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

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

Participant Flow

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Recruitment Details
Pre-assignment Details

Arm/Group Title	Lenalidomide, Low-dose Dexamethasone (Rd)	Daratumumab, Lenalidomide, Dexamethasone (DRd)
Arm/Group Description	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).	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).
Period Title: Overall Study
Started	283	286
Treated	281	283
Completed	0	0
Not Completed	283	286
Reason Not Completed
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

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Arm/Group Title		Lenalidomide, Low-dose Dexamethasone (Rd)	Daratumumab, Lenalidomide, Dexamethasone (DRd)	Total
Arm/Group Description		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).	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 of all reporting groups
Overall Number of Baseline Participants		283	286	569
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: Number; Unit of measure: Participants	Number Analyzed	283 participants	286 participants	569 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]; Measure Type: Number; Unit of measure: Participants	Number Analyzed	283 participants	286 participants	569 participants
I		140	137	277
II		86	93	179
III		57	56	113
		[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: Number; Unit of measure: Participants	Number Analyzed	283 participants	286 participants	569 participants
1		146	149	295
2		80	85	165
3		38	38	76
>3		19	14	33

Outcome Measures

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1. Primary Outcome

Title	Progression-free Survival (PFS)
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

Outcome Measure Data

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, Dexamethasone (DRd)
Arm/Group Description:	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).	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).
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)
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

Outcome Measure Data

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, Dexamethasone (DRd)
Arm/Group Description:	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).	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).
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
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)

Outcome Measure Data

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, Dexamethasone (DRd)
Arm/Group Description:	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).	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).
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)
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

Outcome Measure Data

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, Dexamethasone (DRd)
Arm/Group Description:	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).	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).
Overall Number of Participants Analyzed	283	286
Measure Type: Number; Unit of Measure: percentage of participants
	7.8	29.0

5. Secondary Outcome

Title	Overall Response Rate
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)

Outcome Measure Data

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, Dexamethasone (DRd)
Arm/Group Description:	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).	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).
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)
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

Outcome Measure Data

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, Dexamethasone (DRd)
Arm/Group Description:	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).	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).
Overall Number of Participants Analyzed	283	286
Median (95% Confidence Interval); Unit of Measure: months
	NA [1]; (NA to NA)	NA [1]; (NA to NA)

[1]

Data was not calculated and reported due to short follow-up by participants.

7. Secondary Outcome

Title	Time to Response
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

Outcome Measure Data

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, Dexamethasone (DRd)
Arm/Group Description:	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).	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).
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)
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

Outcome Measure Data

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, Dexamethasone (DRd)
Arm/Group Description:	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).	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).
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.

Adverse Events

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Time Frame	[Not Specified]
Adverse Event Reporting Description	Safety Population included participants who were randomized and received at least 1 dose of any study treatment.
Arm/Group Title	Lenalidomide, Low-dose Dexamethasone (Rd)	Daratumumab, Lenalidomide, Dexamethasone (DRd)
Arm/Group Description	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).	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).
All-Cause Mortality
	Lenalidomide, Low-dose Dexamethasone (Rd)	Daratumumab, Lenalidomide, Dexamethasone (DRd)
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events
	Lenalidomide, Low-dose Dexamethasone (Rd)	Daratumumab, Lenalidomide, Dexamethasone (DRd)
	Affected / at Risk (%)	Affected / at Risk (%)
Total	118/281 (41.99%)	138/283 (48.76%)
Blood and lymphatic system disorders
Anaemia * 1	2/281 (0.71%)	2/283 (0.71%)
Bone Marrow Failure * 1	1/281 (0.36%)	0/283 (0.00%)
Febrile Neutropenia * 1	4/281 (1.42%)	12/283 (4.24%)
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%)	2/283 (0.71%)
Sideroblastic Anaemia * 1	1/281 (0.36%)	0/283 (0.00%)
Thrombocytopenia * 1	1/281 (0.36%)	1/283 (0.35%)
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	3/281 (1.07%)	0/283 (0.00%)
Angina Pectoris * 1	0/281 (0.00%)	1/283 (0.35%)
Atrial Fibrillation * 1	2/281 (0.71%)	2/283 (0.71%)
Atrial Flutter * 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%)	0/283 (0.00%)
Cardiac Failure Congestive * 1	0/281 (0.00%)	1/283 (0.35%)
Cardiopulmonary Failure * 1	0/281 (0.00%)	1/283 (0.35%)
Myocardial Infarction * 1	1/281 (0.36%)	1/283 (0.35%)
Pericarditis * 1	1/281 (0.36%)	0/283 (0.00%)
Sinus Arrhythmia * 1	0/281 (0.00%)	1/283 (0.35%)
Supraventricular Tachycardia * 1	1/281 (0.36%)	0/283 (0.00%)
Eye disorders
Cataract * 1	0/281 (0.00%)	1/283 (0.35%)
Posterior Capsule Rupture * 1	0/281 (0.00%)	1/283 (0.35%)
Gastrointestinal disorders
Colitis * 1	1/281 (0.36%)	1/283 (0.35%)
Constipation * 1	0/281 (0.00%)	1/283 (0.35%)
Diarrhoea * 1	6/281 (2.14%)	5/283 (1.77%)
Diverticular Perforation * 1	0/281 (0.00%)	2/283 (0.71%)
Gastrointestinal Angiodysplasia Haemorrhagic * 1	0/281 (0.00%)	1/283 (0.35%)
Gastrointestinal Disorder * 1	0/281 (0.00%)	1/283 (0.35%)
Haematemesis * 1	1/281 (0.36%)	0/283 (0.00%)
Inguinal Hernia * 1	0/281 (0.00%)	1/283 (0.35%)
Intestinal Obstruction * 1	1/281 (0.36%)	0/283 (0.00%)
Lower Gastrointestinal Haemorrhage * 1	1/281 (0.36%)	0/283 (0.00%)
Nausea * 1	0/281 (0.00%)	2/283 (0.71%)
Oesophagitis * 1	1/281 (0.36%)	0/283 (0.00%)
Vomiting * 1	1/281 (0.36%)	1/283 (0.35%)
General disorders
Asthenia * 1	0/281 (0.00%)	1/283 (0.35%)
Chest Discomfort * 1	0/281 (0.00%)	1/283 (0.35%)
Fatigue * 1	1/281 (0.36%)	0/283 (0.00%)
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%)
Multi-Organ Failure * 1	0/281 (0.00%)	1/283 (0.35%)
Non-Cardiac Chest Pain * 1	1/281 (0.36%)	1/283 (0.35%)
Pain * 1	2/281 (0.71%)	1/283 (0.35%)
Pyrexia * 1	4/281 (1.42%)	8/283 (2.83%)
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%)
Liver Disorder * 1	1/281 (0.36%)	0/283 (0.00%)
Infections and infestations
Acute Sinusitis * 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%)
Bacterial Infection * 1	0/281 (0.00%)	1/283 (0.35%)
Bronchiolitis * 1	0/281 (0.00%)	1/283 (0.35%)
Bronchitis * 1	4/281 (1.42%)	5/283 (1.77%)
Bronchitis Bacterial * 1	0/281 (0.00%)	1/283 (0.35%)
Bronchopneumonia * 1	0/281 (0.00%)	2/283 (0.71%)
Candida Infection * 1	0/281 (0.00%)	1/283 (0.35%)
Cellulitis * 1	1/281 (0.36%)	1/283 (0.35%)
Clostridium Difficile Infection * 1	2/281 (0.71%)	0/283 (0.00%)
Cytomegalovirus Infection * 1	0/281 (0.00%)	1/283 (0.35%)
Enterocolitis Infectious * 1	1/281 (0.36%)	0/283 (0.00%)
Epiglottitis * 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%)
Extradural Abscess * 1	0/281 (0.00%)	1/283 (0.35%)
Gastroenteritis * 1	1/281 (0.36%)	1/283 (0.35%)
Gastroenteritis Viral * 1	1/281 (0.36%)	2/283 (0.71%)
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%)
Infection * 1	3/281 (1.07%)	2/283 (0.71%)
Infective Spondylitis * 1	0/281 (0.00%)	1/283 (0.35%)
Influenza * 1	4/281 (1.42%)	8/283 (2.83%)
Keratitis Fungal * 1	1/281 (0.36%)	0/283 (0.00%)
Listeria Sepsis * 1	0/281 (0.00%)	1/283 (0.35%)
Lobar Pneumonia * 1	1/281 (0.36%)	2/283 (0.71%)
Lower Respiratory Tract Infection * 1	3/281 (1.07%)	7/283 (2.47%)
Lung Infection * 1	1/281 (0.36%)	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%)	1/283 (0.35%)
Oral Fungal Infection * 1	0/281 (0.00%)	1/283 (0.35%)
Osteomyelitis * 1	2/281 (0.71%)	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%)
Periorbital Cellulitis * 1	0/281 (0.00%)	1/283 (0.35%)
Pharyngitis * 1	1/281 (0.36%)	0/283 (0.00%)
Pneumonia * 1	24/281 (8.54%)	23/283 (8.13%)
Pneumonia Bacterial * 1	1/281 (0.36%)	2/283 (0.71%)
Pneumonia Haemophilus * 1	0/281 (0.00%)	1/283 (0.35%)
Pneumonia Influenzal * 1	0/281 (0.00%)	3/283 (1.06%)
Pneumonia Klebsiella * 1	0/281 (0.00%)	1/283 (0.35%)
Pneumonia Legionella * 1	1/281 (0.36%)	1/283 (0.35%)
Pneumonia Streptococcal * 1	0/281 (0.00%)	1/283 (0.35%)
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%)	2/283 (0.71%)
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%)
Salmonella Bacteraemia * 1	0/281 (0.00%)	1/283 (0.35%)
Sepsis * 1	5/281 (1.78%)	2/283 (0.71%)
Septic Shock * 1	1/281 (0.36%)	3/283 (1.06%)
Skin Infection * 1	0/281 (0.00%)	1/283 (0.35%)
Soft Tissue Infection * 1	0/281 (0.00%)	1/283 (0.35%)
Tonsillitis * 1	0/281 (0.00%)	1/283 (0.35%)
Upper Respiratory Tract Infection * 1	5/281 (1.78%)	1/283 (0.35%)
Upper Respiratory Tract Infection Bacterial * 1	0/281 (0.00%)	1/283 (0.35%)
Urinary Tract Infection * 1	1/281 (0.36%)	3/283 (1.06%)
Urosepsis * 1	1/281 (0.36%)	0/283 (0.00%)
Uterine Abscess * 1	0/281 (0.00%)	1/283 (0.35%)
Varicella Zoster Virus Infection * 1	1/281 (0.36%)	0/283 (0.00%)
Viral Infection * 1	1/281 (0.36%)	0/283 (0.00%)
Injury, poisoning and procedural complications
Compression Fracture * 1	0/281 (0.00%)	1/283 (0.35%)
Fall * 1	1/281 (0.36%)	0/283 (0.00%)
Femoral Neck Fracture * 1	1/281 (0.36%)	0/283 (0.00%)
Foot 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%)	1/283 (0.35%)
Humerus Fracture * 1	1/281 (0.36%)	0/283 (0.00%)
Joint Dislocation * 1	1/281 (0.36%)	0/283 (0.00%)
Pelvic Fracture * 1	1/281 (0.36%)	0/283 (0.00%)
Peroneal Nerve Injury * 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%)
Spinal Compression Fracture * 1	0/281 (0.00%)	1/283 (0.35%)
Subdural Haematoma * 1	1/281 (0.36%)	0/283 (0.00%)
Investigations
Body Temperature Increased * 1	1/281 (0.36%)	0/283 (0.00%)
Diagnostic Procedure * 1	1/281 (0.36%)	0/283 (0.00%)
International Normalised Ratio Increased * 1	0/281 (0.00%)	1/283 (0.35%)
Troponin Increased * 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%)	1/283 (0.35%)
Electrolyte Imbalance * 1	0/281 (0.00%)	1/283 (0.35%)
Gout * 1	1/281 (0.36%)	0/283 (0.00%)
Hypercalcaemia * 1	1/281 (0.36%)	2/283 (0.71%)
Hyperglycaemia * 1	0/281 (0.00%)	1/283 (0.35%)
Hypocalcaemia * 1	0/281 (0.00%)	1/283 (0.35%)
Musculoskeletal and connective tissue disorders
Back Pain * 1	5/281 (1.78%)	2/283 (0.71%)
Bone Pain * 1	0/281 (0.00%)	2/283 (0.71%)
Flank Pain * 1	0/281 (0.00%)	1/283 (0.35%)
Intervertebral Disc Protrusion * 1	0/281 (0.00%)	1/283 (0.35%)
Muscular Weakness * 1	1/281 (0.36%)	0/283 (0.00%)
Musculoskeletal Pain * 1	1/281 (0.36%)	1/283 (0.35%)
Osteonecrosis of Jaw * 1	2/281 (0.71%)	0/283 (0.00%)
Pain in Extremity * 1	0/281 (0.00%)	1/283 (0.35%)
Pathological Fracture * 1	1/281 (0.36%)	0/283 (0.00%)
Spinal Column Stenosis * 1	2/281 (0.71%)	0/283 (0.00%)
Spinal Pain * 1	1/281 (0.36%)	0/283 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Monocytic Leukaemia * 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%)	1/283 (0.35%)
Epstein-Barr Virus Associated Lymphoproliferative Disorder * 1	0/281 (0.00%)	1/283 (0.35%)
Lung Adenocarcinoma * 1	1/281 (0.36%)	0/283 (0.00%)
Plasma Cell Leukaemia * 1	2/281 (0.71%)	1/283 (0.35%)
Prostate Cancer * 1	1/281 (0.36%)	0/283 (0.00%)
Rectal Adenocarcinoma * 1	1/281 (0.36%)	0/283 (0.00%)
Squamous Cell Carcinoma * 1	1/281 (0.36%)	0/283 (0.00%)
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 Haemorrhage * 1	1/281 (0.36%)	0/283 (0.00%)
Cerebral Infarction * 1	1/281 (0.36%)	1/283 (0.35%)
Cognitive Disorder * 1	0/281 (0.00%)	1/283 (0.35%)
Intercostal Neuralgia * 1	1/281 (0.36%)	0/283 (0.00%)
Ischaemic Stroke * 1	1/281 (0.36%)	0/283 (0.00%)
Loss of Consciousness * 1	1/281 (0.36%)	0/283 (0.00%)
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%)	1/283 (0.35%)
Seizure * 1	0/281 (0.00%)	1/283 (0.35%)
Somnolence * 1	1/281 (0.36%)	0/283 (0.00%)
Syncope * 1	1/281 (0.36%)	2/283 (0.71%)
Transient Ischaemic Attack * 1	1/281 (0.36%)	1/283 (0.35%)
Trigeminal Nerve Disorder * 1	0/281 (0.00%)	1/283 (0.35%)
Viith Nerve Paralysis * 1	1/281 (0.36%)	0/283 (0.00%)
Psychiatric disorders
Confusional State * 1	1/281 (0.36%)	0/283 (0.00%)
Depression * 1	0/281 (0.00%)	1/283 (0.35%)
Depressive Symptom * 1	1/281 (0.36%)	0/283 (0.00%)
Renal and urinary disorders
Acute Kidney Injury * 1	8/281 (2.85%)	3/283 (1.06%)
Azotaemia * 1	1/281 (0.36%)	1/283 (0.35%)
Renal Failure * 1	3/281 (1.07%)	1/283 (0.35%)
Urethral Haemorrhage * 1	0/281 (0.00%)	1/283 (0.35%)
Reproductive system and breast disorders
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%)
Bronchospasm * 1	1/281 (0.36%)	0/283 (0.00%)
Dyspnoea * 1	1/281 (0.36%)	2/283 (0.71%)
Hypoxia * 1	0/281 (0.00%)	1/283 (0.35%)
Interstitial Lung Disease * 1	1/281 (0.36%)	0/283 (0.00%)
Lung Disorder * 1	1/281 (0.36%)	0/283 (0.00%)
Pneumonitis * 1	0/281 (0.00%)	1/283 (0.35%)
Pneumothorax * 1	1/281 (0.36%)	0/283 (0.00%)
Pulmonary Calcification * 1	0/281 (0.00%)	1/283 (0.35%)
Pulmonary Embolism * 1	8/281 (2.85%)	7/283 (2.47%)
Pulmonary Oedema * 1	1/281 (0.36%)	2/283 (0.71%)
Respiratory Failure * 1	1/281 (0.36%)	2/283 (0.71%)
Skin and subcutaneous tissue disorders
Rash Generalised * 1	0/281 (0.00%)	1/283 (0.35%)
Rash Papular * 1	0/281 (0.00%)	1/283 (0.35%)
Vascular disorders
Deep Vein Thrombosis * 1	1/281 (0.36%)	0/283 (0.00%)
Embolism * 1	0/281 (0.00%)	1/283 (0.35%)
Haemorrhagic Infarction * 1	0/281 (0.00%)	1/283 (0.35%)
Hypertension * 1	0/281 (0.00%)	1/283 (0.35%)
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%)
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 18.0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Lenalidomide, Low-dose Dexamethasone (Rd)	Daratumumab, Lenalidomide, Dexamethasone (DRd)
	Affected / at Risk (%)	Affected / at Risk (%)
Total	274/281 (97.51%)	276/283 (97.53%)
Blood and lymphatic system disorders
Anaemia * 1	98/281 (34.88%)	87/283 (30.74%)
Leukopenia * 1	17/281 (6.05%)	21/283 (7.42%)
Lymphopenia * 1	15/281 (5.34%)	17/283 (6.01%)
Neutropenia * 1	121/281 (43.06%)	168/283 (59.36%)
Thrombocytopenia * 1	77/281 (27.40%)	76/283 (26.86%)
Eye disorders
Cataract * 1	8/281 (2.85%)	18/283 (6.36%)
Vision Blurred * 1	14/281 (4.98%)	19/283 (6.71%)
Gastrointestinal disorders
Abdominal Pain * 1	11/281 (3.91%)	20/283 (7.07%)
Abdominal Pain Upper * 1	10/281 (3.56%)	21/283 (7.42%)
Constipation * 1	71/281 (25.27%)	82/283 (28.98%)
Diarrhoea * 1	65/281 (23.13%)	121/283 (42.76%)
Dyspepsia * 1	6/281 (2.14%)	18/283 (6.36%)
Nausea * 1	40/281 (14.23%)	67/283 (23.67%)
Stomatitis * 1	6/281 (2.14%)	17/283 (6.01%)
Vomiting * 1	14/281 (4.98%)	46/283 (16.25%)
General disorders
Asthenia * 1	36/281 (12.81%)	45/283 (15.90%)
Chills * 1	9/281 (3.20%)	17/283 (6.01%)
Fatigue * 1	78/281 (27.76%)	100/283 (35.34%)
Influenza Like Illness * 1	12/281 (4.27%)	17/283 (6.01%)
Oedema Peripheral * 1	37/281 (13.17%)	43/283 (15.19%)
Pyrexia * 1	30/281 (10.68%)	53/283 (18.73%)
Infections and infestations
Bronchitis * 1	31/281 (11.03%)	36/283 (12.72%)
Nasopharyngitis * 1	43/281 (15.30%)	68/283 (24.03%)
Pneumonia * 1	17/281 (6.05%)	20/283 (7.07%)
Respiratory Tract Infection * 1	22/281 (7.83%)	28/283 (9.89%)
Rhinitis * 1	3/281 (1.07%)	15/283 (5.30%)
Sinusitis * 1	10/281 (3.56%)	18/283 (6.36%)
Upper Respiratory Tract Infection * 1	54/281 (19.22%)	89/283 (31.45%)
Investigations
Alanine Aminotransferase Increased * 1	10/281 (3.56%)	15/283 (5.30%)
Weight Decreased * 1	9/281 (3.20%)	16/283 (5.65%)
Metabolism and nutrition disorders
Decreased Appetite * 1	28/281 (9.96%)	32/283 (11.31%)
Hyperglycaemia * 1	19/281 (6.76%)	25/283 (8.83%)
Hypocalcaemia * 1	11/281 (3.91%)	17/283 (6.01%)
Hypokalaemia * 1	22/281 (7.83%)	30/283 (10.60%)
Hypophosphataemia * 1	11/281 (3.91%)	16/283 (5.65%)
Musculoskeletal and connective tissue disorders
Arthralgia * 1	21/281 (7.47%)	24/283 (8.48%)
Back Pain * 1	45/281 (16.01%)	49/283 (17.31%)
Bone Pain * 1	12/281 (4.27%)	17/283 (6.01%)
Muscle Spasms * 1	52/281 (18.51%)	73/283 (25.80%)
Muscular Weakness * 1	21/281 (7.47%)	23/283 (8.13%)
Musculoskeletal Chest Pain * 1	17/281 (6.05%)	15/283 (5.30%)
Musculoskeletal Pain * 1	15/281 (5.34%)	17/283 (6.01%)
Myalgia * 1	9/281 (3.20%)	16/283 (5.65%)
Pain in Extremity * 1	30/281 (10.68%)	20/283 (7.07%)
Nervous system disorders
Dizziness * 1	24/281 (8.54%)	22/283 (7.77%)
Dysgeusia * 1	15/281 (5.34%)	21/283 (7.42%)
Headache * 1	19/281 (6.76%)	37/283 (13.07%)
Neuropathy Peripheral * 1	15/281 (5.34%)	12/283 (4.24%)
Peripheral Sensory Neuropathy * 1	18/281 (6.41%)	23/283 (8.13%)
Tremor * 1	24/281 (8.54%)	26/283 (9.19%)
Psychiatric disorders
Anxiety * 1	12/281 (4.27%)	18/283 (6.36%)
Depression * 1	5/281 (1.78%)	17/283 (6.01%)
Insomnia * 1	55/281 (19.57%)	55/283 (19.43%)
Renal and urinary disorders
Renal Impairment * 1	13/281 (4.63%)	20/283 (7.07%)
Respiratory, thoracic and mediastinal disorders
Cough * 1	35/281 (12.46%)	82/283 (28.98%)
Dyspnoea * 1	32/281 (11.39%)	51/283 (18.02%)
Skin and subcutaneous tissue disorders
Hyperhidrosis * 1	8/281 (2.85%)	20/283 (7.07%)
Pruritus * 1	29/281 (10.32%)	28/283 (9.89%)
Rash * 1	29/281 (10.32%)	35/283 (12.37%)
Vascular disorders
Hypertension * 1	7/281 (2.49%)	20/283 (7.07%)
Hypotension * 1	6/281 (2.14%)	19/283 (6.71%)
* Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA Version 18.0

Limitations and Caveats

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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

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):

Dimopoulos MA, San-Miguel J, Belch A, White D, Benboubker L, Cook G, Leiba M, Morton J, Ho PJ, Kim K, Takezako N, Moreau P, Kaufman JL, Sutherland HJ, Lalancette M, Magen H, Iida S, Kim JS, Prince HM, Cochrane T, Oriol A, Bahlis NJ, Chari A, O' Rourke L, Wu K, Schecter JM, Casneuf T, Chiu C, Soong D, Sasser AK, Khokhar NZ, Avet-Loiseau H, Usmani SZ. Daratumumab plus lenalidomide and dexamethasone versus lenalidomide and dexamethasone in relapsed or refractory multiple myeloma: updated analysis of POLLUX. Haematologica. 2018 Sep 20. pii: haematol.2018.194282. doi: 10.3324/haematol.2018.194282. [Epub ahead of print]

Dimopoulos MA, Oriol A, Nahi H, San-Miguel J, Bahlis NJ, Usmani SZ, Rabin N, Orlowski RZ, Komarnicki M, Suzuki K, Plesner T, Yoon SS, Ben Yehuda D, Richardson PG, Goldschmidt H, Reece D, Lisby S, Khokhar NZ, O'Rourke L, Chiu C, Qin X, Guckert M, Ahmadi T, Moreau P; POLLUX Investigators. Daratumumab, Lenalidomide, and Dexamethasone for Multiple Myeloma. N Engl J Med. 2016 Oct 6;375(14):1319-1331.

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:	April 2, 2018