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A Study to Evaluate Dara-CyBorD in Previously Untreated and Relapsed Subjects With Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT02951819
Recruitment Status : Active, not recruiting
First Posted : November 1, 2016
Results First Posted : April 3, 2019
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Scientific Affairs, LLC

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma
Interventions Drug: Daratumumab
Drug: Cyclophosphamide
Drug: Bortezomib
Drug: Dexamethasone
Enrollment 101
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Newly Diagnosed Multiple Myeloma (NDMM) Relapsed Multiple Myeloma (RMM)
Hide Arm/Group Description Induction therapy:Participants received daratumumab, cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD) as: daratumumab 8 mg/kg IV on Cycle 1(Day 1,2) and 16 mg/kg IV on Cycle 1(Days 8,15,22), Cycle 2 (Days 1,8,15,22), Cycles 3-6 (Days 1,15), Cycles 7-8(Day 1); Cyclophosphamide 300 mg/m^2 orally on Days 1,8,15,22 of each cycle (28 days); Bortezomib 1.5 mg/m^2 SC on Days 1,8,15 of each cycle; Dexamethasone 20 mg IV on Cycle 1(Day1,2,8,15,22) and orally on Cycle 1(Day 9,16,23), 40 mg IV or oral on Cycle 2 (Days 1,8,15,22), Cycle 3-8 ([if with CyBorD] Days 1,8,15,22). Consolidation therapy (CT):Participants who were considered eligible for transplant underwent autologous stem cell transplantation [ASCT] at investigator discretion. Maintenance therapy:Daratumumab 16 mg/kg IV on Day 1 for 12 cycles or until PD, whichever occurred first; Dexamethasone 12 mg IV or oral on Day 1 of each cycle(for ASCT participants, maintenance therapy was to begin approximately 90 days after ASCT). Participants with RMM (defined as having achieved at least a PR with first-line therapy before progression) received treatment as-Induction therapy:Participants received Dara-CyBorD as: daratumumab 8 mg/kg IV on Cycle 1(Day 1,2) and 16 mg/kg IV on Cycle 1(Days 8,15,22),Cycle 2 (Days 1,8,15,22),Cycles 3-6(Days 1,15),Cycles 7-8(Day 1); Cyclophosphamide 300 mg/m^2 orally on Days 1,8,15,22 of each cycle (28 days); Bortezomib 1.5 mg/m^2 SC on Days 1,8,15 of each cycle; Dexamethasone 20 mg IV on Cycle 1(Day1,2,8,15,22) and orally on Cycle 1(Day 9,16,23), 40 mg IV or oral on Cycle 2(Days 1,8,15,22),Cycle 3-8 ([if with CyBorD] Days 1,8,15,22). CT: Participants who were considered eligible for transplant underwent ASCT at investigator discretion. Maintenance therapy:Daratumumab 16 mg/kg IV on Day 1 for 12 cycles or until PD, whichever occurred first; Dexamethasone 12 mg IV or oral on Day 1 of each cycle(for ASCT participants, maintenance therapy was to begin approximately 90 days after ASCT).
Period Title: Overall Study
Started 87 14
Treated 86 14
Completed 0 0
Not Completed 87 14
Reason Not Completed
Death             1             3
Withdrawal by Subject             1             0
Progressive Disease             1             0
Other             1             0
Ongoing             83             11
Arm/Group Title Newly Diagnosed Multiple Myeloma (NDMM) Relapsed Multiple Myeloma (RMM) Total
Hide Arm/Group Description Induction therapy:Participants received daratumumab, cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD) as: daratumumab 8 mg/kg IV on Cycle 1(Day 1,2) and 16 mg/kg IV on Cycle 1(Days 8,15,22), Cycle 2 (Days 1,8,15,22), Cycles 3-6 (Days 1,15), Cycles 7-8(Day 1); Cyclophosphamide 300 mg/m^2 orally on Days 1,8,15,22 of each cycle (28 days); Bortezomib 1.5 mg/m^2 SC on Days 1,8,15 of each cycle; Dexamethasone 20 mg IV on Cycle 1(Day1,2,8,15,22) and orally on Cycle 1(Day 9,16,23), 40 mg IV or oral on Cycle 2 (Days 1,8,15,22), Cycle 3-8 ([if with CyBorD] Days 1,8,15,22). Consolidation therapy (CT):Participants who were considered eligible for transplant underwent autologous stem cell transplantation [ASCT] at investigator discretion. Maintenance therapy:Daratumumab 16 mg/kg IV on Day 1 for 12 cycles or until PD, whichever occurred first; Dexamethasone 12 mg IV or oral on Day 1 of each cycle(for ASCT participants, maintenance therapy was to begin approximately 90 days after ASCT). Participants with RMM (defined as having achieved at least a PR with first-line therapy before progression) received treatment as-Induction therapy:Participants received Dara-CyBorD as: daratumumab 8 mg/kg IV on Cycle 1(Day 1,2) and 16 mg/kg IV on Cycle 1(Days 8,15,22),Cycle 2 (Days 1,8,15,22),Cycles 3-6(Days 1,15),Cycles 7-8(Day 1); Cyclophosphamide 300 mg/m^2 orally on Days 1,8,15,22 of each cycle (28 days); Bortezomib 1.5 mg/m^2 SC on Days 1,8,15 of each cycle; Dexamethasone 20 mg IV on Cycle 1(Day1,2,8,15,22) and orally on Cycle 1(Day 9,16,23), 40 mg IV or oral on Cycle 2(Days 1,8,15,22),Cycle 3-8 ([if with CyBorD] Days 1,8,15,22). CT: Participants who were considered eligible for transplant underwent ASCT at investigator discretion. Maintenance therapy:Daratumumab 16 mg/kg IV on Day 1 for 12 cycles or until PD, whichever occurred first; Dexamethasone 12 mg IV or oral on Day 1 of each cycle(for ASCT participants, maintenance therapy was to begin approximately 90 days after ASCT). Total of all reporting groups
Overall Number of Baseline Participants 87 14 101
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 87 participants 14 participants 101 participants
63.6  (8.95) 66.4  (8.97) 64  (8.96)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 14 participants 101 participants
Female
32
  36.8%
4
  28.6%
36
  35.6%
Male
55
  63.2%
10
  71.4%
65
  64.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 14 participants 101 participants
Hispanic or Latino
4
   4.6%
1
   7.1%
5
   5.0%
Not Hispanic or Latino
80
  92.0%
12
  85.7%
92
  91.1%
Unknown or Not Reported
3
   3.4%
1
   7.1%
4
   4.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 14 participants 101 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
   2.3%
0
   0.0%
2
   2.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
11
  12.6%
0
   0.0%
11
  10.9%
White
68
  78.2%
14
 100.0%
82
  81.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
6
   6.9%
0
   0.0%
6
   5.9%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
UNITED STATES Number Analyzed 87 participants 14 participants 101 participants
87
 100.0%
14
 100.0%
101
 100.0%
1.Primary Outcome
Title Percentage of Participants Who Achieved Complete Response (CR) or Very Good Partial Response (VGPR)
Hide Description Percentage of participants who achieved CR or VGPR (as per International Myeloma Working Group [IMWG] criteria) was reported. CR: negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and less than (<) 5 percent (%) plasma cells (PC) in bone marrow. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis or greater than or equal to (>=) 90% reduction in serum M-protein plus urine M-protein level < 100 milligram per 24 hours (mg/24hours).
Time Frame After 4 cycles of Induction (Approximately 4 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Response-evaluable set includes all enrolled participants who had measurable disease, received at least 1 dose of study treatment, and had at least 1 efficacy evaluation assessment.
Arm/Group Title Newly Diagnosed Multiple Myeloma (NDMM) Relapsed Multiple Myeloma (RMM)
Hide Arm/Group Description:
Induction therapy:Participants received daratumumab, cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD) as: daratumumab 8 mg/kg IV on Cycle 1(Day 1,2) and 16 mg/kg IV on Cycle 1(Days 8,15,22), Cycle 2 (Days 1,8,15,22), Cycles 3-6 (Days 1,15), Cycles 7-8(Day 1); Cyclophosphamide 300 mg/m^2 orally on Days 1,8,15,22 of each cycle (28 days); Bortezomib 1.5 mg/m^2 SC on Days 1,8,15 of each cycle; Dexamethasone 20 mg IV on Cycle 1(Day1,2,8,15,22) and orally on Cycle 1(Day 9,16,23), 40 mg IV or oral on Cycle 2 (Days 1,8,15,22), Cycle 3-8 ([if with CyBorD] Days 1,8,15,22). Consolidation therapy (CT):Participants who were considered eligible for transplant underwent autologous stem cell transplantation [ASCT] at investigator discretion. Maintenance therapy:Daratumumab 16 mg/kg IV on Day 1 for 12 cycles or until PD, whichever occurred first; Dexamethasone 12 mg IV or oral on Day 1 of each cycle(for ASCT participants, maintenance therapy was to begin approximately 90 days after ASCT).
Participants with RMM (defined as having achieved at least a PR with first-line therapy before progression) received treatment as-Induction therapy:Participants received Dara-CyBorD as: daratumumab 8 mg/kg IV on Cycle 1(Day 1,2) and 16 mg/kg IV on Cycle 1(Days 8,15,22),Cycle 2 (Days 1,8,15,22),Cycles 3-6(Days 1,15),Cycles 7-8(Day 1); Cyclophosphamide 300 mg/m^2 orally on Days 1,8,15,22 of each cycle (28 days); Bortezomib 1.5 mg/m^2 SC on Days 1,8,15 of each cycle; Dexamethasone 20 mg IV on Cycle 1(Day1,2,8,15,22) and orally on Cycle 1(Day 9,16,23), 40 mg IV or oral on Cycle 2(Days 1,8,15,22),Cycle 3-8 ([if with CyBorD] Days 1,8,15,22). CT: Participants who were considered eligible for transplant underwent ASCT at investigator discretion. Maintenance therapy:Daratumumab 16 mg/kg IV on Day 1 for 12 cycles or until PD, whichever occurred first; Dexamethasone 12 mg IV or oral on Day 1 of each cycle(for ASCT participants, maintenance therapy was to begin approximately 90 days after ASCT).
Overall Number of Participants Analyzed 86 14
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
44.2
(33.5 to 55.3)
57.1
(28.9 to 82.3)
2.Secondary Outcome
Title Overall Response Rate (ORR)
Hide Description ORR: percentage of participants achieved PR or better (PR,VGPR,CR,sCR) per IMWG. CR:negative immunofixation on serum, urine, disappearance of soft tissue plasmacytomas,<5% PCs in bone marrow(BM). sCR:CR plus normal FLC ratio,absence of clonal cells in BM by immunohistochemistry, immunofluorescence. VGPR:Serum, urine M-protein detectable by immunofixation but not on electrophoresis or >=90% reduction in serum M-protein plus urine M-protein level <100 mg/24hours. PR:>=50% reduction of serum M-protein and reduction in 24hours urinary M-protein by >=90% or to <200mg/24hours. If serum, urine M-protein unmeasurable, a>=50% decrease in difference involved and uninvolved FLC levels required in place of M-protein criteria. If serum, urine M-protein not measurable, serum free light assay is not measurable,>=50% reduction in PCs required in place of M-protein,provided baseline bone marrow PCs% >=30%, if present at baseline, a >=50% reduction in size of soft tissue plasmacytomas is also required.
Time Frame After 4 Cycles of Induction (4 months), at End of Induction (4 to 8 months) and at the End of Maintenance (12 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Response-evaluable set includes all enrolled participants who had measurable disease, received at least 1 dose of study treatment, and had at least 1 efficacy evaluation assessment.
Arm/Group Title Newly Diagnosed Multiple Myeloma (NDMM) Relapsed Multiple Myeloma (RMM)
Hide Arm/Group Description:
Induction therapy:Participants received daratumumab, cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD) as: daratumumab 8 mg/kg IV on Cycle 1(Day 1,2) and 16 mg/kg IV on Cycle 1(Days 8,15,22), Cycle 2 (Days 1,8,15,22), Cycles 3-6 (Days 1,15), Cycles 7-8(Day 1); Cyclophosphamide 300 mg/m^2 orally on Days 1,8,15,22 of each cycle (28 days); Bortezomib 1.5 mg/m^2 SC on Days 1,8,15 of each cycle; Dexamethasone 20 mg IV on Cycle 1(Day1,2,8,15,22) and orally on Cycle 1(Day 9,16,23), 40 mg IV or oral on Cycle 2 (Days 1,8,15,22), Cycle 3-8 ([if with CyBorD] Days 1,8,15,22). Consolidation therapy (CT):Participants who were considered eligible for transplant underwent autologous stem cell transplantation [ASCT] at investigator discretion. Maintenance therapy:Daratumumab 16 mg/kg IV on Day 1 for 12 cycles or until PD, whichever occurred first; Dexamethasone 12 mg IV or oral on Day 1 of each cycle(for ASCT participants, maintenance therapy was to begin approximately 90 days after ASCT).
Participants with RMM (defined as having achieved at least a PR with first-line therapy before progression) received treatment as-Induction therapy:Participants received Dara-CyBorD as: daratumumab 8 mg/kg IV on Cycle 1(Day 1,2) and 16 mg/kg IV on Cycle 1(Days 8,15,22),Cycle 2 (Days 1,8,15,22),Cycles 3-6(Days 1,15),Cycles 7-8(Day 1); Cyclophosphamide 300 mg/m^2 orally on Days 1,8,15,22 of each cycle (28 days); Bortezomib 1.5 mg/m^2 SC on Days 1,8,15 of each cycle; Dexamethasone 20 mg IV on Cycle 1(Day1,2,8,15,22) and orally on Cycle 1(Day 9,16,23), 40 mg IV or oral on Cycle 2(Days 1,8,15,22),Cycle 3-8 ([if with CyBorD] Days 1,8,15,22). CT: Participants who were considered eligible for transplant underwent ASCT at investigator discretion. Maintenance therapy:Daratumumab 16 mg/kg IV on Day 1 for 12 cycles or until PD, whichever occurred first; Dexamethasone 12 mg IV or oral on Day 1 of each cycle(for ASCT participants, maintenance therapy was to begin approximately 90 days after ASCT).
Overall Number of Participants Analyzed 86 14
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
After 4 Cycles of Induction
79.1
(69.0 to 87.1)
71.4
(41.9 to 91.6)
At the End of Induction
81.4
(71.6 to 89.0)
71.4
(41.9 to 91.6)
At the End of Maintenance
81.4
(71.6 to 89.0)
71.4
(41.9 to 91.6)
3.Secondary Outcome
Title Time to Very Good Partial Response (VGPR) or Better
Hide Description Time to VGPR or Better response was defined as duration from the date of first dose (start of induction) to the date of initial documentation of the response (VGPR or better) which was confirmed by a repeated measurement as required by the IMWG criteria. VGPR is defined by IMWG criteria as serum and urine M-protein detectable by immunofixation but not on electrophoresis or greater than or equal to (>=) 90 % reduction in serum M-protein plus urine M-protein level < 100 milligram/24 hours (mg/24 hours).
Time Frame Approximately 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Response-evaluable set includes all enrolled participants who had measurable disease, received at least 1 dose of study treatment, and had at least 1 efficacy evaluation assessment.
Arm/Group Title Newly Diagnosed Multiple Myeloma (NDMM) Relapsed Multiple Myeloma (RMM)
Hide Arm/Group Description:
Induction therapy:Participants received daratumumab, cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD) as: daratumumab 8 mg/kg IV on Cycle 1(Day 1,2) and 16 mg/kg IV on Cycle 1(Days 8,15,22), Cycle 2 (Days 1,8,15,22), Cycles 3-6 (Days 1,15), Cycles 7-8(Day 1); Cyclophosphamide 300 mg/m^2 orally on Days 1,8,15,22 of each cycle (28 days); Bortezomib 1.5 mg/m^2 SC on Days 1,8,15 of each cycle; Dexamethasone 20 mg IV on Cycle 1(Day1,2,8,15,22) and orally on Cycle 1(Day 9,16,23), 40 mg IV or oral on Cycle 2 (Days 1,8,15,22), Cycle 3-8 ([if with CyBorD] Days 1,8,15,22). Consolidation therapy (CT):Participants who were considered eligible for transplant underwent autologous stem cell transplantation [ASCT] at investigator discretion. Maintenance therapy:Daratumumab 16 mg/kg IV on Day 1 for 12 cycles or until PD, whichever occurred first; Dexamethasone 12 mg IV or oral on Day 1 of each cycle(for ASCT participants, maintenance therapy was to begin approximately 90 days after ASCT).
Participants with RMM (defined as having achieved at least a PR with first-line therapy before progression) received treatment as-Induction therapy:Participants received Dara-CyBorD as: daratumumab 8 mg/kg IV on Cycle 1(Day 1,2) and 16 mg/kg IV on Cycle 1(Days 8,15,22),Cycle 2 (Days 1,8,15,22),Cycles 3-6(Days 1,15),Cycles 7-8(Day 1); Cyclophosphamide 300 mg/m^2 orally on Days 1,8,15,22 of each cycle (28 days); Bortezomib 1.5 mg/m^2 SC on Days 1,8,15 of each cycle; Dexamethasone 20 mg IV on Cycle 1(Day1,2,8,15,22) and orally on Cycle 1(Day 9,16,23), 40 mg IV or oral on Cycle 2(Days 1,8,15,22),Cycle 3-8 ([if with CyBorD] Days 1,8,15,22). CT: Participants who were considered eligible for transplant underwent ASCT at investigator discretion. Maintenance therapy:Daratumumab 16 mg/kg IV on Day 1 for 12 cycles or until PD, whichever occurred first; Dexamethasone 12 mg IV or oral on Day 1 of each cycle(for ASCT participants, maintenance therapy was to begin approximately 90 days after ASCT).
Overall Number of Participants Analyzed 86 14
Median (95% Confidence Interval)
Unit of Measure: Months
4.6
(2.8 to 6.4)
1.8 [1] 
(1.0 to NA)
[1]
NA indicates that the upper limit of confidence interval (CI) was not estimable due to insufficient number of events in the given observational period.
4.Secondary Outcome
Title Time to Partial Response (PR) or Better
Hide Description Time to PR or Better response was defined as duration from the date of first dose (start of induction) to the date of initial documentation of the response (PR or better) which was confirmed by a repeated measurement as required by the IMWG criteria. PR is defined as per IMWG criteria as >= 50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by >= 90% or to < 200 mg/24hours. If the serum and urine M-protein are unmeasurable, a>= 50% decrease in the difference between involved and uninvolved Free light chain (FLC) levels is required in the 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 plasma cells is required in place of M-protein, provided baseline bone marrow plasma cells percentage was >=30%. In addition to the above listed criteria, if present at baseline, a >= 50% reduction in the size of soft tissue plasmacytomas is also required.
Time Frame Approximately 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Response-evaluable set includes all enrolled participants who had measurable disease, received at least 1 dose of study treatment, and had at least 1 efficacy evaluation assessment.
Arm/Group Title Newly Diagnosed Multiple Myeloma (NDMM) Relapsed Multiple Myeloma (RMM)
Hide Arm/Group Description:
Induction therapy:Participants received daratumumab, cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD) as: daratumumab 8 mg/kg IV on Cycle 1(Day 1,2) and 16 mg/kg IV on Cycle 1(Days 8,15,22), Cycle 2 (Days 1,8,15,22), Cycles 3-6 (Days 1,15), Cycles 7-8(Day 1); Cyclophosphamide 300 mg/m^2 orally on Days 1,8,15,22 of each cycle (28 days); Bortezomib 1.5 mg/m^2 SC on Days 1,8,15 of each cycle; Dexamethasone 20 mg IV on Cycle 1(Day1,2,8,15,22) and orally on Cycle 1(Day 9,16,23), 40 mg IV or oral on Cycle 2 (Days 1,8,15,22), Cycle 3-8 ([if with CyBorD] Days 1,8,15,22). Consolidation therapy (CT):Participants who were considered eligible for transplant underwent autologous stem cell transplantation [ASCT] at investigator discretion. Maintenance therapy:Daratumumab 16 mg/kg IV on Day 1 for 12 cycles or until PD, whichever occurred first; Dexamethasone 12 mg IV or oral on Day 1 of each cycle(for ASCT participants, maintenance therapy was to begin approximately 90 days after ASCT).
Participants with RMM (defined as having achieved at least a PR with first-line therapy before progression) received treatment as-Induction therapy:Participants received Dara-CyBorD as: daratumumab 8 mg/kg IV on Cycle 1(Day 1,2) and 16 mg/kg IV on Cycle 1(Days 8,15,22),Cycle 2 (Days 1,8,15,22),Cycles 3-6(Days 1,15),Cycles 7-8(Day 1); Cyclophosphamide 300 mg/m^2 orally on Days 1,8,15,22 of each cycle (28 days); Bortezomib 1.5 mg/m^2 SC on Days 1,8,15 of each cycle; Dexamethasone 20 mg IV on Cycle 1(Day1,2,8,15,22) and orally on Cycle 1(Day 9,16,23), 40 mg IV or oral on Cycle 2(Days 1,8,15,22),Cycle 3-8 ([if with CyBorD] Days 1,8,15,22). CT: Participants who were considered eligible for transplant underwent ASCT at investigator discretion. Maintenance therapy:Daratumumab 16 mg/kg IV on Day 1 for 12 cycles or until PD, whichever occurred first; Dexamethasone 12 mg IV or oral on Day 1 of each cycle(for ASCT participants, maintenance therapy was to begin approximately 90 days after ASCT).
Overall Number of Participants Analyzed 86 14
Median (95% Confidence Interval)
Unit of Measure: Months
1.0
(1.0 to 1.0)
1.0 [1] 
(0.9 to NA)
[1]
NA indicates that the upper limit of CI was not estimable due to insufficient number of events in the given observational period.
5.Secondary Outcome
Title Duration of Response (DOR)
Hide Description DOR was defined for participants with a confirmed response (PR or better) as the duration from the date of initial documentation of a response (PR or better) according to the IMWG criteria to the date of first documented evidence of progressive disease according to the IMWG criteria or death due to progressive disease. PR:>=50% reduction of serum M-protein and reduction in 24hours urinary M-protein by >=90% or to <200 mg/24hours. If serum and urine M-protein are unmeasurable, a >=50% decrease in difference involved and uninvolved FLC levels required in place of M-protein criteria. If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, >=50% reduction in PCs is required in place of M-protein, provided baseline bone marrow PCs % 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 Approximately 15 months
Hide Outcome Measure Data
Hide Analysis Population Description
Population included responders (PR or better) in response-evaluable set.
Arm/Group Title Newly Diagnosed Multiple Myeloma (NDMM) Relapsed Multiple Myeloma (RMM)
Hide Arm/Group Description:
Induction therapy:Participants received daratumumab, cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD) as: daratumumab 8 mg/kg IV on Cycle 1(Day 1,2) and 16 mg/kg IV on Cycle 1(Days 8,15,22), Cycle 2 (Days 1,8,15,22), Cycles 3-6 (Days 1,15), Cycles 7-8(Day 1); Cyclophosphamide 300 mg/m^2 orally on Days 1,8,15,22 of each cycle (28 days); Bortezomib 1.5 mg/m^2 SC on Days 1,8,15 of each cycle; Dexamethasone 20 mg IV on Cycle 1(Day1,2,8,15,22) and orally on Cycle 1(Day 9,16,23), 40 mg IV or oral on Cycle 2 (Days 1,8,15,22), Cycle 3-8 ([if with CyBorD] Days 1,8,15,22). Consolidation therapy (CT):Participants who were considered eligible for transplant underwent autologous stem cell transplantation [ASCT] at investigator discretion. Maintenance therapy:Daratumumab 16 mg/kg IV on Day 1 for 12 cycles or until PD, whichever occurred first; Dexamethasone 12 mg IV or oral on Day 1 of each cycle(for ASCT participants, maintenance therapy was to begin approximately 90 days after ASCT).
Participants with RMM (defined as having achieved at least a PR with first-line therapy before progression) received treatment as-Induction therapy:Participants received Dara-CyBorD as: daratumumab 8 mg/kg IV on Cycle 1(Day 1,2) and 16 mg/kg IV on Cycle 1(Days 8,15,22),Cycle 2 (Days 1,8,15,22),Cycles 3-6(Days 1,15),Cycles 7-8(Day 1); Cyclophosphamide 300 mg/m^2 orally on Days 1,8,15,22 of each cycle (28 days); Bortezomib 1.5 mg/m^2 SC on Days 1,8,15 of each cycle; Dexamethasone 20 mg IV on Cycle 1(Day1,2,8,15,22) and orally on Cycle 1(Day 9,16,23), 40 mg IV or oral on Cycle 2(Days 1,8,15,22),Cycle 3-8 ([if with CyBorD] Days 1,8,15,22). CT: Participants who were considered eligible for transplant underwent ASCT at investigator discretion. Maintenance therapy:Daratumumab 16 mg/kg IV on Day 1 for 12 cycles or until PD, whichever occurred first; Dexamethasone 12 mg IV or oral on Day 1 of each cycle(for ASCT participants, maintenance therapy was to begin approximately 90 days after ASCT).
Overall Number of Participants Analyzed 70 10
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(NA to NA)
12.4
(3.7 to 12.4)
[1]
NA indicates that median and CI was not estimable due to insufficient number of events in the given observational period.
6.Secondary Outcome
Title Progression Free Survival (PFS)
Hide Description PFS: duration from date of first dose (start of induction) to date of first documented evidence of progressive disease (PD) based on computerized algorithm per IMWG criteria or death due to any cause, whichever occurred first. PD: 25% increase from lowest response value in one of following: Serum and urine M-component (absolute increase >=0.5 g/dL and >=200 mg/24 hours respectively);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, without measurable disease by FLC levels, bone marrow 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, Development of hypercalcemia (corrected serum calcium >11.5 mg/dL) that can be attributed solely to PC proliferative disorder.
Time Frame Approximately 15 months
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Hide Analysis Population Description
Full analysis set is defined as enrolled participants who provided informed consent and met eligibility criteria.
Arm/Group Title Newly Diagnosed Multiple Myeloma (NDMM) Relapsed Multiple Myeloma (RMM)
Hide Arm/Group Description:
Induction therapy:Participants received daratumumab, cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD) as: daratumumab 8 mg/kg IV on Cycle 1(Day 1,2) and 16 mg/kg IV on Cycle 1(Days 8,15,22), Cycle 2 (Days 1,8,15,22), Cycles 3-6 (Days 1,15), Cycles 7-8(Day 1); Cyclophosphamide 300 mg/m^2 orally on Days 1,8,15,22 of each cycle (28 days); Bortezomib 1.5 mg/m^2 SC on Days 1,8,15 of each cycle; Dexamethasone 20 mg IV on Cycle 1(Day1,2,8,15,22) and orally on Cycle 1(Day 9,16,23), 40 mg IV or oral on Cycle 2 (Days 1,8,15,22), Cycle 3-8 ([if with CyBorD] Days 1,8,15,22). Consolidation therapy (CT):Participants who were considered eligible for transplant underwent autologous stem cell transplantation [ASCT] at investigator discretion. Maintenance therapy:Daratumumab 16 mg/kg IV on Day 1 for 12 cycles or until PD, whichever occurred first; Dexamethasone 12 mg IV or oral on Day 1 of each cycle(for ASCT participants, maintenance therapy was to begin approximately 90 days after ASCT).
Participants with RMM (defined as having achieved at least a PR with first-line therapy before progression) received treatment as-Induction therapy:Participants received Dara-CyBorD as: daratumumab 8 mg/kg IV on Cycle 1(Day 1,2) and 16 mg/kg IV on Cycle 1(Days 8,15,22),Cycle 2 (Days 1,8,15,22),Cycles 3-6(Days 1,15),Cycles 7-8(Day 1); Cyclophosphamide 300 mg/m^2 orally on Days 1,8,15,22 of each cycle (28 days); Bortezomib 1.5 mg/m^2 SC on Days 1,8,15 of each cycle; Dexamethasone 20 mg IV on Cycle 1(Day1,2,8,15,22) and orally on Cycle 1(Day 9,16,23), 40 mg IV or oral on Cycle 2(Days 1,8,15,22),Cycle 3-8 ([if with CyBorD] Days 1,8,15,22). CT: Participants who were considered eligible for transplant underwent ASCT at investigator discretion. Maintenance therapy:Daratumumab 16 mg/kg IV on Day 1 for 12 cycles or until PD, whichever occurred first; Dexamethasone 12 mg IV or oral on Day 1 of each cycle(for ASCT participants, maintenance therapy was to begin approximately 90 days after ASCT).
Overall Number of Participants Analyzed 87 14
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(NA to NA)
13.3
(6.8 to 13.3)
[1]
NA indicates that median and CI was not estimable due to insufficient number of events in the given observational period.
7.Secondary Outcome
Title Time to Disease Progression (TTP)
Hide Description TTP was defined as the time between the date of first dose (start of induction) and the date of first documented evidence of confirmed PD, as defined in the IMWG response criteria. PD per IMWG criteria: Increase of 25% from lowest response value in one of following: Serum and urine M-component (absolute increase >=0.5 g/deciliter (dL) and >=200 mg/24 hours respectively); 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, without measurable disease by FLC levels, bone marrow 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 Approximately 15 months
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Hide Analysis Population Description
Full Analysis Set defined as enrolled subjects who provided informed consent and met eligibility criteria.
Arm/Group Title Newly Diagnosed Multiple Myeloma (NDMM) Relapsed Multiple Myeloma (RMM)
Hide Arm/Group Description:
Induction therapy:Participants received daratumumab, cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD) as: daratumumab 8 mg/kg IV on Cycle 1(Day 1,2) and 16 mg/kg IV on Cycle 1(Days 8,15,22), Cycle 2 (Days 1,8,15,22), Cycles 3-6 (Days 1,15), Cycles 7-8(Day 1); Cyclophosphamide 300 mg/m^2 orally on Days 1,8,15,22 of each cycle (28 days); Bortezomib 1.5 mg/m^2 SC on Days 1,8,15 of each cycle; Dexamethasone 20 mg IV on Cycle 1(Day1,2,8,15,22) and orally on Cycle 1(Day 9,16,23), 40 mg IV or oral on Cycle 2 (Days 1,8,15,22), Cycle 3-8 ([if with CyBorD] Days 1,8,15,22). Consolidation therapy (CT):Participants who were considered eligible for transplant underwent autologous stem cell transplantation [ASCT] at investigator discretion. Maintenance therapy:Daratumumab 16 mg/kg IV on Day 1 for 12 cycles or until PD, whichever occurred first; Dexamethasone 12 mg IV or oral on Day 1 of each cycle(for ASCT participants, maintenance therapy was to begin approximately 90 days after ASCT).
Participants with RMM (defined as having achieved at least a PR with first-line therapy before progression) received treatment as-Induction therapy:Participants received Dara-CyBorD as: daratumumab 8 mg/kg IV on Cycle 1(Day 1,2) and 16 mg/kg IV on Cycle 1(Days 8,15,22),Cycle 2 (Days 1,8,15,22),Cycles 3-6(Days 1,15),Cycles 7-8(Day 1); Cyclophosphamide 300 mg/m^2 orally on Days 1,8,15,22 of each cycle (28 days); Bortezomib 1.5 mg/m^2 SC on Days 1,8,15 of each cycle; Dexamethasone 20 mg IV on Cycle 1(Day1,2,8,15,22) and orally on Cycle 1(Day 9,16,23), 40 mg IV or oral on Cycle 2(Days 1,8,15,22),Cycle 3-8 ([if with CyBorD] Days 1,8,15,22). CT: Participants who were considered eligible for transplant underwent ASCT at investigator discretion. Maintenance therapy:Daratumumab 16 mg/kg IV on Day 1 for 12 cycles or until PD, whichever occurred first; Dexamethasone 12 mg IV or oral on Day 1 of each cycle(for ASCT participants, maintenance therapy was to begin approximately 90 days after ASCT).
Overall Number of Participants Analyzed 87 14
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(NA to NA)
13.31
(6.80 to 13.31)
[1]
NA indicates that median and CI was not estimable due to insufficient number of events in the given observational period.
8.Secondary Outcome
Title Overall Survival (OS)
Hide Description Overall survival (OS) was measured from the date of first dose (start of induction) to the date of death due to any cause.
Time Frame Approximately 15 months
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Hide Analysis Population Description
Full analysis set is defined as enrolled participants who provided informed consent and met eligibility criteria.
Arm/Group Title Newly Diagnosed Multiple Myeloma (NDMM) Relapsed Multiple Myeloma (RMM)
Hide Arm/Group Description:
Induction therapy:Participants received daratumumab, cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD) as: daratumumab 8 mg/kg IV on Cycle 1(Day 1,2) and 16 mg/kg IV on Cycle 1(Days 8,15,22), Cycle 2 (Days 1,8,15,22), Cycles 3-6 (Days 1,15), Cycles 7-8(Day 1); Cyclophosphamide 300 mg/m^2 orally on Days 1,8,15,22 of each cycle (28 days); Bortezomib 1.5 mg/m^2 SC on Days 1,8,15 of each cycle; Dexamethasone 20 mg IV on Cycle 1(Day1,2,8,15,22) and orally on Cycle 1(Day 9,16,23), 40 mg IV or oral on Cycle 2 (Days 1,8,15,22), Cycle 3-8 ([if with CyBorD] Days 1,8,15,22). Consolidation therapy (CT):Participants who were considered eligible for transplant underwent autologous stem cell transplantation [ASCT] at investigator discretion. Maintenance therapy:Daratumumab 16 mg/kg IV on Day 1 for 12 cycles or until PD, whichever occurred first; Dexamethasone 12 mg IV or oral on Day 1 of each cycle(for ASCT participants, maintenance therapy was to begin approximately 90 days after ASCT).
Participants with RMM (defined as having achieved at least a PR with first-line therapy before progression) received treatment as-Induction therapy:Participants received Dara-CyBorD as: daratumumab 8 mg/kg IV on Cycle 1(Day 1,2) and 16 mg/kg IV on Cycle 1(Days 8,15,22),Cycle 2 (Days 1,8,15,22),Cycles 3-6(Days 1,15),Cycles 7-8(Day 1); Cyclophosphamide 300 mg/m^2 orally on Days 1,8,15,22 of each cycle (28 days); Bortezomib 1.5 mg/m^2 SC on Days 1,8,15 of each cycle; Dexamethasone 20 mg IV on Cycle 1(Day1,2,8,15,22) and orally on Cycle 1(Day 9,16,23), 40 mg IV or oral on Cycle 2(Days 1,8,15,22),Cycle 3-8 ([if with CyBorD] Days 1,8,15,22). CT: Participants who were considered eligible for transplant underwent ASCT at investigator discretion. Maintenance therapy:Daratumumab 16 mg/kg IV on Day 1 for 12 cycles or until PD, whichever occurred first; Dexamethasone 12 mg IV or oral on Day 1 of each cycle(for ASCT participants, maintenance therapy was to begin approximately 90 days after ASCT).
Overall Number of Participants Analyzed 87 14
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(NA to NA)
NA [2] 
(7.26 to NA)
[1]
NA indicates that median and CI was not estimable due to insufficient number of events in the given observational period.
[2]
NA indicates that median and upper limit of CI was not estimable due to insufficient number of events in the given observational period.
9.Secondary Outcome
Title Percentage of Participants With Treatment Emergent-Adverse Event
Hide Description An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between administration of study drug and approximately up to 15 months that were absent before treatment or that worsened relative to pre-treatment state.
Time Frame Approximately 15 months
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Hide Analysis Population Description
Safety Analysis Set defined as enrolled participants who received at least 1 dose (partial or complete) of study treatment (Dara-CyBorD).
Arm/Group Title Newly Diagnosed Multiple Myeloma (NDMM) Relapsed Multiple Myeloma (RMM)
Hide Arm/Group Description:
Induction therapy:Participants received daratumumab, cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD) as: daratumumab 8 mg/kg IV on Cycle 1(Day 1,2) and 16 mg/kg IV on Cycle 1(Days 8,15,22), Cycle 2 (Days 1,8,15,22), Cycles 3-6 (Days 1,15), Cycles 7-8(Day 1); Cyclophosphamide 300 mg/m^2 orally on Days 1,8,15,22 of each cycle (28 days); Bortezomib 1.5 mg/m^2 SC on Days 1,8,15 of each cycle; Dexamethasone 20 mg IV on Cycle 1(Day1,2,8,15,22) and orally on Cycle 1(Day 9,16,23), 40 mg IV or oral on Cycle 2 (Days 1,8,15,22), Cycle 3-8 ([if with CyBorD] Days 1,8,15,22). Consolidation therapy (CT):Participants who were considered eligible for transplant underwent autologous stem cell transplantation [ASCT] at investigator discretion. Maintenance therapy:Daratumumab 16 mg/kg IV on Day 1 for 12 cycles or until PD, whichever occurred first; Dexamethasone 12 mg IV or oral on Day 1 of each cycle(for ASCT participants, maintenance therapy was to begin approximately 90 days after ASCT).
Participants with RMM (defined as having achieved at least a PR with first-line therapy before progression) received treatment as-Induction therapy:Participants received Dara-CyBorD as: daratumumab 8 mg/kg IV on Cycle 1(Day 1,2) and 16 mg/kg IV on Cycle 1(Days 8,15,22),Cycle 2 (Days 1,8,15,22),Cycles 3-6(Days 1,15),Cycles 7-8(Day 1); Cyclophosphamide 300 mg/m^2 orally on Days 1,8,15,22 of each cycle (28 days); Bortezomib 1.5 mg/m^2 SC on Days 1,8,15 of each cycle; Dexamethasone 20 mg IV on Cycle 1(Day1,2,8,15,22) and orally on Cycle 1(Day 9,16,23), 40 mg IV or oral on Cycle 2(Days 1,8,15,22),Cycle 3-8 ([if with CyBorD] Days 1,8,15,22). CT: Participants who were considered eligible for transplant underwent ASCT at investigator discretion. Maintenance therapy:Daratumumab 16 mg/kg IV on Day 1 for 12 cycles or until PD, whichever occurred first; Dexamethasone 12 mg IV or oral on Day 1 of each cycle(for ASCT participants, maintenance therapy was to begin approximately 90 days after ASCT).
Overall Number of Participants Analyzed 86 14
Measure Type: Number
Unit of Measure: Percentage of participants
100.0 100.0
Time Frame Approximately 15 months
Adverse Event Reporting Description Safety analysis set is defined as enrolled participants who received at least 1 dose (partial or complete) of study treatment (Dara-CyBorD).
 
Arm/Group Title Newly Diagnosed Multiple Myeloma (NDMM) Relapsed Multiple Myeloma (RMM)
Hide Arm/Group Description Induction therapy:Participants received daratumumab, cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD) as: daratumumab 8 mg/kg IV on Cycle 1(Day 1,2) and 16 mg/kg IV on Cycle 1(Days 8,15,22), Cycle 2 (Days 1,8,15,22), Cycles 3-6 (Days 1,15), Cycles 7-8(Day 1); Cyclophosphamide 300 mg/m^2 orally on Days 1,8,15,22 of each cycle (28 days); Bortezomib 1.5 mg/m^2 SC on Days 1,8,15 of each cycle; Dexamethasone 20 mg IV on Cycle 1(Day1,2,8,15,22) and orally on Cycle 1(Day 9,16,23), 40 mg IV or oral on Cycle 2 (Days 1,8,15,22), Cycle 3-8 ([if with CyBorD] Days 1,8,15,22). Consolidation therapy (CT):Participants who were considered eligible for transplant underwent autologous stem cell transplantation [ASCT] at investigator discretion. Maintenance therapy:Daratumumab 16 mg/kg IV on Day 1 for 12 cycles or until PD, whichever occurred first; Dexamethasone 12 mg IV or oral on Day 1 of each cycle(for ASCT participants, maintenance therapy was to begin approximately 90 days after ASCT). Participants with RMM (defined as having achieved at least a PR with first-line therapy before progression) received treatment as-Induction therapy:Participants received Dara-CyBorD as: daratumumab 8 mg/kg IV on Cycle 1(Day 1,2) and 16 mg/kg IV on Cycle 1(Days 8,15,22),Cycle 2 (Days 1,8,15,22),Cycles 3-6(Days 1,15),Cycles 7-8(Day 1); Cyclophosphamide 300 mg/m^2 orally on Days 1,8,15,22 of each cycle (28 days); Bortezomib 1.5 mg/m^2 SC on Days 1,8,15 of each cycle; Dexamethasone 20 mg IV on Cycle 1(Day1,2,8,15,22) and orally on Cycle 1(Day 9,16,23), 40 mg IV or oral on Cycle 2(Days 1,8,15,22),Cycle 3-8 ([if with CyBorD] Days 1,8,15,22). CT: Participants who were considered eligible for transplant underwent ASCT at investigator discretion. Maintenance therapy:Daratumumab 16 mg/kg IV on Day 1 for 12 cycles or until PD, whichever occurred first; Dexamethasone 12 mg IV or oral on Day 1 of each cycle(for ASCT participants, maintenance therapy was to begin approximately 90 days after ASCT).
All-Cause Mortality
Newly Diagnosed Multiple Myeloma (NDMM) Relapsed Multiple Myeloma (RMM)
Affected / at Risk (%) Affected / at Risk (%)
Total   1/86 (1.16%)   3/14 (21.43%) 
Show Serious Adverse Events Hide Serious Adverse Events
Newly Diagnosed Multiple Myeloma (NDMM) Relapsed Multiple Myeloma (RMM)
Affected / at Risk (%) Affected / at Risk (%)
Total   19/86 (22.09%)   2/14 (14.29%) 
Cardiac disorders     
Atrial Fibrillation * 1  3/86 (3.49%)  0/14 (0.00%) 
Atrial Flutter * 1  1/86 (1.16%)  0/14 (0.00%) 
Gastrointestinal disorders     
Haemorrhoidal Haemorrhage * 1  0/86 (0.00%)  1/14 (7.14%) 
Vomiting * 1  1/86 (1.16%)  0/14 (0.00%) 
General disorders     
Fatigue * 1  1/86 (1.16%)  0/14 (0.00%) 
Non-Cardiac Chest Pain * 1  1/86 (1.16%)  0/14 (0.00%) 
Pain * 1  1/86 (1.16%)  0/14 (0.00%) 
Pyrexia * 1  1/86 (1.16%)  0/14 (0.00%) 
Sudden Death * 1  0/86 (0.00%)  1/14 (7.14%) 
Infections and infestations     
Bacteraemia * 1  2/86 (2.33%)  0/14 (0.00%) 
Bronchitis * 1  1/86 (1.16%)  0/14 (0.00%) 
Cellulitis * 1  1/86 (1.16%)  0/14 (0.00%) 
Influenza * 1  1/86 (1.16%)  0/14 (0.00%) 
Lung Infection * 1  1/86 (1.16%)  0/14 (0.00%) 
Otitis Externa * 1  1/86 (1.16%)  0/14 (0.00%) 
Pneumonia Streptococcal * 1  1/86 (1.16%)  0/14 (0.00%) 
Urinary Tract Infection * 1  1/86 (1.16%)  0/14 (0.00%) 
Viral Upper Respiratory Tract Infection * 1  1/86 (1.16%)  0/14 (0.00%) 
Metabolism and nutrition disorders     
Dehydration * 1  1/86 (1.16%)  0/14 (0.00%) 
Hyperglycaemia * 1  1/86 (1.16%)  0/14 (0.00%) 
Hyponatraemia * 1  1/86 (1.16%)  0/14 (0.00%) 
Musculoskeletal and connective tissue disorders     
Bone Lesion * 1  1/86 (1.16%)  0/14 (0.00%) 
Nervous system disorders     
Syncope * 1  1/86 (1.16%)  0/14 (0.00%) 
Psychiatric disorders     
Mental Status Changes * 1  2/86 (2.33%)  0/14 (0.00%) 
Renal and urinary disorders     
Nephrotic Syndrome * 1  1/86 (1.16%)  0/14 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute Respiratory Failure * 1  1/86 (1.16%)  0/14 (0.00%) 
Atelectasis * 1  1/86 (1.16%)  0/14 (0.00%) 
Dyspnoea * 1  1/86 (1.16%)  0/14 (0.00%) 
Pulmonary Embolism * 1  2/86 (2.33%)  0/14 (0.00%) 
Vascular disorders     
Deep Vein Thrombosis * 1  1/86 (1.16%)  0/14 (0.00%) 
Embolism * 1  0/86 (0.00%)  1/14 (7.14%) 
1
Term from vocabulary, MedDRA Version 19.1
*
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 2%
Newly Diagnosed Multiple Myeloma (NDMM) Relapsed Multiple Myeloma (RMM)
Affected / at Risk (%) Affected / at Risk (%)
Total   86/86 (100.00%)   14/14 (100.00%) 
Blood and lymphatic system disorders     
Anaemia * 1  11/86 (12.79%)  1/14 (7.14%) 
Hyperleukocytosis * 1  0/86 (0.00%)  1/14 (7.14%) 
Leukopenia * 1  7/86 (8.14%)  1/14 (7.14%) 
Lymphopenia * 1  3/86 (3.49%)  0/14 (0.00%) 
Neutropenia * 1  11/86 (12.79%)  3/14 (21.43%) 
Thrombocytopenia * 1  4/86 (4.65%)  1/14 (7.14%) 
Cardiac disorders     
Atrial Fibrillation * 1  2/86 (2.33%)  0/14 (0.00%) 
Palpitations * 1  4/86 (4.65%)  0/14 (0.00%) 
Sinus Tachycardia * 1  0/86 (0.00%)  1/14 (7.14%) 
Tachycardia * 1  3/86 (3.49%)  0/14 (0.00%) 
Ear and labyrinth disorders     
Deafness * 1  0/86 (0.00%)  1/14 (7.14%) 
Ear Pain * 1  3/86 (3.49%)  0/14 (0.00%) 
Eustachian Tube Obstruction * 1  0/86 (0.00%)  1/14 (7.14%) 
Excessive Cerumen Production * 1  0/86 (0.00%)  1/14 (7.14%) 
Tinnitus * 1  3/86 (3.49%)  0/14 (0.00%) 
Eye disorders     
Chalazion * 1  2/86 (2.33%)  0/14 (0.00%) 
Dry Eye * 1  4/86 (4.65%)  0/14 (0.00%) 
Eye Disorder * 1  0/86 (0.00%)  1/14 (7.14%) 
Eye Irritation * 1  2/86 (2.33%)  0/14 (0.00%) 
Lacrimation Increased * 1  3/86 (3.49%)  2/14 (14.29%) 
Periorbital Oedema * 1  2/86 (2.33%)  0/14 (0.00%) 
Photophobia * 1  2/86 (2.33%)  0/14 (0.00%) 
Vision Blurred * 1  4/86 (4.65%)  2/14 (14.29%) 
Visual Impairment * 1  0/86 (0.00%)  1/14 (7.14%) 
Vitreous Floaters * 1  0/86 (0.00%)  1/14 (7.14%) 
Gastrointestinal disorders     
Abdominal Distension * 1  3/86 (3.49%)  0/14 (0.00%) 
Abdominal Pain * 1  8/86 (9.30%)  3/14 (21.43%) 
Abdominal Pain Lower * 1  2/86 (2.33%)  0/14 (0.00%) 
Abdominal Pain Upper * 1  5/86 (5.81%)  0/14 (0.00%) 
Constipation * 1  24/86 (27.91%)  0/14 (0.00%) 
Diarrhoea * 1  31/86 (36.05%)  6/14 (42.86%) 
Dry Mouth * 1  4/86 (4.65%)  1/14 (7.14%) 
Dyspepsia * 1  8/86 (9.30%)  1/14 (7.14%) 
Flatulence * 1  1/86 (1.16%)  1/14 (7.14%) 
Gastrooesophageal Reflux Disease * 1  4/86 (4.65%)  2/14 (14.29%) 
Haemorrhoids * 1  0/86 (0.00%)  1/14 (7.14%) 
Hyperchlorhydria * 1  0/86 (0.00%)  1/14 (7.14%) 
Nausea * 1  38/86 (44.19%)  3/14 (21.43%) 
Oesophageal Pain * 1  0/86 (0.00%)  1/14 (7.14%) 
Oesophagitis * 1  2/86 (2.33%)  1/14 (7.14%) 
Rectal Haemorrhage * 1  2/86 (2.33%)  0/14 (0.00%) 
Stomatitis * 1  0/86 (0.00%)  1/14 (7.14%) 
Toothache * 1  3/86 (3.49%)  0/14 (0.00%) 
Vomiting * 1  21/86 (24.42%)  5/14 (35.71%) 
General disorders     
Asthenia * 1  3/86 (3.49%)  1/14 (7.14%) 
Catheter Site Pain * 1  2/86 (2.33%)  0/14 (0.00%) 
Chest Discomfort * 1  3/86 (3.49%)  2/14 (14.29%) 
Chest Pain * 1  2/86 (2.33%)  0/14 (0.00%) 
Chills * 1  17/86 (19.77%)  1/14 (7.14%) 
Face Oedema * 1  2/86 (2.33%)  0/14 (0.00%) 
Fatigue * 1  52/86 (60.47%)  6/14 (42.86%) 
Feeling Cold * 1  2/86 (2.33%)  0/14 (0.00%) 
Feeling Hot * 1  0/86 (0.00%)  1/14 (7.14%) 
Feeling Jittery * 1  0/86 (0.00%)  1/14 (7.14%) 
Gait Disturbance * 1  0/86 (0.00%)  1/14 (7.14%) 
Influenza Like Illness * 1  0/86 (0.00%)  1/14 (7.14%) 
Injection Site Erythema * 1  3/86 (3.49%)  1/14 (7.14%) 
Injection Site Extravasation * 1  0/86 (0.00%)  1/14 (7.14%) 
Injection Site Rash * 1  1/86 (1.16%)  1/14 (7.14%) 
Injection Site Reaction * 1  4/86 (4.65%)  0/14 (0.00%) 
Mass * 1  2/86 (2.33%)  0/14 (0.00%) 
Non-Cardiac Chest Pain * 1  3/86 (3.49%)  0/14 (0.00%) 
Oedema Peripheral * 1  17/86 (19.77%)  1/14 (7.14%) 
Pain * 1  6/86 (6.98%)  1/14 (7.14%) 
Peripheral Swelling * 1  1/86 (1.16%)  2/14 (14.29%) 
Pyrexia * 1  14/86 (16.28%)  1/14 (7.14%) 
Tenderness * 1  2/86 (2.33%)  1/14 (7.14%) 
Hepatobiliary disorders     
Hyperbilirubinaemia * 1  2/86 (2.33%)  0/14 (0.00%) 
Immune system disorders     
Drug Hypersensitivity * 1  1/86 (1.16%)  1/14 (7.14%) 
Hypersensitivity * 1  2/86 (2.33%)  1/14 (7.14%) 
Seasonal Allergy * 1  2/86 (2.33%)  0/14 (0.00%) 
Infections and infestations     
Bronchiolitis * 1  0/86 (0.00%)  1/14 (7.14%) 
Bronchitis * 1  5/86 (5.81%)  0/14 (0.00%) 
Candida Infection * 1  3/86 (3.49%)  0/14 (0.00%) 
Cellulitis * 1  2/86 (2.33%)  0/14 (0.00%) 
Conjunctivitis * 1  3/86 (3.49%)  0/14 (0.00%) 
Diverticulitis * 1  0/86 (0.00%)  1/14 (7.14%) 
Folliculitis * 1  2/86 (2.33%)  0/14 (0.00%) 
Hordeolum * 1  11/86 (12.79%)  0/14 (0.00%) 
Influenza * 1  2/86 (2.33%)  0/14 (0.00%) 
Otitis Media * 1  1/86 (1.16%)  1/14 (7.14%) 
Pneumonia * 1  2/86 (2.33%)  2/14 (14.29%) 
Rhinitis * 1  3/86 (3.49%)  0/14 (0.00%) 
Sinusitis * 1  2/86 (2.33%)  3/14 (21.43%) 
Upper Respiratory Tract Infection * 1  18/86 (20.93%)  6/14 (42.86%) 
Urinary Tract Infection * 1  5/86 (5.81%)  0/14 (0.00%) 
Viral Upper Respiratory Tract Infection * 1  6/86 (6.98%)  5/14 (35.71%) 
Injury, poisoning and procedural complications     
Arthropod Bite * 1  0/86 (0.00%)  1/14 (7.14%) 
Contusion * 1  2/86 (2.33%)  0/14 (0.00%) 
Eyelid Contusion * 1  0/86 (0.00%)  1/14 (7.14%) 
Fall * 1  4/86 (4.65%)  0/14 (0.00%) 
Pubis Fracture * 1  2/86 (2.33%)  0/14 (0.00%) 
Rib Fracture * 1  2/86 (2.33%)  0/14 (0.00%) 
Investigations     
Alanine Aminotransferase Increased * 1  4/86 (4.65%)  0/14 (0.00%) 
Aspartate Aminotransferase Increased * 1  3/86 (3.49%)  0/14 (0.00%) 
Blood Alkaline Phosphatase Increased * 1  3/86 (3.49%)  0/14 (0.00%) 
Blood Creatine Increased * 1  0/86 (0.00%)  1/14 (7.14%) 
Blood Creatinine Increased * 1  4/86 (4.65%)  0/14 (0.00%) 
Blood Pressure Increased * 1  0/86 (0.00%)  1/14 (7.14%) 
Gamma-Glutamyltransferase Increased * 1  2/86 (2.33%)  0/14 (0.00%) 
Oxygen Saturation Decreased * 1  2/86 (2.33%)  1/14 (7.14%) 
Weight Decreased * 1  6/86 (6.98%)  0/14 (0.00%) 
Weight Increased * 1  5/86 (5.81%)  0/14 (0.00%) 
Metabolism and nutrition disorders     
Decreased Appetite * 1  13/86 (15.12%)  2/14 (14.29%) 
Dehydration * 1  12/86 (13.95%)  2/14 (14.29%) 
Fluid Retention * 1  2/86 (2.33%)  0/14 (0.00%) 
Hyperglycaemia * 1  6/86 (6.98%)  0/14 (0.00%) 
Hyperkalaemia * 1  2/86 (2.33%)  0/14 (0.00%) 
Hypoalbuminaemia * 1  2/86 (2.33%)  0/14 (0.00%) 
Hypocalcaemia * 1  2/86 (2.33%)  2/14 (14.29%) 
Hypokalaemia * 1  12/86 (13.95%)  1/14 (7.14%) 
Hypomagnesaemia * 1  6/86 (6.98%)  2/14 (14.29%) 
Hyponatraemia * 1  2/86 (2.33%)  1/14 (7.14%) 
Type 2 Diabetes Mellitus * 1  0/86 (0.00%)  1/14 (7.14%) 
Vitamin B12 Deficiency * 1  0/86 (0.00%)  1/14 (7.14%) 
Vitamin D Deficiency * 1  0/86 (0.00%)  1/14 (7.14%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  10/86 (11.63%)  2/14 (14.29%) 
Back Pain * 1  16/86 (18.60%)  4/14 (28.57%) 
Bone Pain * 1  6/86 (6.98%)  2/14 (14.29%) 
Exostosis * 1  0/86 (0.00%)  1/14 (7.14%) 
Flank Pain * 1  2/86 (2.33%)  0/14 (0.00%) 
Jaw Disorder * 1  0/86 (0.00%)  1/14 (7.14%) 
Joint Swelling * 1  4/86 (4.65%)  1/14 (7.14%) 
Muscle Spasms * 1  6/86 (6.98%)  1/14 (7.14%) 
Muscular Weakness * 1  8/86 (9.30%)  0/14 (0.00%) 
Musculoskeletal Chest Pain * 1  6/86 (6.98%)  3/14 (21.43%) 
Musculoskeletal Pain * 1  7/86 (8.14%)  3/14 (21.43%) 
Musculoskeletal Stiffness * 1  2/86 (2.33%)  0/14 (0.00%) 
Myalgia * 1  9/86 (10.47%)  5/14 (35.71%) 
Myalgia Intercostal * 1  2/86 (2.33%)  1/14 (7.14%) 
Neck Pain * 1  1/86 (1.16%)  1/14 (7.14%) 
Pain in Extremity * 1  11/86 (12.79%)  3/14 (21.43%) 
Soft Tissue Disorder * 1  0/86 (0.00%)  1/14 (7.14%) 
Nervous system disorders     
Dizziness * 1  13/86 (15.12%)  1/14 (7.14%) 
Dysgeusia * 1  11/86 (12.79%)  2/14 (14.29%) 
Headache * 1  20/86 (23.26%)  3/14 (21.43%) 
Hypoaesthesia * 1  2/86 (2.33%)  0/14 (0.00%) 
Lethargy * 1  0/86 (0.00%)  1/14 (7.14%) 
Muscle Spasticity * 1  0/86 (0.00%)  1/14 (7.14%) 
Neuropathy Peripheral * 1  15/86 (17.44%)  3/14 (21.43%) 
Paraesthesia * 1  2/86 (2.33%)  2/14 (14.29%) 
Peripheral Sensory Neuropathy * 1  13/86 (15.12%)  2/14 (14.29%) 
Peroneal Nerve Palsy * 1  0/86 (0.00%)  1/14 (7.14%) 
Tremor * 1  3/86 (3.49%)  0/14 (0.00%) 
Vith Nerve Disorder * 1  0/86 (0.00%)  1/14 (7.14%) 
Psychiatric disorders     
Agitation * 1  2/86 (2.33%)  1/14 (7.14%) 
Anxiety * 1  7/86 (8.14%)  0/14 (0.00%) 
Confusional State * 1  3/86 (3.49%)  0/14 (0.00%) 
Depression * 1  7/86 (8.14%)  1/14 (7.14%) 
Insomnia * 1  26/86 (30.23%)  2/14 (14.29%) 
Irritability * 1  3/86 (3.49%)  0/14 (0.00%) 
Restlessness * 1  2/86 (2.33%)  0/14 (0.00%) 
Renal and urinary disorders     
Dysuria * 1  3/86 (3.49%)  1/14 (7.14%) 
Nocturia * 1  4/86 (4.65%)  2/14 (14.29%) 
Pollakiuria * 1  1/86 (1.16%)  1/14 (7.14%) 
Urinary Retention * 1  2/86 (2.33%)  0/14 (0.00%) 
Urine Flow Decreased * 1  0/86 (0.00%)  1/14 (7.14%) 
Reproductive system and breast disorders     
Vulvovaginal Pruritus * 1  2/86 (2.33%)  0/14 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Bronchospasm * 1  1/86 (1.16%)  1/14 (7.14%) 
Cough * 1  25/86 (29.07%)  5/14 (35.71%) 
Dysphonia * 1  2/86 (2.33%)  0/14 (0.00%) 
Dyspnoea * 1  19/86 (22.09%)  3/14 (21.43%) 
Epistaxis * 1  4/86 (4.65%)  1/14 (7.14%) 
Hiccups * 1  2/86 (2.33%)  2/14 (14.29%) 
Hypoxia * 1  3/86 (3.49%)  0/14 (0.00%) 
Nasal Congestion * 1  4/86 (4.65%)  2/14 (14.29%) 
Oropharyngeal Pain * 1  9/86 (10.47%)  3/14 (21.43%) 
Paranasal Sinus Discomfort * 1  2/86 (2.33%)  0/14 (0.00%) 
Productive Cough * 1  7/86 (8.14%)  2/14 (14.29%) 
Respiratory Tract Congestion * 1  1/86 (1.16%)  1/14 (7.14%) 
Rhinitis Allergic * 1  4/86 (4.65%)  0/14 (0.00%) 
Rhinorrhoea * 1  2/86 (2.33%)  1/14 (7.14%) 
Sinus Congestion * 1  2/86 (2.33%)  2/14 (14.29%) 
Sinus Pain * 1  2/86 (2.33%)  0/14 (0.00%) 
Sleep Apnoea Syndrome * 1  0/86 (0.00%)  1/14 (7.14%) 
Sneezing * 1  1/86 (1.16%)  2/14 (14.29%) 
Throat Irritation * 1  2/86 (2.33%)  1/14 (7.14%) 
Wheezing * 1  5/86 (5.81%)  0/14 (0.00%) 
Skin and subcutaneous tissue disorders     
Alopecia * 1  5/86 (5.81%)  0/14 (0.00%) 
Hyperhidrosis * 1  4/86 (4.65%)  1/14 (7.14%) 
Nail Disorder * 1  0/86 (0.00%)  1/14 (7.14%) 
Night Sweats * 1  3/86 (3.49%)  0/14 (0.00%) 
Pruritus * 1  12/86 (13.95%)  1/14 (7.14%) 
Rash * 1  8/86 (9.30%)  1/14 (7.14%) 
Rash Macular * 1  2/86 (2.33%)  0/14 (0.00%) 
Skin Lesion * 1  1/86 (1.16%)  1/14 (7.14%) 
Skin Mass * 1  0/86 (0.00%)  1/14 (7.14%) 
Urticaria * 1  2/86 (2.33%)  0/14 (0.00%) 
Surgical and medical procedures     
Sinus Operation * 1  0/86 (0.00%)  1/14 (7.14%) 
Vascular disorders     
Flushing * 1  11/86 (12.79%)  1/14 (7.14%) 
Hypertension * 1  5/86 (5.81%)  1/14 (7.14%) 
Hypotension * 1  6/86 (6.98%)  2/14 (14.29%) 
1
Term from vocabulary, MedDRA Version 19.1
*
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.
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Director
Organization: Janssen Scientific Affairs
Phone: 844-434-4210
EMail: ClinicalTrialDisclosure@its.jnj.com
Layout table for additonal information
Responsible Party: Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier: NCT02951819     History of Changes
Other Study ID Numbers: CR108235
54767414MMY2012 ( Other Identifier: Janssen Scientific Affairs, LLC )
First Submitted: October 31, 2016
First Posted: November 1, 2016
Results First Submitted: March 8, 2019
Results First Posted: April 3, 2019
Last Update Posted: September 16, 2019