Trial Outcomes & Findings for A Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma (NCT NCT02076009)

NCT ID: NCT02076009

Last Updated: 2025-05-01

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

569 participants

Primary outcome timeframe

From randomization to either disease progression or death whichever occurs first (up to 21 months)

Results posted on

2025-05-01

Participant Flow

Participant milestones

Participant milestones
Measure	Lenalidomide, Low-dose Dexamethasone (Rd) 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 \[kg/m\^2\]).	Daratumumab, Lenalidomide, Low-dose Dexamethasone (DRd) 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 Study STARTED	283	286
Overall Study Treated (Safety Population)	281	283
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	283	286

Reasons for withdrawal

Reasons for withdrawal
Measure	Lenalidomide, Low-dose Dexamethasone (Rd) 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 \[kg/m\^2\]).	Daratumumab, Lenalidomide, Low-dose Dexamethasone (DRd) 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 Study Death	172	153
Overall Study Withdrawal by Subject	16	12
Overall Study Lost to Follow-up	4	2
Overall Study Progressive Disease	1	0
Overall Study Physician Decision	0	1
Overall Study End of data collection	90	118

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lenalidomide, Low-dose Dexamethasone (Rd) n=283 Participants 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 \[kg/m\^2\]).	Daratumumab, Lenalidomide, Low-dose Dexamethasone (DRd) n=286 Participants 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 n=569 Participants Total of all reporting groups
Age, Continuous	64.3 years STANDARD_DEVIATION 8.84 • n=5 Participants	64.4 years STANDARD_DEVIATION 9.03 • n=7 Participants	64.4 years STANDARD_DEVIATION 8.93 • n=5 Participants
Sex: Female, Male Female	119 Participants n=5 Participants	113 Participants n=7 Participants	232 Participants n=5 Participants
Sex: Female, Male Male	164 Participants n=5 Participants	173 Participants n=7 Participants	337 Participants n=5 Participants
Region of Enrollment Australia	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Region of Enrollment Belgium	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants
Region of Enrollment Canada	17 Participants n=5 Participants	17 Participants n=7 Participants	34 Participants n=5 Participants
Region of Enrollment Denmark	7 Participants n=5 Participants	10 Participants n=7 Participants	17 Participants n=5 Participants
Region of Enrollment France	36 Participants n=5 Participants	21 Participants n=7 Participants	57 Participants n=5 Participants
Region of Enrollment Germany	7 Participants n=5 Participants	11 Participants n=7 Participants	18 Participants n=5 Participants
Region of Enrollment Greece	8 Participants n=5 Participants	11 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment Israel	20 Participants n=5 Participants	19 Participants n=7 Participants	39 Participants n=5 Participants
Region of Enrollment Japan	15 Participants n=5 Participants	21 Participants n=7 Participants	36 Participants n=5 Participants
Region of Enrollment Korea, Republic of	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Region of Enrollment Netherlands	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment Poland	13 Participants n=5 Participants	15 Participants n=7 Participants	28 Participants n=5 Participants
Region of Enrollment Russian Federation	30 Participants n=5 Participants	18 Participants n=7 Participants	48 Participants n=5 Participants
Region of Enrollment Spain	25 Participants n=5 Participants	26 Participants n=7 Participants	51 Participants n=5 Participants
Region of Enrollment Sweden	15 Participants n=5 Participants	16 Participants n=7 Participants	31 Participants n=5 Participants
Region of Enrollment Taiwan, Province of China	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Region of Enrollment United Kingdom	24 Participants n=5 Participants	27 Participants n=7 Participants	51 Participants n=5 Participants
Region of Enrollment United States	15 Participants n=5 Participants	21 Participants n=7 Participants	36 Participants n=5 Participants
Stage of Disease (ISS) I	140 Participants n=5 Participants	137 Participants n=7 Participants	277 Participants n=5 Participants
Stage of Disease (ISS) II	86 Participants n=5 Participants	93 Participants n=7 Participants	179 Participants n=5 Participants
Stage of Disease (ISS) III	57 Participants n=5 Participants	56 Participants n=7 Participants	113 Participants n=5 Participants
No. of Prior Lines of Therapy 1	146 Participants n=5 Participants	149 Participants n=7 Participants	295 Participants n=5 Participants
No. of Prior Lines of Therapy 2	80 Participants n=5 Participants	85 Participants n=7 Participants	165 Participants n=5 Participants
No. of Prior Lines of Therapy 3	38 Participants n=5 Participants	38 Participants n=7 Participants	76 Participants n=5 Participants
No. of Prior Lines of Therapy >3	19 Participants n=5 Participants	14 Participants n=7 Participants	33 Participants n=5 Participants

PRIMARY outcome

Timeframe: From randomization to either disease progression or death whichever occurs first (up to 21 months)

Population: 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.

Outcome measures

Outcome measures
Measure	Lenalidomide, Low-dose Dexamethasone (Rd) n=283 Participants 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 \[kg/m\^2\]).	Daratumumab, Lenalidomide, Low-dose Dexamethasone (DRd) n=286 Participants 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).
Progression-free Survival (PFS)	18.43 months Interval 13.86 to Upper limit of 95% confidence interval (CI) was not estimable due to short follow-up by participants.	NA months Median and 95% CI was not estimable due to short follow-up by participants.

SECONDARY outcome

Timeframe: From randomization to disease progression (up to 21 months)

Population: ITT analysis set included all participants who were randomly assigned to the DRd or Rd group.

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.

Outcome measures

Outcome measures
Measure	Lenalidomide, Low-dose Dexamethasone (Rd) n=283 Participants 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 \[kg/m\^2\]).	Daratumumab, Lenalidomide, Low-dose Dexamethasone (DRd) n=286 Participants 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).
Time to Disease Progression (TTP)	18.43 months Interval 14.78 to Upper limit of 95% CI was not estimable due to short follow-up.	NA months Median and 95% CI was not estimable due to short follow-up.

SECONDARY outcome

Timeframe: From randomization to disease progression (up to 21 months)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Lenalidomide, Low-dose Dexamethasone (Rd) n=276 Participants 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 \[kg/m\^2\]).	Daratumumab, Lenalidomide, Low-dose Dexamethasone (DRd) n=281 Participants 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).
Percentage of Participants Who Achieved Very Good Partial Response (VGPR) or Better	44.2 percentage of participants Interval 38.3 to 50.3	75.8 percentage of participants Interval 70.4 to 80.7

SECONDARY outcome

Timeframe: From randomization to the date of first documented evidence of PD (up to 87.5 months)

Population: ITT analysis set included all participants who were randomly assigned to the DRd or Rd group.

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.

Outcome measures

Outcome measures
Measure	Lenalidomide, Low-dose Dexamethasone (Rd) n=283 Participants 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 \[kg/m\^2\]).	Daratumumab, Lenalidomide, Low-dose Dexamethasone (DRd) n=286 Participants 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).
Percentage of Participants With Negative Minimal Residual Disease (MRD) MRD negative rate (10^-4)	10.2 percentage of participants Interval 7.0 to 14.4	40.6 percentage of participants Interval 34.8 to 46.5
Percentage of Participants With Negative Minimal Residual Disease (MRD) MRD negative rate (10^-5)	6.7 percentage of participants Interval 4.1 to 10.3	33.2 percentage of participants Interval 27.8 to 39.0
Percentage of Participants With Negative Minimal Residual Disease (MRD) MRD negative rate (10^-6)	1.8 percentage of participants Interval 0.6 to 4.1	13.3 percentage of participants Interval 9.6 to 17.8

SECONDARY outcome

Timeframe: From randomization to disease progression (up to 21 months)

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.

Outcome measures

Outcome measures
Measure	Lenalidomide, Low-dose Dexamethasone (Rd) n=276 Participants 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 \[kg/m\^2\]).	Daratumumab, Lenalidomide, Low-dose Dexamethasone (DRd) n=281 Participants 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 Response Rate	76.4 percentage of participants	92.9 percentage of participants

SECONDARY outcome

Timeframe: From randomization to date of death due to any cause (up to 87.5 months)

Population: 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.

Overall survival was measured from the date of randomization to the date of the participant's death.

Outcome measures

Outcome measures
Measure	Lenalidomide, Low-dose Dexamethasone (Rd) n=175 Participants 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 \[kg/m\^2\]).	Daratumumab, Lenalidomide, Low-dose Dexamethasone (DRd) n=153 Participants 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 Survival (OS)	51.84 months Interval 43.99 to 60.02	67.58 months Interval 53.13 to 80.53

SECONDARY outcome

Timeframe: From randomization up to first documented CR or PR (up to 21 months)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Lenalidomide, Low-dose Dexamethasone (Rd) n=276 Participants 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 \[kg/m\^2\]).	Daratumumab, Lenalidomide, Low-dose Dexamethasone (DRd) n=281 Participants 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).
Time to Response	1.3 months Interval 1.1 to 1.9	1.0 months Interval 1.0 to 1.1

SECONDARY outcome

Timeframe: From randomization to the date of first documented evidence of PD (up to 21 months)

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.

Outcome measures

Outcome measures
Measure	Lenalidomide, Low-dose Dexamethasone (Rd) n=211 Participants 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 \[kg/m\^2\]).	Daratumumab, Lenalidomide, Low-dose Dexamethasone (DRd) n=261 Participants 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).
Duration of Response (DOR)	17.4 months Interval 17.4 to Upper limit of 95% CI was not estimable due to high censoring rate and lesser number of responders who progressed.	NA months Median and 95% CI was not estimable due to high censoring rate and lesser number of responders who progressed.

SECONDARY outcome

Timeframe: From randomization to date of start of subsequent anticancer treatment or death due to PD, whichever occured first (up to 87.5 months)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Lenalidomide, Low-dose Dexamethasone (Rd) n=212 Participants 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 \[kg/m\^2\]).	Daratumumab, Lenalidomide, Low-dose Dexamethasone (DRd) n=138 Participants 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).
Time to Subsequent Anticancer Treatment	23.1 months Interval 18.6 to 26.3	69.3 months Interval 49.7 to 82.8

Adverse Events

Lenalidomide, Low-dose Dexamethasone (Rd)

Serious events: 148 serious events

Other events: 268 other events

Deaths: 0 deaths

Daratumumab, Lenalidomide, Low-dose Dexamethasone (DRd)

Serious events: 205 serious events

Other events: 278 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Director, Clinical Research

Janssen R&D US

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER