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A Study of Combination of Daratumumab and Velcade (Bortezomib) Melphalan-Prednisone (DVMP) Compared to Velcade Melphalan-Prednisone (VMP) in Participants With Previously Untreated Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT02195479
Recruitment Status : Active, not recruiting
First Posted : July 21, 2014
Results First Posted : December 17, 2018
Last Update Posted : December 17, 2018
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: Velcade
Drug: Melphalan
Drug: Prednisone
Drug: Daratumumab
Drug: Dexamethasone
Enrollment 706
Recruitment Details  
Pre-assignment Details Results are reported up to second interim analysis (up to 2.4 years). Complete data through 6.4 years will be reported within 1 year of end of study trial date when final data based on study completion date will be available.
Arm/Group Title Velcade, Melphalan and Prednisone (VMP) Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)
Hide Arm/Group Description Participants received Velcade (bortezomib) 1.3 milligram per square meter (mg/m^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9. Participants received velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre medication and prednisone substitute.
Period Title: Overall Study
Started 356 350
Treated 354 346
Completed 0 [1] 0 [1]
Not Completed 356 350
Reason Not Completed
Lost to Follow-up             3             0
Death             48             45
Physician Decision             1             0
Withdrawal by Subject             11             6
Other             2             2
Ongoing             291             297
[1]
None of the participants completed the study as the study is still on-going.
Arm/Group Title Velcade, Melphalan and Prednisone (VMP) Daratumumab, Velcade, Melphalan and Prednisone (D-VMP) Total
Hide Arm/Group Description Participants received Velcade (bortezomib) 1.3 milligram per square meter (mg/m^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9. Participants received velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre medication and prednisone substitute. Total of all reporting groups
Overall Number of Baseline Participants 356 350 706
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 356 participants 350 participants 706 participants
71.5  (5.82) 71.3  (6.66) 71.4  (6.25)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 356 participants 350 participants 706 participants
Female
189
  53.1%
190
  54.3%
379
  53.7%
Male
167
  46.9%
160
  45.7%
327
  46.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 356 participants 350 participants 706 participants
Hispanic or Latino
16
   4.5%
24
   6.9%
40
   5.7%
Not Hispanic or Latino
332
  93.3%
320
  91.4%
652
  92.4%
Unknown or Not Reported
8
   2.2%
6
   1.7%
14
   2.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 356 participants 350 participants 706 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
45
  12.6%
47
  13.4%
92
  13.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
   0.8%
3
   0.9%
6
   0.8%
White
304
  85.4%
297
  84.9%
601
  85.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
4
   1.1%
3
   0.9%
7
   1.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Argentina Number Analyzed 356 participants 350 participants 706 participants
2
   0.6%
2
   0.6%
4
   0.6%
Australia Number Analyzed 356 participants 350 participants 706 participants
10
   2.8%
5
   1.4%
15
   2.1%
Belgium Number Analyzed 356 participants 350 participants 706 participants
8
   2.2%
6
   1.7%
14
   2.0%
Brazil Number Analyzed 356 participants 350 participants 706 participants
2
   0.6%
4
   1.1%
6
   0.8%
Bulgaria Number Analyzed 356 participants 350 participants 706 participants
15
   4.2%
8
   2.3%
23
   3.3%
Croatia Number Analyzed 356 participants 350 participants 706 participants
2
   0.6%
2
   0.6%
4
   0.6%
Czech Republic Number Analyzed 356 participants 350 participants 706 participants
29
   8.1%
21
   6.0%
50
   7.1%
Georgia Number Analyzed 356 participants 350 participants 706 participants
11
   3.1%
11
   3.1%
22
   3.1%
Germany Number Analyzed 356 participants 350 participants 706 participants
2
   0.6%
5
   1.4%
7
   1.0%
Greece Number Analyzed 356 participants 350 participants 706 participants
15
   4.2%
14
   4.0%
29
   4.1%
Hungary Number Analyzed 356 participants 350 participants 706 participants
12
   3.4%
14
   4.0%
26
   3.7%
Italy Number Analyzed 356 participants 350 participants 706 participants
26
   7.3%
28
   8.0%
54
   7.6%
Japan Number Analyzed 356 participants 350 participants 706 participants
26
   7.3%
24
   6.9%
50
   7.1%
Poland Number Analyzed 356 participants 350 participants 706 participants
27
   7.6%
39
  11.1%
66
   9.3%
Portugal Number Analyzed 356 participants 350 participants 706 participants
4
   1.1%
3
   0.9%
7
   1.0%
Macedonia Number Analyzed 356 participants 350 participants 706 participants
10
   2.8%
1
   0.3%
11
   1.6%
Romania Number Analyzed 356 participants 350 participants 706 participants
18
   5.1%
10
   2.9%
28
   4.0%
Russia Number Analyzed 356 participants 350 participants 706 participants
21
   5.9%
22
   6.3%
43
   6.1%
Serbia Number Analyzed 356 participants 350 participants 706 participants
3
   0.8%
7
   2.0%
10
   1.4%
Korea, Democratic People'S Republic Of Number Analyzed 356 participants 350 participants 706 participants
18
   5.1%
23
   6.6%
41
   5.8%
Spain Number Analyzed 356 participants 350 participants 706 participants
47
  13.2%
56
  16.0%
103
  14.6%
Turkey Number Analyzed 356 participants 350 participants 706 participants
10
   2.8%
5
   1.4%
15
   2.1%
Ukraine Number Analyzed 356 participants 350 participants 706 participants
20
   5.6%
28
   8.0%
48
   6.8%
United Kingdom Number Analyzed 356 participants 350 participants 706 participants
15
   4.2%
9
   2.6%
24
   3.4%
United States Number Analyzed 356 participants 350 participants 706 participants
3
   0.8%
3
   0.9%
6
   0.8%
Stage of Disease (ISS)   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
I Number Analyzed 331 participants 333 participants 664 participants
38
  11.5%
47
  14.1%
85
  12.8%
II Number Analyzed 331 participants 333 participants 664 participants
247
  74.6%
226
  67.9%
473
  71.2%
III Number Analyzed 331 participants 333 participants 664 participants
46
  13.9%
60
  18.0%
106
  16.0%
[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.
[2]
Measure Analysis Population Description: Here, 'N' (number of participants analyzed) signifies number of participants who were evaluable for this study specific characteristic.
Time from multiple myeloma (MM) diagnosis   [1] 
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 356 participants 350 participants 706 participants
1.27  (1.737) 1.09  (1.056) 1.18  (1.442)
[1]
Measure Description: Time from multiple myeloma (MM) diagnosis is the time from diagnosis of multiple myeloma to randomization in each treatment group.
1.Primary Outcome
Title Progression Free Survival (PFS)
Hide Description PFS- duration from date of randomization to Progressive disease (PD)/death, whichever occurs first. PD per IMWG criteria-Increase of 25% from lowest response value in one of following: Serum and urine M-component (absolute increase >=0.5 gram per deciliter [g/dL] and >=200 milligram [mg]/24 hours respectively); Only participants without measurable serum and urine M-protein levels: difference between involved and uninvolved free light chain (FLC) levels (absolute increase>10 mg/dL); Only participants without measurable serum and urine M-protein levels,without measurable disease by FLC levels,bone marrow Plasma cells (PC) %(absolute % >=10%);Bone marrow PC%: absolute% >10%; Definite development of new bone lesions/soft tissue plasmacytomas/definite increase in size of existing bone lesions/soft tissue plasmacytomas and Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to the PC proliferative disorder.
Time Frame From randomization to either disease progression or death whichever occurs first (up to 2.4 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received.
Arm/Group Title Velcade, Melphalan and Prednisone (VMP) Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)
Hide Arm/Group Description:
Participants received Velcade (bortezomib) 1.3 milligram per square meter (mg/m^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9.
Participants received velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre medication and prednisone substitute.
Overall Number of Participants Analyzed 356 350
Median (95% Confidence Interval)
Unit of Measure: Months
18.14
(16.53 to 19.91)
NA [1] 
(NA to NA)
[1]
Median and 95% confidence interval (CI) was not estimable due to insufficient number of events.
2.Secondary Outcome
Title Overall Response Rate (ORR)
Hide Description The 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 the study or during follow up. IMWG criteria for PR: greater than or equal to (>=) 50 percentage(%) 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 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 From randomization to disease progression (up to 2.4 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received.
Arm/Group Title Velcade, Melphalan and Prednisone (VMP) Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)
Hide Arm/Group Description:
Participants received Velcade (bortezomib) 1.3 milligram per square meter (mg/m^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9.
Participants received velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre medication and prednisone substitute.
Overall Number of Participants Analyzed 356 350
Measure Type: Number
Unit of Measure: Percentage of participants
73.9 90.9
3.Secondary Outcome
Title Percentage of Participants With Very Good Partial Response (VGPR) or Better
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 less than (<) 100 milligram (mg) per 24 hour; CR: negative immunofixation on the serum and urine, Disappearance of any soft tissue plasmacytomas and < 5% plasms cells (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 From randomization to disease progression (up to 2.4 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received.
Arm/Group Title Velcade, Melphalan and Prednisone (VMP) Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)
Hide Arm/Group Description:
Participants received Velcade (bortezomib) 1.3 milligram per square meter (mg/m^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9.
Participants received velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre medication and prednisone substitute.
Overall Number of Participants Analyzed 356 350
Measure Type: Number
Unit of Measure: Percentage of participants
49.7 71.1
4.Secondary Outcome
Title Percentage of Participants With Complete Response (CR) or Better
Hide Description CR or better rate was defined as the percentage of participants with a CR or better (i.e. 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 free light chain (FLC) ratio and absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry.
Time Frame From randomization to disease progression (up to 2.4 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received.
Arm/Group Title Velcade, Melphalan and Prednisone (VMP) Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)
Hide Arm/Group Description:
Participants received Velcade (bortezomib) 1.3 milligram per square meter (mg/m^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9.
Participants received velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre medication and prednisone substitute.
Overall Number of Participants Analyzed 356 350
Measure Type: Number
Unit of Measure: Percentage of participants
24.4 42.6
5.Secondary Outcome
Title Percentage of Participants With Negative Minimal Residual Disease (MRD)
Hide Description The Minimal Residual Disease negativity rate was defined as the percentage of participants who had negative MRD (detection of less than 1 malignant cell among 100,000 normal cells) assessment at any timepoint after the first dose of study drugs by evaluation of bone marrow aspirates or whole blood at 10^-5 threshold. MRD was evaluated by using Deoxyribonucleic acid (DNA) sequencing of immunoglobulin genes. MRD was assessed in participants who achieved complete response or stringent complete response (CR/sCR).
Time Frame From randomization to disease progression (up to 2.4 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received.
Arm/Group Title Velcade, Melphalan and Prednisone (VMP) Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)
Hide Arm/Group Description:
Participants received Velcade (bortezomib) 1.3 milligram per square meter (mg/m^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9.
Participants received velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre medication and prednisone substitute.
Overall Number of Participants Analyzed 356 350
Measure Type: Number
Unit of Measure: Percentage of participants
6.2 22.3
6.Secondary Outcome
Title Overall Survival (OS)
Hide Description Overall Survival (OS) was defined as the number of days the date of randomization to date of death. Median Overall Survival was estimated by using the Kaplan-Meier method.
Time Frame From randomization to death (up to approximately 2.4 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received.
Arm/Group Title Velcade, Melphalan and Prednisone (VMP) Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)
Hide Arm/Group Description:
Participants received Velcade (bortezomib) 1.3 milligram per square meter (mg/m^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9.
Participants received velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre medication and prednisone substitute.
Overall Number of Participants Analyzed 356 350
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Median and 95% CI was not estimable due to insufficient number of events.
7.Secondary Outcome
Title Progression Free Survival on Next Line of Therapy (PFS2)
Hide Description Progression-free survival after next-line therapy is defined as the time from randomization to progression on the next line of subsequent antimyeloma therapy or death due to any cause (prior to start of second line of antimyeloma therapy), whichever comes first. Disease progression on next line of treatment was based on investigator judgment.
Time Frame From randomization to either disease progression or death whichever occurs first (up to 2.4 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received.
Arm/Group Title Velcade, Melphalan and Prednisone (VMP) Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)
Hide Arm/Group Description:
Participants received Velcade (bortezomib) 1.3 milligram per square meter (mg/m^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9.
Participants received velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre medication and prednisone substitute.
Overall Number of Participants Analyzed 356 350
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Median and 95% CI was not estimable due to insufficient number of events.
8.Secondary Outcome
Title Percentage of Participants With Stringent Complete Response (sCR)
Hide Description sCR as per IMWG criteria is CR plus normal free light chain (FLC) ratio and absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry. CR: Negative immunofixation on the serum and urine; Disappearance of any soft tissue plasmacytomas; <5% plasma cells (PCs) in bone marrow.
Time Frame From randomization to disease progression (up to 2.4 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received.
Arm/Group Title Velcade, Melphalan and Prednisone (VMP) Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)
Hide Arm/Group Description:
Participants received Velcade (bortezomib) 1.3 milligram per square meter (mg/m^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9.
Participants received velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre medication and prednisone substitute.
Overall Number of Participants Analyzed 356 350
Measure Type: Number
Unit of Measure: Percentage of participants
9.3 20.3
9.Secondary Outcome
Title Time to Disease Progression (TTP)
Hide Description TTP: Time from date of randomization to date of first documented evidence of PD or death due to PD, whichever occurs first. PD per IMWG criteria- Increase of 25 % from lowest response value in one of following: Serum and urine M-component (absolute increase >=0.5 gram per deciliter [g/dL] and >=200 mg/24 hours respectively); Only in participants without measurable serum and urine M-protein levels: difference between involved and uninvolved FLC levels (absolute increase >10 milligram per deciliter [mg/dL]); Only in participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow plasma cells (PC)% (absolute % >=10%); Bone marrow PC %: absolute % >10%; Definite development of new bone lesions/soft tissue plasmacytomas or definite increase in size of existing bone lesions/soft tissue plasmacytomas and Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to the PC proliferative disorder.
Time Frame From randomization to either disease progression or death due to PD whichever occurs first (up to 2.4 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received.
Arm/Group Title Velcade, Melphalan and Prednisone (VMP) Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)
Hide Arm/Group Description:
Participants received Velcade (bortezomib) 1.3 milligram per square meter (mg/m^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9.
Participants received velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre medication and prednisone substitute.
Overall Number of Participants Analyzed 356 350
Median (95% Confidence Interval)
Unit of Measure: Months
19.35
(17.38 to 22.67)
NA [1] 
(NA to NA)
[1]
Median and 95% CI was not estimable due to insufficient number of events.
10.Secondary Outcome
Title Time to Response
Hide Description Time to response, defined as the time between the date of randomization and the first efficacy evaluation that the participant has met all criteria for PR or better. 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%.
Time Frame From randomization to first documented PR or better (up to 2.4 years)
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Hide Analysis Population Description
Response-evaluable population: participants who have a confirmed diagnosis of MM and measurable disease at baseline or screening, must receive at least one component of study treatment and have adequate post-baseline disease assessments. "N" (number of participants analyzed) signifies number of participants evaluable for this endpoint.
Arm/Group Title Velcade, Melphalan and Prednisone (VMP) Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)
Hide Arm/Group Description:
Participants received Velcade (bortezomib) 1.3 milligram per square meter (mg/m^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9.
Participants received velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre medication and prednisone substitute.
Overall Number of Participants Analyzed 263 318
Median (95% Confidence Interval)
Unit of Measure: Months
0.82
(0.7 to 12.6)
0.79
(0.4 to 15.5)
11.Secondary Outcome
Title Duration of Response (DOR)
Hide Description DOR: participants with a confirmed response (PR or better) as time between first documentation of response and disease progression, IMWG response criteria, or death due to PD, whichever occurs first. PD: Increase of 25% from lowest response value in any one of following: Serum M-component (absolute increase>=0.5 g/dL); Urine M-component (absolute increase>=200 mg/24 hours); Only participants without measurable serum and urine M-protein levels: difference between involved and uninvolved FLC levels (absolute increase >10 mg/dL); Only participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow PC%(absolute%>=10%); Bone marrow PC’s %: absolute%>10%; Definite development of new bone lesions/soft tissue plasmacytomas/definite increase in the size of existing bone lesions or soft tissue plasmacytomas and Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to PC proliferative disorder.
Time Frame Up to 2.4 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Response-evaluable set: participants who have a confirmed diagnosis of MM and measurable disease at baseline or screening. Participants must have received at least one component of study treatment and have adequate post-baseline disease assessments. "N"(number of participants analyzed) signifies number of participants evaluable for this endpoint.
Arm/Group Title Velcade, Melphalan and Prednisone (VMP) Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)
Hide Arm/Group Description:
Participants received Velcade (bortezomib) 1.3 milligram per square meter (mg/m^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9.
Participants received velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre medication and prednisone substitute.
Overall Number of Participants Analyzed 263 318
Median (95% Confidence Interval)
Unit of Measure: Months
21.3 [1] 
(18.4 to NA)
NA [2] 
(NA to NA)
[1]
Upper limit of 95% CI was not estimable due to insufficient number of events.
[2]
Median and 95% CI was not estimable due to insufficient number of events.
12.Secondary Outcome
Title Time to Next Treatment (TNT)
Hide Description Time to next treatment is defined as the time from randomization to the start of the next-line treatment.
Time Frame Approximately up to 2.4 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants randomized into the study; classified according to assigned treatment group, regardless of the actual treatment received.
Arm/Group Title Velcade, Melphalan and Prednisone (VMP) Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)
Hide Arm/Group Description:
Participants received Velcade (bortezomib) 1.3 milligram per square meter (mg/m^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9.
Participants received velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre medication and prednisone substitute.
Overall Number of Participants Analyzed 356 350
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(21.4 to NA)
NA [2] 
(NA to NA)
[1]
Median and upper limit of 95% CI was not estimable due to insufficient number of events.
[2]
Median and 95% CI was not estimable due to insufficient number of events.
13.Secondary Outcome
Title Percentage of Participants With Best M-protein Response
Hide Description Percentage of participants with Best M- protein response of 100% reduction and >=90% to < 100% reduction were assessed. Best M-protein response was defined as the maximal percent reduction or the lowest percent increase from baseline in serum M-protein for participants with measurable heavy chain at baseline or urine M-protein for participants without measurable heavy chain, but with measurable light chain disease at baseline. For participants without measurable heavy chain and light chain disease at baseline, best response in serum free light chain (FLC) was defined as the maximal percent reduction or the lowest percent increase from baseline in the difference between involved and uninvolved serum FLC level (dFLC).
Time Frame Approximately up to 2.4 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Response-evaluable set: participants have confirmed diagnosis of MM and measurable disease at baseline or screening. Participants must receive at least one component of study treatment, have adequate post-baseline disease assessments. 'n' (number of participants analyzed) signifies number of participants analyzed for each specified category.
Arm/Group Title Velcade, Melphalan and Prednisone (VMP) Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)
Hide Arm/Group Description:
Participants received Velcade (bortezomib) 1.3 milligram per square meter (mg/m^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9.
Participants received velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre medication and prednisone substitute.
Overall Number of Participants Analyzed 341 337
Measure Type: Number
Unit of Measure: Percentage of participants
Best M-protein response in serum: 100% reduction Number Analyzed 287 participants 277 participants
38.7 58.5
Best M-protein response in serum:>= 90 to < 100% Number Analyzed 287 participants 277 participants
14.6 15.2
Best M-protein response in urine:100% reduction Number Analyzed 36 participants 42 participants
69.4 90.5
Best M-protein response in urine:>=90 to < 100% Number Analyzed 36 participants 42 participants
13.9 7.1
Best response in dFLC:100% reduction Number Analyzed 18 participants 18 participants
0 0
Best response in dFLC: >=90% to < 100% reduction Number Analyzed 18 participants 18 participants
77.8 100.0
14.Secondary Outcome
Title Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30: Emotional Functioning Score
Hide Description The EORTC QLQ-C30 is a 30 items self-reporting questionnaire, with a 1 week recall period, resulting in 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 Global Health Status (GHS) scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The questionnaire includes 28 items with 4-point Likert type responses from “1-not at all” to “4-very much” to assess functioning and symptoms; 2 items with 7-point Likert scales (1= poor and 7= excellent) for global health and overall QoL. Scores are transformed to a 0 to 100 scale, with higher scores representing better GHS, better functioning, and more symptoms. Negative change from baseline values indicate deterioration in quality of life or functioning and positive values indicate improvement.
Time Frame Baseline, Months 3, 6, 9, 12 and 18
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population: participants randomized into the study; classified according to assigned treatment group,regardless actual treatment received. 'N' (number of participants analyzed) signifies participants evaluable for this endpoint and 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.
Arm/Group Title Velcade, Melphalan and Prednisone (VMP) Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)
Hide Arm/Group Description:
Participants received Velcade (bortezomib) 1.3 milligram per square meter (mg/m^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9.
Participants received velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre medication and prednisone substitute.
Overall Number of Participants Analyzed 327 316
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
Month 3 Number Analyzed 244 participants 261 participants
9.4
(7.1 to 11.7)
8.8
(6.6 to 11.1)
Month 6 Number Analyzed 212 participants 233 participants
10.5
(8.1 to 12.9)
10.6
(8.3 to 12.9)
Month 9 Number Analyzed 189 participants 226 participants
11.9
(9.4 to 14.4)
11.1
(8.8 to 13.5)
Month 12 Number Analyzed 179 participants 220 participants
11
(8.4 to 13.6)
12.6
(10.2 to 14.9)
Month 18 Number Analyzed 52 participants 78 participants
12.7
(8.5 to 16.9)
11.4
(7.9 to 14.9)
15.Secondary Outcome
Title Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L): Visual Analogue Scale (VAS)
Hide Description EQ-5D-5L is a standardized, participant-rated questionnaire to assess health-related quality of life. The EQ-5D-5L includes 2 components: the EQ-5D-5L health state profile (descriptive system) and the EQ-5D-5L Visual Analog Scale. The Visual Analogue Scale is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.
Time Frame Baseline, Months 3, 6, 9, 12 and 18
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population: participants randomized into the study; classified according to assigned treatment group,regardless actual treatment received. 'N' (number of participants analyzed) signifies participants evaluable for this endpoint and 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.
Arm/Group Title Velcade, Melphalan and Prednisone (VMP) Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)
Hide Arm/Group Description:
Participants received Velcade (bortezomib) 1.3 milligram per square meter (mg/m^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9.
Participants received velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre medication and prednisone substitute.
Overall Number of Participants Analyzed 325 315
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline Number Analyzed 325 participants 315 participants
60.33  (20.610) 57.90  (20.190)
Month 3 Number Analyzed 241 participants 258 participants
4.20  (18.417) 9.28  (20.195)
Month 6 Number Analyzed 209 participants 229 participants
7.40  (18.002) 10.83  (20.123)
Month 9 Number Analyzed 186 participants 225 participants
9.89  (19.516) 12.50  (20.616)
Month 12 Number Analyzed 179 participants 216 participants
10.80  (19.386) 10.79  (20.271)
Month 18 Number Analyzed 51 participants 77 participants
7.65  (19.284) 12.04  (20.126)
16.Secondary Outcome
Title Change From Baseline in EuroQol 5 Dimensions-5 Level (EQ-5D-5L) Utility Score
Hide Description EQ-5D-5L is a standardized, participant-rated questionnaire to assess health-related quality of life. The EQ-5D-5L includes 2 components: the EQ-5D-5L health state profile (descriptive system) and the EQ-5D-5L Visual Analog Scale. The EQ-5D-5L descriptive system provides a profile of the participant’s health state 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The participant was asked to indicate his/her current health state by selecting the most appropriate level in each of the 5 dimensions. Responses to the 5 dimension scores were combined and converted into a single preference-weighted health utility index score 0 (0.0- worst health state) to 1 (1.0- better health state) representing the general health status of the individual based on the UK scoring algorithm.
Time Frame Baseline, Months 3, 6, 9, 12 and 18
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population: participants randomized into the study; classified according to assigned treatment group,regardless actual treatment received. 'N' (number of participants analyzed) signifies participants evaluable for this endpoint and 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.
Arm/Group Title Velcade, Melphalan and Prednisone (VMP) Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)
Hide Arm/Group Description:
Participants received Velcade (bortezomib) 1.3 milligram per square meter (mg/m^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9.
Participants received velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre medication and prednisone substitute.
Overall Number of Participants Analyzed 325 315
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline Number Analyzed 325 participants 315 participants
0.59  (0.301) 0.57  (0.292)
Month 3 Number Analyzed 241 participants 258 participants
0.09  (0.312) 0.12  (0.265)
Month 6 Number Analyzed 209 participants 229 participants
0.12  (0.270) 0.13  (0.271)
Month 9 Number Analyzed 186 participants 225 participants
0.16  (0.270) 0.16  (0.270)
Month 12 Number Analyzed 179 participants 216 participants
0.15  (0.278) 0.17  (0.287)
Month 18 Number Analyzed 51 participants 77 participants
0.13  (0.247) 0.13  (0.314)
Time Frame Up to 2.4 years
Adverse Event Reporting Description Safety population defined as participants who have received at least 1 administration of any study drug.
 
Arm/Group Title Velcade, Melphalan and Prednisone (VMP) Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)
Hide Arm/Group Description Participants received Velcade (bortezomib) 1.3 milligram per square meter (mg/m^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2 orally once daily on Days 1 to 4 and prednisone 60 mg/m^2 orally once daily on Days 1 to 4 of each cycle up to Cycle 9. Participants received velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2, orally once daily on Days 1 to 4 and prednisone 60 mg/m^2, orally once daily on Days 2 to 4 of each cycle up to Cycle 9. In addition, participants also received daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion once weekly for 6 weeks in Cycle 1 and then every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or study end. On Day 1 of each cycle, dexamethasone 20 mg IV or per oral (PO) was given 1 hour or less prior to daratumumab infusion as pre medication and prednisone substitute.
All-Cause Mortality
Velcade, Melphalan and Prednisone (VMP) Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)
Affected / at Risk (%) Affected / at Risk (%)
Total   48/354 (13.56%)   45/346 (13.01%) 
Show Serious Adverse Events Hide Serious Adverse Events
Velcade, Melphalan and Prednisone (VMP) Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)
Affected / at Risk (%) Affected / at Risk (%)
Total   115/354 (32.49%)   144/346 (41.62%) 
Blood and lymphatic system disorders     
Anaemia * 1  9/354 (2.54%)  6/346 (1.73%) 
Febrile Neutropenia * 1  7/354 (1.98%)  2/346 (0.58%) 
Leukopenia * 1  1/354 (0.28%)  0/346 (0.00%) 
Neutropenia * 1  4/354 (1.13%)  3/346 (0.87%) 
Thrombocytopenia * 1  4/354 (1.13%)  5/346 (1.45%) 
Cardiac disorders     
Acute Coronary Syndrome * 1  1/354 (0.28%)  1/346 (0.29%) 
Acute Myocardial Infarction * 1  0/354 (0.00%)  2/346 (0.58%) 
Angina Unstable * 1  1/354 (0.28%)  0/346 (0.00%) 
Atrial Fibrillation * 1  2/354 (0.56%)  6/346 (1.73%) 
Cardiac Arrest * 1  2/354 (0.56%)  1/346 (0.29%) 
Cardiac Failure * 1  7/354 (1.98%)  1/346 (0.29%) 
Cardiac Failure Acute * 1  0/354 (0.00%)  1/346 (0.29%) 
Cardiac Failure Chronic * 1  0/354 (0.00%)  1/346 (0.29%) 
Cardiac Failure Congestive * 1  0/354 (0.00%)  1/346 (0.29%) 
Cardio-Respiratory Arrest * 1  1/354 (0.28%)  0/346 (0.00%) 
Cardiovascular Insufficiency * 1  0/354 (0.00%)  1/346 (0.29%) 
Sinus Bradycardia * 1  0/354 (0.00%)  2/346 (0.58%) 
Stress Cardiomyopathy * 1  0/354 (0.00%)  1/346 (0.29%) 
Supraventricular Tachycardia * 1  1/354 (0.28%)  1/346 (0.29%) 
Tachycardia * 1  0/354 (0.00%)  1/346 (0.29%) 
Eye disorders     
Conjunctival Haemorrhage * 1  0/354 (0.00%)  1/346 (0.29%) 
Retinal Detachment * 1  0/354 (0.00%)  1/346 (0.29%) 
Gastrointestinal disorders     
Abdominal Adhesions * 1  0/354 (0.00%)  1/346 (0.29%) 
Abdominal Pain * 1  0/354 (0.00%)  1/346 (0.29%) 
Abdominal Pain Upper * 1  1/354 (0.28%)  0/346 (0.00%) 
Anal Haemorrhage * 1  0/354 (0.00%)  1/346 (0.29%) 
Colitis * 1  1/354 (0.28%)  0/346 (0.00%) 
Constipation * 1  1/354 (0.28%)  0/346 (0.00%) 
Diarrhoea * 1  2/354 (0.56%)  2/346 (0.58%) 
Diverticular Perforation * 1  1/354 (0.28%)  0/346 (0.00%) 
Enterocolitis * 1  0/354 (0.00%)  1/346 (0.29%) 
Gastric Haemorrhage * 1  1/354 (0.28%)  0/346 (0.00%) 
Gastritis * 1  1/354 (0.28%)  0/346 (0.00%) 
Gastrointestinal Disorder * 1  1/354 (0.28%)  0/346 (0.00%) 
Gastrointestinal Haemorrhage * 1  0/354 (0.00%)  2/346 (0.58%) 
Haematemesis * 1  2/354 (0.56%)  0/346 (0.00%) 
Haemorrhoidal Haemorrhage * 1  0/354 (0.00%)  1/346 (0.29%) 
Ileus * 1  1/354 (0.28%)  0/346 (0.00%) 
Ileus Paralytic * 1  1/354 (0.28%)  1/346 (0.29%) 
Inguinal Hernia * 1  0/354 (0.00%)  1/346 (0.29%) 
Large Intestine Perforation * 1  0/354 (0.00%)  1/346 (0.29%) 
Nausea * 1  1/354 (0.28%)  0/346 (0.00%) 
Oesophageal Rupture * 1  1/354 (0.28%)  0/346 (0.00%) 
Oesophagitis Haemorrhagic * 1  1/354 (0.28%)  0/346 (0.00%) 
Rectal Haemorrhage * 1  1/354 (0.28%)  1/346 (0.29%) 
Vomiting * 1  6/354 (1.69%)  2/346 (0.58%) 
General disorders     
Asthenia * 1  2/354 (0.56%)  2/346 (0.58%) 
Chest Pain * 1  0/354 (0.00%)  1/346 (0.29%) 
Death * 1  2/354 (0.56%)  2/346 (0.58%) 
Fatigue * 1  2/354 (0.56%)  1/346 (0.29%) 
Generalised Oedema * 1  0/354 (0.00%)  1/346 (0.29%) 
Hyperthermia * 1  0/354 (0.00%)  1/346 (0.29%) 
Malaise * 1  1/354 (0.28%)  0/346 (0.00%) 
Multiple Organ Dysfunction Syndrome * 1  1/354 (0.28%)  0/346 (0.00%) 
Non-Cardiac Chest Pain * 1  2/354 (0.56%)  1/346 (0.29%) 
Pain * 1  1/354 (0.28%)  1/346 (0.29%) 
Pyrexia * 1  5/354 (1.41%)  5/346 (1.45%) 
Hepatobiliary disorders     
Cholelithiasis * 1  1/354 (0.28%)  0/346 (0.00%) 
Infections and infestations     
Abdominal Abscess * 1  1/354 (0.28%)  0/346 (0.00%) 
Bacteraemia * 1  0/354 (0.00%)  2/346 (0.58%) 
Bronchitis * 1  2/354 (0.56%)  8/346 (2.31%) 
Candida Sepsis * 1  1/354 (0.28%)  0/346 (0.00%) 
Cellulitis * 1  1/354 (0.28%)  0/346 (0.00%) 
Clostridium Colitis * 1  1/354 (0.28%)  1/346 (0.29%) 
Clostridium Difficile Colitis * 1  1/354 (0.28%)  0/346 (0.00%) 
Clostridium Difficile Infection * 1  2/354 (0.56%)  0/346 (0.00%) 
Cytomegalovirus Infection * 1  0/354 (0.00%)  2/346 (0.58%) 
Device Related Infection * 1  1/354 (0.28%)  0/346 (0.00%) 
Diverticulitis * 1  0/354 (0.00%)  1/346 (0.29%) 
Enterococcal Bacteraemia * 1  1/354 (0.28%)  0/346 (0.00%) 
Epiglottitis * 1  0/354 (0.00%)  1/346 (0.29%) 
Gastroenteritis * 1  2/354 (0.56%)  1/346 (0.29%) 
H1n1 Influenza * 1  0/354 (0.00%)  1/346 (0.29%) 
Herpes Zoster * 1  1/354 (0.28%)  0/346 (0.00%) 
Herpes Zoster Disseminated * 1  0/354 (0.00%)  1/346 (0.29%) 
Infection * 1  1/354 (0.28%)  3/346 (0.87%) 
Infective Exacerbation of Chronic Obstructive Airways Disease * 1  1/354 (0.28%)  0/346 (0.00%) 
Infective Myositis * 1  0/354 (0.00%)  1/346 (0.29%) 
Influenza * 1  2/354 (0.56%)  3/346 (0.87%) 
Lower Respiratory Tract Infection * 1  3/354 (0.85%)  8/346 (2.31%) 
Lower Respiratory Tract Infection Bacterial * 1  0/354 (0.00%)  1/346 (0.29%) 
Lung Infection * 1  1/354 (0.28%)  1/346 (0.29%) 
Meningitis Pneumococcal * 1  0/354 (0.00%)  1/346 (0.29%) 
Neutropenic Infection * 1  1/354 (0.28%)  1/346 (0.29%) 
Pelvic Infection * 1  1/354 (0.28%)  0/346 (0.00%) 
Peritonitis * 1  0/354 (0.00%)  1/346 (0.29%) 
Pharyngitis * 1  0/354 (0.00%)  1/346 (0.29%) 
Pneumococcal Sepsis * 1  0/354 (0.00%)  1/346 (0.29%) 
Pneumonia * 1  11/354 (3.11%)  35/346 (10.12%) 
Pneumonia Bacterial * 1  1/354 (0.28%)  0/346 (0.00%) 
Pneumonia Pneumococcal * 1  0/354 (0.00%)  2/346 (0.58%) 
Pneumonia Streptococcal * 1  1/354 (0.28%)  0/346 (0.00%) 
Pneumonia Viral * 1  0/354 (0.00%)  1/346 (0.29%) 
Pseudomembranous Colitis * 1  0/354 (0.00%)  1/346 (0.29%) 
Pulmonary Sepsis * 1  1/354 (0.28%)  0/346 (0.00%) 
Respiratory Syncytial Virus Infection * 1  0/354 (0.00%)  1/346 (0.29%) 
Respiratory Tract Infection * 1  0/354 (0.00%)  2/346 (0.58%) 
Sepsis * 1  5/354 (1.41%)  5/346 (1.45%) 
Septic Shock * 1  2/354 (0.56%)  1/346 (0.29%) 
Staphylococcal Infection * 1  1/354 (0.28%)  0/346 (0.00%) 
Tuberculosis * 1  0/354 (0.00%)  1/346 (0.29%) 
Tuberculous Pleurisy * 1  1/354 (0.28%)  0/346 (0.00%) 
Upper Respiratory Tract Infection * 1  3/354 (0.85%)  7/346 (2.02%) 
Urinary Tract Infection * 1  1/354 (0.28%)  4/346 (1.16%) 
Urinary Tract Infection Bacterial * 1  1/354 (0.28%)  1/346 (0.29%) 
Urosepsis * 1  0/354 (0.00%)  1/346 (0.29%) 
Wound Infection * 1  0/354 (0.00%)  1/346 (0.29%) 
Injury, poisoning and procedural complications     
Chest Injury * 1  0/354 (0.00%)  1/346 (0.29%) 
Femoral Neck Fracture * 1  1/354 (0.28%)  0/346 (0.00%) 
Femur Fracture * 1  2/354 (0.56%)  4/346 (1.16%) 
Foot Fracture * 1  0/354 (0.00%)  1/346 (0.29%) 
Humerus Fracture * 1  2/354 (0.56%)  0/346 (0.00%) 
Infusion Related Reaction * 1  0/354 (0.00%)  1/346 (0.29%) 
Skeletal Injury * 1  1/354 (0.28%)  0/346 (0.00%) 
Spinal Compression Fracture * 1  1/354 (0.28%)  4/346 (1.16%) 
Subarachnoid Haemorrhage * 1  0/354 (0.00%)  1/346 (0.29%) 
Toxicity to Various Agents * 1  0/354 (0.00%)  1/346 (0.29%) 
Traumatic Shock * 1  1/354 (0.28%)  0/346 (0.00%) 
Upper Limb Fracture * 1  0/354 (0.00%)  1/346 (0.29%) 
Wrist Fracture * 1  1/354 (0.28%)  0/346 (0.00%) 
Investigations     
Alanine Aminotransferase Increased * 1  1/354 (0.28%)  0/346 (0.00%) 
Aspartate Aminotransferase Increased * 1  2/354 (0.56%)  0/346 (0.00%) 
Blood Creatinine Increased * 1  1/354 (0.28%)  1/346 (0.29%) 
C-Reactive Protein Increased * 1  0/354 (0.00%)  1/346 (0.29%) 
Oxygen Saturation Decreased * 1  0/354 (0.00%)  2/346 (0.58%) 
Troponin Increased * 1  1/354 (0.28%)  0/346 (0.00%) 
Metabolism and nutrition disorders     
Decreased Appetite * 1  0/354 (0.00%)  1/346 (0.29%) 
Dehydration * 1  1/354 (0.28%)  2/346 (0.58%) 
Hyperkalaemia * 1  1/354 (0.28%)  0/346 (0.00%) 
Hypophagia * 1  0/354 (0.00%)  1/346 (0.29%) 
Tumour Lysis Syndrome * 1  1/354 (0.28%)  1/346 (0.29%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  0/354 (0.00%)  1/346 (0.29%) 
Back Pain * 1  3/354 (0.85%)  6/346 (1.73%) 
Bone Pain * 1  1/354 (0.28%)  2/346 (0.58%) 
Dactylitis * 1  0/354 (0.00%)  1/346 (0.29%) 
Neck Pain * 1  0/354 (0.00%)  1/346 (0.29%) 
Osteonecrosis * 1  1/354 (0.28%)  0/346 (0.00%) 
Spinal Column Stenosis * 1  0/354 (0.00%)  1/346 (0.29%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acute Myeloid Leukaemia * 1  1/354 (0.28%)  0/346 (0.00%) 
Adenocarcinoma of Colon * 1  1/354 (0.28%)  0/346 (0.00%) 
Bile Duct Cancer * 1  0/354 (0.00%)  1/346 (0.29%) 
Breast Cancer * 1  1/354 (0.28%)  0/346 (0.00%) 
Meningioma * 1  1/354 (0.28%)  0/346 (0.00%) 
Oesophageal Adenocarcinoma * 1  0/354 (0.00%)  1/346 (0.29%) 
Plasmacytoma * 1  0/354 (0.00%)  1/346 (0.29%) 
Rectal Adenocarcinoma * 1  1/354 (0.28%)  0/346 (0.00%) 
Renal Cell Carcinoma * 1  0/354 (0.00%)  1/346 (0.29%) 
Nervous system disorders     
Autonomic Nervous System Imbalance * 1  1/354 (0.28%)  0/346 (0.00%) 
Cerebral Infarction * 1  1/354 (0.28%)  0/346 (0.00%) 
Cerebral Ischaemia * 1  1/354 (0.28%)  0/346 (0.00%) 
Cerebrovascular Accident * 1  0/354 (0.00%)  1/346 (0.29%) 
Dizziness * 1  1/354 (0.28%)  0/346 (0.00%) 
Epilepsy * 1  0/354 (0.00%)  1/346 (0.29%) 
Haemorrhage Intracranial * 1  0/354 (0.00%)  1/346 (0.29%) 
Headache * 1  2/354 (0.56%)  0/346 (0.00%) 
Ischaemic Stroke * 1  1/354 (0.28%)  2/346 (0.58%) 
Neuralgia * 1  0/354 (0.00%)  1/346 (0.29%) 
Neurotoxicity * 1  1/354 (0.28%)  0/346 (0.00%) 
Paraesthesia * 1  1/354 (0.28%)  1/346 (0.29%) 
Paraparesis * 1  0/354 (0.00%)  1/346 (0.29%) 
Parkinson's Disease * 1  0/354 (0.00%)  1/346 (0.29%) 
Peripheral Motor Neuropathy * 1  0/354 (0.00%)  1/346 (0.29%) 
Peripheral Sensorimotor Neuropathy * 1  0/354 (0.00%)  1/346 (0.29%) 
Peripheral Sensory Neuropathy * 1  2/354 (0.56%)  2/346 (0.58%) 
Sciatica * 1  0/354 (0.00%)  1/346 (0.29%) 
Somnolence * 1  0/354 (0.00%)  1/346 (0.29%) 
Spinal Cord Compression * 1  0/354 (0.00%)  1/346 (0.29%) 
Syncope * 1  0/354 (0.00%)  1/346 (0.29%) 
Psychiatric disorders     
Agitation * 1  0/354 (0.00%)  1/346 (0.29%) 
Delirium * 1  1/354 (0.28%)  0/346 (0.00%) 
Depression * 1  1/354 (0.28%)  1/346 (0.29%) 
Psychotic Disorder * 1  1/354 (0.28%)  0/346 (0.00%) 
Renal and urinary disorders     
Acute Kidney Injury * 1  5/354 (1.41%)  3/346 (0.87%) 
Anuria * 1  1/354 (0.28%)  0/346 (0.00%) 
Chronic Kidney Disease * 1  1/354 (0.28%)  0/346 (0.00%) 
Haematuria * 1  0/354 (0.00%)  1/346 (0.29%) 
Prerenal Failure * 1  1/354 (0.28%)  0/346 (0.00%) 
Renal Failure * 1  1/354 (0.28%)  1/346 (0.29%) 
Urinary Retention * 1  1/354 (0.28%)  0/346 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute Respiratory Distress Syndrome * 1  0/354 (0.00%)  1/346 (0.29%) 
Acute Respiratory Failure * 1  0/354 (0.00%)  2/346 (0.58%) 
Bronchiectasis * 1  0/354 (0.00%)  1/346 (0.29%) 
Bronchospasm * 1  0/354 (0.00%)  2/346 (0.58%) 
Chronic Obstructive Pulmonary Disease * 1  0/354 (0.00%)  1/346 (0.29%) 
Cough * 1  0/354 (0.00%)  1/346 (0.29%) 
Dyspnoea * 1  4/354 (1.13%)  6/346 (1.73%) 
Haemoptysis * 1  1/354 (0.28%)  0/346 (0.00%) 
Hypoxia * 1  0/354 (0.00%)  2/346 (0.58%) 
Interstitial Lung Disease * 1  0/354 (0.00%)  1/346 (0.29%) 
Laryngeal Oedema * 1  1/354 (0.28%)  0/346 (0.00%) 
Obstructive Airways Disorder * 1  1/354 (0.28%)  0/346 (0.00%) 
Pneumonitis * 1  0/354 (0.00%)  1/346 (0.29%) 
Pneumothorax Spontaneous * 1  1/354 (0.28%)  0/346 (0.00%) 
Pulmonary Embolism * 1  4/354 (1.13%)  0/346 (0.00%) 
Pulmonary Oedema * 1  0/354 (0.00%)  6/346 (1.73%) 
Tachypnoea * 1  0/354 (0.00%)  1/346 (0.29%) 
Wheezing * 1  0/354 (0.00%)  1/346 (0.29%) 
Skin and subcutaneous tissue disorders     
Decubitus Ulcer * 1  0/354 (0.00%)  1/346 (0.29%) 
Erythema Multiforme * 1  2/354 (0.56%)  0/346 (0.00%) 
Rash Erythematous * 1  0/354 (0.00%)  1/346 (0.29%) 
Rash Vesicular * 1  1/354 (0.28%)  0/346 (0.00%) 
Vascular disorders     
Hypertension * 1  1/354 (0.28%)  2/346 (0.58%) 
Hypotension * 1  1/354 (0.28%)  1/346 (0.29%) 
Hypovolaemic Shock * 1  0/354 (0.00%)  1/346 (0.29%) 
Orthostatic Hypotension * 1  0/354 (0.00%)  1/346 (0.29%) 
Thrombophlebitis * 1  2/354 (0.56%)  0/346 (0.00%) 
1
Term from vocabulary, MedDRA Version 20.0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Velcade, Melphalan and Prednisone (VMP) Daratumumab, Velcade, Melphalan and Prednisone (D-VMP)
Affected / at Risk (%) Affected / at Risk (%)
Total   331/354 (93.50%)   324/346 (93.64%) 
Blood and lymphatic system disorders     
Anaemia * 1  131/354 (37.01%)  94/346 (27.17%) 
Leukopenia * 1  53/354 (14.97%)  46/346 (13.29%) 
Lymphopenia * 1  36/354 (10.17%)  37/346 (10.69%) 
Neutropenia * 1  186/354 (52.54%)  171/346 (49.42%) 
Thrombocytopenia * 1  189/354 (53.39%)  168/346 (48.55%) 
Gastrointestinal disorders     
Abdominal Pain * 1  25/354 (7.06%)  18/346 (5.20%) 
Constipation * 1  64/354 (18.08%)  63/346 (18.21%) 
Diarrhoea * 1  87/354 (24.58%)  81/346 (23.41%) 
Dyspepsia * 1  12/354 (3.39%)  18/346 (5.20%) 
Nausea * 1  76/354 (21.47%)  72/346 (20.81%) 
Vomiting * 1  52/354 (14.69%)  59/346 (17.05%) 
General disorders     
Asthenia * 1  42/354 (11.86%)  40/346 (11.56%) 
Chills * 1  6/354 (1.69%)  26/346 (7.51%) 
Fatigue * 1  50/354 (14.12%)  47/346 (13.58%) 
Injection Site Erythema * 1  28/354 (7.91%)  12/346 (3.47%) 
Oedema Peripheral * 1  39/354 (11.02%)  62/346 (17.92%) 
Pyrexia * 1  70/354 (19.77%)  78/346 (22.54%) 
Infections and infestations     
Bronchitis * 1  25/354 (7.06%)  44/346 (12.72%) 
Nasopharyngitis * 1  20/354 (5.65%)  19/346 (5.49%) 
Pneumonia * 1  7/354 (1.98%)  25/346 (7.23%) 
Upper Respiratory Tract Infection * 1  48/354 (13.56%)  87/346 (25.14%) 
Urinary Tract Infection * 1  12/354 (3.39%)  26/346 (7.51%) 
Metabolism and nutrition disorders     
Decreased Appetite * 1  46/354 (12.99%)  40/346 (11.56%) 
Hyperglycaemia * 1  13/354 (3.67%)  21/346 (6.07%) 
Hypocalcaemia * 1  17/354 (4.80%)  20/346 (5.78%) 
Hypokalaemia * 1  17/354 (4.80%)  19/346 (5.49%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  22/354 (6.21%)  26/346 (7.51%) 
Back Pain * 1  40/354 (11.30%)  42/346 (12.14%) 
Bone Pain * 1  8/354 (2.26%)  19/346 (5.49%) 
Pain in Extremity * 1  22/354 (6.21%)  29/346 (8.38%) 
Nervous system disorders     
Dizziness * 1  21/354 (5.93%)  22/346 (6.36%) 
Headache * 1  12/354 (3.39%)  23/346 (6.65%) 
Neuralgia * 1  16/354 (4.52%)  24/346 (6.94%) 
Paraesthesia * 1  19/354 (5.37%)  15/346 (4.34%) 
Peripheral Sensory Neuropathy * 1  121/354 (34.18%)  98/346 (28.32%) 
Psychiatric disorders     
Insomnia * 1  32/354 (9.04%)  26/346 (7.51%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  27/354 (7.63%)  51/346 (14.74%) 
Dyspnoea * 1  14/354 (3.95%)  39/346 (11.27%) 
Skin and subcutaneous tissue disorders     
Pruritus * 1  10/354 (2.82%)  19/346 (5.49%) 
Rash * 1  39/354 (11.02%)  29/346 (8.38%) 
Vascular disorders     
Hypertension * 1  10/354 (2.82%)  33/346 (9.54%) 
Hypotension * 1  23/354 (6.50%)  30/346 (8.67%) 
1
Term from vocabulary, MedDRA Version 20.0
*
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
Name/Title: Executive Medical Director
Organization: Janssen Research and Development, LLC
Phone: 844-434-4210
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02195479     History of Changes
Other Study ID Numbers: CR104761
54767414MMY3007 ( Other Identifier: Janssen Research and Development, LLC )
2014-002272-88 ( EudraCT Number )
First Submitted: July 18, 2014
First Posted: July 21, 2014
Results First Submitted: November 21, 2018
Results First Posted: December 17, 2018
Last Update Posted: December 17, 2018