / 75 (1.33%)	1 / 75 (1.33%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Back pain
subjects affected / exposed	1 / 75 (1.33%)	0 / 75 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal chest pain
subjects affected / exposed	0 / 75 (0.00%)	1 / 75 (1.33%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal pain
subjects affected / exposed	1 / 75 (1.33%)	0 / 75 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Osteoarthritis
subjects affected / exposed	0 / 75 (0.00%)	1 / 75 (1.33%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
Aspergillus infection
subjects affected / exposed	1 / 75 (1.33%)	0 / 75 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bacteraemia
subjects affected / exposed	1 / 75 (1.33%)	0 / 75 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bacterial pyelonephritis
subjects affected / exposed	0 / 75 (0.00%)	1 / 75 (1.33%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchitis
subjects affected / exposed	1 / 75 (1.33%)	0 / 75 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cellulitis
subjects affected / exposed	2 / 75 (2.67%)	0 / 75 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cytomegalovirus colitis
subjects affected / exposed	1 / 75 (1.33%)	0 / 75 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cytomegalovirus infection
subjects affected / exposed	1 / 75 (1.33%)	0 / 75 (0.00%)
occurrences causally related to treatment / all	2 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Diverticulitis
subjects affected / exposed	0 / 75 (0.00%)	1 / 75 (1.33%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatitis b
subjects affected / exposed	1 / 75 (1.33%)	0 / 75 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	7 / 75 (9.33%)	5 / 75 (6.67%)
occurrences causally related to treatment / all	0 / 8	1 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia bacterial
subjects affected / exposed	0 / 75 (0.00%)	1 / 75 (1.33%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia fungal
subjects affected / exposed	1 / 75 (1.33%)	1 / 75 (1.33%)
occurrences causally related to treatment / all	1 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia pneumococcal
subjects affected / exposed	1 / 75 (1.33%)	0 / 75 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory tract infection
subjects affected / exposed	0 / 75 (0.00%)	1 / 75 (1.33%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Sepsis
subjects affected / exposed	1 / 75 (1.33%)	2 / 75 (2.67%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 1
Septic shock
subjects affected / exposed	1 / 75 (1.33%)	1 / 75 (1.33%)
occurrences causally related to treatment / all	1 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	1 / 75 (1.33%)	0 / 75 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
subjects affected / exposed	1 / 75 (1.33%)	0 / 75 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperglycaemia
subjects affected / exposed	2 / 75 (2.67%)	0 / 75 (0.00%)
occurrences causally related to treatment / all	2 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypernatraemia
subjects affected / exposed	1 / 75 (1.33%)	0 / 75 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperuricaemia
subjects affected / exposed	0 / 75 (0.00%)	1 / 75 (1.33%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypokalaemia
subjects affected / exposed	1 / 75 (1.33%)	0 / 75 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hyponatraemia
subjects affected / exposed	1 / 75 (1.33%)	0 / 75 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lactic acidosis
subjects affected / exposed	1 / 75 (1.33%)	0 / 75 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0

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

Non-serious adverse events	Elotuzumab + Bortezomib + Dexamethasone	Bortezomib + Dexamethasone
Total subjects affected by non serious adverse events
subjects affected / exposed	72 / 75 (96.00%)	71 / 75 (94.67%)
Vascular disorders
Hypertension
subjects affected / exposed	12 / 75 (16.00%)	3 / 75 (4.00%)
occurrences all number	24	3
Hypotension
subjects affected / exposed	7 / 75 (9.33%)	6 / 75 (8.00%)
occurrences all number	7	6
General disorders and administration site conditions
Asthenia
subjects affected / exposed	20 / 75 (26.67%)	21 / 75 (28.00%)
occurrences all number	27	24
Chest pain
subjects affected / exposed	6 / 75 (8.00%)	2 / 75 (2.67%)
occurrences all number	8	2
Chills
subjects affected / exposed	4 / 75 (5.33%)	2 / 75 (2.67%)
occurrences all number	6	2
Face oedema
subjects affected / exposed	4 / 75 (5.33%)	4 / 75 (5.33%)
occurrences all number	4	5
Influenza like illness
subjects affected / exposed	7 / 75 (9.33%)	4 / 75 (5.33%)
occurrences all number	11	4
Fatigue
subjects affected / exposed	22 / 75 (29.33%)	17 / 75 (22.67%)
occurrences all number	30	19
Oedema
subjects affected / exposed	5 / 75 (6.67%)	3 / 75 (4.00%)
occurrences all number	5	3
Injection site erythema
subjects affected / exposed	3 / 75 (4.00%)	4 / 75 (5.33%)
occurrences all number	3	4
Oedema peripheral
subjects affected / exposed	22 / 75 (29.33%)	18 / 75 (24.00%)
occurrences all number	26	21
Pyrexia
subjects affected / exposed	26 / 75 (34.67%)	15 / 75 (20.00%)
occurrences all number	39	22
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	31 / 75 (41.33%)	18 / 75 (24.00%)
occurrences all number	44	25
Dysphonia
subjects affected / exposed	4 / 75 (5.33%)	1 / 75 (1.33%)
occurrences all number	4	1
Dyspnoea
subjects affected / exposed	12 / 75 (16.00%)	7 / 75 (9.33%)
occurrences all number	18	7
Epistaxis
subjects affected / exposed	9 / 75 (12.00%)	2 / 75 (2.67%)
occurrences all number	9	2
Productive cough
subjects affected / exposed	5 / 75 (6.67%)	5 / 75 (6.67%)
occurrences all number	5	5
Oropharyngeal pain
subjects affected / exposed	5 / 75 (6.67%)	7 / 75 (9.33%)
occurrences all number	8	8
Psychiatric disorders
Anxiety
subjects affected / exposed	7 / 75 (9.33%)	2 / 75 (2.67%)
occurrences all number	8	2
Confusional state
subjects affected / exposed	4 / 75 (5.33%)	2 / 75 (2.67%)
occurrences all number	5	2
Depression
subjects affected / exposed	4 / 75 (5.33%)	1 / 75 (1.33%)
occurrences all number	4	1
Insomnia
subjects affected / exposed	20 / 75 (26.67%)	15 / 75 (20.00%)
occurrences all number	25	17
Investigations
Blood creatinine increased
subjects affected / exposed	5 / 75 (6.67%)	4 / 75 (5.33%)
occurrences all number	6	4
Platelet count decreased
subjects affected / exposed	6 / 75 (8.00%)	8 / 75 (10.67%)
occurrences all number	19	19
Weight increased
subjects affected / exposed	4 / 75 (5.33%)	4 / 75 (5.33%)
occurrences all number	4	4
Weight decreased
subjects affected / exposed	7 / 75 (9.33%)	4 / 75 (5.33%)
occurrences all number	7	4
Injury, poisoning and procedural complications
Rib fracture
subjects affected / exposed	5 / 75 (6.67%)	2 / 75 (2.67%)
occurrences all number	6	2
Cardiac disorders
Tachycardia
subjects affected / exposed	3 / 75 (4.00%)	4 / 75 (5.33%)
occurrences all number	3	5
Nervous system disorders
Dizziness
subjects affected / exposed	9 / 75 (12.00%)	7 / 75 (9.33%)
occurrences all number	10	7
Dysgeusia
subjects affected / exposed	2 / 75 (2.67%)	4 / 75 (5.33%)
occurrences all number	2	4
Headache
subjects affected / exposed	9 / 75 (12.00%)	6 / 75 (8.00%)
occurrences all number	9	6
Neuralgia
subjects affected / exposed	5 / 75 (6.67%)	4 / 75 (5.33%)
occurrences all number	6	4
Neuropathy peripheral
subjects affected / exposed	28 / 75 (37.33%)	28 / 75 (37.33%)
occurrences all number	52	37
Paraesthesia
subjects affected / exposed	19 / 75 (25.33%)	13 / 75 (17.33%)
occurrences all number	24	15
Peripheral sensory neuropathy
subjects affected / exposed	8 / 75 (10.67%)	9 / 75 (12.00%)
occurrences all number	10	11
Somnolence
subjects affected / exposed	0 / 75 (0.00%)	6 / 75 (8.00%)
occurrences all number	0	6
Tremor
subjects affected / exposed	3 / 75 (4.00%)	5 / 75 (6.67%)
occurrences all number	5	6
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	25 / 75 (33.33%)	20 / 75 (26.67%)
occurrences all number	40	26
Lymphopenia
subjects affected / exposed	5 / 75 (6.67%)	3 / 75 (4.00%)
occurrences all number	16	5
Thrombocytopenia
subjects affected / exposed	13 / 75 (17.33%)	22 / 75 (29.33%)
occurrences all number	24	41
Neutropenia
subjects affected / exposed	4 / 75 (5.33%)	8 / 75 (10.67%)
occurrences all number	8	16
Eye disorders
Cataract
subjects affected / exposed	3 / 75 (4.00%)	4 / 75 (5.33%)
occurrences all number	4	4
Vision blurred
subjects affected / exposed	4 / 75 (5.33%)	5 / 75 (6.67%)
occurrences all number	4	5
Gastrointestinal disorders
Abdominal distension
subjects affected / exposed	9 / 75 (12.00%)	2 / 75 (2.67%)
occurrences all number	9	2
Abdominal pain upper
subjects affected / exposed	2 / 75 (2.67%)	6 / 75 (8.00%)
occurrences all number	2	6
Abdominal pain
subjects affected / exposed	8 / 75 (10.67%)	8 / 75 (10.67%)
occurrences all number	8	8
Diarrhoea
subjects affected / exposed	31 / 75 (41.33%)	24 / 75 (32.00%)
occurrences all number	58	39
Constipation
subjects affected / exposed	28 / 75 (37.33%)	21 / 75 (28.00%)
occurrences all number	33	33
Gastrooesophageal reflux disease
subjects affected / exposed	1 / 75 (1.33%)	5 / 75 (6.67%)
occurrences all number	1	7
Dyspepsia
subjects affected / exposed	7 / 75 (9.33%)	5 / 75 (6.67%)
occurrences all number	9	5
Vomiting
subjects affected / exposed	14 / 75 (18.67%)	7 / 75 (9.33%)
occurrences all number	15	7
Nausea
subjects affected / exposed	19 / 75 (25.33%)	16 / 75 (21.33%)
occurrences all number	28	17
Skin and subcutaneous tissue disorders
Dry skin
subjects affected / exposed	2 / 75 (2.67%)	5 / 75 (6.67%)
occurrences all number	2	6
Hyperhidrosis
subjects affected / exposed	4 / 75 (5.33%)	2 / 75 (2.67%)
occurrences all number	5	2
Pruritus
subjects affected / exposed	4 / 75 (5.33%)	6 / 75 (8.00%)
occurrences all number	6	6
Rash
subjects affected / exposed	8 / 75 (10.67%)	5 / 75 (6.67%)
occurrences all number	14	5
Renal and urinary disorders
Pollakiuria
subjects affected / exposed	4 / 75 (5.33%)	1 / 75 (1.33%)
occurrences all number	5	1
Musculoskeletal and connective tissue disorders
Back pain
subjects affected / exposed	14 / 75 (18.67%)	15 / 75 (20.00%)
occurrences all number	16	17
Arthralgia
subjects affected / exposed	7 / 75 (9.33%)	12 / 75 (16.00%)
occurrences all number	9	15
Bone pain
subjects affected / exposed	12 / 75 (16.00%)	7 / 75 (9.33%)
occurrences all number	16	11
Muscle spasms
subjects affected / exposed	5 / 75 (6.67%)	5 / 75 (6.67%)
occurrences all number	5	5
Muscular weakness
subjects affected / exposed	6 / 75 (8.00%)	2 / 75 (2.67%)
occurrences all number	7	2
Musculoskeletal chest pain
subjects affected / exposed	7 / 75 (9.33%)	7 / 75 (9.33%)
occurrences all number	8	9
Pain in extremity
subjects affected / exposed	16 / 75 (21.33%)	12 / 75 (16.00%)
occurrences all number	25	15
Infections and infestations
Bronchitis
subjects affected / exposed	8 / 75 (10.67%)	7 / 75 (9.33%)
occurrences all number	11	13
Conjunctivitis
subjects affected / exposed	9 / 75 (12.00%)	4 / 75 (5.33%)
occurrences all number	12	4
Herpes zoster
subjects affected / exposed	6 / 75 (8.00%)	3 / 75 (4.00%)
occurrences all number	6	3
Influenza
subjects affected / exposed	3 / 75 (4.00%)	7 / 75 (9.33%)
occurrences all number	3	7
Upper respiratory tract infection
subjects affected / exposed	10 / 75 (13.33%)	4 / 75 (5.33%)
occurrences all number	25	4
Pneumonia
subjects affected / exposed	1 / 75 (1.33%)	6 / 75 (8.00%)
occurrences all number	1	6
Urinary tract infection
subjects affected / exposed	3 / 75 (4.00%)	5 / 75 (6.67%)
occurrences all number	3	9
Viral upper respiratory tract infection
subjects affected / exposed	6 / 75 (8.00%)	4 / 75 (5.33%)
occurrences all number	8	4
Metabolism and nutrition disorders
Decreased appetite
subjects affected / exposed	12 / 75 (16.00%)	9 / 75 (12.00%)
occurrences all number	16	9
Hypercalcaemia
subjects affected / exposed	1 / 75 (1.33%)	4 / 75 (5.33%)
occurrences all number	3	6
Hyperglycaemia
subjects affected / exposed	10 / 75 (13.33%)	7 / 75 (9.33%)
occurrences all number	34	13
Hypocalcaemia
subjects affected / exposed	13 / 75 (17.33%)	3 / 75 (4.00%)
occurrences all number	21	4
Hypokalaemia
subjects affected / exposed	8 / 75 (10.67%)	5 / 75 (6.67%)
occurrences all number	17	5
Hyponatraemia
subjects affected / exposed	5 / 75 (6.67%)	2 / 75 (2.67%)
occurrences all number	5	2

More information

Top of page

Were there any global substantial amendments to the protocol? Yes

25 Oct 2012

Broadening the number of lines of prior therapy from 1 - 2 lines to 1 - 3 and allowing up to 15% of subjects to have had prior non-bortezomib proteasome inhibitor therapy. Broadening the stratification criteria to adapt to these changes, ie, stratification of subjects during randomization will be based on subjects have 1 versus 2 or 3 lines of therapy, instead of 1 versus 2 lines of therapy, and subjects being proteasome inhibitor naive versus having had prior proteasome inhibitor exposure, instead of bortezomib naive versus prior bortezomib exposure. Removal of the exclusion criteria describing subjects with uncontrolled diabetes defined as an HbA1c ≥ 8.0 and decreasing the disease-free interval for subjects with other prior malignancy from 5 years to 3 years. The dose modification guideline in reference to the adverse event of bortezomib-related peripheral neuropathy is modified to match the bortezomib Prescribing Information. Clarification that once subjects reach cycle 5 without any Grade 2 infusion reactions, the infusion rate at C5D1 should be increased by 1 mL per minute in a stepwise fashion in each cycle up to a maximum of 5 mL per minute.

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

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Clinical trials

Clinical Trial Results:
A Phase 2, Randomized Study of Bortezomib/Dexamethasone With or Without Elotuzumab in subjects with Relapsed/Refractory Multiple Myeloma

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Median Investigator-Assessed Progression-free survival (PFS) Time (Months) from Randomization to Date of First Tumor Progression or Death due to any Cause - Randomized Participants

Primary: Median Investigator-Assessed Progression-free survival (PFS) Time (Months) from Randomization to Date of First Tumor Progression or Death due to any Cause - Randomized Participants

Primary: Number of Investigator-Assessed Progression-free survival Events from Randomization to Date of First Tumor Progression or Death Due to Any Cause - All Randomized Participants

Primary: Number of Investigator-Assessed Progression-free survival Events from Randomization to Date of First Tumor Progression or Death Due to Any Cause - All Randomized Participants

Primary: 1 Year Progression-Free Survival Rate - Randomized Participants

Primary: 1 Year Progression-Free Survival Rate - Randomized Participants

Secondary: Median Progression-free survival Time (Months) from Randomization to Date of First Tumor Progression or Death due to any cause, in Randomized Participants With at Least One FcγRIIIa V allele

Secondary: Median Progression-free survival Time (Months) from Randomization to Date of First Tumor Progression or Death due to any cause, in Randomized Participants With at Least One FcγRIIIa V allele

Secondary: Investigator-Assessed Objective Response Rate (ORR) - All Randomized Participants

Secondary: Investigator-Assessed Objective Response Rate (ORR) - All Randomized Participants

Secondary: Investigator-Assessed Objective Response Rate in Randomized Participants With at Least One FcγRIIIa V Allele

Secondary: Investigator-Assessed Objective Response Rate in Randomized Participants With at Least One FcγRIIIa V Allele

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials

Clinical Trial Results: A Phase 2, Randomized Study of Bortezomib/Dexamethasone With or Without Elotuzumab in subjects with Relapsed/Refractory Multiple Myeloma

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Median Investigator-Assessed Progression-free survival (PFS) Time (Months) from Randomization to Date of First Tumor Progression or Death due to any Cause - Randomized Participants

Primary: Median Investigator-Assessed Progression-free survival (PFS) Time (Months) from Randomization to Date of First Tumor Progression or Death due to any Cause - Randomized Participants

Primary: Number of Investigator-Assessed Progression-free survival Events from Randomization to Date of First Tumor Progression or Death Due to Any Cause - All Randomized Participants

Primary: Number of Investigator-Assessed Progression-free survival Events from Randomization to Date of First Tumor Progression or Death Due to Any Cause - All Randomized Participants

Primary: 1 Year Progression-Free Survival Rate - Randomized Participants

Primary: 1 Year Progression-Free Survival Rate - Randomized Participants

Secondary: Median Progression-free survival Time (Months) from Randomization to Date of First Tumor Progression or Death due to any cause, in Randomized Participants With at Least One FcγRIIIa V allele

Secondary: Median Progression-free survival Time (Months) from Randomization to Date of First Tumor Progression or Death due to any cause, in Randomized Participants With at Least One FcγRIIIa V allele

Secondary: Investigator-Assessed Objective Response Rate (ORR) - All Randomized Participants

Secondary: Investigator-Assessed Objective Response Rate (ORR) - All Randomized Participants

Secondary: Investigator-Assessed Objective Response Rate in Randomized Participants With at Least One FcγRIIIa V Allele

Secondary: Investigator-Assessed Objective Response Rate in Randomized Participants With at Least One FcγRIIIa V Allele

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Phase 2, Randomized Study of Bortezomib/Dexamethasone With or Without Elotuzumab in subjects with Relapsed/Refractory Multiple Myeloma