Download PDF

Clinical Trial Results:
An Open label, International, Multicenter, Dose Escalating Phase 1/2 Trial Investigating the Safety of Daratumumab in Combination with Lenalidomide and Dexamethasone in Patients with Relapsed or Relapsed and Refractory Multiple Myeloma

Summary
EudraCT number	2011-005709-62
Trial protocol	NL DK GB
Global end of trial date	13 Feb 2017

Results information
Results version number	v1(current)
This version publication date	07 Nov 2025
First version publication date	07 Nov 2025
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

DARA-GEN503

ISRCTN number

US NCT number

NCT01615029

WHO universal trial number (UTN)

Sponsor organisation name

Janssen-Cilag International N.V.

Sponsor organisation address

Turnhoutseweg 30, Beerse, Belgium, B-2340

Public contact

Clinical Registry Group, Janssen-Cilag International N.V., ClinicalTrialsEU@its.jnj.com

Scientific contact

Clinical Registry Group, Janssen-Cilag International N.V., ClinicalTrialsEU@its.jnj.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

23 Oct 2024

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

13 Feb 2017

Was the trial ended prematurely?

Main objective of the trial

The main objective of the trial is to establish the safety profile of daratumumab when given in combination with lenalidomide/dexamethasone in participants with relapsed or relapsed and refractory multiple myeloma.

Protection of trial subjects

This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements.

Background therapy

Evidence for comparator

Actual start date of recruitment

26 Jun 2012

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Denmark: 11

Country: Number of subjects enrolled

France: 7

Country: Number of subjects enrolled

Italy: 8

Country: Number of subjects enrolled

Netherlands: 9

Country: Number of subjects enrolled

United Kingdom: 7

Country: Number of subjects enrolled

United States: 3

Worldwide total number of subjects

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

Top of page

Recruitment details

A total of 45 participants were enrolled in the study, received the treatment, and were included in the analysis.

Screening details

Adult participants aged 18 years or older who had relapsed multiple myeloma after receiving a minimum of 2 and a maximum of 4 prior lines of therapy (phase 1) and have received at least 1 prior line of therapy for multiple myeloma (phase 2) were included in the study.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Not applicable

Blinding used

Not blinded

Blinding implementation details

No blinding

Are arms mutually exclusive

Yes

Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone

Arm description

Participants administered with daratumumab 2 milligrams per kilogram (mg/kg) on Days 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with lenalidomide 25 milligrams (mg) on Day 1 to 21 of each 28-day cycle and dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.

Arm type

Experimental

Investigational medicinal product name

Daratumumab 2 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Infusion

Dosage and administration details

Participants received daratumumab 2 mg/kg on Days 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (cycles 3 to 6), Day 1 (cycle 7+).

Investigational medicinal product name

Dexamethasone

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Infusion

Dosage and administration details

Participants received dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion).

Investigational medicinal product name

Lenalidomide 25 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Participants received lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle.

Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone

Arm description

Participants administered with daratumumab 4 mg/kg on Days 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.

Arm type

Experimental

Investigational medicinal product name

Daratumumab 4 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Infusion

Dosage and administration details

Participants received daratumumab 4 mg/kg on Days 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (cycles 3 to 6), Day 1 (cycle 7+).

Investigational medicinal product name

Dexamethasone

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Infusion

Dosage and administration details

Participants received dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion).

Investigational medicinal product name

Lenalidomide 25 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Participants received lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle.

Phase 1: 8 mg/kg Daratumumab + Lenalidomide and Dexamethasone

Arm description

Participants administered with daratumumab 8 mg/kg on Days 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.

Arm type

Experimental

Investigational medicinal product name

Daratumumab 8 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Infusion

Dosage and administration details

Participants received daratumumab 8 mg/kg on Days 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (cycles 3 to 6), Day 1 (cycle 7+).

Investigational medicinal product name

Dexamethasone

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Infusion

Dosage and administration details

Participants received dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion).

Investigational medicinal product name

Lenalidomide 25 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Participants received lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle.

Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone

Arm description

Participants administered with daratumumab 16 mg/kg on Days 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.

Arm type

Experimental

Investigational medicinal product name

Daratumumab 16 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Infusion

Dosage and administration details

Participants received daratumumab 16 mg/kg on Days 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (cycles 3 to 6), Day 1 (cycle 7+).

Investigational medicinal product name

Dexamethasone

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Infusion

Dosage and administration details

Participants received dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion).

Investigational medicinal product name

Lenalidomide 25 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Participants received lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle.

Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone

Arm description

Participants administered with daratumumab 16 mg/kg on Days 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.

Arm type

Experimental

Investigational medicinal product name

Daratumumab 16 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Infusion

Dosage and administration details

Participants received daratumumab 16 mg/kg on Days 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (cycles 3 to 6), Day 1 (cycle 7+).

Investigational medicinal product name

Dexamethasone

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Infusion

Dosage and administration details

Participants received dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion).

Investigational medicinal product name

Lenalidomide 25 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Participants received lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle.

Number of subjects in period 1	Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone	Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone	Phase 1: 8 mg/kg Daratumumab + Lenalidomide and Dexamethasone	Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone	Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone
Started	3	3	4	3	32
Completed	1	2	0	2	16
Not completed	2	1	4	1	16
Physician decision	-	-	-	-	2
Adverse event, non-fatal	1	-	3	-	4
Progressive disease	1	1	1	1	10

Baseline characteristics

Top of page

Reporting group title

Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone

Reporting group description

Reporting group title

Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone

Reporting group description

Reporting group title

Phase 1: 8 mg/kg Daratumumab + Lenalidomide and Dexamethasone

Reporting group description

Reporting group title

Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone

Reporting group description

Reporting group title

Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone

Reporting group description

Reporting group values	Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone	Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone	Phase 1: 8 mg/kg Daratumumab + Lenalidomide and Dexamethasone	Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone	Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone	Total
Number of subjects	3	3	4	3	32
Age Categorical
Units: Subjects
Age continuous
Units: Years
arithmetic mean (standard deviation)	62.7 ( 12.74 )	62.7 ( 2.08 )	57.5 ( 9.68 )	67.3 ( 10.26 )	59.7 ( 8.38 )	-
Gender categorical
Units: Participants
Male	3	2	4	1	22	32
Female	0	1	0	2	10	13
Stage of Disease [International Staging System (ISS)
Units: Subjects
Stage I	0	1	4	1	15	21
Stage II	2	1	0	1	14	18
Stage III	1	1	0	1	3	6
No. of Prior Lines of Therapy
Units: Subjects
1 Line	0	0	0	0	15	15
2-3 Lines	2	3	3	2	17	27
>3 Lines	1	0	1	1	0	3
Refractory to Proteasome Inhibitor (PI)/ Immunomodulatory drug (IMiD)
Units: Subjects
Both a PI and IMiD	0	0	3	1	0	4
PI only	0	2	0	0	5	7
IMiD only	0	1	0	1	1	3
None	3	0	1	1	26	31

End points

Top of page

Reporting group title

Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone

Reporting group description

Reporting group title

Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone

Reporting group description

Reporting group title

Phase 1: 8 mg/kg Daratumumab + Lenalidomide and Dexamethasone

Reporting group description

Reporting group title

Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone

Reporting group description

Reporting group title

Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone

Reporting group description

Subject analysis set title

Phase 1: Daratumumab (2-16mg/kg)+Lenalidomide & Dexamethasone

Subject analysis set type

Full analysis

Subject analysis set description

Participants were administered Daratumumab at escalating doses of 2 mg/kg, 4 mg/kg, 8 mg/kg, or 16 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Day 1 of Cycles 3 to 6, and Day 1 of Cycles 7 and beyond. Each cycle consisted of 28 days. Lenalidomide (25 mg was administered orally once daily on Days 1 to 21 of each 28-day cycle) and Dexamethasone (40 mg weekly) were administered concurrently. Dexamethasone dosage could be reduced to 20 mg weekly after Cycle 6 or at the investigator’s discretion. Each treatment cycle consisted of 28 days.

Primary: Phase 1: Percentage of Participants With Overall Response Rate (ORR)

Top of page

End point title

Phase 1: Percentage of Participants With Overall Response Rate (ORR) ^[1] ^[2]

End point description

ORR is defined as percentage of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR). International myeloma working group (IMWG) criteria (2011)- CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and less than (<) 5 percent (%) plasma cells in bone marrow; sCR: CR+Normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry or immuno fluorescence; PR: greater than equal to (>=) 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >= 90% or to <200 mg/24 hours; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100 mg per 24 hour. All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1.

End point type

Primary

End point timeframe

Up to 3 years

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: No inferential statistics were planned for this endpoint.
[2] - 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 data was planned to be reported for specified baseline arms only.

End point values	Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone	Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone	Phase 1: 8 mg/kg Daratumumab + Lenalidomide and Dexamethasone	Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone	Phase 1: Daratumumab (2-16mg/kg)+Lenalidomide & Dexamethasone
Number of subjects analysed	3	3	4	3	13
Units: Percentage of participants
number (confidence interval 95%)	100.0 (29.2 to 100.0)	100.0 (29.2 to 100.0)	75.0 (19.4 to 99.4)	66.7 (9.4 to 99.2)	85.4 (64.8 to 98.1)

No statistical analyses for this end point

Primary: Phase 2: Percentage of Participants With Overall Response Rate (ORR)

Top of page

End point title

Phase 2: Percentage of Participants With Overall Response Rate (ORR) ^[3] ^[4]

End point description

ORR is defined as percentage of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR). IMWG criteria 2011- CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and less than (<) 5% plasma cells in bone marrow; sCR: CR+Normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; PR: greater than eqaul to (>=) 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >= 90 percentage (%) or to <200 mg/24 hours; VGPR: Serum and urine Mprotein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100 mg per 24 hour. Intent-to-Treat (ITT) population analysis set included all enrolled participants who signed the informed consent (ICF) during Phase 2.

End point type

Primary

End point timeframe

Up to 3 years

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: No inferential statistics were planned for this endpoint.
[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 data was planned to be reported for specified baseline arms only.

End point values	Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone
Number of subjects analysed	32
Units: Percentage of participants
number (not applicable)	81.3

No statistical analyses for this end point

Secondary: Phase 2: Duration of Response

Top of page

End point title

Phase 2: Duration of Response ^[5]

End point description

Duration of response was calculated from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the IMWG criteria 2011. Responders in ITT population analysis set included. ITT population analysis set included all enrolled participants who signed the informed consent during Phase 2. Here, 'N' (overall number of participants analyzed) signifies participants evaluable for this outcome measure. Here, 99999 signifies median and 95% CI lower limit was not estimable due to insufficient number of participants with events.

End point type

Secondary

End point timeframe

Up to 5 years

Notes
[5] - 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 data was planned to be reported for specified baseline arms only.

End point values	Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone
Number of subjects analysed	26
Units: Months
median (confidence interval 95%)	99999 (26.5 to 99999)

No statistical analyses for this end point

Secondary: Phase 1: Time to Response

Top of page

End point title

Phase 1: Time to Response ^[6]

End point description

Time to first response was defined as the time from the date of first dose of daratumumab to the date of initial documentation of a response (PR or better). Time to best response was defined as the time between the date of first dose of daratumumab and the date of the initial evaluation of the best response (PR or better) to treatment. Responders in all treated population analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. Here, 'N' (overall number of participants analyzed) signifies participants evaluable for this outcome measure.

End point type

Secondary

End point timeframe

Up to 5 years

Notes
[6] - 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 data was planned to be reported for specified baseline arms only.

End point values	Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone	Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone	Phase 1: 8 mg/kg Daratumumab + Lenalidomide and Dexamethasone	Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone
Number of subjects analysed	3	3	3	2
Units: Months
median (full range (min-max))
Time to first response	0.99 (0.5 to 1.0)	1.02 (0.5 to 1.9)	1.02 (1.0 to 1.8)	2.25 (1.9 to 2.6)
Time to best response	1.9 (1.0 to 6.5)	13.17 (3.7 to 20.7)	8.41 (1.0 to 19.9)	16.72 (6.5 to 26.9)

No statistical analyses for this end point

Secondary: Phase 2: Time to Response

Top of page

End point title

Phase 2: Time to Response ^[7]

End point description

Time to first response was defined as the time from the date of first dose of daratumumab to the date of initial documentation of a response (PR or better). Time to best response was defined as the time between the date of first dose of daratumumab and the date of the initial evaluation of the best response (PR or better) to treatment. ITT population analysis set included all enrolled participants who signed the informed consent during Phase 2. Here, 'N' (overall number of participants analyzed) signifies participants evaluable for this outcome measure.

End point type

Secondary

End point timeframe

Up to 5 years

Notes
[7] - 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 data was planned to be reported for specified baseline arms only.

End point values	Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone
Number of subjects analysed	26
Units: Months
median (full range (min-max))
Time to first response	0.99 (0.5 to 5.6)
Time to best response	6.95 (0.5 to 26.8)

No statistical analyses for this end point

Secondary: Phase 2: Time to Progression (TTP)

Top of page

End point title

Phase 2: Time to Progression (TTP) ^[8]

End point description

TTP was defined as the number of days from the date of first infusion (Day 1) to the date of first record of disease progression. Disease progression (IMWG criteria 2011): increase of >=25% from lowest response level in serum M-component and/or (the absolute increase must be >=0.5 g/dL) urine M-component and/or (the absolute increase must be >=200 mg/24 hour; only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels. The absolute increase must be >10 mg/dL; Bone marrow plasma cell percentage: the absolute % must be >=10 %; Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas. ITT population analysis set included all enrolled participants who signed the ICF during Phase 2. Here, 99999 signifies median and 95% CI lower limit was not estimable due to insufficient number of participants with events.

End point type

Secondary

End point timeframe

Up to 5 years

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 data was planned to be reported for specified baseline arms only.

End point values	Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone
Number of subjects analysed	32
Units: Months
median (confidence interval 95%)	99999 (27.0 to 99999)

No statistical analyses for this end point

Secondary: Phase 2: Progression-Free Survival (PFS)

Top of page

End point title

Phase 2: Progression-Free Survival (PFS) ^[9]

End point description

Progression free survival (PFS) was defined as the time between the date of first dose of daratumumab and either disease progression or death, whichever occurs first. ITT population analysis set included all enrolled participants who signed the informed consent during Phase 2. Here, 99999 signifies median and 95% CI lower limit was not estimable due to insufficient number of participants with events.

End point type

Secondary

End point timeframe

Up to 5 years

Notes
[9] - 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 data was planned to be reported for specified baseline arms only.

End point values	Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone
Number of subjects analysed	32
Units: Months
median (confidence interval 95%)	99999 (16.62 to 99999)

No statistical analyses for this end point

Secondary: Phase 2: Overall Survival (OS)

Top of page

End point title

Phase 2: Overall Survival (OS) ^[10]

End point description

Overall Survival (OS) was defined as the number of days from administration of the first infusion (Day 1) to date of death. Median Overall Survival was estimated by using the Kaplan Meier method. ITT population analysis set included all enrolled participants who signed the informed consent during Phase 2. Here, 99999 signifies median and 95% CI lower limit was not estimable due to insufficient number of participants with events.

End point type

Secondary

End point timeframe

Up to 5 years

Notes
[10] - 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 data was planned to be reported for specified baseline arms only.

End point values	Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone
Number of subjects analysed	32
Units: Months
median (confidence interval 95%)	99999 (32.23 to 99999)

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

Deaths: From screening (Day -21) up to 5 years; Serious and Non-serious AEs: From Day 1 up to 50.4 months

Adverse event reporting additional description

All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

18.0

Reporting group title

Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone

Reporting group description

Participants received daratumumab 2 mg/kg on Days 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (cycles 3 to 6), Day 1 (cycle 7+) along with lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.

Reporting group title

Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone

Reporting group description

Participants received daratumumab 4 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (cycles 3 to 6), Day 1 (cycle 7+) along with lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.

Reporting group title

Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone

Reporting group description

Participants received daratumumab 16 mg/kg on Days 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (cycles 3 to 6), Day 1 (cycle 7+) along with lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.

Reporting group title

Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone

Reporting group description

Participants received daratumumab 16 mg/kg on Days 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (cycles 3 to 6), Day 1 (cycle 7+) along with lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.

Reporting group title

Phase 1: 8mg/kg Daratumumab + Lenalidomide and Dexamethasone

Reporting group description

Participants received with daratumumab 8 mg/kg on Days 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (cycles 3 to 6), Day 1 (cycle 7+) along with lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.

Serious adverse events	Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone	Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone	Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone	Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone	Phase 1: 8mg/kg Daratumumab + Lenalidomide and Dexamethasone
Total subjects affected by serious adverse events
subjects affected / exposed	2 / 3 (66.67%)	2 / 3 (66.67%)	22 / 32 (68.75%)	2 / 3 (66.67%)	3 / 4 (75.00%)
number of deaths (all causes)	0	0	2	0	1
number of deaths resulting from adverse events	0	0	0	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma Gastric
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 32 (3.13%)	0 / 3 (0.00%)	0 / 4 (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
Epstein-Barr Virus Associated Lymphoma
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 32 (0.00%)	0 / 3 (0.00%)	1 / 4 (25.00%)
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%)	3 / 32 (9.38%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 4	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Sudden Death
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 32 (0.00%)	0 / 3 (0.00%)	1 / 4 (25.00%)
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%)	2 / 32 (6.25%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Laryngeal Oedema
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 32 (3.13%)	0 / 3 (0.00%)	0 / 4 (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
Pulmonary Embolism
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 32 (3.13%)	0 / 3 (0.00%)	0 / 4 (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
Investigations
Influenza A Virus Test Positive
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 32 (3.13%)	0 / 3 (0.00%)	0 / 4 (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
Injury, poisoning and procedural complications
Spinal Fracture
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 32 (3.13%)	0 / 3 (0.00%)	0 / 4 (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
Pelvic Fracture
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 32 (0.00%)	0 / 3 (0.00%)	0 / 4 (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
Fall
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 32 (3.13%)	0 / 3 (0.00%)	0 / 4 (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
Ankle Fracture
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 32 (0.00%)	0 / 3 (0.00%)	0 / 4 (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
Cardiac disorders
Atrial Fibrillation
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 32 (0.00%)	0 / 3 (0.00%)	1 / 4 (25.00%)
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
Nervous system disorders
Cerebral Infarction
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 32 (0.00%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cerebrovascular Accident
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	1 / 32 (3.13%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0	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%)	1 / 3 (33.33%)	0 / 32 (0.00%)	0 / 3 (0.00%)	0 / 4 (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
Blood and lymphatic system disorders
Neutropenia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	3 / 32 (9.38%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 3	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Anaemia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 32 (0.00%)	1 / 3 (33.33%)	0 / 4 (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
Eye disorders
Retinal Artery Thrombosis
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 32 (0.00%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Nausea
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 32 (3.13%)	0 / 3 (0.00%)	0 / 4 (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
Diarrhoea
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	2 / 32 (6.25%)	0 / 3 (0.00%)	1 / 4 (25.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 2	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Abdominal Pain
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 32 (0.00%)	0 / 3 (0.00%)	0 / 4 (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 / 0	0 / 0	0 / 0	0 / 0
Vomiting
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 32 (3.13%)	0 / 3 (0.00%)	0 / 4 (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
Hepatobiliary disorders
Cholelithiasis
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 32 (0.00%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Endocrine disorders
Steroid Withdrawal Syndrome
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 32 (0.00%)	1 / 3 (33.33%)	0 / 4 (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 and connective tissue disorders
Back Pain
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 32 (0.00%)	1 / 3 (33.33%)	0 / 4 (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
Osteonecrosis
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 32 (3.13%)	0 / 3 (0.00%)	0 / 4 (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
Infections and infestations
Bacteraemia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 32 (3.13%)	0 / 3 (0.00%)	0 / 4 (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
Gastroenteritis
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 32 (6.25%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Endocarditis
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 32 (3.13%)	0 / 3 (0.00%)	0 / 4 (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%)	1 / 3 (33.33%)	1 / 32 (3.13%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infection
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 32 (3.13%)	0 / 3 (0.00%)	0 / 4 (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
Nasopharyngitis
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 32 (0.00%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	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%)	1 / 32 (3.13%)	0 / 3 (0.00%)	0 / 4 (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
Lower Respiratory Tract Infection
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 32 (0.00%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	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 / 32 (0.00%)	1 / 3 (33.33%)	0 / 4 (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
Pneumonia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	3 / 32 (9.38%)	0 / 3 (0.00%)	1 / 4 (25.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 3	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%)	1 / 32 (3.13%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
Urinary Tract Infection
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 32 (3.13%)	1 / 3 (33.33%)	0 / 4 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Upper Respiratory Tract Infection
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 32 (3.13%)	0 / 3 (0.00%)	0 / 4 (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
Sinusitis
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 32 (3.13%)	0 / 3 (0.00%)	0 / 4 (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
Septic Shock
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 32 (3.13%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
Viral Infection
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 32 (3.13%)	0 / 3 (0.00%)	0 / 4 (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

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

Non-serious adverse events	Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone	Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone	Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone	Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone	Phase 1: 8mg/kg Daratumumab + Lenalidomide and Dexamethasone
Total subjects affected by non serious adverse events
subjects affected / exposed	3 / 3 (100.00%)	3 / 3 (100.00%)	31 / 32 (96.88%)	3 / 3 (100.00%)	4 / 4 (100.00%)
Vascular disorders
Hypertension
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	10 / 32 (31.25%)	0 / 3 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	12	0	1
Flushing
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 32 (6.25%)	0 / 3 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	3	0	1
Hypotension
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	3 / 32 (9.38%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	5	0	0
General disorders and administration site conditions
Fatigue
subjects affected / exposed	3 / 3 (100.00%)	1 / 3 (33.33%)	13 / 32 (40.63%)	1 / 3 (33.33%)	4 / 4 (100.00%)
occurrences all number	3	1	19	3	6
Application Site Erythema
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 32 (0.00%)	0 / 3 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	1
Asthenia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	4 / 32 (12.50%)	1 / 3 (33.33%)	0 / 4 (0.00%)
occurrences all number	0	0	7	4	0
Chest Pain
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 32 (0.00%)	1 / 3 (33.33%)	0 / 4 (0.00%)
occurrences all number	0	1	0	1	0
Facial Pain
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 32 (0.00%)	1 / 3 (33.33%)	0 / 4 (0.00%)
occurrences all number	0	0	0	1	0
Inflammation
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 32 (0.00%)	1 / 3 (33.33%)	0 / 4 (0.00%)
occurrences all number	0	0	0	1	0
Oedema
subjects affected / exposed	1 / 3 (33.33%)	1 / 3 (33.33%)	3 / 32 (9.38%)	1 / 3 (33.33%)	1 / 4 (25.00%)
occurrences all number	2	1	3	1	2
Oedema Peripheral
subjects affected / exposed	2 / 3 (66.67%)	0 / 3 (0.00%)	8 / 32 (25.00%)	3 / 3 (100.00%)	1 / 4 (25.00%)
occurrences all number	3	0	9	4	2
Pain
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	1 / 32 (3.13%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	1	1	0	0
Peripheral Swelling
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	1 / 32 (3.13%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	1	1	0	0
Pyrexia
subjects affected / exposed	1 / 3 (33.33%)	1 / 3 (33.33%)	9 / 32 (28.13%)	0 / 3 (0.00%)	1 / 4 (25.00%)
occurrences all number	1	1	12	0	2
Influenza Like Illness
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	4 / 32 (12.50%)	0 / 3 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	2	7	0	1
Immune system disorders
Hypogammaglobulinaemia
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	1 / 32 (3.13%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	0	1	0	0
Immune System Disorder
subjects affected / exposed	1 / 3 (33.33%)	1 / 3 (33.33%)	0 / 32 (0.00%)	1 / 3 (33.33%)	0 / 4 (0.00%)
occurrences all number	1	1	0	1	0
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 32 (0.00%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	1	0	0	0
Respiratory, thoracic and mediastinal disorders
Productive Cough
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	3 / 32 (9.38%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	3	0	0
Oropharyngeal Pain
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	3 / 32 (9.38%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	0	3	0	0
Nasal Congestion
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	2 / 32 (6.25%)	0 / 3 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	1	4	0	1
Epistaxis
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 32 (3.13%)	0 / 3 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	1	0	1
Dyspnoea Exertional
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 32 (0.00%)	1 / 3 (33.33%)	0 / 4 (0.00%)
occurrences all number	0	0	0	1	0
Dyspnoea
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	3 / 32 (9.38%)	1 / 3 (33.33%)	2 / 4 (50.00%)
occurrences all number	0	0	4	2	2
Dysphonia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	3 / 32 (9.38%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	4	0	0
Dry Throat
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 32 (0.00%)	0 / 3 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	1
Cough
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	16 / 32 (50.00%)	1 / 3 (33.33%)	2 / 4 (50.00%)
occurrences all number	0	2	30	1	7
Bronchospasm
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 32 (3.13%)	1 / 3 (33.33%)	0 / 4 (0.00%)
occurrences all number	0	0	1	1	0
Allergic Bronchitis
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 32 (0.00%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	1	0	0	0
Rhinitis Allergic
subjects affected / exposed	0 / 3 (0.00%)	2 / 3 (66.67%)	4 / 32 (12.50%)	1 / 3 (33.33%)	0 / 4 (0.00%)
occurrences all number	0	3	4	1	0
Sputum Discoloured
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 32 (0.00%)	1 / 3 (33.33%)	0 / 4 (0.00%)
occurrences all number	0	0	0	1	0
Wheezing
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 32 (0.00%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	0	0	0	0
Psychiatric disorders
Mood Altered
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	1 / 32 (3.13%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	1	1	0	0
Insomnia
subjects affected / exposed	1 / 3 (33.33%)	2 / 3 (66.67%)	8 / 32 (25.00%)	0 / 3 (0.00%)	3 / 4 (75.00%)
occurrences all number	1	2	11	0	3
Disinhibition
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 32 (0.00%)	0 / 3 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	1
Depressed Mood
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 32 (0.00%)	1 / 3 (33.33%)	0 / 4 (0.00%)
occurrences all number	1	0	0	1	0
Agitation
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 32 (3.13%)	0 / 3 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	1	0	1
Depression
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	1 / 32 (3.13%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	0	1	0	0
Investigations
Alanine Aminotransferase Increased
subjects affected / exposed	2 / 3 (66.67%)	0 / 3 (0.00%)	2 / 32 (6.25%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	2	0	7	0	0
Aspartate Aminotransferase Increased
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	3 / 32 (9.38%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	0	3	0	0
Blood Alkaline Phosphatase Increased
subjects affected / exposed	0 / 3 (0.00%)	2 / 3 (66.67%)	3 / 32 (9.38%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	2	4	0	0
Blood Creatine Phosphokinase Increased
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	1 / 32 (3.13%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	0	1	0	0
Blood Iron Decreased
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 32 (0.00%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	1	0	0	0
Blood Lactate Dehydrogenase Increased
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	1 / 32 (3.13%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	0	2	0	0
Blood Phosphorus Decreased
subjects affected / exposed	1 / 3 (33.33%)	1 / 3 (33.33%)	0 / 32 (0.00%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	1	0	0	0
Blood Pressure Increased
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 32 (6.25%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	3	0	0
Weight Decreased
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	3 / 32 (9.38%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	1	3	0	0
C-Reactive Protein Increased
subjects affected / exposed	1 / 3 (33.33%)	1 / 3 (33.33%)	1 / 32 (3.13%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	1	1	0	0
Creatinine Renal Clearance Decreased
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 32 (3.13%)	1 / 3 (33.33%)	0 / 4 (0.00%)
occurrences all number	0	0	1	1	0
Electrocardiogram QT Prolonged
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	1 / 32 (3.13%)	1 / 3 (33.33%)	1 / 4 (25.00%)
occurrences all number	3	0	7	1	1
Injury, poisoning and procedural complications
Ankle Fracture
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 32 (0.00%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	1	0	0	0
Clavicle Fracture
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 32 (0.00%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	0	0	0	0
Contusion
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	1 / 32 (3.13%)	0 / 3 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	1	1	0	1
Fall
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 32 (0.00%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	1	0	0	0
Limb Injury
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 32 (0.00%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	0	0	0	0
Pelvic Fracture
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 32 (0.00%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	1	0	0	0
Cardiac disorders
Atrial Fibrillation
subjects affected / exposed	2 / 3 (66.67%)	0 / 3 (0.00%)	1 / 32 (3.13%)	0 / 3 (0.00%)	1 / 4 (25.00%)
occurrences all number	2	0	1	0	1
Palpitations
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 32 (0.00%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	0	0	0	0
Supraventricular Tachycardia
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 32 (0.00%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	0	0	0	0
Bradycardia
subjects affected / exposed	1 / 3 (33.33%)	1 / 3 (33.33%)	2 / 32 (6.25%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	1	2	0	0
Nervous system disorders
Sciatica
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 32 (0.00%)	1 / 3 (33.33%)	0 / 4 (0.00%)
occurrences all number	0	0	0	1	0
Post Herpetic Neuralgia
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	1 / 32 (3.13%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	2	2	0	0
Peripheral Sensory Neuropathy
subjects affected / exposed	1 / 3 (33.33%)	1 / 3 (33.33%)	7 / 32 (21.88%)	1 / 3 (33.33%)	3 / 4 (75.00%)
occurrences all number	1	1	9	1	4
Paraesthesia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 32 (6.25%)	1 / 3 (33.33%)	0 / 4 (0.00%)
occurrences all number	0	0	2	1	0
Headache
subjects affected / exposed	1 / 3 (33.33%)	1 / 3 (33.33%)	6 / 32 (18.75%)	1 / 3 (33.33%)	1 / 4 (25.00%)
occurrences all number	2	2	9	1	2
Embolic Stroke
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 32 (0.00%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	0	0	0	0
Dysgeusia
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	2 / 32 (6.25%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	0	3	0	0
Dizziness Postural
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 32 (0.00%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	1	0	0	0
Dizziness
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	2 / 32 (6.25%)	0 / 3 (0.00%)	1 / 4 (25.00%)
occurrences all number	1	0	4	0	1
Visual Field Defect
subjects affected / exposed	1 / 3 (33.33%)	1 / 3 (33.33%)	1 / 32 (3.13%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	1	1	0	0
Tremor
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 32 (6.25%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	4	0	0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	0 / 3 (0.00%)	2 / 3 (66.67%)	8 / 32 (25.00%)	1 / 3 (33.33%)	0 / 4 (0.00%)
occurrences all number	0	3	26	1	0
Leukocytosis
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 32 (6.25%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	2	0	0
Leukopenia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	8 / 32 (25.00%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	27	0	0
Lymphopenia
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	5 / 32 (15.63%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	1	8	0	0
Neutropenia
subjects affected / exposed	3 / 3 (100.00%)	2 / 3 (66.67%)	29 / 32 (90.63%)	2 / 3 (66.67%)	4 / 4 (100.00%)
occurrences all number	8	3	114	8	13
Thrombocytopenia
subjects affected / exposed	1 / 3 (33.33%)	2 / 3 (66.67%)	11 / 32 (34.38%)	0 / 3 (0.00%)	2 / 4 (50.00%)
occurrences all number	3	10	29	0	5
Ear and labyrinth disorders
Hearing Impaired
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 32 (0.00%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	1	0	0	0
Tinnitus
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	3 / 32 (9.38%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	3	0	0
Vertigo
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 32 (0.00%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	1	0	0	0
Eye disorders
Glaucoma
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 32 (0.00%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	1	0	0	0
Lacrimation Increased
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 32 (6.25%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	2	0	0
Retinal Artery Thrombosis
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 32 (0.00%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	2	0	0	0	0
Vision Blurred
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	2 / 32 (6.25%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	1	2	0	0
Visual Impairment
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 32 (0.00%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	1	0	0	0
Vitreous Detachment
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 32 (0.00%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	1	0	0	0
Cataract
subjects affected / exposed	0 / 3 (0.00%)	3 / 3 (100.00%)	3 / 32 (9.38%)	0 / 3 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	4	3	0	1
Gastrointestinal disorders
Dyspepsia
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	1 / 32 (3.13%)	0 / 3 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	1	1	0	1
Abdominal Discomfort
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 32 (6.25%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	3	0	0
Abdominal Pain
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	1 / 32 (3.13%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	2	1	0	0
Abdominal Pain Upper
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	4 / 32 (12.50%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	6	0	0
Constipation
subjects affected / exposed	3 / 3 (100.00%)	3 / 3 (100.00%)	7 / 32 (21.88%)	1 / 3 (33.33%)	1 / 4 (25.00%)
occurrences all number	3	4	13	1	1
Diarrhoea
subjects affected / exposed	2 / 3 (66.67%)	3 / 3 (100.00%)	18 / 32 (56.25%)	2 / 3 (66.67%)	3 / 4 (75.00%)
occurrences all number	9	7	33	2	12
Dry Mouth
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 32 (6.25%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	2	0	0
Faeces Discoloured
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 32 (0.00%)	1 / 3 (33.33%)	0 / 4 (0.00%)
occurrences all number	0	0	0	1	0
Gastrooesophageal Reflux Disease
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	1 / 32 (3.13%)	1 / 3 (33.33%)	0 / 4 (0.00%)
occurrences all number	1	0	2	1	0
Haemorrhoids
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 32 (3.13%)	0 / 3 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	1	0	1
Hypoaesthesia Oral
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 32 (0.00%)	1 / 3 (33.33%)	0 / 4 (0.00%)
occurrences all number	0	0	0	1	0
Mouth Ulceration
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 32 (0.00%)	0 / 3 (0.00%)	1 / 4 (25.00%)
occurrences all number	1	0	0	0	1
Nausea
subjects affected / exposed	1 / 3 (33.33%)	2 / 3 (66.67%)	11 / 32 (34.38%)	1 / 3 (33.33%)	2 / 4 (50.00%)
occurrences all number	2	2	14	1	4
Toothache
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	2 / 32 (6.25%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	0	2	0	0
Vomiting
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	5 / 32 (15.63%)	0 / 3 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	1	6	0	1
Tongue Blistering
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 32 (0.00%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	1	0	0	0
Hepatobiliary disorders
Cholelithiasis
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 32 (0.00%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	1	0	0	0
Skin and subcutaneous tissue disorders
Hyperhidrosis
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	4 / 32 (12.50%)	1 / 3 (33.33%)	1 / 4 (25.00%)
occurrences all number	0	0	5	1	2
Pruritus
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	1 / 32 (3.13%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	1	1	0	0
Purpura
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 32 (0.00%)	0 / 3 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	1
Rash
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	3 / 32 (9.38%)	0 / 3 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	3	0	1
Rash Generalised
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 32 (0.00%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	1	0	0	0
Dermal Cyst
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 32 (0.00%)	1 / 3 (33.33%)	0 / 4 (0.00%)
occurrences all number	0	0	0	1	0
Ecchymosis
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 32 (0.00%)	1 / 3 (33.33%)	0 / 4 (0.00%)
occurrences all number	1	0	0	1	0
Eczema
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 32 (0.00%)	0 / 3 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	1
Skin Disorder
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 32 (0.00%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	0	0	0	0
Skin Fragility
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 32 (0.00%)	1 / 3 (33.33%)	0 / 4 (0.00%)
occurrences all number	0	0	0	1	0
Skin Lesion
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 32 (3.13%)	0 / 3 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	1	0	1
Skin Ulcer
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 32 (0.00%)	1 / 3 (33.33%)	0 / 4 (0.00%)
occurrences all number	1	0	0	2	0
Renal and urinary disorders
Pollakiuria
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	1 / 32 (3.13%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	0	1	0	0
Nocturia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 32 (3.13%)	1 / 3 (33.33%)	0 / 4 (0.00%)
occurrences all number	0	0	1	1	0
Dysuria
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 32 (0.00%)	0 / 3 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	1	0	0	1
Renal Impairment
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	1 / 32 (3.13%)	1 / 3 (33.33%)	0 / 4 (0.00%)
occurrences all number	0	5	1	1	0
Polyuria
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 32 (0.00%)	0 / 3 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	1
Urinary Retention
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 32 (0.00%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	1	0	0	0
Endocrine disorders
Pituitary-Dependent Cushing's Syndrome
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 32 (0.00%)	0 / 3 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	1
Steroid Withdrawal Syndrome
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 32 (0.00%)	1 / 3 (33.33%)	0 / 4 (0.00%)
occurrences all number	0	0	0	3	0
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	2 / 32 (6.25%)	1 / 3 (33.33%)	1 / 4 (25.00%)
occurrences all number	1	0	2	3	2
Muscular Weakness
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 32 (0.00%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	2	0	0	0	0
Muscle Spasms
subjects affected / exposed	1 / 3 (33.33%)	3 / 3 (100.00%)	15 / 32 (46.88%)	3 / 3 (100.00%)	3 / 4 (75.00%)
occurrences all number	2	4	23	3	5
Joint Contracture
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 32 (0.00%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	1	0	0	0
Gouty Arthritis
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 32 (0.00%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	0	0	0	0
Bone Pain
subjects affected / exposed	1 / 3 (33.33%)	1 / 3 (33.33%)	6 / 32 (18.75%)	0 / 3 (0.00%)	2 / 4 (50.00%)
occurrences all number	1	2	9	0	6
Myopathy
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 32 (0.00%)	0 / 3 (0.00%)	1 / 4 (25.00%)
occurrences all number	1	0	0	0	1
Arthritis
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 32 (0.00%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	0	0	0	0
Myalgia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	3 / 32 (9.38%)	0 / 3 (0.00%)	2 / 4 (50.00%)
occurrences all number	0	0	3	0	2
Musculoskeletal Pain
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	3 / 32 (9.38%)	1 / 3 (33.33%)	1 / 4 (25.00%)
occurrences all number	0	0	5	1	1
Musculoskeletal Chest Pain
subjects affected / exposed	1 / 3 (33.33%)	1 / 3 (33.33%)	1 / 32 (3.13%)	0 / 3 (0.00%)	1 / 4 (25.00%)
occurrences all number	1	1	1	0	2
Back Pain
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	8 / 32 (25.00%)	0 / 3 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	2	9	0	1
Neck Pain
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 32 (3.13%)	1 / 3 (33.33%)	0 / 4 (0.00%)
occurrences all number	0	0	1	1	0
Osteonecrosis
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 32 (0.00%)	1 / 3 (33.33%)	0 / 4 (0.00%)
occurrences all number	0	0	0	1	0
Tendonitis
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 32 (0.00%)	0 / 3 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	1
Pain in Jaw
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 32 (0.00%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	1	0	0	0
Pain in Extremity
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	4 / 32 (12.50%)	1 / 3 (33.33%)	1 / 4 (25.00%)
occurrences all number	1	0	5	1	1
Osteonecrosis of Jaw
subjects affected / exposed	1 / 3 (33.33%)	1 / 3 (33.33%)	0 / 32 (0.00%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	2	0	0	0
Infections and infestations
Diarrhoea Infectious
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 32 (0.00%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	1	0	0	0
Bronchitis
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	9 / 32 (28.13%)	2 / 3 (66.67%)	0 / 4 (0.00%)
occurrences all number	0	0	14	5	0
Cellulitis
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	1 / 32 (3.13%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	1	1	0	0
Conjunctivitis
subjects affected / exposed	0 / 3 (0.00%)	2 / 3 (66.67%)	1 / 32 (3.13%)	1 / 3 (33.33%)	0 / 4 (0.00%)
occurrences all number	0	6	1	1	0
Cystitis
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 32 (0.00%)	1 / 3 (33.33%)	0 / 4 (0.00%)
occurrences all number	0	1	0	2	0
Erysipelas
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 32 (0.00%)	0 / 3 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	1
Fungal Skin Infection
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 32 (3.13%)	0 / 3 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	1	0	1
Gastroenteritis
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	4 / 32 (12.50%)	0 / 3 (0.00%)	1 / 4 (25.00%)
occurrences all number	3	0	5	0	1
Gastroenteritis Viral
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 32 (6.25%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	2	0	0
Herpes Zoster
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	3 / 32 (9.38%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	1	3	0	0
Infection
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 32 (6.25%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	5	0	0
Oral Herpes
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	2 / 32 (6.25%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	1	3	0	0
Kidney Infection
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 32 (0.00%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	0	0	0	0
Lower Respiratory Tract Infection
subjects affected / exposed	1 / 3 (33.33%)	1 / 3 (33.33%)	0 / 32 (0.00%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	4	3	0	0	0
Lower Respiratory Tract Infection Viral
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 32 (0.00%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	0	0	0	0
Lung Infection
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 32 (3.13%)	0 / 3 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	1	0	1
Nasopharyngitis
subjects affected / exposed	1 / 3 (33.33%)	2 / 3 (66.67%)	10 / 32 (31.25%)	2 / 3 (66.67%)	3 / 4 (75.00%)
occurrences all number	1	3	19	2	6
Oral Candidiasis
subjects affected / exposed	1 / 3 (33.33%)	1 / 3 (33.33%)	0 / 32 (0.00%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	1	0	0	0
Influenza
subjects affected / exposed	1 / 3 (33.33%)	1 / 3 (33.33%)	3 / 32 (9.38%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	1	3	0	0
Oral Infection
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 32 (0.00%)	1 / 3 (33.33%)	0 / 4 (0.00%)
occurrences all number	0	0	0	1	0
Pharyngitis
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	4 / 32 (12.50%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	4	0	0
Pneumonia
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 32 (3.13%)	0 / 3 (0.00%)	2 / 4 (50.00%)
occurrences all number	0	0	1	0	2
Postoperative Wound Infection
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 32 (0.00%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	1	0	0	0
Urinary Tract Infection
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	1 / 32 (3.13%)	1 / 3 (33.33%)	0 / 4 (0.00%)
occurrences all number	0	1	1	3	0
Rhinitis
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	8 / 32 (25.00%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	8	0	0
Sinusitis
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	1 / 32 (3.13%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	2	0	1	0	0
Tooth Infection
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 32 (0.00%)	1 / 3 (33.33%)	0 / 4 (0.00%)
occurrences all number	0	0	0	1	0
Upper Respiratory Tract Infection
subjects affected / exposed	2 / 3 (66.67%)	2 / 3 (66.67%)	8 / 32 (25.00%)	0 / 3 (0.00%)	2 / 4 (50.00%)
occurrences all number	3	9	16	0	3
Respiratory Tract Infection
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 32 (6.25%)	1 / 3 (33.33%)	0 / 4 (0.00%)
occurrences all number	0	0	4	1	0
Viral Infection
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	2 / 32 (6.25%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	2	2	0	0
Viral Upper Respiratory Tract Infection
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 32 (6.25%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	2	0	0
Vulvovaginal Mycotic Infection
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 32 (0.00%)	1 / 3 (33.33%)	0 / 4 (0.00%)
occurrences all number	0	0	0	1	0
Metabolism and nutrition disorders
Type 2 Diabetes Mellitus
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 32 (0.00%)	0 / 3 (0.00%)	1 / 4 (25.00%)
occurrences all number	0	0	0	0	1
Hypophosphataemia
subjects affected / exposed	1 / 3 (33.33%)	1 / 3 (33.33%)	0 / 32 (0.00%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	1	0	0	0
Hypomagnesaemia
subjects affected / exposed	0 / 3 (0.00%)	1 / 3 (33.33%)	1 / 32 (3.13%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	1	1	0	0
Hypokalaemia
subjects affected / exposed	1 / 3 (33.33%)	1 / 3 (33.33%)	4 / 32 (12.50%)	1 / 3 (33.33%)	0 / 4 (0.00%)
occurrences all number	3	2	4	2	0
Hypocalcaemia
subjects affected / exposed	1 / 3 (33.33%)	2 / 3 (66.67%)	4 / 32 (12.50%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	4	8	0	0
Hyperuricaemia
subjects affected / exposed	1 / 3 (33.33%)	1 / 3 (33.33%)	1 / 32 (3.13%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	1	1	1	0	0
Hyperglycaemia
subjects affected / exposed	1 / 3 (33.33%)	0 / 3 (0.00%)	3 / 32 (9.38%)	1 / 3 (33.33%)	1 / 4 (25.00%)
occurrences all number	1	0	3	1	2
Decreased Appetite
subjects affected / exposed	0 / 3 (0.00%)	0 / 3 (0.00%)	3 / 32 (9.38%)	0 / 3 (0.00%)	0 / 4 (0.00%)
occurrences all number	0	0	3	0	0

More information

Top of page

Were there any global substantial amendments to the protocol? Yes

03 Feb 2012

The overall rationale for the amendment was to be substantial based on the criteria set forth in Article 10(a) of Directive 2001/20/EC of the European Parliament and the Council of the European Union.

23 Feb 2012

The overall rationale for the amendment was to be nonsubstantial based on the criteria set forth in Article 10(a) of Directive 2001/20/European community (EC) of the European Parliament and the Council of the European Union, in that it does not significantly impact the safety or physical/mental integrity of subjects, nor the scientific value of the study.

26 Jul 2012

25 Feb 2013

26 Feb 2014

12 Jan 2015

06 Oct 2015

29 Sep 2016

The overall rationale for the amendment was to be substantial based on the criteria set forth in Article 10(a) of Directive 2001/20/EC of the European Parliament and the Council of the European.

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:
An Open label, International, Multicenter, Dose Escalating Phase 1/2 Trial Investigating the Safety of Daratumumab in Combination with Lenalidomide and Dexamethasone in Patients with Relapsed or Relapsed and Refractory Multiple Myeloma

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Phase 1: Percentage of Participants With Overall Response Rate (ORR)

Primary: Phase 1: Percentage of Participants With Overall Response Rate (ORR)

Primary: Phase 2: Percentage of Participants With Overall Response Rate (ORR)

Primary: Phase 2: Percentage of Participants With Overall Response Rate (ORR)

Secondary: Phase 2: Duration of Response

Secondary: Phase 2: Duration of Response

Secondary: Phase 1: Time to Response

Secondary: Phase 1: Time to Response

Secondary: Phase 2: Time to Response

Secondary: Phase 2: Time to Response

Secondary: Phase 2: Time to Progression (TTP)

Secondary: Phase 2: Time to Progression (TTP)

Secondary: Phase 2: Progression-Free Survival (PFS)

Secondary: Phase 2: Progression-Free Survival (PFS)

Secondary: Phase 2: Overall Survival (OS)

Secondary: Phase 2: Overall Survival (OS)

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: An Open label, International, Multicenter, Dose Escalating Phase 1/2 Trial Investigating the Safety of Daratumumab in Combination with Lenalidomide and Dexamethasone in Patients with Relapsed or Relapsed and Refractory Multiple Myeloma

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Phase 1: Percentage of Participants With Overall Response Rate (ORR)

Primary: Phase 1: Percentage of Participants With Overall Response Rate (ORR)

Primary: Phase 2: Percentage of Participants With Overall Response Rate (ORR)

Primary: Phase 2: Percentage of Participants With Overall Response Rate (ORR)

Secondary: Phase 2: Duration of Response

Secondary: Phase 2: Duration of Response

Secondary: Phase 1: Time to Response

Secondary: Phase 1: Time to Response

Secondary: Phase 2: Time to Response

Secondary: Phase 2: Time to Response

Secondary: Phase 2: Time to Progression (TTP)

Secondary: Phase 2: Time to Progression (TTP)

Secondary: Phase 2: Progression-Free Survival (PFS)

Secondary: Phase 2: Progression-Free Survival (PFS)

Secondary: Phase 2: Overall Survival (OS)

Secondary: Phase 2: Overall Survival (OS)

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
An Open label, International, Multicenter, Dose Escalating Phase 1/2 Trial Investigating the Safety of Daratumumab in Combination with Lenalidomide and Dexamethasone in Patients with Relapsed or Relapsed and Refractory Multiple Myeloma