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A Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT02076009
Recruitment Status : Active, not recruiting
First Posted : March 3, 2014
Results First Posted : February 10, 2017
Last Update Posted : April 25, 2024
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
Drug: Lenalidomide
Drug: Dexamethasone
Enrollment 569
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lenalidomide, Low-dose Dexamethasone (Rd) Daratumumab, Lenalidomide, Low-dose Dexamethasone (DRd)
Hide Arm/Group Description Participants received lenalidomide at a dose of 25 milligrams (mg) orally on Day 1 through Day 21 of each 28-day treatment cycle and low-dose dexamethasone at a total dose of 40 mg weekly (or 20 mg weekly for participants greater than [>] 75 years old or with a body mass index less than [<] 18.5 kilograms per meter square [kg/m^2]). Participants received daratumumab 16 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks, each 28-day cycle); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks, each 28-day cycle); once only on Day 1 during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Day 1 through Day 21 of each 28-day treatment cycle and low-dose dexamethasone was administered at a total dose of 40 mg weekly (or 20 mg weekly for participants >75 years old or with a body mass index < 18.5 kg/m^2).
Period Title: Overall Study
Started 283 286
Treated (Safety Population) 281 283
Completed 0 0
Not Completed 283 286
Reason Not Completed
Death             172             153
Withdrawal by Subject             16             12
Lost to Follow-up             4             2
Progressive Disease             1             0
Physician Decision             0             1
End of data collection             90             118
Arm/Group Title Lenalidomide, Low-dose Dexamethasone (Rd) Daratumumab, Lenalidomide, Low-dose Dexamethasone (DRd) Total
Hide Arm/Group Description Participants received lenalidomide at a dose of 25 milligrams (mg) orally on Day 1 through Day 21 of each 28-day treatment cycle and low-dose dexamethasone at a total dose of 40 mg weekly (or 20 mg weekly for participants greater than [>] 75 years old or with a body mass index less than [<] 18.5 kilograms per meter square [kg/m^2]). Participants received daratumumab 16 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks, each 28-day cycle); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks, each 28-day cycle); once only on Day 1 during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Day 1 through Day 21 of each 28-day treatment cycle and low-dose dexamethasone was administered at a total dose of 40 mg weekly (or 20 mg weekly for participants >75 years old or with a body mass index < 18.5 kg/m^2). Total of all reporting groups
Overall Number of Baseline Participants 283 286 569
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 283 participants 286 participants 569 participants
64.3  (8.84) 64.4  (9.03) 64.4  (8.93)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 283 participants 286 participants 569 participants
Female
119
  42.0%
113
  39.5%
232
  40.8%
Male
164
  58.0%
173
  60.5%
337
  59.2%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 283 participants 286 participants 569 participants
Australia
9
   3.2%
9
   3.1%
18
   3.2%
Belgium
10
   3.5%
12
   4.2%
22
   3.9%
Canada
17
   6.0%
17
   5.9%
34
   6.0%
Denmark
7
   2.5%
10
   3.5%
17
   3.0%
France
36
  12.7%
21
   7.3%
57
  10.0%
Germany
7
   2.5%
11
   3.8%
18
   3.2%
Greece
8
   2.8%
11
   3.8%
19
   3.3%
Israel
20
   7.1%
19
   6.6%
39
   6.9%
Japan
15
   5.3%
21
   7.3%
36
   6.3%
Korea, Republic of
20
   7.1%
20
   7.0%
40
   7.0%
Netherlands
3
   1.1%
1
   0.3%
4
   0.7%
Poland
13
   4.6%
15
   5.2%
28
   4.9%
Russian Federation
30
  10.6%
18
   6.3%
48
   8.4%
Spain
25
   8.8%
26
   9.1%
51
   9.0%
Sweden
15
   5.3%
16
   5.6%
31
   5.4%
Taiwan, Province of China
9
   3.2%
11
   3.8%
20
   3.5%
United Kingdom
24
   8.5%
27
   9.4%
51
   9.0%
United States
15
   5.3%
21
   7.3%
36
   6.3%
Stage of Disease (ISS)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 283 participants 286 participants 569 participants
I
140
  49.5%
137
  47.9%
277
  48.7%
II
86
  30.4%
93
  32.5%
179
  31.5%
III
57
  20.1%
56
  19.6%
113
  19.9%
[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.
No. of Prior Lines of Therapy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 283 participants 286 participants 569 participants
1
146
  51.6%
149
  52.1%
295
  51.8%
2
80
  28.3%
85
  29.7%
165
  29.0%
3
38
  13.4%
38
  13.3%
76
  13.4%
>3
19
   6.7%
14
   4.9%
33
   5.8%
1.Primary Outcome
Title Progression-free Survival (PFS)
Hide Description PFS: duration from date of randomization to either progressive disease (PD)/death, whichever occurred first. PD: defined as meeting any 1 of following criteria: Increase of greater than equal to (>=)25 percent(%) in level of serum M-protein from lowest response value and absolute increase must be >=0.5 gram per deciliter (g/dL); Increase of >=25% in 24-hours(h) urinary light chain excretion (urine M-protein) from lowest response value and absolute increase must be >=200 mg/24h; Only in participants without measurable serum and urine M-protein levels: increase of >=25% in difference between involved and uninvolved free light chain (FLC) levels from lowest response value and absolute increase must be >10 mg/dL; Definite increase in size of existing bone lesions or soft tissue plasmacytomas; Definite development of new bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) attributed solely to plasma cell (PC) proliferative disorder.
Time Frame From randomization to either disease progression or death whichever occurs first (up to 21 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) analysis set included all participants who were randomly assigned to the daratumumab, lenalidomide, dexamethasone (DRd) or lenalidomide, low-dose dexamethasone (Rd) group.
Arm/Group Title Lenalidomide, Low-dose Dexamethasone (Rd) Daratumumab, Lenalidomide, Low-dose Dexamethasone (DRd)
Hide Arm/Group Description:
Participants received lenalidomide at a dose of 25 milligrams (mg) orally on Day 1 through Day 21 of each 28-day treatment cycle and low-dose dexamethasone at a total dose of 40 mg weekly (or 20 mg weekly for participants greater than [>] 75 years old or with a body mass index less than [<] 18.5 kilograms per meter square [kg/m^2]).
Participants received daratumumab 16 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks, each 28-day cycle); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks, each 28-day cycle); once only on Day 1 during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Day 1 through Day 21 of each 28-day treatment cycle and low-dose dexamethasone was administered at a total dose of 40 mg weekly (or 20 mg weekly for participants >75 years old or with a body mass index < 18.5 kg/m^2).
Overall Number of Participants Analyzed 283 286
Median (95% Confidence Interval)
Unit of Measure: months
18.43 [1] 
(13.86 to NA)
NA [2] 
(NA to NA)
[1]
Upper limit of 95% confidence interval (CI) was not estimable due to short follow-up by participants.
[2]
Median and 95% CI was not estimable due to short follow-up by participants.
2.Secondary Outcome
Title Time to Disease Progression (TTP)
Hide Description TTP was defined as time from date of randomization to date of first documented evidence of progressive disease (PD). PD was defined as meeting any one of following criteria: Increase of >=25% in level of serum M-protein from lowest response value and absolute increase must be >=0.5 g/dL; Increase of >=25% in 24-hour urinary light chain excretion (urine M-protein) from lowest response value and absolute increase must be >=200 mg/24hours; Only in participants without measurable serum and urine M-protein levels: increase of >=25% in difference between involved and uninvolved free light chain (FLC) levels from lowest response value and absolute increase must be >10 milligram per deciliter (mg/dL); Definite increase in size of existing bone lesions or soft tissue plasmacytomas; Definite development of new 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 (up to 21 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all participants who were randomly assigned to the DRd or Rd group.
Arm/Group Title Lenalidomide, Low-dose Dexamethasone (Rd) Daratumumab, Lenalidomide, Low-dose Dexamethasone (DRd)
Hide Arm/Group Description:
Participants received lenalidomide at a dose of 25 milligrams (mg) orally on Day 1 through Day 21 of each 28-day treatment cycle and low-dose dexamethasone at a total dose of 40 mg weekly (or 20 mg weekly for participants greater than [>] 75 years old or with a body mass index less than [<] 18.5 kilograms per meter square [kg/m^2]).
Participants received daratumumab 16 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks, each 28-day cycle); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks, each 28-day cycle); once only on Day 1 during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Day 1 through Day 21 of each 28-day treatment cycle and low-dose dexamethasone was administered at a total dose of 40 mg weekly (or 20 mg weekly for participants >75 years old or with a body mass index < 18.5 kg/m^2).
Overall Number of Participants Analyzed 283 286
Median (95% Confidence Interval)
Unit of Measure: months
18.43 [1] 
(14.78 to NA)
NA [2] 
(NA to NA)
[1]
Upper limit of 95% CI was not estimable due to short follow-up.
[2]
Median and 95% CI was not estimable due to short follow-up.
3.Secondary Outcome
Title Percentage of Participants Who Achieved Very Good Partial Response (VGPR) or Better
Hide Description VGPR or better is defined as the percentage of participants who achieved VGPR, complete response (CR) and stringent complete response (sCR) according to the International Myeloma Working Group criteria (IMWG). IMWG criteria for VGPR: 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, if the serum and urine M-protein are not measurable, a decrease of >90% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria. In addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required; CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and <5% PCs in bone marrow; sCR: CR and normal FLC ratio, absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4 color flow cytometry.
Time Frame From randomization to disease progression (up to 21 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Response-evaluable set included participants who have a confirmed diagnosis of multiple myeloma and measurable disease and must have received at least 1 administration of study treatment and have at least 1 post baseline disease assessment.
Arm/Group Title Lenalidomide, Low-dose Dexamethasone (Rd) Daratumumab, Lenalidomide, Low-dose Dexamethasone (DRd)
Hide Arm/Group Description:
Participants received lenalidomide at a dose of 25 milligrams (mg) orally on Day 1 through Day 21 of each 28-day treatment cycle and low-dose dexamethasone at a total dose of 40 mg weekly (or 20 mg weekly for participants greater than [>] 75 years old or with a body mass index less than [<] 18.5 kilograms per meter square [kg/m^2]).
Participants received daratumumab 16 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks, each 28-day cycle); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks, each 28-day cycle); once only on Day 1 during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Day 1 through Day 21 of each 28-day treatment cycle and low-dose dexamethasone was administered at a total dose of 40 mg weekly (or 20 mg weekly for participants >75 years old or with a body mass index < 18.5 kg/m^2).
Overall Number of Participants Analyzed 276 281
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
44.2
(38.3 to 50.3)
75.8
(70.4 to 80.7)
4.Secondary Outcome
Title Percentage of Participants With Negative Minimal Residual Disease (MRD)
Hide Description Minimal residual disease was assessed for all participants who achieved a complete response (CR) or stringent complete response (sCR). CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and <5% PCs in bone marrow; sCR: CR and normal FLC ratio, absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4 color flow cytometry. The MRD negativity rate was defined as the percentage of participants who had negative MRD assessment at any time point after the first dose of study drugs by evaluation of bone marrow aspirates or whole blood at 10^ minus (-) 4, 10^-5, 10^-6 threshold.
Time Frame From randomization to the date of first documented evidence of PD (up to 87.5 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all participants who were randomly assigned to the DRd or Rd group.
Arm/Group Title Lenalidomide, Low-dose Dexamethasone (Rd) Daratumumab, Lenalidomide, Low-dose Dexamethasone (DRd)
Hide Arm/Group Description:
Participants received lenalidomide at a dose of 25 milligrams (mg) orally on Day 1 through Day 21 of each 28-day treatment cycle and low-dose dexamethasone at a total dose of 40 mg weekly (or 20 mg weekly for participants greater than [>] 75 years old or with a body mass index less than [<] 18.5 kilograms per meter square [kg/m^2]).
Participants received daratumumab 16 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks, each 28-day cycle); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks, each 28-day cycle); once only on Day 1 during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Day 1 through Day 21 of each 28-day treatment cycle and low-dose dexamethasone was administered at a total dose of 40 mg weekly (or 20 mg weekly for participants >75 years old or with a body mass index < 18.5 kg/m^2).
Overall Number of Participants Analyzed 283 286
Measure Type: Number
Unit of Measure: percentage of participants
MRD negative rate (10^-4) 10.2 40.6
MRD negative rate (10^-5) 6.7 33.2
MRD negative rate (10^-6) 1.8 13.3
5.Secondary Outcome
Title Overall Response Rate
Hide Description Overall response rate was defined as the percentage of participants who achieved a partial response (PR) or better according to the International Myeloma Working Group (IMWG) criteria, during or after study treatment. IMWG criteria for 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, in addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required.
Time Frame From randomization to disease progression (up to 21 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Response-evaluable set included participants who have a confirmed diagnosis of multiple myeloma and measurable disease and must have received at least 1 administration of study treatment and have at least 1 post baseline disease assessment.
Arm/Group Title Lenalidomide, Low-dose Dexamethasone (Rd) Daratumumab, Lenalidomide, Low-dose Dexamethasone (DRd)
Hide Arm/Group Description:
Participants received lenalidomide at a dose of 25 milligrams (mg) orally on Day 1 through Day 21 of each 28-day treatment cycle and low-dose dexamethasone at a total dose of 40 mg weekly (or 20 mg weekly for participants greater than [>] 75 years old or with a body mass index less than [<] 18.5 kilograms per meter square [kg/m^2]).
Participants received daratumumab 16 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks, each 28-day cycle); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks, each 28-day cycle); once only on Day 1 during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Day 1 through Day 21 of each 28-day treatment cycle and low-dose dexamethasone was administered at a total dose of 40 mg weekly (or 20 mg weekly for participants >75 years old or with a body mass index < 18.5 kg/m^2).
Overall Number of Participants Analyzed 276 281
Measure Type: Number
Unit of Measure: percentage of participants
76.4 92.9
6.Secondary Outcome
Title Overall Survival (OS)
Hide Description Overall survival was measured from the date of randomization to the date of the participant's death.
Time Frame From randomization to date of death due to any cause (up to 87.5 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all participants who were randomly assigned to the DRd or Rd group. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
Arm/Group Title Lenalidomide, Low-dose Dexamethasone (Rd) Daratumumab, Lenalidomide, Low-dose Dexamethasone (DRd)
Hide Arm/Group Description:
Participants received lenalidomide at a dose of 25 milligrams (mg) orally on Day 1 through Day 21 of each 28-day treatment cycle and low-dose dexamethasone at a total dose of 40 mg weekly (or 20 mg weekly for participants greater than [>] 75 years old or with a body mass index less than [<] 18.5 kilograms per meter square [kg/m^2]).
Participants received daratumumab 16 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks, each 28-day cycle); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks, each 28-day cycle); once only on Day 1 during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Day 1 through Day 21 of each 28-day treatment cycle and low-dose dexamethasone was administered at a total dose of 40 mg weekly (or 20 mg weekly for participants >75 years old or with a body mass index < 18.5 kg/m^2).
Overall Number of Participants Analyzed 175 153
Median (95% Confidence Interval)
Unit of Measure: months
51.84
(43.99 to 60.02)
67.58
(53.13 to 80.53)
7.Secondary Outcome
Title Time to Response
Hide Description Time to response was defined as the time between the date of randomization and the first efficacy evaluation that the participant met all criteria for partial response (PR) or better.
Time Frame From randomization up to first documented CR or PR (up to 21 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Response-evaluable set is defined as participants who have a confirmed diagnosis of multiple myeloma and measurable disease at baseline or screening visit. In addition, participants must have received at least 1 administration of study treatment and have at least 1 post baseline disease assessment.
Arm/Group Title Lenalidomide, Low-dose Dexamethasone (Rd) Daratumumab, Lenalidomide, Low-dose Dexamethasone (DRd)
Hide Arm/Group Description:
Participants received lenalidomide at a dose of 25 milligrams (mg) orally on Day 1 through Day 21 of each 28-day treatment cycle and low-dose dexamethasone at a total dose of 40 mg weekly (or 20 mg weekly for participants greater than [>] 75 years old or with a body mass index less than [<] 18.5 kilograms per meter square [kg/m^2]).
Participants received daratumumab 16 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks, each 28-day cycle); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks, each 28-day cycle); once only on Day 1 during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Day 1 through Day 21 of each 28-day treatment cycle and low-dose dexamethasone was administered at a total dose of 40 mg weekly (or 20 mg weekly for participants >75 years old or with a body mass index < 18.5 kg/m^2).
Overall Number of Participants Analyzed 276 281
Median (95% Confidence Interval)
Unit of Measure: months
1.3
(1.1 to 1.9)
1.0
(1.0 to 1.1)
8.Secondary Outcome
Title Duration of Response (DOR)
Hide Description DOR was defined for participants with confirmed response (PR or better) as time between first documentation of response and disease progression/death due to PD, whichever occurs first. PD was defined as meeting any one of following criteria: Increase of >=25% in level of serum M-protein from lowest response value and absolute increase must be >=0.5g/dL; Increase of >=25% in 24-hour urinary light chain excretion (urine M-protein) from lowest response value and absolute increase must be >=200mg/24hours; Only in participants without measurable serum and urine M-protein levels: increase of >=25% in difference between involved and uninvolved FLC levels from lowest response value and absolute increase must be >10mg/dL; Definite increase in size of existing bone lesions/soft tissue plasmacytomas; Definite development of new bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5mg/dL) that can be attributed solely to PC proliferative disorder.
Time Frame From randomization to the date of first documented evidence of PD (up to 21 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Response-evaluable set included participants who have a confirmed diagnosis of multiple myeloma and measurable disease and must have received at least 1 administration of study treatment and have at least 1 post baseline disease assessment. Here 'N' signifies number of participants who had PR or better response.
Arm/Group Title Lenalidomide, Low-dose Dexamethasone (Rd) Daratumumab, Lenalidomide, Low-dose Dexamethasone (DRd)
Hide Arm/Group Description:
Participants received lenalidomide at a dose of 25 milligrams (mg) orally on Day 1 through Day 21 of each 28-day treatment cycle and low-dose dexamethasone at a total dose of 40 mg weekly (or 20 mg weekly for participants greater than [>] 75 years old or with a body mass index less than [<] 18.5 kilograms per meter square [kg/m^2]).
Participants received daratumumab 16 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks, each 28-day cycle); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks, each 28-day cycle); once only on Day 1 during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Day 1 through Day 21 of each 28-day treatment cycle and low-dose dexamethasone was administered at a total dose of 40 mg weekly (or 20 mg weekly for participants >75 years old or with a body mass index < 18.5 kg/m^2).
Overall Number of Participants Analyzed 211 261
Median (95% Confidence Interval)
Unit of Measure: months
17.4 [1] 
(17.4 to NA)
NA [2] 
(NA to NA)
[1]
Upper limit of 95% CI was not estimable due to high censoring rate and lesser number of responders who progressed.
[2]
Median and 95% CI was not estimable due to high censoring rate and lesser number of responders who progressed.
9.Secondary Outcome
Title Time to Subsequent Anticancer Treatment
Hide Description Time to subsequent anticancer treatment was defined as the time from randomization to the start of subsequent anticancer treatment or death due to progressive disease (PD), whichever occurs first.
Time Frame From randomization to date of start of subsequent anticancer treatment or death due to PD, whichever occured first (up to 87.5 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all participants who were randomly assigned to the DRd or Rd group, and who started subsequent anticancer therapy or died due to progressive disease, whichever occurs first.
Arm/Group Title Lenalidomide, Low-dose Dexamethasone (Rd) Daratumumab, Lenalidomide, Low-dose Dexamethasone (DRd)
Hide Arm/Group Description:
Participants received lenalidomide at a dose of 25 milligrams (mg) orally on Day 1 through Day 21 of each 28-day treatment cycle and low-dose dexamethasone at a total dose of 40 mg weekly (or 20 mg weekly for participants greater than [>] 75 years old or with a body mass index less than [<] 18.5 kilograms per meter square [kg/m^2]).
Participants received daratumumab 16 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks, each 28-day cycle); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks, each 28-day cycle); once only on Day 1 during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Day 1 through Day 21 of each 28-day treatment cycle and low-dose dexamethasone was administered at a total dose of 40 mg weekly (or 20 mg weekly for participants >75 years old or with a body mass index < 18.5 kg/m^2).
Overall Number of Participants Analyzed 212 138
Median (95% Confidence Interval)
Unit of Measure: months
23.1
(18.6 to 26.3)
69.3
(49.7 to 82.8)
Time Frame From randomization up to 30 days after last dose of study treatment (up to 87.5 months)
Adverse Event Reporting Description Safety analysis set included all randomized participants who had at least 1 administration of any study treatment (partial or complete).
 
Arm/Group Title Lenalidomide, Low-dose Dexamethasone (Rd) Daratumumab, Lenalidomide, Low-dose Dexamethasone (DRd)
Hide Arm/Group Description Participants received lenalidomide at a dose of 25 milligrams (mg) orally on Day 1 through Day 21 of each 28-day treatment cycle and low-dose dexamethasone at a total dose of 40 mg weekly (or 20 mg weekly for participants greater than [>] 75 years old or with a body mass index less than [<] 18.5 kilograms per meter square [kg/m^2]). Participants received daratumumab 16 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks, each 28-day cycle); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks, each 28-day cycle); once only on Day 1 during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Day 1 through Day 21 of each 28-day treatment cycle and low-dose dexamethasone was administered at a total dose of 40 mg weekly (or 20 mg weekly for participants >75 years old or with a body mass index < 18.5 kg/m^2).
All-Cause Mortality
Lenalidomide, Low-dose Dexamethasone (Rd) Daratumumab, Lenalidomide, Low-dose Dexamethasone (DRd)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Lenalidomide, Low-dose Dexamethasone (Rd) Daratumumab, Lenalidomide, Low-dose Dexamethasone (DRd)
Affected / at Risk (%) Affected / at Risk (%)
Total   148/281 (52.67%)   205/283 (72.44%) 
Blood and lymphatic system disorders     
Anaemia * 1  2/281 (0.71%)  5/283 (1.77%) 
Bone marrow failure * 1  1/281 (0.36%)  0/283 (0.00%) 
Febrile neutropenia * 1  4/281 (1.42%)  13/283 (4.59%) 
Hyperviscosity syndrome * 1  1/281 (0.36%)  0/283 (0.00%) 
Lymphadenopathy * 1  1/281 (0.36%)  0/283 (0.00%) 
Neutropenia * 1  0/281 (0.00%)  3/283 (1.06%) 
Sideroblastic anaemia * 1  1/281 (0.36%)  0/283 (0.00%) 
Thrombocytopenia * 1  1/281 (0.36%)  3/283 (1.06%) 
Thrombotic thrombocytopenic purpura * 1  1/281 (0.36%)  0/283 (0.00%) 
Cardiac disorders     
Acute coronary syndrome * 1  0/281 (0.00%)  1/283 (0.35%) 
Acute myocardial infarction * 1  4/281 (1.42%)  2/283 (0.71%) 
Angina pectoris * 1  1/281 (0.36%)  2/283 (0.71%) 
Angina unstable * 1  1/281 (0.36%)  0/283 (0.00%) 
Atrial fibrillation * 1  3/281 (1.07%)  5/283 (1.77%) 
Atrial flutter * 1  0/281 (0.00%)  1/283 (0.35%) 
Atrioventricular block complete * 1  0/281 (0.00%)  1/283 (0.35%) 
Bradycardia * 1  0/281 (0.00%)  1/283 (0.35%) 
Cardiac amyloidosis * 1  0/281 (0.00%)  1/283 (0.35%) 
Cardiac arrest * 1  1/281 (0.36%)  3/283 (1.06%) 
Cardiac failure * 1  1/281 (0.36%)  2/283 (0.71%) 
Cardiac failure acute * 1  0/281 (0.00%)  1/283 (0.35%) 
Cardiac failure congestive * 1  0/281 (0.00%)  4/283 (1.41%) 
Cardiopulmonary failure * 1  0/281 (0.00%)  1/283 (0.35%) 
Coronary artery insufficiency * 1  1/281 (0.36%)  0/283 (0.00%) 
Left ventricular failure * 1  0/281 (0.00%)  1/283 (0.35%) 
Myocardial infarction * 1  1/281 (0.36%)  3/283 (1.06%) 
Pericarditis * 1  1/281 (0.36%)  2/283 (0.71%) 
Right ventricular failure * 1  0/281 (0.00%)  1/283 (0.35%) 
Sinus arrhythmia * 1  0/281 (0.00%)  1/283 (0.35%) 
Supraventricular tachycardia * 1  1/281 (0.36%)  1/283 (0.35%) 
Systolic dysfunction * 1  0/281 (0.00%)  1/283 (0.35%) 
Ventricular fibrillation * 1  0/281 (0.00%)  1/283 (0.35%) 
Eye disorders     
Cataract * 1  1/281 (0.36%)  4/283 (1.41%) 
Keratitis * 1  1/281 (0.36%)  0/283 (0.00%) 
Retinal detachment * 1  0/281 (0.00%)  2/283 (0.71%) 
Visual field defect * 1  0/281 (0.00%)  1/283 (0.35%) 
Gastrointestinal disorders     
Abdominal pain * 1  1/281 (0.36%)  3/283 (1.06%) 
Colitis * 1  2/281 (0.71%)  1/283 (0.35%) 
Constipation * 1  0/281 (0.00%)  1/283 (0.35%) 
Diarrhoea * 1  6/281 (2.14%)  8/283 (2.83%) 
Diverticular perforation * 1  0/281 (0.00%)  3/283 (1.06%) 
Gastric haemorrhage * 1  0/281 (0.00%)  1/283 (0.35%) 
Gastric ulcer * 1  1/281 (0.36%)  0/283 (0.00%) 
Gastrointestinal disorder * 1  0/281 (0.00%)  1/283 (0.35%) 
Gastrointestinal vascular malformation haemorrhagic * 1  0/281 (0.00%)  1/283 (0.35%) 
Haematemesis * 1  1/281 (0.36%)  0/283 (0.00%) 
Hiatus hernia * 1  0/281 (0.00%)  1/283 (0.35%) 
Ileus * 1  0/281 (0.00%)  2/283 (0.71%) 
Incarcerated inguinal hernia * 1  1/281 (0.36%)  0/283 (0.00%) 
Inguinal hernia * 1  0/281 (0.00%)  2/283 (0.71%) 
Intestinal obstruction * 1  1/281 (0.36%)  0/283 (0.00%) 
Large intestine polyp * 1  0/281 (0.00%)  1/283 (0.35%) 
Lower gastrointestinal haemorrhage * 1  1/281 (0.36%)  0/283 (0.00%) 
Nausea * 1  1/281 (0.36%)  3/283 (1.06%) 
Oesophagitis * 1  1/281 (0.36%)  0/283 (0.00%) 
Peptic ulcer haemorrhage * 1  0/281 (0.00%)  1/283 (0.35%) 
Small intestinal obstruction * 1  0/281 (0.00%)  1/283 (0.35%) 
Strangulated umbilical hernia * 1  0/281 (0.00%)  1/283 (0.35%) 
Upper gastrointestinal haemorrhage * 1  1/281 (0.36%)  0/283 (0.00%) 
Vomiting * 1  2/281 (0.71%)  1/283 (0.35%) 
General disorders     
Asthenia * 1  0/281 (0.00%)  1/283 (0.35%) 
Death * 1  1/281 (0.36%)  2/283 (0.71%) 
Fatigue * 1  1/281 (0.36%)  2/283 (0.71%) 
Gait disturbance * 1  0/281 (0.00%)  1/283 (0.35%) 
General physical health deterioration * 1  0/281 (0.00%)  2/283 (0.71%) 
Generalised oedema * 1  1/281 (0.36%)  0/283 (0.00%) 
Hernia * 1  0/281 (0.00%)  1/283 (0.35%) 
Impaired healing * 1  1/281 (0.36%)  0/283 (0.00%) 
Multiple organ dysfunction syndrome * 1  0/281 (0.00%)  2/283 (0.71%) 
Non-cardiac chest pain * 1  3/281 (1.07%)  3/283 (1.06%) 
Pain * 1  2/281 (0.71%)  1/283 (0.35%) 
Peripheral swelling * 1  0/281 (0.00%)  1/283 (0.35%) 
Pyrexia * 1  5/281 (1.78%)  13/283 (4.59%) 
Sudden death * 1  1/281 (0.36%)  3/283 (1.06%) 
Systemic inflammatory response syndrome * 1  0/281 (0.00%)  1/283 (0.35%) 
Hepatobiliary disorders     
Bile duct stone * 1  1/281 (0.36%)  0/283 (0.00%) 
Cholecystitis * 1  0/281 (0.00%)  1/283 (0.35%) 
Cholelithiasis * 1  0/281 (0.00%)  1/283 (0.35%) 
Drug-induced liver injury * 1  0/281 (0.00%)  1/283 (0.35%) 
Liver disorder * 1  1/281 (0.36%)  0/283 (0.00%) 
Immune system disorders     
Sarcoidosis * 1  1/281 (0.36%)  0/283 (0.00%) 
Infections and infestations     
Acute sinusitis * 1  0/281 (0.00%)  1/283 (0.35%) 
Adenovirus infection * 1  0/281 (0.00%)  1/283 (0.35%) 
Anal abscess * 1  1/281 (0.36%)  0/283 (0.00%) 
Appendicitis * 1  1/281 (0.36%)  2/283 (0.71%) 
Arthritis bacterial * 1  1/281 (0.36%)  1/283 (0.35%) 
Arthritis infective * 1  0/281 (0.00%)  1/283 (0.35%) 
Atypical pneumonia * 1  0/281 (0.00%)  1/283 (0.35%) 
Bacteraemia * 1  0/281 (0.00%)  1/283 (0.35%) 
Bacterial infection * 1  0/281 (0.00%)  1/283 (0.35%) 
Bacterial sepsis * 1  1/281 (0.36%)  0/283 (0.00%) 
Bronchiolitis * 1  0/281 (0.00%)  1/283 (0.35%) 
Bronchitis * 1  7/281 (2.49%)  10/283 (3.53%) 
Bronchitis bacterial * 1  0/281 (0.00%)  1/283 (0.35%) 
Brucellosis * 1  0/281 (0.00%)  1/283 (0.35%) 
COVID-19 * 1  0/281 (0.00%)  1/283 (0.35%) 
COVID-19 pneumonia * 1  0/281 (0.00%)  3/283 (1.06%) 
Campylobacter gastroenteritis * 1  0/281 (0.00%)  1/283 (0.35%) 
Candida infection * 1  0/281 (0.00%)  1/283 (0.35%) 
Catheter site infection * 1  0/281 (0.00%)  1/283 (0.35%) 
Cellulitis * 1  2/281 (0.71%)  3/283 (1.06%) 
Clostridium difficile colitis * 1  1/281 (0.36%)  1/283 (0.35%) 
Clostridium difficile infection * 1  2/281 (0.71%)  1/283 (0.35%) 
Cytomegalovirus chorioretinitis * 1  0/281 (0.00%)  1/283 (0.35%) 
Cytomegalovirus infection * 1  0/281 (0.00%)  1/283 (0.35%) 
Diarrhoea infectious * 1  1/281 (0.36%)  0/283 (0.00%) 
Endocarditis bacterial * 1  0/281 (0.00%)  1/283 (0.35%) 
Enterocolitis infectious * 1  1/281 (0.36%)  0/283 (0.00%) 
Epiglottitis * 1  1/281 (0.36%)  1/283 (0.35%) 
Epstein-Barr virus infection * 1  0/281 (0.00%)  1/283 (0.35%) 
Erysipelas * 1  1/281 (0.36%)  0/283 (0.00%) 
Escherichia bacteraemia * 1  0/281 (0.00%)  1/283 (0.35%) 
Escherichia pyelonephritis * 1  0/281 (0.00%)  1/283 (0.35%) 
Escherichia sepsis * 1  0/281 (0.00%)  1/283 (0.35%) 
Escherichia urinary tract infection * 1  1/281 (0.36%)  0/283 (0.00%) 
Extradural abscess * 1  0/281 (0.00%)  1/283 (0.35%) 
Gastroenteritis * 1  1/281 (0.36%)  4/283 (1.41%) 
Gastroenteritis norovirus * 1  1/281 (0.36%)  0/283 (0.00%) 
Gastroenteritis viral * 1  1/281 (0.36%)  3/283 (1.06%) 
Gastrointestinal infection * 1  1/281 (0.36%)  0/283 (0.00%) 
Gingivitis * 1  0/281 (0.00%)  1/283 (0.35%) 
H1N1 influenza * 1  0/281 (0.00%)  1/283 (0.35%) 
Haemophilus infection * 1  1/281 (0.36%)  0/283 (0.00%) 
Herpes zoster * 1  1/281 (0.36%)  0/283 (0.00%) 
Infection * 1  6/281 (2.14%)  3/283 (1.06%) 
Infective exacerbation of bronchiectasis * 1  0/281 (0.00%)  1/283 (0.35%) 
Infective spondylitis * 1  0/281 (0.00%)  2/283 (0.71%) 
Influenza * 1  7/281 (2.49%)  12/283 (4.24%) 
Intervertebral discitis * 1  0/281 (0.00%)  1/283 (0.35%) 
Keratitis fungal * 1  1/281 (0.36%)  0/283 (0.00%) 
Legionella infection * 1  0/281 (0.00%)  1/283 (0.35%) 
Listeria sepsis * 1  0/281 (0.00%)  1/283 (0.35%) 
Lower respiratory tract infection * 1  3/281 (1.07%)  14/283 (4.95%) 
Lower respiratory tract infection viral * 1  0/281 (0.00%)  1/283 (0.35%) 
Lung abscess * 1  0/281 (0.00%)  1/283 (0.35%) 
Meningitis bacterial * 1  1/281 (0.36%)  0/283 (0.00%) 
Metapneumovirus infection * 1  0/281 (0.00%)  1/283 (0.35%) 
Nasal abscess * 1  0/281 (0.00%)  1/283 (0.35%) 
Necrotising fasciitis * 1  1/281 (0.36%)  0/283 (0.00%) 
Neutropenic sepsis * 1  0/281 (0.00%)  3/283 (1.06%) 
Nocardiosis * 1  1/281 (0.36%)  0/283 (0.00%) 
Oral fungal infection * 1  0/281 (0.00%)  1/283 (0.35%) 
Osteomyelitis * 1  3/281 (1.07%)  0/283 (0.00%) 
Otitis externa * 1  1/281 (0.36%)  0/283 (0.00%) 
Parainfluenzae virus infection * 1  1/281 (0.36%)  1/283 (0.35%) 
Parotitis * 1  0/281 (0.00%)  1/283 (0.35%) 
Periodontitis * 1  1/281 (0.36%)  0/283 (0.00%) 
Periorbital cellulitis * 1  0/281 (0.00%)  1/283 (0.35%) 
Peritonitis * 1  0/281 (0.00%)  1/283 (0.35%) 
Pharyngitis * 1  1/281 (0.36%)  0/283 (0.00%) 
Pneumonia * 1  32/281 (11.39%)  48/283 (16.96%) 
Pneumonia bacterial * 1  1/281 (0.36%)  2/283 (0.71%) 
Pneumonia haemophilus * 1  0/281 (0.00%)  2/283 (0.71%) 
Pneumonia influenzal * 1  0/281 (0.00%)  7/283 (2.47%) 
Pneumonia klebsiella * 1  0/281 (0.00%)  1/283 (0.35%) 
Pneumonia legionella * 1  1/281 (0.36%)  1/283 (0.35%) 
Pneumonia parainfluenzae viral * 1  0/281 (0.00%)  1/283 (0.35%) 
Pneumonia pseudomonal * 1  0/281 (0.00%)  1/283 (0.35%) 
Pneumonia staphylococcal * 1  1/281 (0.36%)  0/283 (0.00%) 
Pneumonia streptococcal * 1  0/281 (0.00%)  1/283 (0.35%) 
Progressive multifocal leukoencephalopathy * 1  1/281 (0.36%)  0/283 (0.00%) 
Pulmonary tuberculosis * 1  1/281 (0.36%)  0/283 (0.00%) 
Pyelonephritis acute * 1  1/281 (0.36%)  0/283 (0.00%) 
Respiratory syncytial virus infection * 1  0/281 (0.00%)  3/283 (1.06%) 
Respiratory tract infection * 1  2/281 (0.71%)  5/283 (1.77%) 
Respiratory tract infection viral * 1  0/281 (0.00%)  1/283 (0.35%) 
Rhinovirus infection * 1  0/281 (0.00%)  1/283 (0.35%) 
Salmonella bacteraemia * 1  0/281 (0.00%)  1/283 (0.35%) 
Salmonellosis * 1  0/281 (0.00%)  2/283 (0.71%) 
Sepsis * 1  8/281 (2.85%)  7/283 (2.47%) 
Septic shock * 1  1/281 (0.36%)  4/283 (1.41%) 
Sinusitis * 1  0/281 (0.00%)  1/283 (0.35%) 
Skin infection * 1  0/281 (0.00%)  1/283 (0.35%) 
Soft tissue infection * 1  0/281 (0.00%)  2/283 (0.71%) 
Staphylococcal sepsis * 1  0/281 (0.00%)  2/283 (0.71%) 
Tonsillitis * 1  0/281 (0.00%)  1/283 (0.35%) 
Tooth abscess * 1  1/281 (0.36%)  0/283 (0.00%) 
Tuberculosis * 1  1/281 (0.36%)  0/283 (0.00%) 
Upper respiratory tract infection * 1  7/281 (2.49%)  3/283 (1.06%) 
Upper respiratory tract infection bacterial * 1  0/281 (0.00%)  2/283 (0.71%) 
Urinary tract infection * 1  2/281 (0.71%)  7/283 (2.47%) 
Urinary tract infection bacterial * 1  0/281 (0.00%)  1/283 (0.35%) 
Urosepsis * 1  1/281 (0.36%)  3/283 (1.06%) 
Uterine abscess * 1  0/281 (0.00%)  1/283 (0.35%) 
Varicella zoster virus infection * 1  1/281 (0.36%)  0/283 (0.00%) 
Vascular device infection * 1  0/281 (0.00%)  1/283 (0.35%) 
Viral infection * 1  1/281 (0.36%)  1/283 (0.35%) 
Injury, poisoning and procedural complications     
Acetabulum fracture * 1  0/281 (0.00%)  1/283 (0.35%) 
Ankle fracture * 1  0/281 (0.00%)  1/283 (0.35%) 
Cervical vertebral fracture * 1  0/281 (0.00%)  1/283 (0.35%) 
Compression fracture * 1  0/281 (0.00%)  1/283 (0.35%) 
Concussion * 1  0/281 (0.00%)  1/283 (0.35%) 
Fall * 1  1/281 (0.36%)  2/283 (0.71%) 
Femoral neck fracture * 1  1/281 (0.36%)  2/283 (0.71%) 
Femur fracture * 1  2/281 (0.71%)  4/283 (1.41%) 
Foot fracture * 1  0/281 (0.00%)  1/283 (0.35%) 
Forearm fracture * 1  0/281 (0.00%)  1/283 (0.35%) 
Hand fracture * 1  0/281 (0.00%)  1/283 (0.35%) 
Hip fracture * 1  1/281 (0.36%)  3/283 (1.06%) 
Humerus fracture * 1  1/281 (0.36%)  1/283 (0.35%) 
Joint dislocation * 1  1/281 (0.36%)  0/283 (0.00%) 
Lower limb fracture * 1  0/281 (0.00%)  1/283 (0.35%) 
Multiple fractures * 1  1/281 (0.36%)  0/283 (0.00%) 
Patella fracture * 1  0/281 (0.00%)  1/283 (0.35%) 
Pelvic fracture * 1  1/281 (0.36%)  0/283 (0.00%) 
Peroneal nerve injury * 1  0/281 (0.00%)  1/283 (0.35%) 
Posterior capsule rupture * 1  0/281 (0.00%)  1/283 (0.35%) 
Radius fracture * 1  1/281 (0.36%)  0/283 (0.00%) 
Rib fracture * 1  0/281 (0.00%)  1/283 (0.35%) 
Scapula fracture * 1  0/281 (0.00%)  1/283 (0.35%) 
Skin laceration * 1  0/281 (0.00%)  1/283 (0.35%) 
Spinal compression fracture * 1  0/281 (0.00%)  1/283 (0.35%) 
Subdural haematoma * 1  1/281 (0.36%)  0/283 (0.00%) 
Upper limb fracture * 1  0/281 (0.00%)  1/283 (0.35%) 
Wound * 1  0/281 (0.00%)  1/283 (0.35%) 
Wound decomposition * 1  0/281 (0.00%)  1/283 (0.35%) 
Investigations     
Diagnostic procedure * 1  1/281 (0.36%)  0/283 (0.00%) 
Influenza B virus test positive * 1  0/281 (0.00%)  1/283 (0.35%) 
International normalised ratio increased * 1  0/281 (0.00%)  1/283 (0.35%) 
Prostatic specific antigen increased * 1  0/281 (0.00%)  1/283 (0.35%) 
Troponin increased * 1  0/281 (0.00%)  1/283 (0.35%) 
Urine output decreased * 1  0/281 (0.00%)  1/283 (0.35%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  1/281 (0.36%)  0/283 (0.00%) 
Dehydration * 1  0/281 (0.00%)  2/283 (0.71%) 
Electrolyte imbalance * 1  0/281 (0.00%)  2/283 (0.71%) 
Gout * 1  2/281 (0.71%)  0/283 (0.00%) 
Hypercalcaemia * 1  1/281 (0.36%)  3/283 (1.06%) 
Hyperglycaemia * 1  0/281 (0.00%)  1/283 (0.35%) 
Hypocalcaemia * 1  0/281 (0.00%)  1/283 (0.35%) 
Hypoglycaemia * 1  0/281 (0.00%)  1/283 (0.35%) 
Metabolic acidosis * 1  0/281 (0.00%)  1/283 (0.35%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  1/281 (0.36%)  0/283 (0.00%) 
Back pain * 1  6/281 (2.14%)  3/283 (1.06%) 
Bone pain * 1  0/281 (0.00%)  2/283 (0.71%) 
Bursitis * 1  1/281 (0.36%)  0/283 (0.00%) 
Flank pain * 1  0/281 (0.00%)  1/283 (0.35%) 
Intervertebral disc protrusion * 1  0/281 (0.00%)  2/283 (0.71%) 
Muscular weakness * 1  1/281 (0.36%)  0/283 (0.00%) 
Musculoskeletal pain * 1  1/281 (0.36%)  1/283 (0.35%) 
Osteoarthritis * 1  2/281 (0.71%)  1/283 (0.35%) 
Osteonecrosis of jaw * 1  2/281 (0.71%)  3/283 (1.06%) 
Pain in extremity * 1  0/281 (0.00%)  1/283 (0.35%) 
Pathological fracture * 1  2/281 (0.71%)  0/283 (0.00%) 
Rhabdomyolysis * 1  1/281 (0.36%)  1/283 (0.35%) 
Spinal pain * 1  1/281 (0.36%)  0/283 (0.00%) 
Spinal stenosis * 1  2/281 (0.71%)  0/283 (0.00%) 
Spondylitis * 1  0/281 (0.00%)  1/283 (0.35%) 
Spondylolisthesis * 1  0/281 (0.00%)  1/283 (0.35%) 
Vertebral foraminal stenosis * 1  0/281 (0.00%)  1/283 (0.35%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acute monocytic leukaemia * 1  0/281 (0.00%)  1/283 (0.35%) 
Acute myeloid leukaemia * 1  1/281 (0.36%)  1/283 (0.35%) 
Adenocarcinoma * 1  0/281 (0.00%)  1/283 (0.35%) 
Adenocarcinoma gastric * 1  1/281 (0.36%)  0/283 (0.00%) 
Adenocarcinoma of colon * 1  0/281 (0.00%)  1/283 (0.35%) 
Adenoma benign * 1  0/281 (0.00%)  1/283 (0.35%) 
Benign anorectal neoplasm * 1  1/281 (0.36%)  0/283 (0.00%) 
Bladder transitional cell carcinoma * 1  1/281 (0.36%)  0/283 (0.00%) 
Bowen's disease * 1  0/281 (0.00%)  2/283 (0.71%) 
Breast cancer * 1  1/281 (0.36%)  0/283 (0.00%) 
Clear cell renal cell carcinoma * 1  1/281 (0.36%)  0/283 (0.00%) 
Colorectal adenocarcinoma * 1  0/281 (0.00%)  1/283 (0.35%) 
Epstein-Barr virus associated lymphoproliferative disorder * 1  0/281 (0.00%)  1/283 (0.35%) 
Invasive ductal breast carcinoma * 1  0/281 (0.00%)  1/283 (0.35%) 
Lung adenocarcinoma * 1  1/281 (0.36%)  0/283 (0.00%) 
Malignant melanoma * 1  0/281 (0.00%)  1/283 (0.35%) 
Metastatic squamous cell carcinoma * 1  0/281 (0.00%)  1/283 (0.35%) 
Myelodysplastic syndrome * 1  1/281 (0.36%)  2/283 (0.71%) 
Plasma cell leukaemia * 1  2/281 (0.71%)  1/283 (0.35%) 
Pleural mesothelioma * 1  1/281 (0.36%)  0/283 (0.00%) 
Prostate cancer * 1  1/281 (0.36%)  1/283 (0.35%) 
Rectal adenocarcinoma * 1  1/281 (0.36%)  0/283 (0.00%) 
Skin cancer * 1  0/281 (0.00%)  1/283 (0.35%) 
Squamous cell carcinoma * 1  1/281 (0.36%)  1/283 (0.35%) 
Squamous cell carcinoma of lung * 1  0/281 (0.00%)  2/283 (0.71%) 
Squamous cell carcinoma of skin * 1  0/281 (0.00%)  1/283 (0.35%) 
Transitional cell carcinoma * 1  0/281 (0.00%)  1/283 (0.35%) 
Nervous system disorders     
Aphasia * 1  1/281 (0.36%)  0/283 (0.00%) 
Carotid arteriosclerosis * 1  1/281 (0.36%)  0/283 (0.00%) 
Cerebral arteriosclerosis * 1  0/281 (0.00%)  1/283 (0.35%) 
Cerebral haemorrhage * 1  1/281 (0.36%)  0/283 (0.00%) 
Cerebral infarction * 1  1/281 (0.36%)  3/283 (1.06%) 
Cerebrovascular accident * 1  0/281 (0.00%)  1/283 (0.35%) 
Cognitive disorder * 1  0/281 (0.00%)  1/283 (0.35%) 
Encephalopathy * 1  1/281 (0.36%)  0/283 (0.00%) 
Facial paralysis * 1  2/281 (0.71%)  0/283 (0.00%) 
Generalised tonic-clonic seizure * 1  1/281 (0.36%)  0/283 (0.00%) 
Headache * 1  0/281 (0.00%)  1/283 (0.35%) 
Intercostal neuralgia * 1  1/281 (0.36%)  0/283 (0.00%) 
Ischaemic stroke * 1  2/281 (0.71%)  0/283 (0.00%) 
Loss of consciousness * 1  2/281 (0.71%)  1/283 (0.35%) 
Nervous system disorder * 1  1/281 (0.36%)  0/283 (0.00%) 
Peripheral sensory neuropathy * 1  1/281 (0.36%)  0/283 (0.00%) 
Presyncope * 1  0/281 (0.00%)  2/283 (0.71%) 
Sciatica * 1  1/281 (0.36%)  0/283 (0.00%) 
Seizure * 1  0/281 (0.00%)  3/283 (1.06%) 
Somnolence * 1  1/281 (0.36%)  0/283 (0.00%) 
Spinal cord compression * 1  1/281 (0.36%)  0/283 (0.00%) 
Subarachnoid haemorrhage * 1  0/281 (0.00%)  1/283 (0.35%) 
Syncope * 1  1/281 (0.36%)  5/283 (1.77%) 
Transient ischaemic attack * 1  1/281 (0.36%)  1/283 (0.35%) 
Trigeminal nerve disorder * 1  0/281 (0.00%)  1/283 (0.35%) 
Psychiatric disorders     
Confusional state * 1  1/281 (0.36%)  2/283 (0.71%) 
Depression * 1  1/281 (0.36%)  1/283 (0.35%) 
Depressive symptom * 1  1/281 (0.36%)  0/283 (0.00%) 
Renal and urinary disorders     
Acute kidney injury * 1  11/281 (3.91%)  8/283 (2.83%) 
Azotaemia * 1  1/281 (0.36%)  1/283 (0.35%) 
Haematuria * 1  0/281 (0.00%)  2/283 (0.71%) 
Renal failure * 1  5/281 (1.78%)  1/283 (0.35%) 
Ureterolithiasis * 1  1/281 (0.36%)  0/283 (0.00%) 
Urethral haemorrhage * 1  0/281 (0.00%)  1/283 (0.35%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia * 1  1/281 (0.36%)  0/283 (0.00%) 
Prostatitis * 1  1/281 (0.36%)  0/283 (0.00%) 
Prostatomegaly * 1  0/281 (0.00%)  1/283 (0.35%) 
Respiratory, thoracic and mediastinal disorders     
Acute pulmonary oedema * 1  0/281 (0.00%)  1/283 (0.35%) 
Acute respiratory failure * 1  1/281 (0.36%)  0/283 (0.00%) 
Asthma * 1  0/281 (0.00%)  1/283 (0.35%) 
Bronchospasm * 1  1/281 (0.36%)  1/283 (0.35%) 
Chronic obstructive pulmonary disease * 1  1/281 (0.36%)  2/283 (0.71%) 
Dyspnoea * 1  1/281 (0.36%)  5/283 (1.77%) 
Epistaxis * 1  0/281 (0.00%)  1/283 (0.35%) 
Hypoxia * 1  0/281 (0.00%)  2/283 (0.71%) 
Interstitial lung disease * 1  1/281 (0.36%)  0/283 (0.00%) 
Lung disorder * 1  2/281 (0.71%)  0/283 (0.00%) 
Obstructive airways disorder * 1  0/281 (0.00%)  1/283 (0.35%) 
Pleural effusion * 1  2/281 (0.71%)  0/283 (0.00%) 
Pneumonitis * 1  0/281 (0.00%)  1/283 (0.35%) 
Pneumothorax * 1  1/281 (0.36%)  1/283 (0.35%) 
Pulmonary calcification * 1  0/281 (0.00%)  1/283 (0.35%) 
Pulmonary congestion * 1  1/281 (0.36%)  0/283 (0.00%) 
Pulmonary embolism * 1  10/281 (3.56%)  12/283 (4.24%) 
Pulmonary oedema * 1  1/281 (0.36%)  2/283 (0.71%) 
Respiratory failure * 1  1/281 (0.36%)  3/283 (1.06%) 
Skin and subcutaneous tissue disorders     
Dermal cyst * 1  1/281 (0.36%)  0/283 (0.00%) 
Diabetic foot * 1  1/281 (0.36%)  0/283 (0.00%) 
Rash * 1  0/281 (0.00%)  1/283 (0.35%) 
Rash papular * 1  0/281 (0.00%)  1/283 (0.35%) 
Social circumstances     
Loss of personal independence in daily activities * 1  0/281 (0.00%)  1/283 (0.35%) 
Vascular disorders     
Aortic aneurysm rupture * 1  0/281 (0.00%)  1/283 (0.35%) 
Deep vein thrombosis * 1  1/281 (0.36%)  2/283 (0.71%) 
Embolism * 1  0/281 (0.00%)  1/283 (0.35%) 
Femoral artery embolism * 1  1/281 (0.36%)  0/283 (0.00%) 
Haemorrhagic infarction * 1  0/281 (0.00%)  1/283 (0.35%) 
Hypertension * 1  0/281 (0.00%)  2/283 (0.71%) 
Hypotension * 1  0/281 (0.00%)  1/283 (0.35%) 
Orthostatic hypotension * 1  0/281 (0.00%)  1/283 (0.35%) 
Peripheral artery stenosis * 1  0/281 (0.00%)  1/283 (0.35%) 
Phlebitis * 1  1/281 (0.36%)  0/283 (0.00%) 
Thrombophlebitis * 1  1/281 (0.36%)  0/283 (0.00%) 
Thrombosis * 1  0/281 (0.00%)  1/283 (0.35%) 
Venous occlusion * 1  1/281 (0.36%)  0/283 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 24.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lenalidomide, Low-dose Dexamethasone (Rd) Daratumumab, Lenalidomide, Low-dose Dexamethasone (DRd)
Affected / at Risk (%) Affected / at Risk (%)
Total   268/281 (95.37%)   278/283 (98.23%) 
Blood and lymphatic system disorders     
Anaemia * 1  117/281 (41.64%)  118/283 (41.70%) 
Leukopenia * 1  23/281 (8.19%)  29/283 (10.25%) 
Lymphopenia * 1  17/281 (6.05%)  20/283 (7.07%) 
Neutropenia * 1  136/281 (48.40%)  185/283 (65.37%) 
Thrombocytopenia * 1  90/281 (32.03%)  92/283 (32.51%) 
Cardiac disorders     
Atrial fibrillation * 1  9/281 (3.20%)  17/283 (6.01%) 
Tachycardia * 1  2/281 (0.71%)  16/283 (5.65%) 
Eye disorders     
Cataract * 1  35/281 (12.46%)  59/283 (20.85%) 
Vision blurred * 1  17/281 (6.05%)  28/283 (9.89%) 
Gastrointestinal disorders     
Abdominal pain * 1  16/281 (5.69%)  30/283 (10.60%) 
Abdominal pain upper * 1  13/281 (4.63%)  29/283 (10.25%) 
Constipation * 1  77/281 (27.40%)  94/283 (33.22%) 
Diarrhoea * 1  105/281 (37.37%)  169/283 (59.72%) 
Dyspepsia * 1  9/281 (3.20%)  29/283 (10.25%) 
Nausea * 1  53/281 (18.86%)  86/283 (30.39%) 
Stomatitis * 1  6/281 (2.14%)  19/283 (6.71%) 
Toothache * 1  10/281 (3.56%)  17/283 (6.01%) 
Vomiting * 1  19/281 (6.76%)  65/283 (22.97%) 
General disorders     
Asthenia * 1  47/281 (16.73%)  59/283 (20.85%) 
Chills * 1  9/281 (3.20%)  22/283 (7.77%) 
Fatigue * 1  87/281 (30.96%)  119/283 (42.05%) 
Influenza like illness * 1  20/281 (7.12%)  27/283 (9.54%) 
Non-cardiac chest pain * 1  5/281 (1.78%)  18/283 (6.36%) 
Oedema peripheral * 1  50/281 (17.79%)  72/283 (25.44%) 
Pyrexia * 1  40/281 (14.23%)  71/283 (25.09%) 
Infections and infestations     
Bronchitis * 1  45/281 (16.01%)  60/283 (21.20%) 
Conjunctivitis * 1  6/281 (2.14%)  19/283 (6.71%) 
Gastroenteritis * 1  9/281 (3.20%)  25/283 (8.83%) 
Influenza * 1  17/281 (6.05%)  34/283 (12.01%) 
Lower respiratory tract infection * 1  12/281 (4.27%)  22/283 (7.77%) 
Nasopharyngitis * 1  62/281 (22.06%)  100/283 (35.34%) 
Pneumonia * 1  27/281 (9.61%)  51/283 (18.02%) 
Respiratory tract infection * 1  29/281 (10.32%)  38/283 (13.43%) 
Rhinitis * 1  5/281 (1.78%)  23/283 (8.13%) 
Sinusitis * 1  13/281 (4.63%)  27/283 (9.54%) 
Upper respiratory tract infection * 1  74/281 (26.33%)  123/283 (43.46%) 
Urinary tract infection * 1  26/281 (9.25%)  30/283 (10.60%) 
Injury, poisoning and procedural complications     
Contusion * 1  12/281 (4.27%)  25/283 (8.83%) 
Fall * 1  12/281 (4.27%)  24/283 (8.48%) 
Investigations     
Alanine aminotransferase increased * 1  14/281 (4.98%)  19/283 (6.71%) 
Blood creatinine increased * 1  17/281 (6.05%)  16/283 (5.65%) 
Weight decreased * 1  13/281 (4.63%)  31/283 (10.95%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  36/281 (12.81%)  50/283 (17.67%) 
Hyperglycaemia * 1  22/281 (7.83%)  34/283 (12.01%) 
Hypocalcaemia * 1  16/281 (5.69%)  24/283 (8.48%) 
Hypokalaemia * 1  35/281 (12.46%)  58/283 (20.49%) 
Hypomagnesaemia * 1  17/281 (6.05%)  18/283 (6.36%) 
Hypophosphataemia * 1  14/281 (4.98%)  22/283 (7.77%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  55/281 (19.57%)  75/283 (26.50%) 
Back pain * 1  56/281 (19.93%)  76/283 (26.86%) 
Bone pain * 1  16/281 (5.69%)  29/283 (10.25%) 
Muscle spasms * 1  61/281 (21.71%)  87/283 (30.74%) 
Muscular weakness * 1  26/281 (9.25%)  29/283 (10.25%) 
Musculoskeletal chest pain * 1  24/281 (8.54%)  32/283 (11.31%) 
Myalgia * 1  17/281 (6.05%)  22/283 (7.77%) 
Neck pain * 1  13/281 (4.63%)  22/283 (7.77%) 
Pain in extremity * 1  42/281 (14.95%)  47/283 (16.61%) 
Nervous system disorders     
Dizziness * 1  30/281 (10.68%)  35/283 (12.37%) 
Headache * 1  23/281 (8.19%)  56/283 (19.79%) 
Hypoaesthesia * 1  9/281 (3.20%)  18/283 (6.36%) 
Neuropathy peripheral * 1  18/281 (6.41%)  25/283 (8.83%) 
Paraesthesia * 1  12/281 (4.27%)  17/283 (6.01%) 
Peripheral sensory neuropathy * 1  27/281 (9.61%)  40/283 (14.13%) 
Tremor * 1  26/281 (9.25%)  28/283 (9.89%) 
Psychiatric disorders     
Anxiety * 1  13/281 (4.63%)  25/283 (8.83%) 
Depression * 1  9/281 (3.20%)  29/283 (10.25%) 
Insomnia * 1  65/281 (23.13%)  80/283 (28.27%) 
Renal and urinary disorders     
Renal impairment * 1  15/281 (5.34%)  33/283 (11.66%) 
Respiratory, thoracic and mediastinal disorders     
Dysphonia * 1  9/281 (3.20%)  18/283 (6.36%) 
Dyspnoea * 1  39/281 (13.88%)  65/283 (22.97%) 
Dyspnoea exertional * 1  11/281 (3.91%)  21/283 (7.42%) 
Epistaxis * 1  15/281 (5.34%)  11/283 (3.89%) 
Nasal congestion * 1  7/281 (2.49%)  23/283 (8.13%) 
Oropharyngeal pain * 1  17/281 (6.05%)  23/283 (8.13%) 
Productive cough * 1  11/281 (3.91%)  26/283 (9.19%) 
Rhinitis allergic * 1  4/281 (1.42%)  21/283 (7.42%) 
Rhinorrhoea * 1  8/281 (2.85%)  18/283 (6.36%) 
Cough * 1  43/281 (15.30%)  107/283 (37.81%) 
Skin and subcutaneous tissue disorders     
Hyperhidrosis * 1  10/281 (3.56%)  25/283 (8.83%) 
Pruritus * 1  31/281 (11.03%)  34/283 (12.01%) 
Rash * 1  36/281 (12.81%)  51/283 (18.02%) 
Vascular disorders     
Haematoma * 1  6/281 (2.14%)  15/283 (5.30%) 
Hypertension * 1  22/281 (7.83%)  31/283 (10.95%) 
Hypotension * 1  9/281 (3.20%)  26/283 (9.19%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 24.0
[Not Specified]
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, Clinical Research
Organization: Janssen R&D US
EMail: ClinicalTrialDisclosure@its.jnj.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02076009    
Other Study ID Numbers: CR103663
54767414MMY3003 ( Other Identifier: Janssen Research & Development, LLC )
2013-005525-23 ( EudraCT Number )
First Submitted: February 27, 2014
First Posted: March 3, 2014
Results First Submitted: December 20, 2016
Results First Posted: February 10, 2017
Last Update Posted: April 25, 2024