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Trial record 1 of 1 for:    mmy3008
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Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Participants With Previously Untreated Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT02252172
Recruitment Status : Active, not recruiting
First Posted : September 30, 2014
Results First Posted : January 9, 2020
Last Update Posted : June 26, 2020
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma
Interventions Drug: Daratumumab IV
Drug: Lenalidomide
Drug: Dexamethasone
Drug: Daratumumab SC
Enrollment 737
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lenalidomide + Dexamethasone (Rd) Daratumumab + Lenalidomide + Dexamethasone (DRd)
Hide Arm/Group Description Participants received Lenalidomide 25 milligrams (mg) capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously (IV) once a week (QW) until disease progression or unacceptable toxicity. Participants received Daratumumab 16 milligrams per kilograms (mg/kg) IV QW for the first 8 weeks (cycles 1-2) and then every 2 weeks (Q2W) for 16 weeks (Cycle 3-6), then every 4 weeks (Q4W) (from Cycle 7 and beyond) (each cycle of 28 days), Lenalidomide 25 mg capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or IV QW until disease progression or unacceptable toxicity.
Period Title: Overall Study
Started 369 368
Treated 365 364
Completed [1] 90 69
Not Completed 279 299
Reason Not Completed
Lost to Follow-up             3             1
Ongoing             276             298
[1]
Participants who died or withdrew consent were considered as completed.
Arm/Group Title Lenalidomide + Dexamethasone (Rd) Daratumumab + Lenalidomide + Dexamethasone (DRd) Total
Hide Arm/Group Description Participants received Lenalidomide 25 milligrams (mg) capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously (IV) once a week (QW) until disease progression or unacceptable toxicity. Participants received Daratumumab 16 milligrams per kilograms (mg/kg) IV QW for the first 8 weeks (cycles 1-2) and then every 2 weeks (Q2W) for 16 weeks (Cycle 3-6), then every 4 weeks (Q4W) (from Cycle 7 and beyond) (each cycle of 28 days), Lenalidomide 25 mg capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or IV QW until disease progression or unacceptable toxicity. Total of all reporting groups
Overall Number of Baseline Participants 369 368 737
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 369 participants 368 participants 737 participants
74.2  (5.66) 74.0  (5.44) 74.1  (5.55)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 369 participants 368 participants 737 participants
Female
174
  47.2%
179
  48.6%
353
  47.9%
Male
195
  52.8%
189
  51.4%
384
  52.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 369 participants 368 participants 737 participants
Hispanic or Latino
12
   3.3%
11
   3.0%
23
   3.1%
Not Hispanic or Latino
352
  95.4%
347
  94.3%
699
  94.8%
Unknown or Not Reported
5
   1.4%
10
   2.7%
15
   2.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 369 participants 368 participants 737 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
   0.5%
3
   0.8%
5
   0.7%
Native Hawaiian or Other Pacific Islander
1
   0.3%
0
   0.0%
1
   0.1%
Black or African American
16
   4.3%
12
   3.3%
28
   3.8%
White
339
  91.9%
336
  91.3%
675
  91.6%
Other
6
   1.6%
6
   1.6%
12
   1.6%
Unknown or Not Reported
5
   1.4%
11
   3.0%
16
   2.2%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 369 participants 368 participants 737 participants
AUSTRALIA
18
   4.9%
17
   4.6%
35
   4.7%
AUSTRIA
11
   3.0%
3
   0.8%
14
   1.9%
BELGIUM
5
   1.4%
2
   0.5%
7
   0.9%
CANADA
28
   7.6%
24
   6.5%
52
   7.1%
DENMARK
6
   1.6%
10
   2.7%
16
   2.2%
FRANCE
155
  42.0%
157
  42.7%
312
  42.3%
GERMANY
16
   4.3%
19
   5.2%
35
   4.7%
IRELAND
3
   0.8%
4
   1.1%
7
   0.9%
ISRAEL
3
   0.8%
5
   1.4%
8
   1.1%
ITALY
3
   0.8%
3
   0.8%
6
   0.8%
NETHERLANDS
1
   0.3%
4
   1.1%
5
   0.7%
SWEDEN
12
   3.3%
10
   2.7%
22
   3.0%
UNITED KINGDOM
34
   9.2%
33
   9.0%
67
   9.1%
UNITED STATES
74
  20.1%
77
  20.9%
151
  20.5%
Stage of Disease (ISS)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 369 participants 368 participants 737 participants
Stage I
103
  27.9%
98
  26.6%
201
  27.3%
Stage II
156
  42.3%
163
  44.3%
319
  43.3%
Stage III
110
  29.8%
107
  29.1%
217
  29.4%
[1]
Measure Description: The International Staging System (ISS) consists of following 3 stages - Stage I: serum beta2-microglobulin less than (<) 3.5 milligram per liter (mg/L) and albumin greater than or equal to (>=) 3.5 gram per 100 Milliliter (g/100 mL); Stage II: neither stage I nor stage III and Stage III: serum beta2-microglobulin >= 5.5 mg/L.
Time from Multiple Myeloma (MM) diagnosis   [1] 
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 369 participants 368 participants 737 participants
1.3  (1.4) 1.4  (1.5) 1.3  (1.5)
[1]
Measure Description: Time from MM diagnosis is the time from diagnosis of multiple myeloma to randomization in each treatment group.
1.Primary Outcome
Title Primary: Progression-free Survival (PFS)
Hide Description PFS is defined as time from date of randomization to either progressive disease (PD) or death, whichever occurs first based on computerized algorithm as per International Myeloma Working Group (IMWG) criteria. PD is defined as an increase of 25 percent (%) from the lowest response value in one of the following: serum and urine M-component (absolute increase must be greater than or equal to [>=] 0.5 gram per deciliter [g/dL] and >=200 milligram [mg]/24 hours respectively); Only in participants without measurable serum and urine M-protein levels the difference between involved and uninvolved free light chain (FLC) levels (absolute increase must be greater than [>]10 mg/dL); Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to Plasma cell (PC) proliferative disorder.
Time Frame From randomization to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or clinical cut-off (CCO) whichever occurs first (up to 3.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population included all randomized participants.
Arm/Group Title Lenalidomide + Dexamethasone (Rd) Daratumumab + Lenalidomide + Dexamethasone (DRd)
Hide Arm/Group Description:
Participants received Lenalidomide 25 milligrams (mg) capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously (IV) once a week (QW) until disease progression or unacceptable toxicity.
Participants received Daratumumab 16 milligrams per kilograms (mg/kg) IV QW for the first 8 weeks (cycles 1-2) and then every 2 weeks (Q2W) for 16 weeks (Cycle 3-6), then every 4 weeks (Q4W) (from Cycle 7 and beyond) (each cycle of 28 days), Lenalidomide 25 mg capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or IV QW until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 369 368
Median (95% Confidence Interval)
Unit of Measure: Months
31.87 [1] 
(28.94 to NA)
NA [2] 
(NA to NA)
[1]
Here NA signifies upper limit of confidence interval (CI) was not estimable due to an insufficient number of events.
[2]
Here NA signifies Median and CI was not estimable due to an insufficient number of events.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lenalidomide + Dexamethasone (Rd), Daratumumab + Lenalidomide + Dexamethasone (DRd)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.56
Confidence Interval (2-Sided) 95%
0.43 to 0.73
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With Complete Response (CR) or Better
Hide Description CR or better is defined as percentage of participants with a CR or better (CR or stringent complete response [sCR]) based on computerized algorithm as per IMWG criteria. CR is defined as negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, and less than (<) 5 percent (%) PCs in bone marrow. In participants with only measurable disease by serum FLC levels a normal serum FLC ratio is required. sCR is defined as in addition to CR a normal FLC ratio, and absence of clonal PCs by immunohistochemistry or immunofluorescence or 2 to 4-color flow cytometry.
Time Frame From randomization to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years)
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Percentage of Participants With Very Good Partial Response (VGPR) or Better
Hide Description VGPR or better is defined as the percentage of participants with a response of VGPR or better (VGPR, CR or sCR) based on computerized algorithm as per IMWG criteria. VGPR is defined as serum and urine M-component detectable by immunofixation but not on electrophoresis or >=90% reduction in serum M-protein plus urine M-protein <100 mg/24 hours. In participants with only measurable disease by serum FLC levels a >90% decrease in the difference between involved and uninvolved FLC levels is required.
Time Frame From randomization to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years)
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Percentage of Participants With Negative Minimal Residual Disease (MRD)
Hide Description MRD negativity rate is defined as the percentage of participants who had negative MRD (detection of less than 1 malignant cell among 100,000 normal cells) assessment at any timepoint after the date of randomization by evaluation of bone marrow aspirates. MRD was assessed in participants who achieved CR or better.
Time Frame From randomization to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years)
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Overall Response Rate (ORR)
Hide Description ORR is defined as the percentage of participants who achieved partial response (PR) or better (PR, VGPR, CR or sCR) based on computerized algorithm as per IMWG criteria. PR is defined as >=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to <200 mg/24 hours. If the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved FLC levels is required. A >=50% reduction in the size of soft tissue plasmacytomas is also required.
Time Frame From randomization to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years)
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS was measured from the date of randomization to the date of the death.
Time Frame From randomization to death, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years)
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Time to Disease Progression (TTP)
Hide Description TTP is defined as the time from the date of randomization to the date of PD based on computerized algorithm as per IMWG criteria, or death due to PD.
Time Frame From randomization to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years)
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Time to Response
Hide Description Time to response is defined as the time from the date of randomization to the first efficacy evaluation that met criteria for PR or better based on computerized algorithm as per IMWG criteria. PR: >=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to <200 mg/24 hours. If the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria; If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, >=50% reduction in bone marrow PCs is required. A >=50% reduction in the size of soft tissue plasmacytomas is also required.
Time Frame From randomization to first response (PR or better) (up to 7.8 years)
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Duration of Response (DoR)
Hide Description DoR is defined as the time from the date of initial response (PR or better) to the date of PD, based on computerized algorithm as per IMWG criteria.
Time Frame From first response (PR of better) to disease progression, death, subsequent anti-myeloma therapy, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years)
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Time to Subsequent Anti-myeloma Treatment
Hide Description Time to subsequent anti-myeloma treatment is defined as the time from randomization to the start of first line of subsequent anti-myeloma treatment or death, whichever occurs first.
Time Frame From randomization to start of first subsequent anti-myeloma treatment, death, withdrawal of consent to study participation or CCO whichever is first (up to 7.8 years)
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Progression-free Survival on Next Line of Therapy (PFS2)
Hide Description PFS2 is defined as the time from randomization to progression on the first line of subsequent anti-myeloma therapy or death, whichever occurs first. Disease progression on first line of subsequent anti-myeloma treatment was based on investigator judgment. Participants that were censored for PFS1 were also censored for PFS2.
Time Frame From randomization to disease progression on first line of subsequent anti-myeloma therapy, death, withdrawal of consent to study participation or CCO whichever occurs first (up to 7.8 years)
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30 Global Health Status Score to Day 1 of Cycle 3, 6, 9 and 12
Hide Description EORTC QLQ-C30 is 30 items self-reporting questionnaire, with 1 week recall period, resulting in 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 Global Health Status (GHS) scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Questionnaire includes 28 items with 4-point Likert type responses from "1-not at all" to "4-very much" to assess functioning and symptoms; 2 items with 7-point Likert scales (1= poor and 7= excellent) for global health and overall health related QoL. Scores are transformed to 0 to 100 scale, with higher scores representing better GHS, better functioning, and more symptoms. Negative change from baseline values shows deterioration in quality of life or functioning and reduction in symptom and positive values indicate improvement and worsening of symptoms.
Time Frame Baseline and Day 1 of Cycle 3, 6, 9 and 12 (each Cycle of 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable in this outcome measure. Here 'n' (number analyzed) signifies number of participants analyzed at specified timepoints.
Arm/Group Title Lenalidomide + Dexamethasone (Rd) Daratumumab + Lenalidomide + Dexamethasone (DRd)
Hide Arm/Group Description:
Participants received Lenalidomide 25 milligrams (mg) capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously (IV) once a week (QW) until disease progression or unacceptable toxicity.
Participants received Daratumumab 16 milligrams per kilograms (mg/kg) IV QW for the first 8 weeks (cycles 1-2) and then every 2 weeks (Q2W) for 16 weeks (Cycle 3-6), then every 4 weeks (Q4W) (from Cycle 7 and beyond) (each cycle of 28 days), Lenalidomide 25 mg capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or IV QW until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 348 354
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Score on scale
Global health status score: Cycle 3 Day 1 Number Analyzed 272 participants 303 participants
1.5
(-0.7 to 3.7)
4.5
(2.4 to 6.6)
Global health status score: Cycle 6 Day 1 Number Analyzed 255 participants 295 participants
5.6
(3.3 to 7.9)
6.4
(4.3 to 8.6)
Global health status score: Cycle 9 Day 1 Number Analyzed 214 participants 268 participants
7
(4.6 to 9.4)
8.2
(6 to 10.4)
Global health status score: Cycle 12 Day 1 Number Analyzed 209 participants 260 participants
5.4
(2.9 to 7.9)
8.4
(6.1 to 10.6)
13.Secondary Outcome
Title Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) to Day 1 of Cycle 3, 6, 9 and 12
Hide Description EQ-5D-5L is a standardized, participant-rated questionnaire to assess health-related quality of life. The EQ-5D-5L includes 2 components: the EQ-5D-5L health state profile (descriptive system) and the EQ-5D-5L Visual Analog Scale. The Visual Analogue Scale is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.
Time Frame Baseline and Day 1 of Cycle 3, 6, 9 and 12 (each Cycle of 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable in this outcome measure. Here 'n' signifies number of participants analyzed at specified timepoints.
Arm/Group Title Lenalidomide + Dexamethasone (Rd) Daratumumab + Lenalidomide + Dexamethasone (DRd)
Hide Arm/Group Description:
Participants received Lenalidomide 25 milligrams (mg) capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously (IV) once a week (QW) until disease progression or unacceptable toxicity.
Participants received Daratumumab 16 milligrams per kilograms (mg/kg) IV QW for the first 8 weeks (cycles 1-2) and then every 2 weeks (Q2W) for 16 weeks (Cycle 3-6), then every 4 weeks (Q4W) (from Cycle 7 and beyond) (each cycle of 28 days), Lenalidomide 25 mg capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or IV QW until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 346 349
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Score on scale
Change at Cycle 3 Day 1 Number Analyzed 262 participants 290 participants
2.5
(0.6 to 4.4)
4.9
(3 to 6.7)
Change at Cycle 6 Day 1 Number Analyzed 240 participants 280 participants
5.7
(3.7 to 7.7)
8
(6.1 to 9.8)
Change at Cycle 9 Day 1 Number Analyzed 207 participants 256 participants
7.7
(5.6 to 9.8)
10.2
(8.2 to 12.1)
Change at Cycle 12 Day 1 Number Analyzed 206 participants 247 participants
4.9
(2.8 to 7)
10.1
(8.1 to 12.1)
14.Secondary Outcome
Title Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Utility Score to Day 1 of Cycle 3, 6, 9 and 12
Hide Description EQ-5D-5L is standardized, participant-reported questionnaire to assess health-related quality of life. EQ-5D-5L includes 2 components: EQ-5D-5L health state profile (descriptive system) and EQ-5D-5L VAS. EQ-5D-5L descriptive system provides a profile of participant's health state 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The participant was asked to indicate his/her current health state by selecting the most appropriate level in each of the 5 dimensions. Responses to the 5-dimension scores were combined and converted into single preference-weighted health utility index score 0 (0.0- worst health state) to 1 (1.0- better health state) representing the general health status of individual (but allows for values less than 0 by United kingdom [UK] scoring algorithm).
Time Frame Baseline and Day 1 of Cycle 3, 6, 9 and 12 (each Cycle of 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable in this outcome measure. Here 'n' signifies number of participants analyzed at specified timepoints.
Arm/Group Title Lenalidomide + Dexamethasone (Rd) Daratumumab + Lenalidomide + Dexamethasone (DRd)
Hide Arm/Group Description:
Participants received Lenalidomide 25 milligrams (mg) capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously (IV) once a week (QW) until disease progression or unacceptable toxicity.
Participants received Daratumumab 16 milligrams per kilograms (mg/kg) IV QW for the first 8 weeks (cycles 1-2) and then every 2 weeks (Q2W) for 16 weeks (Cycle 3-6), then every 4 weeks (Q4W) (from Cycle 7 and beyond) (each cycle of 28 days), Lenalidomide 25 mg capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or IV QW until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 346 349
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Score on scale
Change at Cycle 3 Day 1 Number Analyzed 262 participants 291 participants
0.08
(0.057 to 0.102)
0.107
(0.085 to 0.128)
Change at Cycle 6 Day 1 Number Analyzed 240 participants 280 participants
0.116
(0.092 to 0.139)
0.136
(0.114 to 0.158)
Change at Cycle 9 Day 1 Number Analyzed 207 participants 256 participants
0.124
(0.1 to 0.149)
0.124
(0.101 to 0.146)
Change at Cycle 12 Day 1 Number Analyzed 206 participants 247 participants
0.113
(0.088 to 0.138)
0.141
(0.118 to 0.164)
Time Frame Up to 3.5 years
Adverse Event Reporting Description Safety population was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
 
Arm/Group Title Lenalidomide + Dexamethasone (Rd) Daratumumab + Lenalidomide + Dexamethasone (DRd)
Hide Arm/Group Description Participants received Lenalidomide 25 milligrams (mg) capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously (IV) once a week (QW) until disease progression or unacceptable toxicity. Participants received Daratumumab 16 milligrams per kilograms (mg/kg) IV QW for the first 8 weeks (cycles 1-2) and then every 2 weeks (Q2W) for 16 weeks (Cycle 3-6), then every 4 weeks (Q4W) (from Cycle 7 and beyond) (each cycle of 28 days), Lenalidomide 25 mg capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or IV QW until disease progression or unacceptable toxicity.
All-Cause Mortality
Lenalidomide + Dexamethasone (Rd) Daratumumab + Lenalidomide + Dexamethasone (DRd)
Affected / at Risk (%) Affected / at Risk (%)
Total   76/365 (20.82%)   62/364 (17.03%) 
Hide Serious Adverse Events
Lenalidomide + Dexamethasone (Rd) Daratumumab + Lenalidomide + Dexamethasone (DRd)
Affected / at Risk (%) Affected / at Risk (%)
Total   229/365 (62.74%)   229/364 (62.91%) 
Blood and lymphatic system disorders     
Anaemia * 1  12/365 (3.29%)  6/364 (1.65%) 
Anaemia Macrocytic * 1  1/365 (0.27%)  0/364 (0.00%) 
Disseminated Intravascular Coagulation * 1  1/365 (0.27%)  0/364 (0.00%) 
Febrile Neutropenia * 1  9/365 (2.47%)  9/364 (2.47%) 
Heparin-Induced Thrombocytopenia * 1  1/365 (0.27%)  0/364 (0.00%) 
Leukopenia * 1  0/365 (0.00%)  1/364 (0.27%) 
Neutropenia * 1  2/365 (0.55%)  3/364 (0.82%) 
Thrombocytopenia * 1  2/365 (0.55%)  0/364 (0.00%) 
Cardiac disorders     
Acute Coronary Syndrome * 1  5/365 (1.37%)  0/364 (0.00%) 
Acute Myocardial Infarction * 1  1/365 (0.27%)  3/364 (0.82%) 
Angina Pectoris * 1  0/365 (0.00%)  2/364 (0.55%) 
Arrhythmia * 1  1/365 (0.27%)  0/364 (0.00%) 
Arteriosclerosis Coronary Artery * 1  0/365 (0.00%)  1/364 (0.27%) 
Atrial Fibrillation * 1  12/365 (3.29%)  8/364 (2.20%) 
Atrial Flutter * 1  2/365 (0.55%)  2/364 (0.55%) 
Atrial Tachycardia * 1  1/365 (0.27%)  0/364 (0.00%) 
Atrioventricular Block * 1  0/365 (0.00%)  1/364 (0.27%) 
Atrioventricular Block Complete * 1  1/365 (0.27%)  0/364 (0.00%) 
Bradycardia * 1  1/365 (0.27%)  0/364 (0.00%) 
Cardiac Amyloidosis * 1  1/365 (0.27%)  0/364 (0.00%) 
Cardiac Arrest * 1  3/365 (0.82%)  2/364 (0.55%) 
Cardiac Failure * 1  9/365 (2.47%)  5/364 (1.37%) 
Cardiac Failure Acute * 1  0/365 (0.00%)  1/364 (0.27%) 
Cardiac Failure Chronic * 1  1/365 (0.27%)  0/364 (0.00%) 
Cardiac Failure Congestive * 1  5/365 (1.37%)  2/364 (0.55%) 
Cardio-Respiratory Arrest * 1  0/365 (0.00%)  1/364 (0.27%) 
Cardiogenic Shock * 1  1/365 (0.27%)  0/364 (0.00%) 
Coronary Artery Disease * 1  1/365 (0.27%)  2/364 (0.55%) 
Coronary Artery Stenosis * 1  0/365 (0.00%)  1/364 (0.27%) 
Hypertensive Heart Disease * 1  0/365 (0.00%)  1/364 (0.27%) 
Myocardial Infarction * 1  5/365 (1.37%)  1/364 (0.27%) 
Myocardial Ischaemia * 1  1/365 (0.27%)  2/364 (0.55%) 
Myocarditis * 1  1/365 (0.27%)  0/364 (0.00%) 
Pericardial Effusion * 1  0/365 (0.00%)  1/364 (0.27%) 
Stress Cardiomyopathy * 1  0/365 (0.00%)  1/364 (0.27%) 
Ventricular Tachycardia * 1  1/365 (0.27%)  1/364 (0.27%) 
Congenital, familial and genetic disorders     
Corneal Dystrophy * 1  0/365 (0.00%)  1/364 (0.27%) 
Ear and labyrinth disorders     
Deafness Bilateral * 1  0/365 (0.00%)  1/364 (0.27%) 
Vertigo * 1  2/365 (0.55%)  2/364 (0.55%) 
Endocrine disorders     
Adrenal Insufficiency * 1  0/365 (0.00%)  1/364 (0.27%) 
Hypothyroidism * 1  1/365 (0.27%)  0/364 (0.00%) 
Eye disorders     
Blepharitis * 1  0/365 (0.00%)  1/364 (0.27%) 
Cataract * 1  5/365 (1.37%)  2/364 (0.55%) 
Retinal Artery Occlusion * 1  0/365 (0.00%)  1/364 (0.27%) 
Retinal Detachment * 1  1/365 (0.27%)  0/364 (0.00%) 
Retinal Vein Thrombosis * 1  1/365 (0.27%)  0/364 (0.00%) 
Gastrointestinal disorders     
Abdominal Pain * 1  2/365 (0.55%)  4/364 (1.10%) 
Abdominal Pain Upper * 1  0/365 (0.00%)  1/364 (0.27%) 
Ascites * 1  0/365 (0.00%)  2/364 (0.55%) 
Colitis * 1  3/365 (0.82%)  1/364 (0.27%) 
Colitis Ischaemic * 1  0/365 (0.00%)  3/364 (0.82%) 
Constipation * 1  1/365 (0.27%)  3/364 (0.82%) 
Diarrhoea * 1  6/365 (1.64%)  9/364 (2.47%) 
Diarrhoea Haemorrhagic * 1  1/365 (0.27%)  0/364 (0.00%) 
Diverticular Perforation * 1  2/365 (0.55%)  4/364 (1.10%) 
Diverticulum * 1  1/365 (0.27%)  0/364 (0.00%) 
Diverticulum Intestinal Haemorrhagic * 1  1/365 (0.27%)  0/364 (0.00%) 
Dyspepsia * 1  1/365 (0.27%)  1/364 (0.27%) 
Dysphagia * 1  0/365 (0.00%)  1/364 (0.27%) 
Enterovesical Fistula * 1  1/365 (0.27%)  0/364 (0.00%) 
Faecaloma * 1  2/365 (0.55%)  0/364 (0.00%) 
Gastric Haemorrhage * 1  1/365 (0.27%)  0/364 (0.00%) 
Gastric Ulcer * 1  1/365 (0.27%)  0/364 (0.00%) 
Gastrointestinal Haemorrhage * 1  2/365 (0.55%)  2/364 (0.55%) 
Inguinal Hernia * 1  1/365 (0.27%)  3/364 (0.82%) 
Inguinal Hernia Strangulated * 1  1/365 (0.27%)  0/364 (0.00%) 
Intestinal Ischaemia * 1  0/365 (0.00%)  1/364 (0.27%) 
Intestinal Obstruction * 1  0/365 (0.00%)  2/364 (0.55%) 
Large Intestinal Obstruction * 1  1/365 (0.27%)  0/364 (0.00%) 
Large Intestine Perforation * 1  1/365 (0.27%)  1/364 (0.27%) 
Melaena * 1  2/365 (0.55%)  0/364 (0.00%) 
Nausea * 1  2/365 (0.55%)  4/364 (1.10%) 
Oesophageal Achalasia * 1  0/365 (0.00%)  1/364 (0.27%) 
Oesophagitis * 1  1/365 (0.27%)  0/364 (0.00%) 
Pancreatitis * 1  1/365 (0.27%)  1/364 (0.27%) 
Pancreatitis Acute * 1  1/365 (0.27%)  3/364 (0.82%) 
Pneumoperitoneum * 1  1/365 (0.27%)  0/364 (0.00%) 
Rectal Haemorrhage * 1  2/365 (0.55%)  0/364 (0.00%) 
Small Intestinal Obstruction * 1  0/365 (0.00%)  1/364 (0.27%) 
Subileus * 1  1/365 (0.27%)  0/364 (0.00%) 
Upper Gastrointestinal Haemorrhage * 1  0/365 (0.00%)  1/364 (0.27%) 
Vomiting * 1  3/365 (0.82%)  4/364 (1.10%) 
General disorders     
Asthenia * 1  7/365 (1.92%)  3/364 (0.82%) 
Chest Discomfort * 1  1/365 (0.27%)  0/364 (0.00%) 
Chest Pain * 1  2/365 (0.55%)  0/364 (0.00%) 
Chills * 1  0/365 (0.00%)  1/364 (0.27%) 
Extravasation * 1  0/365 (0.00%)  1/364 (0.27%) 
Fatigue * 1  0/365 (0.00%)  4/364 (1.10%) 
General Physical Health Deterioration * 1  10/365 (2.74%)  2/364 (0.55%) 
Granuloma * 1  0/365 (0.00%)  1/364 (0.27%) 
Malaise * 1  1/365 (0.27%)  0/364 (0.00%) 
Multiple Organ Dysfunction Syndrome * 1  1/365 (0.27%)  2/364 (0.55%) 
Non-Cardiac Chest Pain * 1  3/365 (0.82%)  3/364 (0.82%) 
Oedema Peripheral * 1  0/365 (0.00%)  1/364 (0.27%) 
Pain * 1  1/365 (0.27%)  0/364 (0.00%) 
Peripheral Swelling * 1  0/365 (0.00%)  1/364 (0.27%) 
Pyrexia * 1  11/365 (3.01%)  16/364 (4.40%) 
Sudden Cardiac Death * 1  1/365 (0.27%)  0/364 (0.00%) 
Sudden Death * 1  0/365 (0.00%)  1/364 (0.27%) 
Systemic Inflammatory Response Syndrome * 1  1/365 (0.27%)  0/364 (0.00%) 
Hepatobiliary disorders     
Acute Hepatic Failure * 1  1/365 (0.27%)  0/364 (0.00%) 
Bile Duct Stone * 1  0/365 (0.00%)  1/364 (0.27%) 
Cholecystitis * 1  1/365 (0.27%)  0/364 (0.00%) 
Cholecystitis Acute * 1  0/365 (0.00%)  4/364 (1.10%) 
Cholestasis * 1  1/365 (0.27%)  0/364 (0.00%) 
Hepatic Failure * 1  1/365 (0.27%)  0/364 (0.00%) 
Hepatocellular Injury * 1  1/365 (0.27%)  0/364 (0.00%) 
Hyperbilirubinaemia * 1  1/365 (0.27%)  0/364 (0.00%) 
Infections and infestations     
Abdominal Sepsis * 1  1/365 (0.27%)  0/364 (0.00%) 
Anal Abscess * 1  1/365 (0.27%)  0/364 (0.00%) 
Appendicitis Perforated * 1  1/365 (0.27%)  0/364 (0.00%) 
Arthritis Bacterial * 1  1/365 (0.27%)  0/364 (0.00%) 
Arthritis Infective * 1  0/365 (0.00%)  1/364 (0.27%) 
Bacteraemia * 1  1/365 (0.27%)  1/364 (0.27%) 
Bacterial Diarrhoea * 1  0/365 (0.00%)  1/364 (0.27%) 
Bronchiolitis * 1  1/365 (0.27%)  1/364 (0.27%) 
Bronchitis * 1  5/365 (1.37%)  12/364 (3.30%) 
Campylobacter Infection * 1  1/365 (0.27%)  0/364 (0.00%) 
Cellulitis * 1  4/365 (1.10%)  2/364 (0.55%) 
Clostridium Difficile Colitis * 1  1/365 (0.27%)  3/364 (0.82%) 
Colonic Abscess * 1  0/365 (0.00%)  1/364 (0.27%) 
Corona Virus Infection * 1  0/365 (0.00%)  1/364 (0.27%) 
Cystitis * 1  0/365 (0.00%)  1/364 (0.27%) 
Device Related Infection * 1  0/365 (0.00%)  3/364 (0.82%) 
Diverticulitis * 1  3/365 (0.82%)  6/364 (1.65%) 
Endocarditis * 1  0/365 (0.00%)  1/364 (0.27%) 
Endocarditis Staphylococcal * 1  1/365 (0.27%)  0/364 (0.00%) 
Erysipelas * 1  3/365 (0.82%)  3/364 (0.82%) 
Escherichia Pyelonephritis * 1  1/365 (0.27%)  0/364 (0.00%) 
Escherichia Sepsis * 1  2/365 (0.55%)  0/364 (0.00%) 
Escherichia Urinary Tract Infection * 1  0/365 (0.00%)  2/364 (0.55%) 
Gastroenteritis * 1  0/365 (0.00%)  1/364 (0.27%) 
Gastrointestinal Viral Infection * 1  1/365 (0.27%)  0/364 (0.00%) 
Groin Abscess * 1  2/365 (0.55%)  0/364 (0.00%) 
Haematoma Infection * 1  0/365 (0.00%)  1/364 (0.27%) 
Infected Cyst * 1  1/365 (0.27%)  0/364 (0.00%) 
Infection * 1  0/365 (0.00%)  1/364 (0.27%) 
Influenza * 1  6/365 (1.64%)  11/364 (3.02%) 
Klebsiella Bacteraemia * 1  1/365 (0.27%)  1/364 (0.27%) 
Klebsiella Infection * 1  0/365 (0.00%)  1/364 (0.27%) 
Laryngitis * 1  1/365 (0.27%)  0/364 (0.00%) 
Lower Respiratory Tract Infection * 1  11/365 (3.01%)  10/364 (2.75%) 
Lower Respiratory Tract Infection Bacterial * 1  2/365 (0.55%)  0/364 (0.00%) 
Lower Respiratory Tract Infection Viral * 1  1/365 (0.27%)  0/364 (0.00%) 
Lung Infection * 1  1/365 (0.27%)  7/364 (1.92%) 
Metapneumovirus Infection * 1  1/365 (0.27%)  1/364 (0.27%) 
Myocarditis Infectious * 1  0/365 (0.00%)  1/364 (0.27%) 
Neutropenic Infection * 1  1/365 (0.27%)  0/364 (0.00%) 
Neutropenic Sepsis * 1  0/365 (0.00%)  1/364 (0.27%) 
Nocardiosis * 1  0/365 (0.00%)  1/364 (0.27%) 
Oesophageal Candidiasis * 1  0/365 (0.00%)  1/364 (0.27%) 
Osteomyelitis * 1  2/365 (0.55%)  0/364 (0.00%) 
Otitis Externa * 1  1/365 (0.27%)  0/364 (0.00%) 
Peritonitis * 1  1/365 (0.27%)  0/364 (0.00%) 
Pharyngitis * 1  0/365 (0.00%)  1/364 (0.27%) 
Pleural Infection * 1  0/365 (0.00%)  1/364 (0.27%) 
Pneumocystis Jirovecii Infection * 1  0/365 (0.00%)  1/364 (0.27%) 
Pneumocystis Jirovecii Pneumonia * 1  0/365 (0.00%)  1/364 (0.27%) 
Pneumonia * 1  27/365 (7.40%)  48/364 (13.19%) 
Pulmonary Mycosis * 1  0/365 (0.00%)  1/364 (0.27%) 
Pyelonephritis * 1  0/365 (0.00%)  2/364 (0.55%) 
Respiratory Syncytial Virus Bronchiolitis * 1  1/365 (0.27%)  0/364 (0.00%) 
Respiratory Syncytial Virus Infection * 1  2/365 (0.55%)  1/364 (0.27%) 
Respiratory Tract Infection * 1  0/365 (0.00%)  1/364 (0.27%) 
Salmonellosis * 1  0/365 (0.00%)  1/364 (0.27%) 
Sepsis * 1  7/365 (1.92%)  9/364 (2.47%) 
Sepsis Syndrome * 1  0/365 (0.00%)  1/364 (0.27%) 
Septic Arthritis Staphylococcal * 1  0/365 (0.00%)  1/364 (0.27%) 
Septic Embolus * 1  0/365 (0.00%)  1/364 (0.27%) 
Septic Shock * 1  3/365 (0.82%)  4/364 (1.10%) 
Skin Infection * 1  0/365 (0.00%)  1/364 (0.27%) 
Soft Tissue Infection * 1  1/365 (0.27%)  0/364 (0.00%) 
Spinal Cord Infection * 1  1/365 (0.27%)  0/364 (0.00%) 
Staphylococcal Sepsis * 1  1/365 (0.27%)  0/364 (0.00%) 
Subcutaneous Abscess * 1  0/365 (0.00%)  1/364 (0.27%) 
Upper Respiratory Tract Infection * 1  4/365 (1.10%)  5/364 (1.37%) 
Ureteritis * 1  0/365 (0.00%)  1/364 (0.27%) 
Urinary Tract Infection * 1  5/365 (1.37%)  8/364 (2.20%) 
Urinary Tract Infection Bacterial * 1  0/365 (0.00%)  1/364 (0.27%) 
Urosepsis * 1  1/365 (0.27%)  1/364 (0.27%) 
Varicella Zoster Virus Infection * 1  1/365 (0.27%)  0/364 (0.00%) 
Vascular Stent Infection * 1  0/365 (0.00%)  1/364 (0.27%) 
Vestibular Neuronitis * 1  0/365 (0.00%)  1/364 (0.27%) 
Viral Upper Respiratory Tract Infection * 1  0/365 (0.00%)  2/364 (0.55%) 
Injury, poisoning and procedural complications     
Accident * 1  0/365 (0.00%)  1/364 (0.27%) 
Accidental Overdose * 1  1/365 (0.27%)  0/364 (0.00%) 
Acetabulum Fracture * 1  0/365 (0.00%)  1/364 (0.27%) 
Clavicle Fracture * 1  0/365 (0.00%)  1/364 (0.27%) 
Concussion * 1  0/365 (0.00%)  1/364 (0.27%) 
Craniocerebral Injury * 1  0/365 (0.00%)  1/364 (0.27%) 
Face Injury * 1  0/365 (0.00%)  1/364 (0.27%) 
Facial Bones Fracture * 1  0/365 (0.00%)  1/364 (0.27%) 
Fall * 1  1/365 (0.27%)  2/364 (0.55%) 
Femoral Neck Fracture * 1  2/365 (0.55%)  1/364 (0.27%) 
Femur Fracture * 1  3/365 (0.82%)  4/364 (1.10%) 
Foot Fracture * 1  1/365 (0.27%)  0/364 (0.00%) 
Fracture * 1  1/365 (0.27%)  1/364 (0.27%) 
Head Injury * 1  1/365 (0.27%)  0/364 (0.00%) 
Hip Fracture * 1  1/365 (0.27%)  4/364 (1.10%) 
Humerus Fracture * 1  0/365 (0.00%)  2/364 (0.55%) 
Limb Injury * 1  1/365 (0.27%)  0/364 (0.00%) 
Open Fracture * 1  1/365 (0.27%)  0/364 (0.00%) 
Pelvic Fracture * 1  1/365 (0.27%)  1/364 (0.27%) 
Periorbital Haemorrhage * 1  0/365 (0.00%)  1/364 (0.27%) 
Postoperative Fever * 1  1/365 (0.27%)  0/364 (0.00%) 
Pubis Fracture * 1  1/365 (0.27%)  0/364 (0.00%) 
Rib Fracture * 1  1/365 (0.27%)  3/364 (0.82%) 
Spinal Compression Fracture * 1  2/365 (0.55%)  6/364 (1.65%) 
Spinal Fracture * 1  1/365 (0.27%)  0/364 (0.00%) 
Sternal Fracture * 1  1/365 (0.27%)  0/364 (0.00%) 
Subdural Haematoma * 1  0/365 (0.00%)  1/364 (0.27%) 
Tendon Rupture * 1  0/365 (0.00%)  1/364 (0.27%) 
Upper Limb Fracture * 1  0/365 (0.00%)  2/364 (0.55%) 
Investigations     
Blood Creatinine Increased * 1  2/365 (0.55%)  0/364 (0.00%) 
C-Reactive Protein Increased * 1  1/365 (0.27%)  1/364 (0.27%) 
International Normalised Ratio Increased * 1  1/365 (0.27%)  0/364 (0.00%) 
Lipase Increased * 1  0/365 (0.00%)  1/364 (0.27%) 
Occult Blood Positive * 1  1/365 (0.27%)  0/364 (0.00%) 
Oxygen Saturation Decreased * 1  0/365 (0.00%)  1/364 (0.27%) 
Transaminases Increased * 1  1/365 (0.27%)  0/364 (0.00%) 
Troponin I Increased * 1  1/365 (0.27%)  0/364 (0.00%) 
Metabolism and nutrition disorders     
Decreased Appetite * 1  1/365 (0.27%)  2/364 (0.55%) 
Dehydration * 1  1/365 (0.27%)  6/364 (1.65%) 
Diabetes Mellitus Inadequate Control * 1  1/365 (0.27%)  1/364 (0.27%) 
Failure to Thrive * 1  1/365 (0.27%)  0/364 (0.00%) 
Gout * 1  2/365 (0.55%)  1/364 (0.27%) 
Hypercalcaemia * 1  3/365 (0.82%)  1/364 (0.27%) 
Hyperglycaemia * 1  1/365 (0.27%)  2/364 (0.55%) 
Hyperkalaemia * 1  2/365 (0.55%)  2/364 (0.55%) 
Hypocalcaemia * 1  3/365 (0.82%)  1/364 (0.27%) 
Hypokalaemia * 1  5/365 (1.37%)  3/364 (0.82%) 
Hypomagnesaemia * 1  1/365 (0.27%)  0/364 (0.00%) 
Hyponatraemia * 1  3/365 (0.82%)  2/364 (0.55%) 
Hypovolaemia * 1  1/365 (0.27%)  0/364 (0.00%) 
Type 1 Diabetes Mellitus * 1  0/365 (0.00%)  1/364 (0.27%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  2/365 (0.55%)  2/364 (0.55%) 
Arthritis * 1  0/365 (0.00%)  2/364 (0.55%) 
Back Pain * 1  8/365 (2.19%)  12/364 (3.30%) 
Bone Lesion * 1  2/365 (0.55%)  0/364 (0.00%) 
Bone Pain * 1  4/365 (1.10%)  4/364 (1.10%) 
Bursitis * 1  1/365 (0.27%)  0/364 (0.00%) 
Chondrocalcinosis * 1  1/365 (0.27%)  0/364 (0.00%) 
Chondrocalcinosis Pyrophosphate * 1  1/365 (0.27%)  1/364 (0.27%) 
Crystal Arthropathy * 1  1/365 (0.27%)  0/364 (0.00%) 
Intervertebral Disc Compression * 1  0/365 (0.00%)  1/364 (0.27%) 
Intervertebral Disc Protrusion * 1  0/365 (0.00%)  1/364 (0.27%) 
Jaw Fistula * 1  1/365 (0.27%)  0/364 (0.00%) 
Lumbar Spinal Stenosis * 1  0/365 (0.00%)  1/364 (0.27%) 
Muscle Spasms * 1  0/365 (0.00%)  2/364 (0.55%) 
Muscular Weakness * 1  2/365 (0.55%)  4/364 (1.10%) 
Musculoskeletal Chest Pain * 1  2/365 (0.55%)  0/364 (0.00%) 
Musculoskeletal Pain * 1  1/365 (0.27%)  3/364 (0.82%) 
Neck Pain * 1  1/365 (0.27%)  0/364 (0.00%) 
Osteoarthritis * 1  2/365 (0.55%)  1/364 (0.27%) 
Osteolysis * 1  1/365 (0.27%)  1/364 (0.27%) 
Osteonecrosis * 1  0/365 (0.00%)  2/364 (0.55%) 
Osteonecrosis of Jaw * 1  2/365 (0.55%)  1/364 (0.27%) 
Osteoporosis * 1  0/365 (0.00%)  1/364 (0.27%) 
Pain in Extremity * 1  0/365 (0.00%)  1/364 (0.27%) 
Pathological Fracture * 1  1/365 (0.27%)  0/364 (0.00%) 
Primary Sequestrum * 1  1/365 (0.27%)  0/364 (0.00%) 
Spinal Pain * 1  4/365 (1.10%)  2/364 (0.55%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma Gastric * 1  1/365 (0.27%)  1/364 (0.27%) 
Adrenal Adenoma * 1  1/365 (0.27%)  0/364 (0.00%) 
Basal Cell Carcinoma * 1  1/365 (0.27%)  2/364 (0.55%) 
Breast Cancer * 1  1/365 (0.27%)  0/364 (0.00%) 
Cancer Pain * 1  1/365 (0.27%)  0/364 (0.00%) 
Colorectal Adenocarcinoma * 1  0/365 (0.00%)  1/364 (0.27%) 
Diffuse Large B-Cell Lymphoma * 1  1/365 (0.27%)  1/364 (0.27%) 
Gastrointestinal Neoplasm * 1  1/365 (0.27%)  0/364 (0.00%) 
Gastrointestinal Stromal Tumour * 1  0/365 (0.00%)  1/364 (0.27%) 
Invasive Lobular Breast Carcinoma * 1  0/365 (0.00%)  1/364 (0.27%) 
Keratoacanthoma * 1  1/365 (0.27%)  0/364 (0.00%) 
Leiomyosarcoma * 1  1/365 (0.27%)  0/364 (0.00%) 
Lung Neoplasm Malignant * 1  1/365 (0.27%)  0/364 (0.00%) 
Mantle Cell Lymphoma * 1  0/365 (0.00%)  1/364 (0.27%) 
Meningioma * 1  0/365 (0.00%)  1/364 (0.27%) 
Neuroendocrine Carcinoma of the Skin * 1  1/365 (0.27%)  0/364 (0.00%) 
Porocarcinoma * 1  0/365 (0.00%)  1/364 (0.27%) 
Prostate Cancer * 1  1/365 (0.27%)  1/364 (0.27%) 
Prostatic Adenoma * 1  1/365 (0.27%)  0/364 (0.00%) 
Small Cell Lung Cancer * 1  1/365 (0.27%)  0/364 (0.00%) 
Squamous Cell Carcinoma of Skin * 1  2/365 (0.55%)  1/364 (0.27%) 
Transitional Cell Carcinoma * 1  1/365 (0.27%)  0/364 (0.00%) 
Nervous system disorders     
Brain Stem Infarction * 1  1/365 (0.27%)  0/364 (0.00%) 
Cerebral Infarction * 1  1/365 (0.27%)  1/364 (0.27%) 
Cerebrovascular Accident * 1  5/365 (1.37%)  5/364 (1.37%) 
Cognitive Disorder * 1  0/365 (0.00%)  1/364 (0.27%) 
Dementia Alzheimer's Type * 1  1/365 (0.27%)  0/364 (0.00%) 
Dizziness * 1  1/365 (0.27%)  3/364 (0.82%) 
Epilepsy * 1  0/365 (0.00%)  1/364 (0.27%) 
Focal Dyscognitive Seizures * 1  0/365 (0.00%)  1/364 (0.27%) 
Generalised Tonic-Clonic Seizure * 1  1/365 (0.27%)  0/364 (0.00%) 
Haemorrhage Intracranial * 1  1/365 (0.27%)  1/364 (0.27%) 
Haemorrhagic Stroke * 1  0/365 (0.00%)  1/364 (0.27%) 
Headache * 1  0/365 (0.00%)  1/364 (0.27%) 
Hepatic Encephalopathy * 1  0/365 (0.00%)  1/364 (0.27%) 
Hyperaesthesia * 1  1/365 (0.27%)  0/364 (0.00%) 
Hypoaesthesia * 1  0/365 (0.00%)  1/364 (0.27%) 
Ischaemic Stroke * 1  3/365 (0.82%)  1/364 (0.27%) 
Nervous System Disorder * 1  0/365 (0.00%)  1/364 (0.27%) 
Neuralgia * 1  1/365 (0.27%)  1/364 (0.27%) 
Orthostatic Intolerance * 1  0/365 (0.00%)  1/364 (0.27%) 
Peripheral Motor Neuropathy * 1  0/365 (0.00%)  1/364 (0.27%) 
Post Herpetic Neuralgia * 1  0/365 (0.00%)  1/364 (0.27%) 
Presyncope * 1  2/365 (0.55%)  0/364 (0.00%) 
Sciatica * 1  2/365 (0.55%)  2/364 (0.55%) 
Seizure * 1  2/365 (0.55%)  3/364 (0.82%) 
Spinal Cord Compression * 1  1/365 (0.27%)  1/364 (0.27%) 
Syncope * 1  3/365 (0.82%)  4/364 (1.10%) 
Transient Ischaemic Attack * 1  3/365 (0.82%)  0/364 (0.00%) 
Vith Nerve Paralysis * 1  1/365 (0.27%)  0/364 (0.00%) 
Product Issues     
Device Dislocation * 1  1/365 (0.27%)  0/364 (0.00%) 
Psychiatric disorders     
Confusional State * 1  2/365 (0.55%)  3/364 (0.82%) 
Depression * 1  1/365 (0.27%)  1/364 (0.27%) 
Eating Disorder * 1  1/365 (0.27%)  0/364 (0.00%) 
Major Depression * 1  1/365 (0.27%)  0/364 (0.00%) 
Mental Status Changes * 1  2/365 (0.55%)  1/364 (0.27%) 
Personality Change * 1  1/365 (0.27%)  0/364 (0.00%) 
Psychotic Disorder * 1  0/365 (0.00%)  1/364 (0.27%) 
Renal and urinary disorders     
Acute Kidney Injury * 1  14/365 (3.84%)  11/364 (3.02%) 
Bladder Stenosis * 1  0/365 (0.00%)  1/364 (0.27%) 
Chronic Kidney Disease * 1  1/365 (0.27%)  2/364 (0.55%) 
Dysuria * 1  0/365 (0.00%)  1/364 (0.27%) 
Haematuria * 1  1/365 (0.27%)  1/364 (0.27%) 
Renal Disorder * 1  0/365 (0.00%)  1/364 (0.27%) 
Renal Failure * 1  5/365 (1.37%)  4/364 (1.10%) 
Renal Impairment * 1  2/365 (0.55%)  0/364 (0.00%) 
Urethral Caruncle * 1  0/365 (0.00%)  1/364 (0.27%) 
Urinary Retention * 1  3/365 (0.82%)  2/364 (0.55%) 
Reproductive system and breast disorders     
Benign Prostatic Hyperplasia * 1  0/365 (0.00%)  1/364 (0.27%) 
Genital Prolapse * 1  1/365 (0.27%)  1/364 (0.27%) 
Pelvic Pain * 1  1/365 (0.27%)  0/364 (0.00%) 
Vaginal Haemorrhage * 1  0/365 (0.00%)  1/364 (0.27%) 
Respiratory, thoracic and mediastinal disorders     
Acute Pulmonary Oedema * 1  1/365 (0.27%)  3/364 (0.82%) 
Asthma * 1  1/365 (0.27%)  3/364 (0.82%) 
Bronchiectasis * 1  1/365 (0.27%)  0/364 (0.00%) 
Bronchopneumopathy * 1  0/365 (0.00%)  1/364 (0.27%) 
Bronchospasm * 1  0/365 (0.00%)  1/364 (0.27%) 
Chronic Obstructive Pulmonary Disease * 1  3/365 (0.82%)  1/364 (0.27%) 
Dyspnoea * 1  4/365 (1.10%)  6/364 (1.65%) 
Epistaxis * 1  0/365 (0.00%)  1/364 (0.27%) 
Haemoptysis * 1  1/365 (0.27%)  0/364 (0.00%) 
Hiccups * 1  1/365 (0.27%)  0/364 (0.00%) 
Hypoxia * 1  2/365 (0.55%)  4/364 (1.10%) 
Lung Disorder * 1  1/365 (0.27%)  0/364 (0.00%) 
Pleural Effusion * 1  1/365 (0.27%)  1/364 (0.27%) 
Pleurisy * 1  0/365 (0.00%)  1/364 (0.27%) 
Pleuritic Pain * 1  2/365 (0.55%)  0/364 (0.00%) 
Pneumonitis * 1  1/365 (0.27%)  0/364 (0.00%) 
Pulmonary Embolism * 1  14/365 (3.84%)  11/364 (3.02%) 
Pulmonary Thrombosis * 1  0/365 (0.00%)  1/364 (0.27%) 
Respiratory Distress * 1  0/365 (0.00%)  1/364 (0.27%) 
Respiratory Failure * 1  1/365 (0.27%)  0/364 (0.00%) 
Skin and subcutaneous tissue disorders     
Acute Febrile Neutrophilic Dermatosis * 1  1/365 (0.27%)  0/364 (0.00%) 
Dermatitis Exfoliative * 1  1/365 (0.27%)  0/364 (0.00%) 
Drug Reaction with Eosinophilia and Systemic Symptoms * 1  4/365 (1.10%)  0/364 (0.00%) 
Ecchymosis * 1  1/365 (0.27%)  0/364 (0.00%) 
Purpura * 1  1/365 (0.27%)  1/364 (0.27%) 
Rash * 1  1/365 (0.27%)  0/364 (0.00%) 
Rash Generalised * 1  5/365 (1.37%)  0/364 (0.00%) 
Rash Maculo-Papular * 1  0/365 (0.00%)  1/364 (0.27%) 
Skin Ulcer * 1  1/365 (0.27%)  0/364 (0.00%) 
Stevens-Johnson Syndrome * 1  1/365 (0.27%)  0/364 (0.00%) 
Vascular disorders     
Air Embolism * 1  0/365 (0.00%)  1/364 (0.27%) 
Aortic Aneurysm * 1  0/365 (0.00%)  1/364 (0.27%) 
Aortic Aneurysm Rupture * 1  1/365 (0.27%)  0/364 (0.00%) 
Arteritis * 1  1/365 (0.27%)  0/364 (0.00%) 
Deep Vein Thrombosis * 1  8/365 (2.19%)  5/364 (1.37%) 
Embolism * 1  1/365 (0.27%)  2/364 (0.55%) 
Haematoma * 1  3/365 (0.82%)  1/364 (0.27%) 
Haemorrhage * 1  0/365 (0.00%)  1/364 (0.27%) 
Hypertension * 1  0/365 (0.00%)  3/364 (0.82%) 
Hypotension * 1  1/365 (0.27%)  2/364 (0.55%) 
Orthostatic Hypotension * 1  1/365 (0.27%)  0/364 (0.00%) 
Peripheral Arterial Occlusive Disease * 1  1/365 (0.27%)  0/364 (0.00%) 
Peripheral Artery Stenosis * 1  0/365 (0.00%)  1/364 (0.27%) 
Peripheral Ischaemia * 1  0/365 (0.00%)  2/364 (0.55%) 
Phlebitis * 1  2/365 (0.55%)  1/364 (0.27%) 
Superior Vena Cava Occlusion * 1  0/365 (0.00%)  1/364 (0.27%) 
Venous Thrombosis * 1  2/365 (0.55%)  0/364 (0.00%) 
1
Term from vocabulary, MedDRA Version 20.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lenalidomide + Dexamethasone (Rd) Daratumumab + Lenalidomide + Dexamethasone (DRd)
Affected / at Risk (%) Affected / at Risk (%)
Total   355/365 (97.26%)   362/364 (99.45%) 
Blood and lymphatic system disorders     
Anaemia * 1  136/365 (37.26%)  126/364 (34.62%) 
Leukopenia * 1  34/365 (9.32%)  68/364 (18.68%) 
Lymphopenia * 1  45/365 (12.33%)  66/364 (18.13%) 
Neutropenia * 1  154/365 (42.19%)  207/364 (56.87%) 
Thrombocytopenia * 1  68/365 (18.63%)  68/364 (18.68%) 
Cardiac disorders     
Atrial Fibrillation * 1  29/365 (7.95%)  19/364 (5.22%) 
Eye disorders     
Cataract * 1  55/365 (15.07%)  52/364 (14.29%) 
Vision Blurred * 1  16/365 (4.38%)  26/364 (7.14%) 
Gastrointestinal disorders     
Abdominal Pain * 1  33/365 (9.04%)  40/364 (10.99%) 
Abdominal Pain Upper * 1  28/365 (7.67%)  33/364 (9.07%) 
Constipation * 1  129/365 (35.34%)  148/364 (40.66%) 
Diarrhoea * 1  166/365 (45.48%)  204/364 (56.04%) 
Dry Mouth * 1  19/365 (5.21%)  12/364 (3.30%) 
Dyspepsia * 1  27/365 (7.40%)  26/364 (7.14%) 
Nausea * 1  83/365 (22.74%)  115/364 (31.59%) 
Stomatitis * 1  13/365 (3.56%)  22/364 (6.04%) 
Vomiting * 1  43/365 (11.78%)  60/364 (16.48%) 
General disorders     
Asthenia * 1  85/365 (23.29%)  116/364 (31.87%) 
Chills * 1  6/365 (1.64%)  45/364 (12.36%) 
Fatigue * 1  104/365 (28.49%)  145/364 (39.84%) 
Oedema Peripheral * 1  107/365 (29.32%)  140/364 (38.46%) 
Peripheral Swelling * 1  19/365 (5.21%)  10/364 (2.75%) 
Pyrexia * 1  58/365 (15.89%)  70/364 (19.23%) 
Infections and infestations     
Bronchitis * 1  73/365 (20.00%)  100/364 (27.47%) 
Influenza * 1  15/365 (4.11%)  23/364 (6.32%) 
Nasopharyngitis * 1  11/365 (3.01%)  26/364 (7.14%) 
Oral Candidiasis * 1  19/365 (5.21%)  15/364 (4.12%) 
Pneumonia * 1  25/365 (6.85%)  41/364 (11.26%) 
Rhinitis * 1  21/365 (5.75%)  29/364 (7.97%) 
Sinusitis * 1  14/365 (3.84%)  20/364 (5.49%) 
Upper Respiratory Tract Infection * 1  50/365 (13.70%)  81/364 (22.25%) 
Urinary Tract Infection * 1  34/365 (9.32%)  60/364 (16.48%) 
Viral Upper Respiratory Tract Infection * 1  46/365 (12.60%)  55/364 (15.11%) 
Injury, poisoning and procedural complications     
Contusion * 1  22/365 (6.03%)  27/364 (7.42%) 
Investigations     
Blood Creatinine Increased * 1  13/365 (3.56%)  24/364 (6.59%) 
Weight Decreased * 1  63/365 (17.26%)  101/364 (27.75%) 
Weight Increased * 1  6/365 (1.64%)  25/364 (6.87%) 
Metabolism and nutrition disorders     
Decreased Appetite * 1  54/365 (14.79%)  78/364 (21.43%) 
Dehydration * 1  16/365 (4.38%)  19/364 (5.22%) 
Hyperglycaemia * 1  28/365 (7.67%)  50/364 (13.74%) 
Hypocalcaemia * 1  31/365 (8.49%)  49/364 (13.46%) 
Hypokalaemia * 1  60/365 (16.44%)  72/364 (19.78%) 
Hypomagnesaemia * 1  29/365 (7.95%)  18/364 (4.95%) 
Hyponatraemia * 1  11/365 (3.01%)  19/364 (5.22%) 
Hypophosphataemia * 1  7/365 (1.92%)  19/364 (5.22%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  63/365 (17.26%)  69/364 (18.96%) 
Back Pain * 1  93/365 (25.48%)  114/364 (31.32%) 
Bone Pain * 1  33/365 (9.04%)  34/364 (9.34%) 
Muscle Spasms * 1  79/365 (21.64%)  106/364 (29.12%) 
Muscular Weakness * 1  22/365 (6.03%)  30/364 (8.24%) 
Musculoskeletal Chest Pain * 1  41/365 (11.23%)  27/364 (7.42%) 
Musculoskeletal Pain * 1  40/365 (10.96%)  49/364 (13.46%) 
Myalgia * 1  25/365 (6.85%)  25/364 (6.87%) 
Neck Pain * 1  26/365 (7.12%)  21/364 (5.77%) 
Pain in Extremity * 1  50/365 (13.70%)  59/364 (16.21%) 
Nervous system disorders     
Dizziness * 1  57/365 (15.62%)  69/364 (18.96%) 
Dysgeusia * 1  35/365 (9.59%)  40/364 (10.99%) 
Headache * 1  39/365 (10.68%)  68/364 (18.68%) 
Paraesthesia * 1  30/365 (8.22%)  58/364 (15.93%) 
Peripheral Sensory Neuropathy * 1  54/365 (14.79%)  87/364 (23.90%) 
Tremor * 1  51/365 (13.97%)  57/364 (15.66%) 
Psychiatric disorders     
Anxiety * 1  34/365 (9.32%)  32/364 (8.79%) 
Confusional State * 1  19/365 (5.21%)  22/364 (6.04%) 
Depression * 1  32/365 (8.77%)  29/364 (7.97%) 
Insomnia * 1  107/365 (29.32%)  109/364 (29.95%) 
Renal and urinary disorders     
Acute Kidney Injury * 1  15/365 (4.11%)  23/364 (6.32%) 
Chronic Kidney Disease * 1  18/365 (4.93%)  21/364 (5.77%) 
Renal Impairment * 1  27/365 (7.40%)  26/364 (7.14%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  59/365 (16.16%)  100/364 (27.47%) 
Dysphonia * 1  18/365 (4.93%)  27/364 (7.42%) 
Dyspnoea * 1  56/365 (15.34%)  97/364 (26.65%) 
Dyspnoea Exertional * 1  21/365 (5.75%)  23/364 (6.32%) 
Epistaxis * 1  20/365 (5.48%)  17/364 (4.67%) 
Oropharyngeal Pain * 1  9/365 (2.47%)  24/364 (6.59%) 
Rhinorrhoea * 1  11/365 (3.01%)  25/364 (6.87%) 
Skin and subcutaneous tissue disorders     
Dry Skin * 1  14/365 (3.84%)  25/364 (6.87%) 
Erythema * 1  18/365 (4.93%)  23/364 (6.32%) 
Hyperhidrosis * 1  5/365 (1.37%)  19/364 (5.22%) 
Pruritus * 1  29/365 (7.95%)  32/364 (8.79%) 
Rash * 1  43/365 (11.78%)  57/364 (15.66%) 
Rash Generalised * 1  23/365 (6.30%)  16/364 (4.40%) 
Rash Maculo-Papular * 1  9/365 (2.47%)  20/364 (5.49%) 
Vascular disorders     
Deep Vein Thrombosis * 1  27/365 (7.40%)  26/364 (7.14%) 
Hypertension * 1  26/365 (7.12%)  46/364 (12.64%) 
Hypotension * 1  32/365 (8.77%)  34/364 (9.34%) 
1
Term from vocabulary, MedDRA Version 20.0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director
Organization: Janssen Research & Development, LLC
Phone: 844-434-4210
EMail: ClinicalTrialDisclosure@its.jnj.com
Layout table for additonal information
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02252172    
Other Study ID Numbers: CR104762
54767414MMY3008 ( Other Identifier: Janssen Research & Development, LLC )
2014-002273-11 ( EudraCT Number )
First Submitted: August 11, 2014
First Posted: September 30, 2014
Results First Submitted: September 24, 2019
Results First Posted: January 9, 2020
Last Update Posted: June 26, 2020