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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 : January 11, 2021
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma
Interventions Drug: Daratumumab
Drug: Lenalidomide
Drug: Dexamethasone
Enrollment 569
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lenalidomide, Low-dose Dexamethasone (Rd) Daratumumab, Lenalidomide, Dexamethasone (DRd)
Hide 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
Arm/Group Title Lenalidomide, Low-dose Dexamethasone (Rd) Daratumumab, Lenalidomide, Dexamethasone (DRd) Total
Hide 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
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 283 participants 286 participants 569 participants
64.3  (8.84) 64.4  (9.03) 64.4  (8.93)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 283 participants 286 participants 569 participants
Female
119
  42.0%
113
  39.5%
232
  40.8%
Male
164
  58.0%
173
  60.5%
337
  59.2%
Region of Enrollment  
Measure Type: 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
1.Primary Outcome
Title Progression-free Survival (PFS)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) analysis set included all participants who were randomly assigned to the daratumumab, lenalidomide, dexamethasone (DRd) or lenalidomide, low-dose dexamethasone (Rd) group.
Arm/Group Title Lenalidomide, Low-dose Dexamethasone (Rd) Daratumumab, Lenalidomide, Dexamethasone (DRd)
Hide 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)
Hide Description TTP was defined as time from date of randomization to date of first documented evidence of progressive disease (PD). PD was defined as meeting any one of following criteria: Increase of >=25% in level of serum M-protein from lowest response value and absolute increase must be >=0.5 g/dL; Increase of >=25% in 24-hour urinary light chain excretion (urine M-protein) from lowest response value and absolute increase must be >=200 mg/24hours; Only in participants without measurable serum and urine M-protein levels: increase of >=25% in difference between involved and uninvolved free light chain (FLC) levels from lowest response value and absolute increase must be >10 milligram per deciliter (mg/dL); Definite increase in size of existing bone lesions or soft tissue plasmacytomas; Definite development of new bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to Plasma Cell (PC) proliferative disorder.
Time Frame From randomization to disease progression until 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all participants who were randomly assigned to the DRd or Rd group.
Arm/Group Title Lenalidomide, Low-dose Dexamethasone (Rd) Daratumumab, Lenalidomide, Dexamethasone (DRd)
Hide 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
Hide Description VGPR or better is defined as the percentage of participants who achieved VGPR, complete response (CR) and stringent complete response (sCR) according to the International Myeloma Working Group criteria (IMWG). IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or >=90% reduction in serum M-protein plus urine M-protein <100 mg/24 hours, if the serum and urine M-protein are not measurable, a decrease of >90% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria. In addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required; CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and <5% PCs in bone marrow; sCR: CR and normal FLC ratio, absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4 color flow cytometry.
Time Frame From randomization to disease progression (approximately up to 3 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Response-evaluable set included participants who have a confirmed diagnosis of multiple myeloma and measurable disease and must have received at least 1 administration of study treatment and have at least 1 post baseline disease assessment.
Arm/Group Title Lenalidomide, Low-dose Dexamethasone (Rd) Daratumumab, Lenalidomide, Dexamethasone (DRd)
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all participants who were randomly assigned to the DRd or Rd group.
Arm/Group Title Lenalidomide, Low-dose Dexamethasone (Rd) Daratumumab, Lenalidomide, Dexamethasone (DRd)
Hide 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
Hide Description Overall response rate was defined as the percentage of participants who achieved a partial response (PR) or better according to the International Myeloma Working Group (IMWG) criteria, during or after study treatment. IMWG criteria for PR: >=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to <200 mg/24 hours, if the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria, in addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required.
Time Frame From randomization to disease progression (approximately up to 3 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Response-evaluable set included participants who have a confirmed diagnosis of multiple myeloma and measurable disease and must have received at least 1 administration of study treatment and have at least 1 post baseline disease assessment.
Arm/Group Title Lenalidomide, Low-dose Dexamethasone (Rd) Daratumumab, Lenalidomide, Dexamethasone (DRd)
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set included all participants who were randomly assigned to the DRd or Rd group.
Arm/Group Title Lenalidomide, Low-dose Dexamethasone (Rd) Daratumumab, Lenalidomide, Dexamethasone (DRd)
Hide 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
Hide Description Time to response was defined as the time between the date of randomization and the first efficacy evaluation that the participant met all criteria for partial response (PR) or better.
Time Frame From randomization up to first documented CR or PR until 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Response-evaluable set is defined as participants who have a confirmed diagnosis of multiple myeloma and measurable disease at baseline or screening visit. In addition, participants must have received at least 1 administration of study treatment and have at least 1 post baseline disease assessment.
Arm/Group Title Lenalidomide, Low-dose Dexamethasone (Rd) Daratumumab, Lenalidomide, Dexamethasone (DRd)
Hide 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)
Hide Description DOR was defined for participants with confirmed response (PR or better) as time between first documentation of response and disease progression/death due to PD, whichever occurs first. PD was defined as meeting any one of following criteria: Increase of >=25% in level of serum M-protein from lowest response value and absolute increase must be >=0.5g/dL; Increase of >=25% in 24-hour urinary light chain excretion (urine M-protein) from lowest response value and absolute increase must be >=200mg/24hours; Only in participants without measurable serum and urine M-protein levels: increase of >=25% in difference between involved and uninvolved FLC levels from lowest response value and absolute increase must be >10mg/dL; Definite increase in size of existing bone lesions/soft tissue plasmacytomas; Definite development of new bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium >11.5mg/dL) that can be attributed solely to PC proliferative disorder.
Time Frame From randomization to the date of first documented evidence of PD until 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Response-evaluable set included participants who have a confirmed diagnosis of multiple myeloma and measurable disease and must have received at least 1 administration of study treatment and have at least 1 post baseline disease assessment. Here 'N' signifies number of participants who had PR or better response.
Arm/Group Title Lenalidomide, Low-dose Dexamethasone (Rd) Daratumumab, Lenalidomide, Dexamethasone (DRd)
Hide 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.
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)
Hide 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   --/--   --/-- 
Hide 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
Hide 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
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director, Clinical Research
Organization: Janssen R&D US
EMail: ClinicalTrialDisclosure@its.jnj.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02076009    
Other Study ID Numbers: CR103663
54767414MMY3003 ( Other Identifier: Janssen Research & Development, LLC )
2013-005525-23 ( EudraCT Number )
First Submitted: February 27, 2014
First Posted: March 3, 2014
Results First Submitted: December 20, 2016
Results First Posted: February 10, 2017
Last Update Posted: January 11, 2021