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Trial record 1 of 1 for:    mmy3003
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A Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02076009
Recruitment Status : Active, not recruiting
First Posted : March 3, 2014
Results First Posted : February 10, 2017
Last Update Posted : July 28, 2017
Sponsor:
Information provided by (Responsible Party):

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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Lenalidomide, Low-dose Dexamethasone (Rd) Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as 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 [<] 8.5).
Daratumumab, Lenalidomide, Dexamethasone (DRd) Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); 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 Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).

Participant Flow:   Overall Study
    Lenalidomide, Low-dose Dexamethasone (Rd)   Daratumumab, Lenalidomide, Dexamethasone (DRd)
STARTED   283   286 
Treated   281   283 
COMPLETED   0   0 
NOT COMPLETED   283   286 
Death                44                30 
Withdrawal by Subject                9                3 
Lost to Follow-up                1                1 
Progressive disease                1                0 
Ongoing                226                249 
Subjects randomized but not treated                2                3 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Lenalidomide, Low-dose Dexamethasone (Rd) Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as 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 [<] 8.5).
Daratumumab, Lenalidomide, Dexamethasone (DRd) Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); 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 Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).
Total Total of all reporting groups

Baseline Measures
   Lenalidomide, Low-dose Dexamethasone (Rd)   Daratumumab, Lenalidomide, Dexamethasone (DRd)   Total 
Overall Participants Analyzed 
[Units: Participants]
 283   286   569 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.3  (8.84)   64.4  (9.03)   64.4  (8.93) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      119  42.0%      113  39.5%      232  40.8% 
Male      164  58.0%      173  60.5%      337  59.2% 
Region of Enrollment 
[Units: Participants]
     
Australia   9   9   18 
Belgium   10   12   22 
Canada   17   17   34 
Denmark   7   10   17 
France   36   21   57 
Germany   7   11   18 
Greece   8   11   19 
Israel   20   19   39 
Japan   15   21   36 
Korea, Republic of   20   20   40 
Netherlands   3   1   4 
Poland   13   15   28 
Russian Federation   30   18   48 
Spain   25   26   51 
Sweden   15   16   31 
Taiwan, Province of China   9   11   20 
United Kingdom   24   27   51 
United States   15   21   36 
Stage of Disease (ISS) [1] 
[Units: Participants]
     
 140   137   277 
II   86   93   179 
III   57   56   113 
[1] 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 
[Units: Participants]
     
 146   149   295 
 80   85   165 
 38   38   76 
>3   19   14   33 


  Outcome Measures

1.  Primary:   Progression-free Survival (PFS)   [ Time Frame: From randomization to either disease progression or death whichever occurs first until 3 years ]

Measure Type Primary
Measure Title Progression-free Survival (PFS)
Measure Description PFS was defined as duration from date of randomization to either progressive disease (PD)/death, whichever occurred first. PD was defined as meeting any one 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-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 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) that can be attributed solely to PC proliferative disorder.
Time Frame From randomization to either disease progression or death whichever occurs first until 3 years  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Lenalidomide, Low-dose Dexamethasone (Rd) Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as 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 [<] 8.5).
Daratumumab, Lenalidomide, Dexamethasone (DRd) Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); 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 Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).

Measured Values
   Lenalidomide, Low-dose Dexamethasone (Rd)   Daratumumab, Lenalidomide, Dexamethasone (DRd) 
Participants Analyzed 
[Units: Participants]
 283   286 
Progression-free Survival (PFS) 
[Units: Months]
Median (95% Confidence Interval)
 18.43 [1] 
 (13.86 to N/A) 
 NA [2] 
[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.

No statistical analysis provided for Progression-free Survival (PFS)



2.  Secondary:   Time to Disease Progression (TTP)   [ Time Frame: From randomization to disease progression until 3 years ]

Measure Type Secondary
Measure Title Time to Disease Progression (TTP)
Measure 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 until 3 years  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT analysis set included all participants who were randomly assigned to the DRd or Rd group.

Reporting Groups
  Description
Lenalidomide, Low-dose Dexamethasone (Rd) Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as 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 [<] 8.5).
Daratumumab, Lenalidomide, Dexamethasone (DRd) Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); 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 Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).

Measured Values
   Lenalidomide, Low-dose Dexamethasone (Rd)   Daratumumab, Lenalidomide, Dexamethasone (DRd) 
Participants Analyzed 
[Units: Participants]
 283   286 
Time to Disease Progression (TTP) 
[Units: Months]
Median (95% Confidence Interval)
 18.43 [1] 
 (14.78 to N/A) 
 NA [2] 
[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.

No statistical analysis provided for Time to Disease Progression (TTP)



3.  Secondary:   Percentage of Participants Who Achieved Very Good Partial Response (VGPR) or Better   [ Time Frame: From randomization to disease progression (approximately up to 3 years) ]

Measure Type Secondary
Measure Title Percentage of Participants Who Achieved Very Good Partial Response (VGPR) or Better
Measure 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 (approximately up to 3 years)  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Lenalidomide, Low-dose Dexamethasone (Rd) Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as 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 [<] 8.5).
Daratumumab, Lenalidomide, Dexamethasone (DRd) Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); 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 Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).

Measured Values
   Lenalidomide, Low-dose Dexamethasone (Rd)   Daratumumab, Lenalidomide, Dexamethasone (DRd) 
Participants Analyzed 
[Units: Participants]
 276   281 
Percentage of Participants Who Achieved Very Good Partial Response (VGPR) or Better 
[Units: Percentage of participants]
Number (95% Confidence Interval)
 44.2 
 (38.3 to 50.3) 
 75.8 
 (70.4 to 80.7) 

No statistical analysis provided for Percentage of Participants Who Achieved Very Good Partial Response (VGPR) or Better



4.  Secondary:   Percentage of Participants With Negative Minimal Residual Disease (MRD)   [ Time Frame: From randomization to the date of first documented evidence of PD until 3 years ]

Measure Type Secondary
Measure Title Percentage of Participants With Negative Minimal Residual Disease (MRD)
Measure Description Minimal residual disease was assessed for all participants who achieved a complete response (CR) or stringent complete response (sCR). 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^- 4 threshold.
Time Frame From randomization to the date of first documented evidence of PD until 3 years  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT analysis set included all participants who were randomly assigned to the DRd or Rd group.

Reporting Groups
  Description
Lenalidomide, Low-dose Dexamethasone (Rd) Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as 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 [<] 8.5).
Daratumumab, Lenalidomide, Dexamethasone (DRd) Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); 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 Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).

Measured Values
   Lenalidomide, Low-dose Dexamethasone (Rd)   Daratumumab, Lenalidomide, Dexamethasone (DRd) 
Participants Analyzed 
[Units: Participants]
 283   286 
Percentage of Participants With Negative Minimal Residual Disease (MRD) 
[Units: Percentage of participants]
 7.8   29.0 

No statistical analysis provided for Percentage of Participants With Negative Minimal Residual Disease (MRD)



5.  Secondary:   Overall Response Rate   [ Time Frame: From randomization to disease progression (approximately up to 3 years) ]

Measure Type Secondary
Measure Title Overall Response Rate
Measure 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 (approximately up to 3 years)  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Lenalidomide, Low-dose Dexamethasone (Rd) Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as 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 [<] 8.5).
Daratumumab, Lenalidomide, Dexamethasone (DRd) Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); 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 Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).

Measured Values
   Lenalidomide, Low-dose Dexamethasone (Rd)   Daratumumab, Lenalidomide, Dexamethasone (DRd) 
Participants Analyzed 
[Units: Participants]
 276   281 
Overall Response Rate 
[Units: Percentage of participants]
 76.4   92.9 

No statistical analysis provided for Overall Response Rate



6.  Secondary:   Overall Survival (OS)   [ Time Frame: Up to approximately 5 years (anticipated) after the last participant is randomized ]

Measure Type Secondary
Measure Title Overall Survival (OS)
Measure Description Overall survival was measured from the date of randomization to the date of the participant's death.
Time Frame Up to approximately 5 years (anticipated) after the last participant is randomized  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT analysis set included all participants who were randomly assigned to the DRd or Rd group.

Reporting Groups
  Description
Lenalidomide, Low-dose Dexamethasone (Rd) Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as 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 [<] 8.5).
Daratumumab, Lenalidomide, Dexamethasone (DRd) Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); 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 Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).

Measured Values
   Lenalidomide, Low-dose Dexamethasone (Rd)   Daratumumab, Lenalidomide, Dexamethasone (DRd) 
Participants Analyzed 
[Units: Participants]
 283   286 
Overall Survival (OS) 
[Units: Months]
Median (95% Confidence Interval)
 NA [1]   NA [1] 
[1] Data was not calculated and reported due to short follow-up by participants.

No statistical analysis provided for Overall Survival (OS)



7.  Secondary:   Time to Response   [ Time Frame: From randomization up to first documented CR or PR until 3 years ]

Measure Type Secondary
Measure Title Time to Response
Measure 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 until 3 years  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Lenalidomide, Low-dose Dexamethasone (Rd) Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as 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 [<] 8.5).
Daratumumab, Lenalidomide, Dexamethasone (DRd) Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); 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 Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).

Measured Values
   Lenalidomide, Low-dose Dexamethasone (Rd)   Daratumumab, Lenalidomide, Dexamethasone (DRd) 
Participants Analyzed 
[Units: Participants]
 276   281 
Time to Response 
[Units: Months]
Median (95% Confidence Interval)
 1.3 
 (1.1 to 1.9) 
 1.0 
 (1.0 to 1.1) 

No statistical analysis provided for Time to Response



8.  Secondary:   Duration of Response (DOR)   [ Time Frame: From randomization to the date of first documented evidence of PD until 3 years ]

Measure Type Secondary
Measure Title Duration of Response (DOR)
Measure 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 until 3 years  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
Lenalidomide, Low-dose Dexamethasone (Rd) Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as 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 [<] 8.5).
Daratumumab, Lenalidomide, Dexamethasone (DRd) Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); 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 Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).

Measured Values
   Lenalidomide, Low-dose Dexamethasone (Rd)   Daratumumab, Lenalidomide, Dexamethasone (DRd) 
Participants Analyzed 
[Units: Participants]
 211   261 
Duration of Response (DOR) 
[Units: Months]
Median (95% Confidence Interval)
 17.4 [1] 
 (17.4 to N/A) 
 NA [2] 
[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.

No statistical analysis provided for Duration of Response (DOR)




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Director, Clinical Research
Organization: Janssen R&D US
e-mail: ClinicalTrialDisclosure@its.jnj.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02076009     History of Changes
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: July 28, 2017