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A Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens

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: NCT03412565
Recruitment Status : Active, not recruiting
First Posted : January 26, 2018
Results First Posted : January 12, 2022
Last Update Posted : September 9, 2022
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma
Interventions Drug: Daratumumab
Drug: Bortezomib
Drug: Lenalidomide
Drug: Dexamethasone
Drug: Melphalan
Drug: Prednisone
Drug: Carfilzomib
Enrollment 265
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Daratumumab (D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd) D + Bortezomib + Melphalan + Prednisone (D-VMP) Daratumumab + Lenalidomide + Dexamethasone (D-Rd) Daratumumab + Carfilzomib + Dexamethasone (D-Kd)
Hide Arm/Group Description Participants received daratumumab 1800 milligrams (mg) as a subcutaneous (SC) injection on Days 1, 8 and 15 of Cycles 1 to 3 (each cycle of 21 days) and on Day 1 of Cycle 4; bortezomib 1.3 milligrams per square meter (mg/m^2) SC injection on Days 1, 4, 8 and 11 of Cycles 1 to 4; lenalidomide 25 mg orally on Day 1 through Day 14 of Cycles 1 to 4 and dexamethasone 20 mg orally or intravenously (IV) on Days 1, 2 ,8, 9, 15 and 16 of Cycle 1 to 4. Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15, 22, 29 and 36 of Cycle 1, then on Days 1 and 22 in Cycles 2 to 9, and Day 1 of Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months; bortezomib 1.3 mg/m^2 SC injection on Day 1, 4, 8, 11, 22, 25, 29 and 32 of Cycle 1 and on Days 1, 8, 22 and 29 of Cycles 2 to 9; melphalan 9 mg/m^2 orally on Day 1 through Day 4 of Cycles 1 to 9; prednisone 60 mg/m^2 orally on Days 1 to 4 of cycles 1 to 9. Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2, then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months; lenalidomide 25 mg orally on Day 1 through Day 21 of each cycle until documented progression of disease, unacceptable toxicity, or end of study and dexamethasone 40 mg orally or intravenously weekly until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months. Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 (each cycle is of 28 days), then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months; Carfilzomib 20 mg/m^2 IV on Day 1 of Cycle 1 only, then 70 mg/m^2 IV on Days 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months and dexamethasone 40 mg orally or IV weekly for Cycles 1-9, then on Days 1, 8, 15 of each cycle for Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months.
Period Title: Overall Study
Started 67 67 65 66
Completed 66 2 3 12
Not Completed 1 65 62 54
Reason Not Completed
Other             0             0             0             3
Withdrawal by Subject             0             0             1             5
Physician Decision             0             1             0             1
Death             1             2             2             4
Still ongoing             0             62             59             41
Arm/Group Title Daratumumab (D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd) D + Bortezomib + Melphalan + Prednisone (D-VMP) Daratumumab + Lenalidomide + Dexamethasone (D-Rd) Daratumumab + Carfilzomib + Dexamethasone (D-Kd) Total
Hide Arm/Group Description Participants received daratumumab 1800 milligrams (mg) as a subcutaneous (SC) injection on Days 1, 8 and 15 of Cycles 1 to 3 (each cycle of 21 days) and on Day 1 of Cycle 4; bortezomib 1.3 milligrams per square meter (mg/m^2) SC injection on Days 1, 4, 8 and 11 of Cycles 1 to 4; lenalidomide 25 mg orally on Day 1 through Day 14 of Cycles 1 to 4 and dexamethasone 20 mg orally or intravenously (IV) on Days 1, 2 ,8, 9, 15 and 16 of Cycle 1 to 4. Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15, 22, 29 and 36 of Cycle 1, then on Days 1 and 22 in Cycles 2 to 9, and Day 1 of Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months; bortezomib 1.3 mg/m^2 SC injection on Day 1, 4, 8, 11, 22, 25, 29 and 32 of Cycle 1 and on Days 1, 8, 22 and 29 of Cycles 2 to 9; melphalan 9 mg/m^2 orally on Day 1 through Day 4 of Cycles 1 to 9; prednisone 60 mg/m^2 orally on Days 1 to 4 of cycles 1 to 9. Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2, then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months; lenalidomide 25 mg orally on Day 1 through Day 21 of each cycle until documented progression of disease, unacceptable toxicity, or end of study and dexamethasone 40 mg orally or intravenously weekly until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months. Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 (each cycle is of 28 days), then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months; Carfilzomib 20 mg/m^2 IV on Day 1 of Cycle 1 only, then 70 mg/m^2 IV on Days 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months and dexamethasone 40 mg orally or IV weekly for Cycles 1-9, then on Days 1, 8, 15 of each cycle for Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months. Total of all reporting groups
Overall Number of Baseline Participants 67 67 65 66 265
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 67 participants 67 participants 65 participants 66 participants 265 participants
57.3  (9.47) 74.9  (4.54) 66.8  (9.58) 61  (9.77) 65  (10.87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants 67 participants 65 participants 66 participants 265 participants
Female
19
  28.4%
36
  53.7%
20
  30.8%
32
  48.5%
107
  40.4%
Male
48
  71.6%
31
  46.3%
45
  69.2%
34
  51.5%
158
  59.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants 67 participants 65 participants 66 participants 265 participants
Hispanic or Latino
3
   4.5%
6
   9.0%
0
   0.0%
7
  10.6%
16
   6.0%
Not Hispanic or Latino
34
  50.7%
39
  58.2%
45
  69.2%
43
  65.2%
161
  60.8%
Unknown or Not Reported
30
  44.8%
22
  32.8%
20
  30.8%
16
  24.2%
88
  33.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants 67 participants 65 participants 66 participants 265 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
5
   7.5%
0
   0.0%
0
   0.0%
5
   1.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
5
   7.5%
1
   1.5%
2
   3.1%
2
   3.0%
10
   3.8%
White
38
  56.7%
46
  68.7%
45
  69.2%
48
  72.7%
177
  66.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
24
  35.8%
15
  22.4%
18
  27.7%
16
  24.2%
73
  27.5%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants 67 participants 65 participants 66 participants 265 participants
BRAZIL
1
   1.5%
4
   6.0%
0
   0.0%
0
   0.0%
5
   1.9%
CZECH REPUBLIC
4
   6.0%
4
   6.0%
15
  23.1%
0
   0.0%
23
   8.7%
FRANCE
26
  38.8%
21
  31.3%
17
  26.2%
15
  22.7%
79
  29.8%
GERMANY
0
   0.0%
0
   0.0%
0
   0.0%
19
  28.8%
19
   7.2%
ISRAEL
0
   0.0%
7
  10.4%
14
  21.5%
0
   0.0%
21
   7.9%
JAPAN
0
   0.0%
4
   6.0%
0
   0.0%
0
   0.0%
4
   1.5%
SPAIN
11
  16.4%
19
  28.4%
0
   0.0%
25
  37.9%
55
  20.8%
UNITED KINGDOM
9
  13.4%
8
  11.9%
12
  18.5%
0
   0.0%
29
  10.9%
UNITED STATES
16
  23.9%
0
   0.0%
7
  10.8%
7
  10.6%
30
  11.3%
1.Primary Outcome
Title D-VMP, D-Rd, and D-Kd Cohorts: Overall Response Rate (ORR)
Hide Description ORR was defined as the percentage of participants who achieved partial response (PR) or better according to international myeloma working group (IMWG) criteria. IMWG criteria for PR: greater than or equal to (>=) 50 percent (%) reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to less than (<) 200 milligrams (mg) per 24 hours, If the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, >=50% reduction in bone marrow plasma cells (PCs) is required in place of M-protein, provided baseline bone marrow plasma cell percentage was >=30%. 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 Up to 2 years 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
All treated analysis set included all participants who have received at least 1 dose of study treatment. This primary outcome measure (OM) was planned to be analyzed for D-VMP, D-Rd and D-Kd cohorts only.
Arm/Group Title Daratumumab (D) + Bortezomib + Melphalan + Prednisone (D-VMP) Daratumumab + Lenalidomide + Dexamethasone (D-Rd) Daratumumab + Carfilzomib + Dexamethasone (D-Kd)
Hide Arm/Group Description:
Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15, 22, 29 and 36 of Cycle 1, then on Days 1 and 22 in Cycles 2 to 9, and Day 1 of Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months; bortezomib 1.3 mg/m^2 SC injection on Day 1, 4, 8, 11, 22, 25, 29 and 32 of Cycle 1 and on Days 1, 8, 22 and 29 of Cycles 2 to 9; melphalan 9 mg/m^2 orally on Day 1 through Day 4 of Cycles 1 to 9; prednisone 60 mg/m^2 orally on Days 1 to 4 of cycles 1 to 9.
Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2, then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months; lenalidomide 25 mg orally on Day 1 through Day 21 of each cycle until documented progression of disease, unacceptable toxicity, or end of study and dexamethasone 40 mg orally or intravenously weekly until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months.
Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 (each cycle is of 28 days), then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months; Carfilzomib 20 mg/m^2 IV on Day 1 of Cycle 1 only, then 70 mg/m^2 IV on Days 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months and dexamethasone 40 mg orally or IV weekly for Cycles 1-9, then on Days 1, 8, 15 of each cycle for Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months.
Overall Number of Participants Analyzed 67 65 66
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
88.1
(79.5 to 93.9)
90.8
(82.6 to 95.9)
84.8
(75.7 to 91.5)
2.Primary Outcome
Title D-VRd Cohort: Percentage of Participants With Very Good Partial Response (VGPR) or Better Response
Hide Description VGPR or better rate was defined as the percentage of participants who achieved VGPR or complete response (CR) (including stringent complete response [sCR]) according to the IMWG criteria during or after the study treatment. VGPR: Serum and urine component detectable by immunofixation but not on electrophoresis, or >= 90% reduction in serum M-protein plus urine M-protein level <100 mg/24 hour; CR: negative immunofixation on the serum and urine, Disappearance of any soft tissue plasmacytomas and <5% PCs in bone marrow; sCR: CR in addition to having a normal FLC ratio and an absence of clonal cells in bone marrow by immunohistochemistry, immunofluorescence, 2-4 color flow cytometry.
Time Frame Up to 2 years and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
All treated analysis set included all participants who have received at least 1 dose of study treatment. This primary outcome measure (OM) was planned to be analyzed for D-VRd cohort only.
Arm/Group Title Daratumumab (D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd)
Hide Arm/Group Description:
Participants received daratumumab 1800 milligrams (mg) as a subcutaneous (SC) injection on Days 1, 8 and 15 of Cycles 1 to 3 (each cycle of 21 days) and on Day 1 of Cycle 4; bortezomib 1.3 milligrams per square meter (mg/m^2) SC injection on Days 1, 4, 8 and 11 of Cycles 1 to 4; lenalidomide 25 mg orally on Day 1 through Day 14 of Cycles 1 to 4 and dexamethasone 20 mg orally or intravenously (IV) on Days 1, 2 ,8, 9, 15 and 16 of Cycle 1 to 4.
Overall Number of Participants Analyzed 67
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
71.6
(61.2 to 80.6)
3.Secondary Outcome
Title Maximum Observed Serum Concentration (Cmax) of Daratumumab
Hide Description Cmax was defined as maximum serum concentration observed following daratumumab administration. Each cycle for: D-VRd cohort is of 21 days, D-VMP cohort is of 42 days and D-Rd and D-Kd cohorts is of 28 days. Each cohort have a treatment period of 84 days.
Time Frame D-VRd: Day 4 of Cycles 1 and 4 and post treatment at Week 8; D-VMP: Day 4 of Cycles 1 and 2 and post treatment at Week 8; D-Rd and D-Kd: Day 4 of Cycles 1 and 3 and post treatment at Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetics (PK) analysis set: participants who received at least 1 dose of daratumumab SC and had at least 1 PK sample value after first dose. 'N' (number of participants analyzed): participants evaluated for this OM; 'n' (number analyzed): participants analyzed at specific timepoints. The "0" in the number analyzed field indicates that no participant was evaluable for PK at that timepoint.
Arm/Group Title Daratumumab (D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd) D-VMP Daratumumab + Lenalidomide + Dexamethasone (D-Rd) Daratumumab + Carfilzomib + Dexamethasone (D-Kd)
Hide Arm/Group Description:
Participants received daratumumab 1800 milligrams (mg) as a subcutaneous (SC) injection on Days 1, 8 and 15 of Cycles 1 to 3 (each cycle of 21 days) and on Day 1 of Cycle 4; bortezomib 1.3 milligrams per square meter (mg/m^2) SC injection on Days 1, 4, 8 and 11 of Cycles 1 to 4; lenalidomide 25 mg orally on Day 1 through Day 14 of Cycles 1 to 4 and dexamethasone 20 mg orally or intravenously (IV) on Days 1, 2 ,8, 9, 15 and 16 of Cycle 1 to 4.
Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15, 22, 29 and 36 of Cycle 1, then on Days 1 and 22 in Cycles 2 to 9, and Day 1 of Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months; bortezomib 1.3 mg/m^2 SC injection on Day 1, 4, 8, 11, 22, 25, 29 and 32 of Cycle 1 and on Days 1, 8, 22 and 29 of Cycles 2 to 9; melphalan 9 mg/m^2 orally on Day 1 through Day 4 of Cycles 1 to 9; prednisone 60 mg/m^2 orally on Days 1 to 4 of cycles 1 to 9.
Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2, then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months; lenalidomide 25 mg orally on Day 1 through Day 21 of each cycle until documented progression of disease, unacceptable toxicity, or end of study and dexamethasone 40 mg orally or intravenously weekly until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months.
Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 (each cycle is of 28 days), then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months; Carfilzomib 20 mg/m^2 IV on Day 1 of Cycle 1 only, then 70 mg/m^2 IV on Days 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months and dexamethasone 40 mg orally or IV weekly for Cycles 1-9, then on Days 1, 8, 15 of each cycle for Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months.
Overall Number of Participants Analyzed 60 66 56 57
Mean (Standard Deviation)
Unit of Measure: micrograms per milliliter (mcg/mL)
Cycle 1 Day 4 Number Analyzed 60 participants 66 participants 56 participants 57 participants
100  (48.5) 98.6  (51.6) 108  (49.9) 137  (56.7)
Cycle 2 Day 4 Number Analyzed 0 participants 55 participants 0 participants 0 participants
612  (256)
Cycle 3 Day 4 Number Analyzed 0 participants 0 participants 50 participants 45 participants
648  (238) 869  (274)
Cycle 4 Day 4 Number Analyzed 56 participants 0 participants 0 participants 0 participants
746  (275)
Post-treatment Phase Week 8 Number Analyzed 43 participants 1 participants 0 participants 6 participants
263  (190) 162 [1]   (NA) 49.3  (109)
[1]
Standard deviation (SD) data is 0 as SD cannot be calculated for 1 participant.
4.Secondary Outcome
Title Percentage of Participants With Infusion-Related Reactions (IRRs)
Hide Description Percentage of Participants with IRRs were reported. The administration-related systemic reactions are referred to as IRRs.
Time Frame Up to 2 years and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
All treated analysis set included all participants who have received at least 1 dose of study treatment.
Arm/Group Title Daratumumab (D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd) D-VMP Daratumumab + Lenalidomide + Dexamethasone (D-Rd) Daratumumab + Carfilzomib + Dexamethasone (D-Kd)
Hide Arm/Group Description:
Participants received daratumumab 1800 milligrams (mg) as a subcutaneous (SC) injection on Days 1, 8 and 15 of Cycles 1 to 3 (each cycle of 21 days) and on Day 1 of Cycle 4; bortezomib 1.3 milligrams per square meter (mg/m^2) SC injection on Days 1, 4, 8 and 11 of Cycles 1 to 4; lenalidomide 25 mg orally on Day 1 through Day 14 of Cycles 1 to 4 and dexamethasone 20 mg orally or intravenously (IV) on Days 1, 2 ,8, 9, 15 and 16 of Cycle 1 to 4.
Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15, 22, 29 and 36 of Cycle 1, then on Days 1 and 22 in Cycles 2 to 9, and Day 1 of Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months; bortezomib 1.3 mg/m^2 SC injection on Day 1, 4, 8, 11, 22, 25, 29 and 32 of Cycle 1 and on Days 1, 8, 22 and 29 of Cycles 2 to 9; melphalan 9 mg/m^2 orally on Day 1 through Day 4 of Cycles 1 to 9; prednisone 60 mg/m^2 orally on Days 1 to 4 of cycles 1 to 9.
Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2, then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months; lenalidomide 25 mg orally on Day 1 through Day 21 of each cycle until documented progression of disease, unacceptable toxicity, or end of study and dexamethasone 40 mg orally or intravenously weekly until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months.
Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 (each cycle is of 28 days), then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months; Carfilzomib 20 mg/m^2 IV on Day 1 of Cycle 1 only, then 70 mg/m^2 IV on Days 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months and dexamethasone 40 mg orally or IV weekly for Cycles 1-9, then on Days 1, 8, 15 of each cycle for Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months.
Overall Number of Participants Analyzed 67 67 65 66
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
9.0
(4.0 to 16.9)
9.0
(4.0 to 16.9)
4.6
(1.3 to 11.5)
4.5
(1.3 to 11.3)
5.Secondary Outcome
Title D-VMP, D-Rd, and D-Kd Cohorts: Percentage of Participants With VGPR or Better Response
Hide Description VGPR or better rate was defined as the percentage of participants who achieved VGPR or CR (including sCR) according to the IMWG criteria during or after the study treatment. VGPR: Serum and urine component detectable by immunofixation but not on electrophoresis, or >= 90% reduction in serum M-protein plus urine M-protein level <100 mg per 24 hour; CR: negative immunofixation on the serum and urine, Disappearance of any soft tissue plasmacytomas and <5% PCs in bone marrow; sCR: CR in addition to having a normal FLC ratio and an absence of clonal cells in bone marrow by immunohistochemistry, immunofluorescence, 2-4 color flow cytometry.
Time Frame Up to 2 years and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
All treated analysis set included all participants who have received at least 1 dose of study treatment. This secondary OM was planned to be analyzed for D-VMP, D-Rd and D-Kd cohorts only.
Arm/Group Title D-VMP Daratumumab + Lenalidomide + Dexamethasone (D-Rd) Daratumumab + Carfilzomib + Dexamethasone (D-Kd)
Hide Arm/Group Description:
Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15, 22, 29 and 36 of Cycle 1, then on Days 1 and 22 in Cycles 2 to 9, and Day 1 of Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months; bortezomib 1.3 mg/m^2 SC injection on Day 1, 4, 8, 11, 22, 25, 29 and 32 of Cycle 1 and on Days 1, 8, 22 and 29 of Cycles 2 to 9; melphalan 9 mg/m^2 orally on Day 1 through Day 4 of Cycles 1 to 9; prednisone 60 mg/m^2 orally on Days 1 to 4 of cycles 1 to 9.
Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2, then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months; lenalidomide 25 mg orally on Day 1 through Day 21 of each cycle until documented progression of disease, unacceptable toxicity, or end of study and dexamethasone 40 mg orally or intravenously weekly until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months.
Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 (each cycle is of 28 days), then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months; Carfilzomib 20 mg/m^2 IV on Day 1 of Cycle 1 only, then 70 mg/m^2 IV on Days 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months and dexamethasone 40 mg orally or IV weekly for Cycles 1-9, then on Days 1, 8, 15 of each cycle for Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months.
Overall Number of Participants Analyzed 67 65 66
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
64.2
(53.5 to 73.9)
64.6
(53.7 to 74.5)
77.3
(67.2 to 85.4)
6.Secondary Outcome
Title D-VRd Cohort: Overall Response Rate (ORR)
Hide Description ORR was defined as the percentage of participants who achieved a PR or better, IMWG criteria, during the study or during follow up. 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, If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, >=50% reduction in bone marrow PCs is required in place of M-protein, provided baseline bone marrow plasma cell percentage was >=30%, 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 Up to 2 years and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
All treated analysis set included all participants who have received at least 1 dose of study treatment. This secondary OM was planned to be analyzed for D-VRd cohort only.
Arm/Group Title Daratumumab (D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd)
Hide Arm/Group Description:
Participants received daratumumab 1800 milligrams (mg) as a subcutaneous (SC) injection on Days 1, 8 and 15 of Cycles 1 to 3 (each cycle of 21 days) and on Day 1 of Cycle 4; bortezomib 1.3 milligrams per square meter (mg/m^2) SC injection on Days 1, 4, 8 and 11 of Cycles 1 to 4; lenalidomide 25 mg orally on Day 1 through Day 14 of Cycles 1 to 4 and dexamethasone 20 mg orally or intravenously (IV) on Days 1, 2 ,8, 9, 15 and 16 of Cycle 1 to 4.
Overall Number of Participants Analyzed 67
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
97.0
(90.9 to 99.5)
7.Secondary Outcome
Title Percentage of Participants With CR or Better Response
Hide Description CR or better rate was defined as the percentage of participants with a CR or better response (that is, CR and sCR) as per IMWG criteria. CR: as negative immunofixation on the serum and urine and disappearance of soft tissue plasmacytomas and less than (<) 5 percent plasma cells in bone marrow; sCR: CR plus normal FLC ratio and absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry.
Time Frame Up to 2 years and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
All treated analysis set included all participants who have received at least 1 dose of study treatment.
Arm/Group Title Daratumumab (D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd) D-VMP Daratumumab + Lenalidomide + Dexamethasone (D-Rd) Daratumumab + Carfilzomib + Dexamethasone (D-Kd)
Hide Arm/Group Description:
Participants received daratumumab 1800 milligrams (mg) as a subcutaneous (SC) injection on Days 1, 8 and 15 of Cycles 1 to 3 (each cycle of 21 days) and on Day 1 of Cycle 4; bortezomib 1.3 milligrams per square meter (mg/m^2) SC injection on Days 1, 4, 8 and 11 of Cycles 1 to 4; lenalidomide 25 mg orally on Day 1 through Day 14 of Cycles 1 to 4 and dexamethasone 20 mg orally or intravenously (IV) on Days 1, 2 ,8, 9, 15 and 16 of Cycle 1 to 4.
Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15, 22, 29 and 36 of Cycle 1, then on Days 1 and 22 in Cycles 2 to 9, and Day 1 of Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months; bortezomib 1.3 mg/m^2 SC injection on Day 1, 4, 8, 11, 22, 25, 29 and 32 of Cycle 1 and on Days 1, 8, 22 and 29 of Cycles 2 to 9; melphalan 9 mg/m^2 orally on Day 1 through Day 4 of Cycles 1 to 9; prednisone 60 mg/m^2 orally on Days 1 to 4 of cycles 1 to 9.
Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2, then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months; lenalidomide 25 mg orally on Day 1 through Day 21 of each cycle until documented progression of disease, unacceptable toxicity, or end of study and dexamethasone 40 mg orally or intravenously weekly until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months.
Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 (each cycle is of 28 days), then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months; Carfilzomib 20 mg/m^2 IV on Day 1 of Cycle 1 only, then 70 mg/m^2 IV on Days 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months and dexamethasone 40 mg orally or IV weekly for Cycles 1-9, then on Days 1, 8, 15 of each cycle for Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months.
Overall Number of Participants Analyzed 67 67 65 66
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
16.4
(9.5 to 25.7)
17.9
(10.7 to 27.4)
18.5
(11.0 to 28.2)
37.9
(27.9 to 48.7)
8.Secondary Outcome
Title D-VMP, D-Rd and D-Kd Cohorts: Duration of Response (DOR)
Hide Description DOR was defined as the time from the date of initial documented response (PR or better response) to the date of first documented evidence of progressive disease (PD) or death due to PD. PD is defined as an increase of 25% from the lowest response value in one of the following: serum and urine M-component (absolute increase must be >=0.5 gram per deciliter [g/dL] and >=200 mg/24 hours respectively); only in participants without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels (absolute increase must be >10 mg/dL); definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing 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 Up to 2 years and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
All treated analysis set included all participants who have received at least 1 dose of study treatment. This secondary OM was planned to be analyzed for D-VMP, D-Rd and D-Kd cohorts.
Arm/Group Title D-VMP Daratumumab + Lenalidomide + Dexamethasone (D-Rd) Daratumumab + Carfilzomib + Dexamethasone (D-Kd)
Hide Arm/Group Description:
Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15, 22, 29 and 36 of Cycle 1, then on Days 1 and 22 in Cycles 2 to 9, and Day 1 of Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months; bortezomib 1.3 mg/m^2 SC injection on Day 1, 4, 8, 11, 22, 25, 29 and 32 of Cycle 1 and on Days 1, 8, 22 and 29 of Cycles 2 to 9; melphalan 9 mg/m^2 orally on Day 1 through Day 4 of Cycles 1 to 9; prednisone 60 mg/m^2 orally on Days 1 to 4 of cycles 1 to 9.
Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2, then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months; lenalidomide 25 mg orally on Day 1 through Day 21 of each cycle until documented progression of disease, unacceptable toxicity, or end of study and dexamethasone 40 mg orally or intravenously weekly until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months.
Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 (each cycle is of 28 days), then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months; Carfilzomib 20 mg/m^2 IV on Day 1 of Cycle 1 only, then 70 mg/m^2 IV on Days 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months and dexamethasone 40 mg orally or IV weekly for Cycles 1-9, then on Days 1, 8, 15 of each cycle for Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months.
Overall Number of Participants Analyzed 67 65 66
Median (Full Range)
Unit of Measure: months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Here, NA signifies that as per Kaplan-Meier estimate, the median duration of response was not estimable due to less number of events.
9.Secondary Outcome
Title Percentage of Participants With Anti-Daratumumab Antibodies
Hide Description Percentage of participants with antibodies to daratumumab were reported.
Time Frame Up to 10 months
Hide Outcome Measure Data
Hide Analysis Population Description
Immunogenicity-evaluable analysis set was defined as all participants who received at least 1 dose administration of daratumumab SC and had at least 1 immunogenicity sample for detection of anti-daratumumab antibodies after the first dose.
Arm/Group Title Daratumumab (D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd) D-VMP Daratumumab + Lenalidomide + Dexamethasone (D-Rd) Daratumumab + Carfilzomib + Dexamethasone (D-Kd)
Hide Arm/Group Description:
Participants received daratumumab 1800 milligrams (mg) as a subcutaneous (SC) injection on Days 1, 8 and 15 of Cycles 1 to 3 (each cycle of 21 days) and on Day 1 of Cycle 4; bortezomib 1.3 milligrams per square meter (mg/m^2) SC injection on Days 1, 4, 8 and 11 of Cycles 1 to 4; lenalidomide 25 mg orally on Day 1 through Day 14 of Cycles 1 to 4 and dexamethasone 20 mg orally or intravenously (IV) on Days 1, 2 ,8, 9, 15 and 16 of Cycle 1 to 4.
Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15, 22, 29 and 36 of Cycle 1, then on Days 1 and 22 in Cycles 2 to 9, and Day 1 of Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months; bortezomib 1.3 mg/m^2 SC injection on Day 1, 4, 8, 11, 22, 25, 29 and 32 of Cycle 1 and on Days 1, 8, 22 and 29 of Cycles 2 to 9; melphalan 9 mg/m^2 orally on Day 1 through Day 4 of Cycles 1 to 9; prednisone 60 mg/m^2 orally on Days 1 to 4 of cycles 1 to 9.
Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2, then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months; lenalidomide 25 mg orally on Day 1 through Day 21 of each cycle until documented progression of disease, unacceptable toxicity, or end of study and dexamethasone 40 mg orally or intravenously weekly until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months.
Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 (each cycle is of 28 days), then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months; Carfilzomib 20 mg/m^2 IV on Day 1 of Cycle 1 only, then 70 mg/m^2 IV on Days 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months and dexamethasone 40 mg orally or IV weekly for Cycles 1-9, then on Days 1, 8, 15 of each cycle for Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months.
Overall Number of Participants Analyzed 65 64 61 63
Measure Type: Number
Unit of Measure: percentage of participants
0 0 0 0
10.Secondary Outcome
Title Percentage of Participants With Anti-rHuPH20 Antibodies
Hide Description Percentage of participants with antibodies to rHuPH20 were reported.
Time Frame Up to 10 months
Hide Outcome Measure Data
Hide Analysis Population Description
Immunogenicity-evaluable analysis set for rHuPH20 is defined as all participants who received at least one dose of daratumumab SC and had appropriate plasma samples for detection of antibodies to rHuPH20 (at least 1 sample after the start of the first dose of daratumumab SC).
Arm/Group Title Daratumumab (D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd) D-VMP Daratumumab + Lenalidomide + Dexamethasone (D-Rd) Daratumumab + Carfilzomib + Dexamethasone (D-Kd)
Hide Arm/Group Description:
Participants received daratumumab 1800 milligrams (mg) as a subcutaneous (SC) injection on Days 1, 8 and 15 of Cycles 1 to 3 (each cycle of 21 days) and on Day 1 of Cycle 4; bortezomib 1.3 milligrams per square meter (mg/m^2) SC injection on Days 1, 4, 8 and 11 of Cycles 1 to 4; lenalidomide 25 mg orally on Day 1 through Day 14 of Cycles 1 to 4 and dexamethasone 20 mg orally or intravenously (IV) on Days 1, 2 ,8, 9, 15 and 16 of Cycle 1 to 4.
Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15, 22, 29 and 36 of Cycle 1, then on Days 1 and 22 in Cycles 2 to 9, and Day 1 of Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months; bortezomib 1.3 mg/m^2 SC injection on Day 1, 4, 8, 11, 22, 25, 29 and 32 of Cycle 1 and on Days 1, 8, 22 and 29 of Cycles 2 to 9; melphalan 9 mg/m^2 orally on Day 1 through Day 4 of Cycles 1 to 9; prednisone 60 mg/m^2 orally on Days 1 to 4 of cycles 1 to 9.
Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2, then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months; lenalidomide 25 mg orally on Day 1 through Day 21 of each cycle until documented progression of disease, unacceptable toxicity, or end of study and dexamethasone 40 mg orally or intravenously weekly until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months.
Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 (each cycle is of 28 days), then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months; Carfilzomib 20 mg/m^2 IV on Day 1 of Cycle 1 only, then 70 mg/m^2 IV on Days 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months and dexamethasone 40 mg orally or IV weekly for Cycles 1-9, then on Days 1, 8, 15 of each cycle for Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months.
Overall Number of Participants Analyzed 66 61 60 62
Measure Type: Number
Unit of Measure: percentage of participants
6.1 4.9 1.7 4.8
11.Secondary Outcome
Title D-VMP, D-Rd, and D-Kd Cohorts: Percentage of Participants With Minimal Residual Disease (MRD) Negative Rate
Hide Description MRD negativity rate was defined as the percentage of participants who were considered MRD negative after MRD testing at any timepoint after the first dose by bone marrow aspirate. MRD negativity rate was assessed by next-generation sequencing at a threshold of <10^5.
Time Frame Up to 2 years and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
All treated analysis set included all participants who have received at least 1 dose of study treatment. This secondary OM was planned to be analyzed for D-VMP, D-Rd and D-Kd cohorts only.
Arm/Group Title D-VMP Daratumumab + Lenalidomide + Dexamethasone (D-Rd) Daratumumab + Carfilzomib + Dexamethasone (D-Kd)
Hide Arm/Group Description:
Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15, 22, 29 and 36 of Cycle 1 then on Days 1 and 22 in Cycles 2 to 9 and Day 1 of Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or end of study; bortezomib 1.3 mg/m^2 SC injection on Day 1, 4, 8, 11, 22, 25, 29 and 32 of Cycle 1 and on Days 1, 8, 22 and 29 of Cycles 2 to 9; melphalan 9 mg/m^2 orally on Day 1 through Day 4 of Cycles 1 to 9; prednisone 60 mg/m^2 orally on Days 1 to 4 of cycles 1 to 9.
Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2, then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months; lenalidomide 25 mg orally on Day 1 through Day 21 of each cycle until documented progression of disease, unacceptable toxicity, or end of study and dexamethasone 40 mg orally or intravenously weekly until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months.
Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 (each cycle is of 28 days), then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months; Carfilzomib 20 mg/m^2 IV on Day 1 of Cycle 1 only, then 70 mg/m^2 IV on Days 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months and dexamethasone 40 mg orally or IV weekly for Cycles 1-9, then on Days 1, 8, 15 of each cycle for Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months.
Overall Number of Participants Analyzed 67 65 66
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
25.4
(16.9 to 35.6)
21.5
(13.5 to 31.6)
27.3
(18.4 to 37.7)
Time Frame Up to 2 years and 3 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Daratumumab (D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd) D + Bortezomib + Melphalan + Prednisone (D-VMP) Daratumumab + Lenalidomide + Dexamethasone (D-Rd) Daratumumab + Carfilzomib + Dexamethasone (D-Kd)
Hide Arm/Group Description Participants received daratumumab 1800 milligrams (mg) as a subcutaneous (SC) injection on Days 1, 8 and 15 of Cycles 1 to 3 (each cycle of 21 days) and on Day 1 of Cycle 4; bortezomib 1.3 milligrams per square meter (mg/m^2) SC injection on Days 1, 4, 8 and 11 of Cycles 1 to 4; lenalidomide 25 mg orally on Day 1 through Day 14 of Cycles 1 to 4 and dexamethasone 20 mg orally or intravenously (IV) on Days 1, 2 ,8, 9, 15 and 16 of Cycle 1 to 4. Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15, 22, 29 and 36 of Cycle 1, then on Days 1 and 22 in Cycles 2 to 9, and Day 1 of Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months; bortezomib 1.3 mg/m^2 SC injection on Day 1, 4, 8, 11, 22, 25, 29 and 32 of Cycle 1 and on Days 1, 8, 22 and 29 of Cycles 2 to 9; melphalan 9 mg/m^2 orally on Day 1 through Day 4 of Cycles 1 to 9; prednisone 60 mg/m^2 orally on Days 1 to 4 of cycles 1 to 9. Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2, then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months; lenalidomide 25 mg orally on Day 1 through Day 21 of each cycle until documented progression of disease, unacceptable toxicity, or end of study and dexamethasone 40 mg orally or intravenously weekly until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months. Participants received daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 (each cycle is of 28 days), then on Day 1 and 15 of Cycles 3 to 6, and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months; Carfilzomib 20 mg/m^2 IV on Day 1 of Cycle 1 only, then 70 mg/m^2 IV on Days 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months and dexamethasone 40 mg orally or IV weekly for Cycles 1-9, then on Days 1, 8, 15 of each cycle for Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or up to 2 years and 3 months.
All-Cause Mortality
Daratumumab (D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd) D + Bortezomib + Melphalan + Prednisone (D-VMP) Daratumumab + Lenalidomide + Dexamethasone (D-Rd) Daratumumab + Carfilzomib + Dexamethasone (D-Kd)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/67 (1.49%)   2/67 (2.99%)   2/65 (3.08%)   4/66 (6.06%) 
Hide Serious Adverse Events
Daratumumab (D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd) D + Bortezomib + Melphalan + Prednisone (D-VMP) Daratumumab + Lenalidomide + Dexamethasone (D-Rd) Daratumumab + Carfilzomib + Dexamethasone (D-Kd)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   19/67 (28.36%)   25/67 (37.31%)   26/65 (40.00%)   18/66 (27.27%) 
Blood and lymphatic system disorders         
Anaemia * 1  0/67 (0.00%)  0/67 (0.00%)  1/65 (1.54%)  0/66 (0.00%) 
Febrile Neutropenia * 1  1/67 (1.49%)  2/67 (2.99%)  1/65 (1.54%)  0/66 (0.00%) 
Neutropenia * 1  0/67 (0.00%)  0/67 (0.00%)  3/65 (4.62%)  0/66 (0.00%) 
Thrombocytopenia * 1  1/67 (1.49%)  2/67 (2.99%)  1/65 (1.54%)  0/66 (0.00%) 
Cardiac disorders         
Atrial Fibrillation * 1  1/67 (1.49%)  0/67 (0.00%)  1/65 (1.54%)  0/66 (0.00%) 
Atrial Flutter * 1  0/67 (0.00%)  1/67 (1.49%)  0/65 (0.00%)  0/66 (0.00%) 
Cardiac Failure * 1  0/67 (0.00%)  1/67 (1.49%)  2/65 (3.08%)  1/66 (1.52%) 
Left Ventricular Dysfunction * 1  0/67 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  1/66 (1.52%) 
Myocardial Infarction * 1  0/67 (0.00%)  0/67 (0.00%)  1/65 (1.54%)  0/66 (0.00%) 
Eye disorders         
Ophthalmic Vein Thrombosis * 1  0/67 (0.00%)  1/67 (1.49%)  0/65 (0.00%)  0/66 (0.00%) 
Gastrointestinal disorders         
Diarrhoea * 1  0/67 (0.00%)  1/67 (1.49%)  2/65 (3.08%)  0/66 (0.00%) 
Enterocolitis * 1  0/67 (0.00%)  1/67 (1.49%)  0/65 (0.00%)  0/66 (0.00%) 
Nausea * 1  1/67 (1.49%)  1/67 (1.49%)  0/65 (0.00%)  0/66 (0.00%) 
Rectal Haemorrhage * 1  1/67 (1.49%)  0/67 (0.00%)  0/65 (0.00%)  1/66 (1.52%) 
Vomiting * 1  2/67 (2.99%)  0/67 (0.00%)  0/65 (0.00%)  0/66 (0.00%) 
General disorders         
Chills * 1  1/67 (1.49%)  0/67 (0.00%)  0/65 (0.00%)  0/66 (0.00%) 
Fatigue * 1  2/67 (2.99%)  0/67 (0.00%)  1/65 (1.54%)  0/66 (0.00%) 
General Physical Health Deterioration * 1  0/67 (0.00%)  0/67 (0.00%)  1/65 (1.54%)  0/66 (0.00%) 
Non-Cardiac Chest Pain * 1  0/67 (0.00%)  1/67 (1.49%)  1/65 (1.54%)  0/66 (0.00%) 
Performance Status Decreased * 1  0/67 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  1/66 (1.52%) 
Pyrexia * 1  4/67 (5.97%)  5/67 (7.46%)  2/65 (3.08%)  2/66 (3.03%) 
Infections and infestations         
Bronchitis * 1  0/67 (0.00%)  0/67 (0.00%)  1/65 (1.54%)  0/66 (0.00%) 
Campylobacter Gastroenteritis * 1  0/67 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  1/66 (1.52%) 
Central Nervous System Infection * 1  0/67 (0.00%)  0/67 (0.00%)  1/65 (1.54%)  0/66 (0.00%) 
Clostridium Difficile Colitis * 1  0/67 (0.00%)  0/67 (0.00%)  1/65 (1.54%)  0/66 (0.00%) 
Covid-19 * 1  0/67 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  2/66 (3.03%) 
Gastroenteritis * 1  0/67 (0.00%)  1/67 (1.49%)  1/65 (1.54%)  0/66 (0.00%) 
Infection * 1  1/67 (1.49%)  0/67 (0.00%)  0/65 (0.00%)  0/66 (0.00%) 
Infective Exacerbation of Chronic Obstructive Airways Disease * 1  0/67 (0.00%)  1/67 (1.49%)  0/65 (0.00%)  0/66 (0.00%) 
Influenza * 1  0/67 (0.00%)  1/67 (1.49%)  3/65 (4.62%)  1/66 (1.52%) 
Lower Respiratory Tract Infection * 1  1/67 (1.49%)  0/67 (0.00%)  1/65 (1.54%)  0/66 (0.00%) 
Lung Infection * 1  0/67 (0.00%)  0/67 (0.00%)  1/65 (1.54%)  0/66 (0.00%) 
Neutropenic Sepsis * 1  0/67 (0.00%)  2/67 (2.99%)  0/65 (0.00%)  0/66 (0.00%) 
Pneumococcal Sepsis * 1  1/67 (1.49%)  0/67 (0.00%)  0/65 (0.00%)  0/66 (0.00%) 
Pneumocystis Jirovecii Pneumonia * 1  0/67 (0.00%)  1/67 (1.49%)  0/65 (0.00%)  0/66 (0.00%) 
Pneumonia * 1  1/67 (1.49%)  3/67 (4.48%)  4/65 (6.15%)  2/66 (3.03%) 
Sepsis * 1  0/67 (0.00%)  0/67 (0.00%)  1/65 (1.54%)  1/66 (1.52%) 
Upper Respiratory Tract Infection * 1  0/67 (0.00%)  0/67 (0.00%)  2/65 (3.08%)  0/66 (0.00%) 
Urinary Tract Infection * 1  1/67 (1.49%)  1/67 (1.49%)  0/65 (0.00%)  1/66 (1.52%) 
Urosepsis * 1  1/67 (1.49%)  0/67 (0.00%)  0/65 (0.00%)  0/66 (0.00%) 
Viral Pharyngitis * 1  0/67 (0.00%)  1/67 (1.49%)  0/65 (0.00%)  0/66 (0.00%) 
Injury, poisoning and procedural complications         
Fall * 1  0/67 (0.00%)  1/67 (1.49%)  0/65 (0.00%)  0/66 (0.00%) 
Hip Fracture * 1  0/67 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  1/66 (1.52%) 
Wrist Fracture * 1  0/67 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  1/66 (1.52%) 
Investigations         
Alanine Aminotransferase Increased * 1  0/67 (0.00%)  0/67 (0.00%)  1/65 (1.54%)  0/66 (0.00%) 
Body Temperature Increased * 1  1/67 (1.49%)  0/67 (0.00%)  0/65 (0.00%)  0/66 (0.00%) 
Oxygen Saturation Decreased * 1  1/67 (1.49%)  0/67 (0.00%)  0/65 (0.00%)  0/66 (0.00%) 
Respirovirus Test Positive * 1  1/67 (1.49%)  0/67 (0.00%)  0/65 (0.00%)  0/66 (0.00%) 
Transaminases Increased * 1  0/67 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  1/66 (1.52%) 
Metabolism and nutrition disorders         
Diabetic Metabolic Decompensation * 1  0/67 (0.00%)  0/67 (0.00%)  1/65 (1.54%)  0/66 (0.00%) 
Hypercalcaemia * 1  0/67 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  1/66 (1.52%) 
Hypercreatininaemia * 1  0/67 (0.00%)  1/67 (1.49%)  0/65 (0.00%)  0/66 (0.00%) 
Hyperkalaemia * 1  1/67 (1.49%)  0/67 (0.00%)  0/65 (0.00%)  0/66 (0.00%) 
Hyponatraemia * 1  0/67 (0.00%)  1/67 (1.49%)  0/65 (0.00%)  1/66 (1.52%) 
Musculoskeletal and connective tissue disorders         
Arthralgia * 1  1/67 (1.49%)  0/67 (0.00%)  0/65 (0.00%)  0/66 (0.00%) 
Back Pain * 1  0/67 (0.00%)  1/67 (1.49%)  0/65 (0.00%)  1/66 (1.52%) 
Bone Pain * 1  0/67 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  1/66 (1.52%) 
Muscular Weakness * 1  1/67 (1.49%)  0/67 (0.00%)  0/65 (0.00%)  0/66 (0.00%) 
Musculoskeletal Chest Pain * 1  1/67 (1.49%)  0/67 (0.00%)  0/65 (0.00%)  0/66 (0.00%) 
Osteonecrosis * 1  0/67 (0.00%)  0/67 (0.00%)  1/65 (1.54%)  0/66 (0.00%) 
Spinal Pain * 1  1/67 (1.49%)  1/67 (1.49%)  0/65 (0.00%)  1/66 (1.52%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Plasma Cell Myeloma * 1  0/67 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  1/66 (1.52%) 
Nervous system disorders         
Cerebral Small Vessel Ischaemic Disease * 1  0/67 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  1/66 (1.52%) 
Incoherent * 1  1/67 (1.49%)  0/67 (0.00%)  0/65 (0.00%)  0/66 (0.00%) 
Loss of Consciousness * 1  0/67 (0.00%)  1/67 (1.49%)  0/65 (0.00%)  0/66 (0.00%) 
Spinal Cord Compression * 1  0/67 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  1/66 (1.52%) 
Syncope * 1  0/67 (0.00%)  1/67 (1.49%)  0/65 (0.00%)  0/66 (0.00%) 
Thalamic Infarction * 1  1/67 (1.49%)  0/67 (0.00%)  0/65 (0.00%)  0/66 (0.00%) 
Vith Nerve Paresis * 1  0/67 (0.00%)  0/67 (0.00%)  0/65 (0.00%)  1/66 (1.52%) 
Renal and urinary disorders         
Acute Kidney Injury * 1  0/67 (0.00%)  1/67 (1.49%)  2/65 (3.08%)  0/66 (0.00%) 
Renal Failure * 1  0/67 (0.00%)  0/67 (0.00%)  1/65 (1.54%)  0/66 (0.00%) 
Renal Impairment * 1  0/67 (0.00%)  0/67 (0.00%)  1/65 (1.54%)  0/66 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Chronic Obstructive Pulmonary Disease * 1  0/67 (0.00%)  1/67 (1.49%)  0/65 (0.00%)  0/66 (0.00%) 
Hypoxia * 1  1/67 (1.49%)  0/67 (0.00%)  0/65 (0.00%)  0/66 (0.00%) 
Pneumonitis * 1  1/67 (1.49%)  1/67 (1.49%)  0/65 (0.00%)  0/66 (0.00%) 
Pulmonary Embolism * 1  2/67 (2.99%)  0/67 (0.00%)  1/65 (1.54%)  0/66 (0.00%) 
Pulmonary Hypertension * 1  0/67 (0.00%)  0/67 (0.00%)  1/65 (1.54%)  0/66 (0.00%) 
Respiratory Failure * 1  1/67 (1.49%)  0/67 (0.00%)  0/65 (0.00%)  1/66 (1.52%) 
Skin and subcutaneous tissue disorders         
Hyperhidrosis * 1  1/67 (1.49%)  0/67 (0.00%)  0/65 (0.00%)  0/66 (0.00%) 
Rash Maculo-Papular * 1  0/67 (0.00%)  1/67 (1.49%)  0/65 (0.00%)  0/66 (0.00%) 
Rash Pruritic * 1  1/67 (1.49%)  0/67 (0.00%)  0/65 (0.00%)  0/66 (0.00%) 
Vascular disorders         
Hypotension * 1  1/67 (1.49%)  2/67 (2.99%)  0/65 (0.00%)  0/66 (0.00%) 
1
Term from vocabulary, MedDRA V21.1&23.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Daratumumab (D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd) D + Bortezomib + Melphalan + Prednisone (D-VMP) Daratumumab + Lenalidomide + Dexamethasone (D-Rd) Daratumumab + Carfilzomib + Dexamethasone (D-Kd)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   66/67 (98.51%)   66/67 (98.51%)   64/65 (98.46%)   66/66 (100.00%) 
Blood and lymphatic system disorders         
Anaemia * 1  12/67 (17.91%)  24/67 (35.82%)  17/65 (26.15%)  24/66 (36.36%) 
Leukopenia * 1  9/67 (13.43%)  8/67 (11.94%)  10/65 (15.38%)  6/66 (9.09%) 
Lymphopenia * 1  13/67 (19.40%)  14/67 (20.90%)  10/65 (15.38%)  12/66 (18.18%) 
Neutropenia * 1  25/67 (37.31%)  25/67 (37.31%)  38/65 (58.46%)  15/66 (22.73%) 
Thrombocytopenia * 1  25/67 (37.31%)  35/67 (52.24%)  20/65 (30.77%)  34/66 (51.52%) 
Ear and labyrinth disorders         
Vertigo * 1  1/67 (1.49%)  2/67 (2.99%)  0/65 (0.00%)  6/66 (9.09%) 
Gastrointestinal disorders         
Abdominal Pain * 1  3/67 (4.48%)  4/67 (5.97%)  1/65 (1.54%)  4/66 (6.06%) 
Constipation * 1  26/67 (38.81%)  23/67 (34.33%)  15/65 (23.08%)  6/66 (9.09%) 
Diarrhoea * 1  16/67 (23.88%)  19/67 (28.36%)  22/65 (33.85%)  19/66 (28.79%) 
Nausea * 1  12/67 (17.91%)  23/67 (34.33%)  7/65 (10.77%)  14/66 (21.21%) 
Odynophagia * 1  3/67 (4.48%)  2/67 (2.99%)  1/65 (1.54%)  4/66 (6.06%) 
Vomiting * 1  6/67 (8.96%)  14/67 (20.90%)  5/65 (7.69%)  10/66 (15.15%) 
General disorders         
Asthenia * 1  10/67 (14.93%)  15/67 (22.39%)  17/65 (26.15%)  14/66 (21.21%) 
Chills * 1  8/67 (11.94%)  3/67 (4.48%)  3/65 (4.62%)  2/66 (3.03%) 
Fatigue * 1  18/67 (26.87%)  9/67 (13.43%)  16/65 (24.62%)  13/66 (19.70%) 
Injection Site Erythema * 1  9/67 (13.43%)  5/67 (7.46%)  0/65 (0.00%)  4/66 (6.06%) 
Malaise * 1  0/67 (0.00%)  4/67 (5.97%)  1/65 (1.54%)  0/66 (0.00%) 
Oedema Peripheral * 1  13/67 (19.40%)  8/67 (11.94%)  5/65 (7.69%)  11/66 (16.67%) 
Pyrexia * 1  22/67 (32.84%)  18/67 (26.87%)  14/65 (21.54%)  14/66 (21.21%) 
Infections and infestations         
Bronchitis * 1  2/67 (2.99%)  8/67 (11.94%)  7/65 (10.77%)  7/66 (10.61%) 
Herpes Zoster * 1  0/67 (0.00%)  5/67 (7.46%)  1/65 (1.54%)  1/66 (1.52%) 
Nasopharyngitis * 1  2/67 (2.99%)  3/67 (4.48%)  3/65 (4.62%)  16/66 (24.24%) 
Pneumonia * 1  3/67 (4.48%)  4/67 (5.97%)  3/65 (4.62%)  2/66 (3.03%) 
Rhinitis * 1  0/67 (0.00%)  2/67 (2.99%)  2/65 (3.08%)  5/66 (7.58%) 
Upper Respiratory Tract Infection * 1  5/67 (7.46%)  14/67 (20.90%)  16/65 (24.62%)  11/66 (16.67%) 
Urinary Tract Infection * 1  0/67 (0.00%)  4/67 (5.97%)  4/65 (6.15%)  1/66 (1.52%) 
Investigations         
Alanine Aminotransferase Increased * 1  3/67 (4.48%)  2/67 (2.99%)  3/65 (4.62%)  7/66 (10.61%) 
Blood Alkaline Phosphatase Increased * 1  1/67 (1.49%)  4/67 (5.97%)  2/65 (3.08%)  5/66 (7.58%) 
Blood Creatinine Increased * 1  2/67 (2.99%)  3/67 (4.48%)  7/65 (10.77%)  2/66 (3.03%) 
Gamma-Glutamyltransferase Increased * 1  1/67 (1.49%)  4/67 (5.97%)  0/65 (0.00%)  8/66 (12.12%) 
Weight Decreased * 1  2/67 (2.99%)  5/67 (7.46%)  6/65 (9.23%)  1/66 (1.52%) 
Metabolism and nutrition disorders         
Decreased Appetite * 1  2/67 (2.99%)  10/67 (14.93%)  4/65 (6.15%)  4/66 (6.06%) 
Hyperglycaemia * 1  1/67 (1.49%)  1/67 (1.49%)  7/65 (10.77%)  6/66 (9.09%) 
Hypocalcaemia * 1  5/67 (7.46%)  4/67 (5.97%)  6/65 (9.23%)  4/66 (6.06%) 
Hypokalaemia * 1  2/67 (2.99%)  5/67 (7.46%)  5/65 (7.69%)  1/66 (1.52%) 
Musculoskeletal and connective tissue disorders         
Arthralgia * 1  1/67 (1.49%)  6/67 (8.96%)  4/65 (6.15%)  5/66 (7.58%) 
Back Pain * 1  7/67 (10.45%)  13/67 (19.40%)  8/65 (12.31%)  10/66 (15.15%) 
Bone Pain * 1  0/67 (0.00%)  4/67 (5.97%)  1/65 (1.54%)  6/66 (9.09%) 
Muscle Spasms * 1  4/67 (5.97%)  1/67 (1.49%)  18/65 (27.69%)  6/66 (9.09%) 
Musculoskeletal Chest Pain * 1  1/67 (1.49%)  6/67 (8.96%)  3/65 (4.62%)  7/66 (10.61%) 
Musculoskeletal Pain * 1  1/67 (1.49%)  2/67 (2.99%)  2/65 (3.08%)  7/66 (10.61%) 
Myalgia * 1  0/67 (0.00%)  2/67 (2.99%)  4/65 (6.15%)  2/66 (3.03%) 
Pain in Extremity * 1  6/67 (8.96%)  3/67 (4.48%)  2/65 (3.08%)  4/66 (6.06%) 
Spinal Pain * 1  1/67 (1.49%)  0/67 (0.00%)  1/65 (1.54%)  4/66 (6.06%) 
Nervous system disorders         
Dizziness * 1  6/67 (8.96%)  6/67 (8.96%)  5/65 (7.69%)  3/66 (4.55%) 
Dysgeusia * 1  3/67 (4.48%)  2/67 (2.99%)  4/65 (6.15%)  0/66 (0.00%) 
Headache * 1  7/67 (10.45%)  4/67 (5.97%)  4/65 (6.15%)  15/66 (22.73%) 
Paraesthesia * 1  2/67 (2.99%)  6/67 (8.96%)  3/65 (4.62%)  6/66 (9.09%) 
Peripheral Sensory Neuropathy * 1  28/67 (41.79%)  23/67 (34.33%)  9/65 (13.85%)  7/66 (10.61%) 
Tremor * 1  4/67 (5.97%)  3/67 (4.48%)  4/65 (6.15%)  2/66 (3.03%) 
Psychiatric disorders         
Anxiety * 1  2/67 (2.99%)  1/67 (1.49%)  3/65 (4.62%)  5/66 (7.58%) 
Insomnia * 1  12/67 (17.91%)  13/67 (19.40%)  10/65 (15.38%)  22/66 (33.33%) 
Irritability * 1  1/67 (1.49%)  1/67 (1.49%)  1/65 (1.54%)  4/66 (6.06%) 
Respiratory, thoracic and mediastinal disorders         
Cough * 1  5/67 (7.46%)  8/67 (11.94%)  5/65 (7.69%)  12/66 (18.18%) 
Dyspnoea * 1  9/67 (13.43%)  2/67 (2.99%)  12/65 (18.46%)  11/66 (16.67%) 
Dyspnoea Exertional * 1  3/67 (4.48%)  1/67 (1.49%)  1/65 (1.54%)  4/66 (6.06%) 
Productive Cough * 1  0/67 (0.00%)  5/67 (7.46%)  2/65 (3.08%)  4/66 (6.06%) 
Rhinorrhoea * 1  0/67 (0.00%)  2/67 (2.99%)  0/65 (0.00%)  4/66 (6.06%) 
Skin and subcutaneous tissue disorders         
Erythema * 1  4/67 (5.97%)  5/67 (7.46%)  1/65 (1.54%)  4/66 (6.06%) 
Pruritus * 1  4/67 (5.97%)  7/67 (10.45%)  2/65 (3.08%)  4/66 (6.06%) 
Rash * 1  9/67 (13.43%)  8/67 (11.94%)  5/65 (7.69%)  5/66 (7.58%) 
Rash Generalised * 1  4/67 (5.97%)  2/67 (2.99%)  3/65 (4.62%)  0/66 (0.00%) 
Rash Maculo-Papular * 1  3/67 (4.48%)  3/67 (4.48%)  4/65 (6.15%)  1/66 (1.52%) 
Vascular disorders         
Hypertension * 1  1/67 (1.49%)  9/67 (13.43%)  1/65 (1.54%)  21/66 (31.82%) 
Hypotension * 1  3/67 (4.48%)  4/67 (5.97%)  4/65 (6.15%)  2/66 (3.03%) 
1
Term from vocabulary, MedDRA V21.1&23.0
*
Indicates events were collected by non-systematic assessment
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.
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 in writing, such publication will be withheld for up to an additional 60 days.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GLOBAL MEDICAL HEAD
Organization: Janssen Research & Development, LLC
Phone: 844-434-4210
EMail: ClinicalTrialDisclosure@its.jnj.com
Layout table for additonal information
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT03412565    
Other Study ID Numbers: CR108435
2017-004203-41 ( EudraCT Number )
54767414MMY2040 ( Other Identifier: Janssen Research & Development, LLC )
First Submitted: January 22, 2018
First Posted: January 26, 2018
Results First Submitted: December 16, 2021
Results First Posted: January 12, 2022
Last Update Posted: September 9, 2022