Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) Amyloidosis (NCT NCT03201965)
NCT ID: NCT03201965
Last Updated: 2025-11-26
Results Overview
Overall CHR rate was defined as percentage of participants who achieved CHR, according to the International Amyloidosis Consensus Criteria. CHR: normalization of free light chain levels and ratio, negative serum, and urine immunofixation. If involved free light chain (iFLC) is less than (\<) upper limit of normal (ULN) and serum and urine Immunofixation electrophoresis (IFE) are negative, then neither a normal uninvolved free light chain (uFLC) level nor a normal free light chain (FLC) ratio are required for complete response (CR).
COMPLETED
PHASE3
416 participants
Up to 2.4 years
2025-11-26
Participant Flow
Participants with newly diagnosed Amyloid Light-chain (AL) amyloidosis with measurable disease and at least one organ involvement, and Mayo cardiac stage I - IIIA, who had not received prior therapy for AL amyloidosis or multiple myeloma were enrolled.
Participant milestones
| Measure |
Run-In: Daratumumab Plus CyBorD
Participants received the combination therapy during Run-in phase starting with 20 milligrams (mg) dexamethasone as premedication followed by daratumumab 1800 mg on Day 1 Cycle 1, then cyclophosphamide 300 milligram per meter square (mg/m\^2) orally or intravenous (IV) maximum weekly dose 500 mg, followed by bortezomib 1.3 mg/m\^2 subcutaneous (SC) injection once every week and dexamethasone remaining 20 mg post daratumumab dosing for up to 1 cycle (28 Days) to assess the safety before randomizing participants in CyBorD or daratumumab plus CyBorD arms. However, participants also continued daratumumab plus CyBorD for up to 6 cycles and then daratumumab monotherapy for up to 24 months from the start of treatment. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
|
CyBorD
Participants received dexamethasone (40 mg weekly dose)starting from cycle 1 day1 in every 28-day cycle followed by cyclophosphamide 300 mg/m\^2 orally or IV maximum weekly dose 500 mg and then bortezomib 1.3 mg/m\^2 SC injection once weekly up to 7.33 months. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
|
Daratumumab Plus CyBorD
Participants received combination therapy for six cycles of 28 days each, daratumumab 1800 mg SC weekly starting from cycles 1 day 1 and cycle 2, every 2 weeks in cycles 3 through 6, dexamethasone 40 mg weekly (on days of daratumumab dosing, dexamethasone was split, 20 mg as premedication and 20 mg as post daratumumab dosing), cyclophosphamide 300 mg/m\^2 orally or IV maximum weekly dose 500 mg, bortezomib 1.3 mg/m\^2 SC injection once weekly. After 6 cycles, participants continued to receive daratumumab SC monotherapy until disease progression, start of subsequent therapy or up to 26.71 months from the first dose of study treatment. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
|
|---|---|---|---|
|
Overall Study
STARTED
|
28
|
193
|
195
|
|
Overall Study
Treated
|
28
|
188
|
193
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
28
|
193
|
195
|
Reasons for withdrawal
| Measure |
Run-In: Daratumumab Plus CyBorD
Participants received the combination therapy during Run-in phase starting with 20 milligrams (mg) dexamethasone as premedication followed by daratumumab 1800 mg on Day 1 Cycle 1, then cyclophosphamide 300 milligram per meter square (mg/m\^2) orally or intravenous (IV) maximum weekly dose 500 mg, followed by bortezomib 1.3 mg/m\^2 subcutaneous (SC) injection once every week and dexamethasone remaining 20 mg post daratumumab dosing for up to 1 cycle (28 Days) to assess the safety before randomizing participants in CyBorD or daratumumab plus CyBorD arms. However, participants also continued daratumumab plus CyBorD for up to 6 cycles and then daratumumab monotherapy for up to 24 months from the start of treatment. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
|
CyBorD
Participants received dexamethasone (40 mg weekly dose)starting from cycle 1 day1 in every 28-day cycle followed by cyclophosphamide 300 mg/m\^2 orally or IV maximum weekly dose 500 mg and then bortezomib 1.3 mg/m\^2 SC injection once weekly up to 7.33 months. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
|
Daratumumab Plus CyBorD
Participants received combination therapy for six cycles of 28 days each, daratumumab 1800 mg SC weekly starting from cycles 1 day 1 and cycle 2, every 2 weeks in cycles 3 through 6, dexamethasone 40 mg weekly (on days of daratumumab dosing, dexamethasone was split, 20 mg as premedication and 20 mg as post daratumumab dosing), cyclophosphamide 300 mg/m\^2 orally or IV maximum weekly dose 500 mg, bortezomib 1.3 mg/m\^2 SC injection once weekly. After 6 cycles, participants continued to receive daratumumab SC monotherapy until disease progression, start of subsequent therapy or up to 26.71 months from the first dose of study treatment. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
|
|---|---|---|---|
|
Overall Study
Death
|
5
|
65
|
47
|
|
Overall Study
Lost to Follow-up
|
0
|
6
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
23
|
8
|
|
Overall Study
Sponsor's Decision
|
20
|
99
|
140
|
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) Amyloidosis
Baseline characteristics by cohort
| Measure |
Run-In: Daratumumab Plus CyBorD
n=28 Participants
Participants received the combination therapy during Run-in phase starting with 20 milligrams (mg) dexamethasone as premedication followed by daratumumab 1800 mg on Day 1 Cycle 1, then cyclophosphamide 300 milligram per meter square (mg/m\^2) orally or intravenous (IV) maximum weekly dose 500 mg, followed by bortezomib 1.3 mg/m\^2 subcutaneous (SC) injection once every week and dexamethasone remaining 20 mg post daratumumab dosing for up to 1 cycle (28 Days) to assess the safety before randomizing participants in CyBorD or daratumumab plus CyBorD arms. However, participants also continued daratumumab plus CyBorD for up to 6 cycles and then daratumumab monotherapy for up to 24 months from the start of treatment. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
|
CyBorD
n=193 Participants
Participants received dexamethasone (40 mg weekly dose)starting from cycle 1 day1 in every 28-day cycle followed by cyclophosphamide 300 mg/m\^2 orally or IV maximum weekly dose 500 mg and then bortezomib 1.3 mg/m\^2 SC injection once weekly up to 7.33 months. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
|
Daratumumab Plus CyBorD
n=195 Participants
Participants received combination therapy for six cycles of 28 days each, daratumumab 1800 mg SC weekly starting from cycles 1 day 1 and cycle 2, every 2 weeks in cycles 3 through 6, dexamethasone 40 mg weekly (on days of daratumumab dosing, dexamethasone was split, 20 mg as premedication and 20 mg as post daratumumab dosing), cyclophosphamide 300 mg/m\^2 orally or IV maximum weekly dose 500 mg, bortezomib 1.3 mg/m\^2 SC injection once weekly. After 6 cycles, participants continued to receive daratumumab SC monotherapy until disease progression, start of subsequent therapy or up to 26.71 months from the first dose of study treatment. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
|
Total
n=416 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
64.8 years
STANDARD_DEVIATION 11.2 • n=492 Participants
|
64 years
STANDARD_DEVIATION 9.66 • n=492 Participants
|
62.2 years
STANDARD_DEVIATION 10.16 • n=984 Participants
|
63.2 years
STANDARD_DEVIATION 10.03 • n=3 Participants
|
|
Sex/Gender, Customized
Female
|
11 Participants
n=492 Participants
|
76 Participants
n=492 Participants
|
87 Participants
n=984 Participants
|
174 Participants
n=3 Participants
|
|
Sex/Gender, Customized
Male
|
16 Participants
n=492 Participants
|
117 Participants
n=492 Participants
|
108 Participants
n=984 Participants
|
241 Participants
n=3 Participants
|
|
Sex/Gender, Customized
Undifferentiated Sex
|
1 Participants
n=492 Participants
|
0 Participants
n=492 Participants
|
0 Participants
n=984 Participants
|
1 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=492 Participants
|
13 Participants
n=492 Participants
|
9 Participants
n=984 Participants
|
23 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=492 Participants
|
176 Participants
n=492 Participants
|
179 Participants
n=984 Participants
|
381 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=492 Participants
|
4 Participants
n=492 Participants
|
7 Participants
n=984 Participants
|
12 Participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=492 Participants
|
2 Participants
n=492 Participants
|
1 Participants
n=984 Participants
|
3 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=492 Participants
|
34 Participants
n=492 Participants
|
30 Participants
n=984 Participants
|
64 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=492 Participants
|
1 Participants
n=492 Participants
|
0 Participants
n=984 Participants
|
1 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=492 Participants
|
7 Participants
n=492 Participants
|
6 Participants
n=984 Participants
|
15 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=492 Participants
|
143 Participants
n=492 Participants
|
151 Participants
n=984 Participants
|
319 Participants
n=3 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=492 Participants
|
1 Participants
n=492 Participants
|
0 Participants
n=984 Participants
|
1 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=492 Participants
|
5 Participants
n=492 Participants
|
7 Participants
n=984 Participants
|
13 Participants
n=3 Participants
|
|
Region of Enrollment
AUSTRALIA
|
0 Participants
n=492 Participants
|
15 Participants
n=492 Participants
|
12 Participants
n=984 Participants
|
27 Participants
n=3 Participants
|
|
Region of Enrollment
BELGIUM
|
0 Participants
n=492 Participants
|
1 Participants
n=492 Participants
|
2 Participants
n=984 Participants
|
3 Participants
n=3 Participants
|
|
Region of Enrollment
BRAZIL
|
0 Participants
n=492 Participants
|
7 Participants
n=492 Participants
|
4 Participants
n=984 Participants
|
11 Participants
n=3 Participants
|
|
Region of Enrollment
CANADA
|
0 Participants
n=492 Participants
|
10 Participants
n=492 Participants
|
9 Participants
n=984 Participants
|
19 Participants
n=3 Participants
|
|
Region of Enrollment
CHINA
|
0 Participants
n=492 Participants
|
6 Participants
n=492 Participants
|
6 Participants
n=984 Participants
|
12 Participants
n=3 Participants
|
|
Region of Enrollment
DENMARK
|
0 Participants
n=492 Participants
|
1 Participants
n=492 Participants
|
1 Participants
n=984 Participants
|
2 Participants
n=3 Participants
|
|
Region of Enrollment
FRANCE
|
0 Participants
n=492 Participants
|
22 Participants
n=492 Participants
|
16 Participants
n=984 Participants
|
38 Participants
n=3 Participants
|
|
Region of Enrollment
GERMANY
|
0 Participants
n=492 Participants
|
11 Participants
n=492 Participants
|
8 Participants
n=984 Participants
|
19 Participants
n=3 Participants
|
|
Region of Enrollment
GREECE
|
0 Participants
n=492 Participants
|
11 Participants
n=492 Participants
|
16 Participants
n=984 Participants
|
27 Participants
n=3 Participants
|
|
Region of Enrollment
HUNGARY
|
0 Participants
n=492 Participants
|
2 Participants
n=492 Participants
|
2 Participants
n=984 Participants
|
4 Participants
n=3 Participants
|
|
Region of Enrollment
ISRAEL
|
0 Participants
n=492 Participants
|
5 Participants
n=492 Participants
|
6 Participants
n=984 Participants
|
11 Participants
n=3 Participants
|
|
Region of Enrollment
ITALY
|
0 Participants
n=492 Participants
|
5 Participants
n=492 Participants
|
4 Participants
n=984 Participants
|
9 Participants
n=3 Participants
|
|
Region of Enrollment
JAPAN
|
0 Participants
n=492 Participants
|
13 Participants
n=492 Participants
|
15 Participants
n=984 Participants
|
28 Participants
n=3 Participants
|
|
Region of Enrollment
MEXICO
|
0 Participants
n=492 Participants
|
1 Participants
n=492 Participants
|
1 Participants
n=984 Participants
|
2 Participants
n=3 Participants
|
|
Region of Enrollment
NETHERLANDS
|
0 Participants
n=492 Participants
|
4 Participants
n=492 Participants
|
7 Participants
n=984 Participants
|
11 Participants
n=3 Participants
|
|
Region of Enrollment
POLAND
|
0 Participants
n=492 Participants
|
2 Participants
n=492 Participants
|
2 Participants
n=984 Participants
|
4 Participants
n=3 Participants
|
|
Region of Enrollment
SOUTH KOREA
|
0 Participants
n=492 Participants
|
12 Participants
n=492 Participants
|
8 Participants
n=984 Participants
|
20 Participants
n=3 Participants
|
|
Region of Enrollment
SPAIN
|
0 Participants
n=492 Participants
|
11 Participants
n=492 Participants
|
21 Participants
n=984 Participants
|
32 Participants
n=3 Participants
|
|
Region of Enrollment
SWEDEN
|
0 Participants
n=492 Participants
|
2 Participants
n=492 Participants
|
1 Participants
n=984 Participants
|
3 Participants
n=3 Participants
|
|
Region of Enrollment
TURKEY
|
0 Participants
n=492 Participants
|
7 Participants
n=492 Participants
|
10 Participants
n=984 Participants
|
17 Participants
n=3 Participants
|
|
Region of Enrollment
UNITED KINGDOM
|
0 Participants
n=492 Participants
|
4 Participants
n=492 Participants
|
4 Participants
n=984 Participants
|
8 Participants
n=3 Participants
|
|
Region of Enrollment
UNITED STATES
|
28 Participants
n=492 Participants
|
41 Participants
n=492 Participants
|
40 Participants
n=984 Participants
|
109 Participants
n=3 Participants
|
|
Weight group in Kilograms (Kg)
<=65 kg
|
5 Participants
n=492 Participants
|
74 Participants
n=492 Participants
|
62 Participants
n=984 Participants
|
141 Participants
n=3 Participants
|
|
Weight group in Kilograms (Kg)
>65 to 85 kg
|
12 Participants
n=492 Participants
|
74 Participants
n=492 Participants
|
96 Participants
n=984 Participants
|
182 Participants
n=3 Participants
|
|
Weight group in Kilograms (Kg)
>85 kg
|
11 Participants
n=492 Participants
|
45 Participants
n=492 Participants
|
37 Participants
n=984 Participants
|
93 Participants
n=3 Participants
|
|
Baseline Major Organ Involvement
Baseline Organ Involvement: Heart
|
17 Participants
n=492 Participants
|
137 Participants
n=492 Participants
|
140 Participants
n=984 Participants
|
294 Participants
n=3 Participants
|
|
Baseline Major Organ Involvement
Baseline Organ Involvement: Kidney
|
19 Participants
n=492 Participants
|
114 Participants
n=492 Participants
|
115 Participants
n=984 Participants
|
248 Participants
n=3 Participants
|
|
Baseline Major Organ Involvement
Baseline Organ Involvement: Liver
|
4 Participants
n=492 Participants
|
16 Participants
n=492 Participants
|
15 Participants
n=984 Participants
|
35 Participants
n=3 Participants
|
|
Number of Organs Involved
|
2.0 organs
STANDARD_DEVIATION 0.881 • n=492 Participants
|
2.0 organs
STANDARD_DEVIATION 1.03 • n=492 Participants
|
2.0 organs
STANDARD_DEVIATION 0.97 • n=984 Participants
|
2.0 organs
STANDARD_DEVIATION 0.99 • n=3 Participants
|
|
Number of Organs Involved
1 Organ
|
9 Participants
n=492 Participants
|
68 Participants
n=492 Participants
|
66 Participants
n=984 Participants
|
143 Participants
n=3 Participants
|
|
Number of Organs Involved
2 Organs
|
13 Participants
n=492 Participants
|
77 Participants
n=492 Participants
|
76 Participants
n=984 Participants
|
166 Participants
n=3 Participants
|
|
Number of Organs Involved
>=3 Organ
|
6 Participants
n=492 Participants
|
48 Participants
n=492 Participants
|
53 Participants
n=984 Participants
|
107 Participants
n=3 Participants
|
|
Cardiac Stage Based on Mayo Clinic Cardiac Staging System
Class I
|
6 Participants
n=492 Participants
|
43 Participants
n=492 Participants
|
47 Participants
n=984 Participants
|
96 Participants
n=3 Participants
|
|
Cardiac Stage Based on Mayo Clinic Cardiac Staging System
Class II
|
16 Participants
n=492 Participants
|
80 Participants
n=492 Participants
|
76 Participants
n=984 Participants
|
172 Participants
n=3 Participants
|
|
Cardiac Stage Based on Mayo Clinic Cardiac Staging System
Class IIIa
|
5 Participants
n=492 Participants
|
64 Participants
n=492 Participants
|
70 Participants
n=984 Participants
|
139 Participants
n=3 Participants
|
|
Cardiac Stage Based on Mayo Clinic Cardiac Staging System
Class IIIb
|
1 Participants
n=492 Participants
|
6 Participants
n=492 Participants
|
2 Participants
n=984 Participants
|
9 Participants
n=3 Participants
|
|
New York Heart Association (NYHA) Class
Class I
|
17 Participants
n=492 Participants
|
94 Participants
n=492 Participants
|
101 Participants
n=984 Participants
|
212 Participants
n=3 Participants
|
|
New York Heart Association (NYHA) Class
Class II
|
10 Participants
n=492 Participants
|
89 Participants
n=492 Participants
|
77 Participants
n=984 Participants
|
176 Participants
n=3 Participants
|
|
New York Heart Association (NYHA) Class
Class IIIA
|
1 Participants
n=492 Participants
|
10 Participants
n=492 Participants
|
17 Participants
n=984 Participants
|
28 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: Up to 2.4 yearsPopulation: The intent to treat analysis set included all the participants who were randomized and received at least one dose of study treatment in the study. Data for this outcome measure (OM) was planned to be collected and analyzed for specified arms only.
Overall CHR rate was defined as percentage of participants who achieved CHR, according to the International Amyloidosis Consensus Criteria. CHR: normalization of free light chain levels and ratio, negative serum, and urine immunofixation. If involved free light chain (iFLC) is less than (\<) upper limit of normal (ULN) and serum and urine Immunofixation electrophoresis (IFE) are negative, then neither a normal uninvolved free light chain (uFLC) level nor a normal free light chain (FLC) ratio are required for complete response (CR).
Outcome measures
| Measure |
CyBorD
n=193 Participants
Participants received dexamethasone (40 mg weekly dose)starting from cycle 1 day1 in every 28-day cycle followed by cyclophosphamide 300 mg/m\^2 orally or IV maximum weekly dose 500 mg and then bortezomib 1.3 mg/m\^2 SC injection once weekly up to 7.33 months. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
|
Daratumumab Plus CyBorD
n=195 Participants
Participants received combination therapy for six cycles of 28 days each, daratumumab 1800 mg SC weekly starting from cycles 1 day 1 and cycle 2, every 2 weeks in cycles 3 through 6, dexamethasone 40 mg weekly (on days of daratumumab dosing, dexamethasone was split, 20 mg as premedication and 20 mg as post daratumumab dosing), cyclophosphamide 300 mg/m\^2 orally or IV maximum weekly dose 500 mg, bortezomib 1.3 mg/m\^2 SC injection once weekly. After 6 cycles, participants continued to receive daratumumab SC monotherapy until disease progression, start of subsequent therapy or up to 26.71 months from the first dose of study treatment. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
|
|---|---|---|
|
Percentage of Participants With Overall Complete Hematologic Response (CHR)
|
18.1 percentage of participants
Interval 13.0 to 24.3
|
53.3 percentage of participants
Interval 46.1 to 60.5
|
SECONDARY outcome
Timeframe: From date of first randomization (Day -3) upto 6.5 yearsPopulation: The intent to treat analysis set included all randomized participants. Data for this outcome measure was planned to be collected and analyzed for specified arms only.
MOD-PFS was defined as duration from the date of randomization to either hematologic progression, or major organ deterioration (clinical manifestation of cardiac failure or renal failure), or death, whichever occurred first. Per international amyloidosis consensus criteria (IACC), hematologic progression was defined as satisfying any one of the following criteria: 1) From CHR, abnormal free light chain ratio (light chain must be double and \>ULN); 2) From CHR/VGPR/PR, 50 percent (%) increase in serum M-protein to \>0.5 grams per deciliter (g/dL) or 50% increase in urine M-protein to 200 milligrams (mg)/day; 3) free light chain increase of 50% to 100 milligrams (mg)/Liter (L).
Outcome measures
| Measure |
CyBorD
n=193 Participants
Participants received dexamethasone (40 mg weekly dose)starting from cycle 1 day1 in every 28-day cycle followed by cyclophosphamide 300 mg/m\^2 orally or IV maximum weekly dose 500 mg and then bortezomib 1.3 mg/m\^2 SC injection once weekly up to 7.33 months. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
|
Daratumumab Plus CyBorD
n=195 Participants
Participants received combination therapy for six cycles of 28 days each, daratumumab 1800 mg SC weekly starting from cycles 1 day 1 and cycle 2, every 2 weeks in cycles 3 through 6, dexamethasone 40 mg weekly (on days of daratumumab dosing, dexamethasone was split, 20 mg as premedication and 20 mg as post daratumumab dosing), cyclophosphamide 300 mg/m\^2 orally or IV maximum weekly dose 500 mg, bortezomib 1.3 mg/m\^2 SC injection once weekly. After 6 cycles, participants continued to receive daratumumab SC monotherapy until disease progression, start of subsequent therapy or up to 26.71 months from the first dose of study treatment. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
|
|---|---|---|
|
Major Organ Deterioration Progression-Free Survival (MOD-PFS)
|
30.23 months
Interval 16.66 to 48.89
|
NA months
Here, 'NA' signifies that Median, lower limit and upper limit of 95% confidence interval (CI) could not be estimated due to an insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: From date of first randomization (Day -3) up to 7.1 yearsPopulation: The intent to treat analysis set included all randomized participants. Data for this outcome measure was planned to be collected and analyzed for specified arms only.
Overall survival (OS) was measured from the date of randomization to the date of the participant's death.
Outcome measures
| Measure |
CyBorD
n=193 Participants
Participants received dexamethasone (40 mg weekly dose)starting from cycle 1 day1 in every 28-day cycle followed by cyclophosphamide 300 mg/m\^2 orally or IV maximum weekly dose 500 mg and then bortezomib 1.3 mg/m\^2 SC injection once weekly up to 7.33 months. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
|
Daratumumab Plus CyBorD
n=195 Participants
Participants received combination therapy for six cycles of 28 days each, daratumumab 1800 mg SC weekly starting from cycles 1 day 1 and cycle 2, every 2 weeks in cycles 3 through 6, dexamethasone 40 mg weekly (on days of daratumumab dosing, dexamethasone was split, 20 mg as premedication and 20 mg as post daratumumab dosing), cyclophosphamide 300 mg/m\^2 orally or IV maximum weekly dose 500 mg, bortezomib 1.3 mg/m\^2 SC injection once weekly. After 6 cycles, participants continued to receive daratumumab SC monotherapy until disease progression, start of subsequent therapy or up to 26.71 months from the first dose of study treatment. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
|
|---|---|---|
|
Overall Survival (OS)
|
NA Months
Here, 'NA' signifies that median, lower limit and upper limit of 95% CI could not be estimated due to an insufficient number of participants with events.
|
NA Months
Here, 'NA' signifies that median, lower limit and upper limit of 95% CI could not be estimated due to an insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Month 6Population: Cardiac response-evaluable participants had baseline NT-proBNP \>=650 ng/L or NYHA class 3 or 4, plus received at least 1 administration of study treatment and had at least one post-baseline. NT-proBNP measurement (if baseline NT-proBNP \>=650 nanograms per liter \[ng/L\]) or NYHA function evaluation (if baseline NYHA class 3 or 4). Data for this outcome measure was planned to be collected and analyzed for specified arms only.
The Organ Response Rate (OrRR) for heart was defined as the percentage of participants with baseline involvement of the heart who achieved a confirmed organ response in the heart. Cardiac response was defined as as a decrease of \>30% in N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels and greater than (\>)300 nanogram/Litre (ng/L).
Outcome measures
| Measure |
CyBorD
n=117 Participants
Participants received dexamethasone (40 mg weekly dose)starting from cycle 1 day1 in every 28-day cycle followed by cyclophosphamide 300 mg/m\^2 orally or IV maximum weekly dose 500 mg and then bortezomib 1.3 mg/m\^2 SC injection once weekly up to 7.33 months. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
|
Daratumumab Plus CyBorD
n=118 Participants
Participants received combination therapy for six cycles of 28 days each, daratumumab 1800 mg SC weekly starting from cycles 1 day 1 and cycle 2, every 2 weeks in cycles 3 through 6, dexamethasone 40 mg weekly (on days of daratumumab dosing, dexamethasone was split, 20 mg as premedication and 20 mg as post daratumumab dosing), cyclophosphamide 300 mg/m\^2 orally or IV maximum weekly dose 500 mg, bortezomib 1.3 mg/m\^2 SC injection once weekly. After 6 cycles, participants continued to receive daratumumab SC monotherapy until disease progression, start of subsequent therapy or up to 26.71 months from the first dose of study treatment. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
|
|---|---|---|
|
Organ Response Rate (OrRR) at 6 Months: Cardiac Response
|
22.2 Percentage of participants
Interval 15.1 to 30.8
|
41.5 Percentage of participants
Interval 32.5 to 51.0
|
SECONDARY outcome
Timeframe: Month 6Population: Renal response-evaluable participants had baseline urine protein \>0.5 g/day, received at least one administration of study treatment, and had at least post-baseline urine protein measurement. Data for this outcome measure was planned to be collected and analyzed for specified arms only.
The OrRR for kidney was defined as the percentage of participants with baseline involvement of the kidney who achieved a confirmed renal response in the kidney. Renal response was defined as more than equal to (≥) 30% decrease in proteinuria or proteinuria decreased to \<0.5 grams (g)/24 hours in the absence of renal progression.
Outcome measures
| Measure |
CyBorD
n=113 Participants
Participants received dexamethasone (40 mg weekly dose)starting from cycle 1 day1 in every 28-day cycle followed by cyclophosphamide 300 mg/m\^2 orally or IV maximum weekly dose 500 mg and then bortezomib 1.3 mg/m\^2 SC injection once weekly up to 7.33 months. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
|
Daratumumab Plus CyBorD
n=117 Participants
Participants received combination therapy for six cycles of 28 days each, daratumumab 1800 mg SC weekly starting from cycles 1 day 1 and cycle 2, every 2 weeks in cycles 3 through 6, dexamethasone 40 mg weekly (on days of daratumumab dosing, dexamethasone was split, 20 mg as premedication and 20 mg as post daratumumab dosing), cyclophosphamide 300 mg/m\^2 orally or IV maximum weekly dose 500 mg, bortezomib 1.3 mg/m\^2 SC injection once weekly. After 6 cycles, participants continued to receive daratumumab SC monotherapy until disease progression, start of subsequent therapy or up to 26.71 months from the first dose of study treatment. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
|
|---|---|---|
|
Organ Response Rate (OrRR) at 6 Months: Renal Response
|
27.4 Percentage of participants
Interval 19.5 to 36.6
|
53.8 Percentage of participants
Interval 44.4 to 63.1
|
SECONDARY outcome
Timeframe: Month 6Population: Liver response-evaluable participants had baseline abnormal alkaline phosphatase \>1.5\*upper limit of normal (ULN), at least 1 administration of study treatment and had at least one post-baseline alkaline phosphatase measurement. Data for this outcome measure was planned to be collected and analyzed for specified arms.
The OrRR for liver was defined as the percentage of participants with baseline involvement of the liver who achieved a confirmed liver response in the liver. Liver response was defined as 50% decrease in abnormal alkaline phosphatase value.
Outcome measures
| Measure |
CyBorD
n=14 Participants
Participants received dexamethasone (40 mg weekly dose)starting from cycle 1 day1 in every 28-day cycle followed by cyclophosphamide 300 mg/m\^2 orally or IV maximum weekly dose 500 mg and then bortezomib 1.3 mg/m\^2 SC injection once weekly up to 7.33 months. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
|
Daratumumab Plus CyBorD
n=10 Participants
Participants received combination therapy for six cycles of 28 days each, daratumumab 1800 mg SC weekly starting from cycles 1 day 1 and cycle 2, every 2 weeks in cycles 3 through 6, dexamethasone 40 mg weekly (on days of daratumumab dosing, dexamethasone was split, 20 mg as premedication and 20 mg as post daratumumab dosing), cyclophosphamide 300 mg/m\^2 orally or IV maximum weekly dose 500 mg, bortezomib 1.3 mg/m\^2 SC injection once weekly. After 6 cycles, participants continued to receive daratumumab SC monotherapy until disease progression, start of subsequent therapy or up to 26.71 months from the first dose of study treatment. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
|
|---|---|---|
|
Organ Response Rate (OrRR) at 6 Months: Liver Response
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
40.0 Percentage of participants
Interval 12.2 to 73.8
|
SECONDARY outcome
Timeframe: Month 6Population: The intent to treat analysis set included all randomized participants. Data for this outcome measure was planned to be collected and analyzed for specified arms only.
CHR rate was defined as percentage of participants who achieved CHR, according to the International Amyloidosis Consensus Criteria. CHR: normalization of free light chain levels and ratio, negative serum, and urine immunofixation. If involved free light chain is \< ULN and serum and urine IFE are negative, then neither a normal uninvolved free light chain (uFLC) level nor a normal free light chain (FLC) ratio are required for Complete Response (CR).
Outcome measures
| Measure |
CyBorD
n=193 Participants
Participants received dexamethasone (40 mg weekly dose)starting from cycle 1 day1 in every 28-day cycle followed by cyclophosphamide 300 mg/m\^2 orally or IV maximum weekly dose 500 mg and then bortezomib 1.3 mg/m\^2 SC injection once weekly up to 7.33 months. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
|
Daratumumab Plus CyBorD
n=195 Participants
Participants received combination therapy for six cycles of 28 days each, daratumumab 1800 mg SC weekly starting from cycles 1 day 1 and cycle 2, every 2 weeks in cycles 3 through 6, dexamethasone 40 mg weekly (on days of daratumumab dosing, dexamethasone was split, 20 mg as premedication and 20 mg as post daratumumab dosing), cyclophosphamide 300 mg/m\^2 orally or IV maximum weekly dose 500 mg, bortezomib 1.3 mg/m\^2 SC injection once weekly. After 6 cycles, participants continued to receive daratumumab SC monotherapy until disease progression, start of subsequent therapy or up to 26.71 months from the first dose of study treatment. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
|
|---|---|---|
|
Percentage of Participants Who Achieved Complete Hematologic Response (CHR) at 6 Months
|
14.0 Percentage of participants
Interval 9.4 to 19.7
|
50.3 Percentage of participants
Interval 43.0 to 57.5
|
SECONDARY outcome
Timeframe: From date of first randomization (Day -3) up to 6.5 yearsPopulation: Responders in intent to-treat analysis set included participants of intent to-treat analysis set who had hematologic response (complete hematologic response, VGPR and PR). Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Data for this outcome measure was planned to be collected and analyzed for specified arms only.
Time to CHR was defined as time between the date of randomization and first efficacy evaluation at which the participant has met all criteria for hematologic CR. CHR was primarily defined by negative immunofixation results and normalized free light chain (FLC) parameters.
Outcome measures
| Measure |
CyBorD
n=37 Participants
Participants received dexamethasone (40 mg weekly dose)starting from cycle 1 day1 in every 28-day cycle followed by cyclophosphamide 300 mg/m\^2 orally or IV maximum weekly dose 500 mg and then bortezomib 1.3 mg/m\^2 SC injection once weekly up to 7.33 months. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
|
Daratumumab Plus CyBorD
n=116 Participants
Participants received combination therapy for six cycles of 28 days each, daratumumab 1800 mg SC weekly starting from cycles 1 day 1 and cycle 2, every 2 weeks in cycles 3 through 6, dexamethasone 40 mg weekly (on days of daratumumab dosing, dexamethasone was split, 20 mg as premedication and 20 mg as post daratumumab dosing), cyclophosphamide 300 mg/m\^2 orally or IV maximum weekly dose 500 mg, bortezomib 1.3 mg/m\^2 SC injection once weekly. After 6 cycles, participants continued to receive daratumumab SC monotherapy until disease progression, start of subsequent therapy or up to 26.71 months from the first dose of study treatment. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
|
|---|---|---|
|
Time to Complete Hematologic Response (CHR)
|
85.00 Days
Interval 14.0 to 617.0
|
67.50 Days
Interval 8.0 to 879.0
|
SECONDARY outcome
Timeframe: From date of first randomization (Day -3) up to 6.5 yearsPopulation: Cardiac response-evaluable participants had baseline NT-proBNP greater than equal to \>= 650 ng/L or NYHA class 3/4, with at least one post-baseline NT-proBNP or NYHA assessment after receiving treatment. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Data for this outcome measure was planned to be collected and analyzed for specified arms.
Time to cardiac response was defined as the time between the date of randomization and the first efficacy evaluation at which the participant had cardiac response.
Outcome measures
| Measure |
CyBorD
n=49 Participants
Participants received dexamethasone (40 mg weekly dose)starting from cycle 1 day1 in every 28-day cycle followed by cyclophosphamide 300 mg/m\^2 orally or IV maximum weekly dose 500 mg and then bortezomib 1.3 mg/m\^2 SC injection once weekly up to 7.33 months. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
|
Daratumumab Plus CyBorD
n=75 Participants
Participants received combination therapy for six cycles of 28 days each, daratumumab 1800 mg SC weekly starting from cycles 1 day 1 and cycle 2, every 2 weeks in cycles 3 through 6, dexamethasone 40 mg weekly (on days of daratumumab dosing, dexamethasone was split, 20 mg as premedication and 20 mg as post daratumumab dosing), cyclophosphamide 300 mg/m\^2 orally or IV maximum weekly dose 500 mg, bortezomib 1.3 mg/m\^2 SC injection once weekly. After 6 cycles, participants continued to receive daratumumab SC monotherapy until disease progression, start of subsequent therapy or up to 26.71 months from the first dose of study treatment. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
|
|---|---|---|
|
Time to Cardiac Response
|
4.67 Months
Interval 0.9 to 25.5
|
3.84 Months
Interval 1.0 to 17.8
|
SECONDARY outcome
Timeframe: From date of first randomization (Day -3) up to 6.5 yearsPopulation: Liver response-evaluable participant had alkaline phosphatase \>1.5\*ULN, received treatment, and had a post-baseline test. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Data for this outcome measure was planned to be collected and analyzed for specified arms only.
Time to liver response was defined as the time between the date of randomization and the first efficacy evaluation at which the participant had liver response.
Outcome measures
| Measure |
CyBorD
n=3 Participants
Participants received dexamethasone (40 mg weekly dose)starting from cycle 1 day1 in every 28-day cycle followed by cyclophosphamide 300 mg/m\^2 orally or IV maximum weekly dose 500 mg and then bortezomib 1.3 mg/m\^2 SC injection once weekly up to 7.33 months. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
|
Daratumumab Plus CyBorD
n=6 Participants
Participants received combination therapy for six cycles of 28 days each, daratumumab 1800 mg SC weekly starting from cycles 1 day 1 and cycle 2, every 2 weeks in cycles 3 through 6, dexamethasone 40 mg weekly (on days of daratumumab dosing, dexamethasone was split, 20 mg as premedication and 20 mg as post daratumumab dosing), cyclophosphamide 300 mg/m\^2 orally or IV maximum weekly dose 500 mg, bortezomib 1.3 mg/m\^2 SC injection once weekly. After 6 cycles, participants continued to receive daratumumab SC monotherapy until disease progression, start of subsequent therapy or up to 26.71 months from the first dose of study treatment. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
|
|---|---|---|
|
Time to Liver Response
|
10.61 Months
Interval 2.0 to 15.2
|
4.68 Months
Interval 1.0 to 22.6
|
SECONDARY outcome
Timeframe: From date of first randomization (Day -3) up to 6.5 yearsPopulation: Renal response-evaluable participants had urine protein \>0.5 g/day at baseline, received treatment, and had a postbaseline urine test. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Data for this outcome measure was planned to be collected and analyzed for specified arms only.
Time to renal response was defined as the time between the date of randomization and the first efficacy evaluation at which the participant had renal response.
Outcome measures
| Measure |
CyBorD
n=55 Participants
Participants received dexamethasone (40 mg weekly dose)starting from cycle 1 day1 in every 28-day cycle followed by cyclophosphamide 300 mg/m\^2 orally or IV maximum weekly dose 500 mg and then bortezomib 1.3 mg/m\^2 SC injection once weekly up to 7.33 months. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
|
Daratumumab Plus CyBorD
n=96 Participants
Participants received combination therapy for six cycles of 28 days each, daratumumab 1800 mg SC weekly starting from cycles 1 day 1 and cycle 2, every 2 weeks in cycles 3 through 6, dexamethasone 40 mg weekly (on days of daratumumab dosing, dexamethasone was split, 20 mg as premedication and 20 mg as post daratumumab dosing), cyclophosphamide 300 mg/m\^2 orally or IV maximum weekly dose 500 mg, bortezomib 1.3 mg/m\^2 SC injection once weekly. After 6 cycles, participants continued to receive daratumumab SC monotherapy until disease progression, start of subsequent therapy or up to 26.71 months from the first dose of study treatment. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
|
|---|---|---|
|
Time to Renal Response
|
3.75 Months
Interval 0.9 to 42.2
|
1.91 Months
Interval 0.4 to 38.3
|
SECONDARY outcome
Timeframe: From date of first randomization (Day -3) up to 6.5 yearsPopulation: The intent to treat analysis set included all randomized participants. Data for this outcome measure was planned to be collected and analyzed for specified arms only.
Time to subsequent non-cross resistant anti-plasma cell therapy was defined as the time from the date of randomization to the start date of subsequent non-cross resistant, anti-plasma cell therapy.
Outcome measures
| Measure |
CyBorD
n=193 Participants
Participants received dexamethasone (40 mg weekly dose)starting from cycle 1 day1 in every 28-day cycle followed by cyclophosphamide 300 mg/m\^2 orally or IV maximum weekly dose 500 mg and then bortezomib 1.3 mg/m\^2 SC injection once weekly up to 7.33 months. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
|
Daratumumab Plus CyBorD
n=195 Participants
Participants received combination therapy for six cycles of 28 days each, daratumumab 1800 mg SC weekly starting from cycles 1 day 1 and cycle 2, every 2 weeks in cycles 3 through 6, dexamethasone 40 mg weekly (on days of daratumumab dosing, dexamethasone was split, 20 mg as premedication and 20 mg as post daratumumab dosing), cyclophosphamide 300 mg/m\^2 orally or IV maximum weekly dose 500 mg, bortezomib 1.3 mg/m\^2 SC injection once weekly. After 6 cycles, participants continued to receive daratumumab SC monotherapy until disease progression, start of subsequent therapy or up to 26.71 months from the first dose of study treatment. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
|
|---|---|---|
|
Time to Subsequent Non-cross Resistant Anti-plasma Cell Therapy
|
11.30 Months
Interval 8.71 to 21.03
|
NA Months
Here, 'NA' signifies that median, lower limit and upper limit of 95% CI could not be estimated due to an insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: From date of first randomization (Day -3) up to 6.5 yearsPopulation: Responders in intent-to-treat analysis set included all randomized participants. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Data for this outcome measure was planned to be collected and analyzed for specified arms only.
Duration of CHR was defined as the time between the date of initial documentation of CHR to the date of first documented evidence of hematologic progressive diseased. CHR was primarily defined by negative immunofixation results and normalized FLC parameters.
Outcome measures
| Measure |
CyBorD
n=37 Participants
Participants received dexamethasone (40 mg weekly dose)starting from cycle 1 day1 in every 28-day cycle followed by cyclophosphamide 300 mg/m\^2 orally or IV maximum weekly dose 500 mg and then bortezomib 1.3 mg/m\^2 SC injection once weekly up to 7.33 months. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
|
Daratumumab Plus CyBorD
n=116 Participants
Participants received combination therapy for six cycles of 28 days each, daratumumab 1800 mg SC weekly starting from cycles 1 day 1 and cycle 2, every 2 weeks in cycles 3 through 6, dexamethasone 40 mg weekly (on days of daratumumab dosing, dexamethasone was split, 20 mg as premedication and 20 mg as post daratumumab dosing), cyclophosphamide 300 mg/m\^2 orally or IV maximum weekly dose 500 mg, bortezomib 1.3 mg/m\^2 SC injection once weekly. After 6 cycles, participants continued to receive daratumumab SC monotherapy until disease progression, start of subsequent therapy or up to 26.71 months from the first dose of study treatment. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
|
|---|---|---|
|
Duration of Complete Hematologic Response (CHR)
|
NA Months
Interval 56.74 to
Here, 'NA' signifies that Median and upper limit of 95% CI could not be estimated due to an insufficient number of participants with events.
|
NA Months
Here, 'NA' signifies that Median, lower limit and upper limit of 95% CIcould not be estimated due to an insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: From date of first randomization (Day -3) up to 6.5 yearsPopulation: The intent to treat analysis set included all randomized participants. Data for this outcome measure was planned to be collected and analyzed for specified arms only.
Hematologic VGPR or Better Rate was defined as percentage of participants who achieved hematologic Complete response (CR) or VGPR. VGPR was defined as the difference between involved iFLC and uFLC after treatment for baseline difference between iFLC and uFLC (dFLC) \>50 milligrams per liter (mg/L): Reduction in the dFLC \<40 mg/L. For Baseline dFLC \< 50 mg/L: more than (\>) 90% reduction in serum M-protein plus urine M-protein \<100 mg/24 hours. CR was negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, and \< 5% PCs in bone marrow.
Outcome measures
| Measure |
CyBorD
n=193 Participants
Participants received dexamethasone (40 mg weekly dose)starting from cycle 1 day1 in every 28-day cycle followed by cyclophosphamide 300 mg/m\^2 orally or IV maximum weekly dose 500 mg and then bortezomib 1.3 mg/m\^2 SC injection once weekly up to 7.33 months. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
|
Daratumumab Plus CyBorD
n=195 Participants
Participants received combination therapy for six cycles of 28 days each, daratumumab 1800 mg SC weekly starting from cycles 1 day 1 and cycle 2, every 2 weeks in cycles 3 through 6, dexamethasone 40 mg weekly (on days of daratumumab dosing, dexamethasone was split, 20 mg as premedication and 20 mg as post daratumumab dosing), cyclophosphamide 300 mg/m\^2 orally or IV maximum weekly dose 500 mg, bortezomib 1.3 mg/m\^2 SC injection once weekly. After 6 cycles, participants continued to receive daratumumab SC monotherapy until disease progression, start of subsequent therapy or up to 26.71 months from the first dose of study treatment. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
|
|---|---|---|
|
Hematologic Very Good Partial Response (VGPR) or Better Rate
|
50.3 Percentage of participants
Interval 43.0 to 57.5
|
79.0 Percentage of participants
Interval 72.6 to 84.5
|
SECONDARY outcome
Timeframe: Baseline (Day -28), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92 and 96Population: The intent to treat analysis set included all randomized participants. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. Here 'n' (number analyzed) signifies number of participants analyzed at specified timepoints. Data for this outcome measure was planned to be collected and analyzed for specified arms only.
The EORTC-QLQ-C30 a 30-question tool was used to assess the overall quality of life (QoL) in cancer patients. It included 30 items resulting in 5 functional scales (physical, role, emotional, cognitive, and social functioning), 1 Global health status (GHS) scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single 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 were transformed to a 0 to 100 scale, with higher scores representing better GHS, better functioning, and more symptoms.
Outcome measures
| Measure |
CyBorD
n=178 Participants
Participants received dexamethasone (40 mg weekly dose)starting from cycle 1 day1 in every 28-day cycle followed by cyclophosphamide 300 mg/m\^2 orally or IV maximum weekly dose 500 mg and then bortezomib 1.3 mg/m\^2 SC injection once weekly up to 7.33 months. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
|
Daratumumab Plus CyBorD
n=179 Participants
Participants received combination therapy for six cycles of 28 days each, daratumumab 1800 mg SC weekly starting from cycles 1 day 1 and cycle 2, every 2 weeks in cycles 3 through 6, dexamethasone 40 mg weekly (on days of daratumumab dosing, dexamethasone was split, 20 mg as premedication and 20 mg as post daratumumab dosing), cyclophosphamide 300 mg/m\^2 orally or IV maximum weekly dose 500 mg, bortezomib 1.3 mg/m\^2 SC injection once weekly. After 6 cycles, participants continued to receive daratumumab SC monotherapy until disease progression, start of subsequent therapy or up to 26.71 months from the first dose of study treatment. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
|
|---|---|---|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Fatigue
Week 28
|
3.30 Score on scale
Interval -0.9 to 7.51
|
2.14 Score on scale
Interval -4.41 to 8.69
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Fatigue
Week 16
|
9.92 Score on scale
Interval 6.25 to 13.6
|
1.54 Score on scale
Interval -2.1 to 5.17
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Fatigue
Week 20
|
6.83 Score on scale
Interval 3.01 to 10.65
|
3.87 Score on scale
Interval 0.27 to 7.47
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Fatigue
Week 24
|
0.69 Score on scale
Interval -5.4 to 6.79
|
0.30 Score on scale
Interval -3.37 to 3.98
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Fatigue
Week 12
|
6.35 Score on scale
Interval 2.74 to 9.96
|
2.77 Score on scale
Interval -0.82 to 6.37
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Fatigue
Week 32
|
-3.14 Score on scale
Interval -11.77 to 5.49
|
-4.92 Score on scale
Interval -8.82 to -1.03
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Fatigue
Week 4
|
3.79 Score on scale
Interval 0.33 to 7.25
|
2.07 Score on scale
Interval -1.39 to 5.53
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Fatigue
Week 8
|
4.04 Score on scale
Interval 0.5 to 7.58
|
3.93 Score on scale
Interval 0.44 to 7.42
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Fatigue
Week 36
|
-10.25 Score on scale
Interval -21.95 to 1.45
|
-12.59 Score on scale
Interval -20.06 to -5.13
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Fatigue
Week 40
|
2.09 Score on scale
Interval -7.49 to 11.68
|
-5.39 Score on scale
Interval -9.34 to -1.43
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Fatigue
Week 44
|
1.57 Score on scale
Interval -9.46 to 12.59
|
-9.55 Score on scale
Interval -17.19 to -1.9
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Fatigue
Week 48
|
-2.82 Score on scale
Interval -8.98 to 3.34
|
-7.99 Score on scale
Interval -12.03 to -3.95
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Fatigue
Week 52
|
-1.69 Score on scale
Interval -9.28 to 5.9
|
-5.56 Score on scale
Interval -12.58 to 1.46
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Fatigue
Week 56
|
-1.88 Score on scale
Interval -10.0 to 6.24
|
-6.77 Score on scale
Interval -10.89 to -2.64
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Fatigue
Week 60
|
-2.62 Score on scale
Interval -10.99 to 5.75
|
-9.23 Score on scale
Interval -16.12 to -2.34
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Fatigue
Week 64
|
-3.55 Score on scale
Interval -13.13 to 6.04
|
-10.36 Score on scale
Interval -14.61 to -6.12
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Fatigue
Week 68
|
0.84 Score on scale
Interval -9.63 to 11.3
|
-5.96 Score on scale
Interval -11.9 to -0.03
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Fatigue
Week 72
|
-0.44 Score on scale
Interval -7.55 to 6.67
|
-11.80 Score on scale
Interval -16.16 to -7.45
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Fatigue
Week 76
|
-5.08 Score on scale
Interval -14.68 to 4.51
|
-8.91 Score on scale
Interval -15.07 to -2.75
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Fatigue
Week 80
|
-6.00 Score on scale
Interval -12.96 to 0.97
|
-10.79 Score on scale
Interval -15.07 to -6.51
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Fatigue
Week 84
|
-17.23 Score on scale
Interval -28.87 to -5.58
|
-10.39 Score on scale
Interval -16.63 to -4.14
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Fatigue
Week 88
|
-6.71 Score on scale
Interval -16.34 to 2.91
|
-9.83 Score on scale
Interval -14.08 to -5.57
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Fatigue
Week 92
|
-7.43 Score on scale
Interval -19.78 to 4.92
|
-12.11 Score on scale
Interval -18.43 to -5.78
|
|
Change From Baseline in the European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Fatigue
Week 96
|
-5.75 Score on scale
Interval -13.87 to 2.37
|
-8.56 Score on scale
Interval -13.16 to -3.95
|
SECONDARY outcome
Timeframe: Baseline (Day -28), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92 and 96Population: The intent to treat analysis set included all randomized participants. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. Here 'n' (number analyzed) signifies number of participants analyzed at specified timepoints. Data for this outcome measure was planned to be collected and analyzed for specified arms only.
The SF-36 Health Survey was a generic measure of health status. The SF-36 consisted of 36 questions that yield an eight-scale (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health) profile of functional health and well-being, as well as 2 physical and mental health summary measures and a preference-based health utility index. The physical component summary (PCS), the mental component summary (MCS), and the 8 domain scores range from zero (0) to 100, with higher scores representing higher level of functioning.
Outcome measures
| Measure |
CyBorD
n=176 Participants
Participants received dexamethasone (40 mg weekly dose)starting from cycle 1 day1 in every 28-day cycle followed by cyclophosphamide 300 mg/m\^2 orally or IV maximum weekly dose 500 mg and then bortezomib 1.3 mg/m\^2 SC injection once weekly up to 7.33 months. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
|
Daratumumab Plus CyBorD
n=176 Participants
Participants received combination therapy for six cycles of 28 days each, daratumumab 1800 mg SC weekly starting from cycles 1 day 1 and cycle 2, every 2 weeks in cycles 3 through 6, dexamethasone 40 mg weekly (on days of daratumumab dosing, dexamethasone was split, 20 mg as premedication and 20 mg as post daratumumab dosing), cyclophosphamide 300 mg/m\^2 orally or IV maximum weekly dose 500 mg, bortezomib 1.3 mg/m\^2 SC injection once weekly. After 6 cycles, participants continued to receive daratumumab SC monotherapy until disease progression, start of subsequent therapy or up to 26.71 months from the first dose of study treatment. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
|
|---|---|---|
|
Change From Baseline in the Short Form Health Survey, Version 2, the Mental Component Summary, (SF-36v2 MCS)
Week 4
|
-0.43 Score on scale
Interval -1.95 to 1.09
|
-0.19 Score on scale
Interval -1.71 to 1.34
|
|
Change From Baseline in the Short Form Health Survey, Version 2, the Mental Component Summary, (SF-36v2 MCS)
Week 8
|
-1.09 Score on scale
Interval -2.64 to 0.46
|
-1.42 Score on scale
Interval -2.96 to 0.12
|
|
Change From Baseline in the Short Form Health Survey, Version 2, the Mental Component Summary, (SF-36v2 MCS)
Week 12
|
-1.86 Score on scale
Interval -3.44 to -0.28
|
-0.17 Score on scale
Interval -1.74 to 1.4
|
|
Change From Baseline in the Short Form Health Survey, Version 2, the Mental Component Summary, (SF-36v2 MCS)
Week 16
|
-3.15 Score on scale
Interval -4.76 to -1.54
|
-0.35 Score on scale
Interval -1.94 to 1.23
|
|
Change From Baseline in the Short Form Health Survey, Version 2, the Mental Component Summary, (SF-36v2 MCS)
Week 20
|
-2.36 Score on scale
Interval -4.04 to -0.68
|
-0.42 Score on scale
Interval -1.99 to 1.16
|
|
Change From Baseline in the Short Form Health Survey, Version 2, the Mental Component Summary, (SF-36v2 MCS)
Week 24
|
-1.84 Score on scale
Interval -4.5 to 0.82
|
-0.60 Score on scale
Interval -2.2 to 1.01
|
|
Change From Baseline in the Short Form Health Survey, Version 2, the Mental Component Summary, (SF-36v2 MCS)
Week 28
|
-3.26 Score on scale
Interval -5.1 to -1.42
|
-0.93 Score on scale
Interval -3.74 to 1.88
|
|
Change From Baseline in the Short Form Health Survey, Version 2, the Mental Component Summary, (SF-36v2 MCS)
Week 32
|
0.19 Score on scale
Interval -3.51 to 3.89
|
0.61 Score on scale
Interval -1.09 to 2.31
|
|
Change From Baseline in the Short Form Health Survey, Version 2, the Mental Component Summary, (SF-36v2 MCS)
Week 36
|
-0.45 Score on scale
Interval -5.47 to 4.57
|
1.22 Score on scale
Interval -2.05 to 4.49
|
|
Change From Baseline in the Short Form Health Survey, Version 2, the Mental Component Summary, (SF-36v2 MCS)
Week 40
|
-0.56 Score on scale
Interval -4.67 to 3.54
|
2.02 Score on scale
Interval 0.3 to 3.74
|
|
Change From Baseline in the Short Form Health Survey, Version 2, the Mental Component Summary, (SF-36v2 MCS)
Week 44
|
1.30 Score on scale
Interval -3.7 to 6.3
|
1.55 Score on scale
Interval -1.73 to 4.82
|
|
Change From Baseline in the Short Form Health Survey, Version 2, the Mental Component Summary, (SF-36v2 MCS)
Week 48
|
0.26 Score on scale
Interval -2.39 to 2.91
|
2.18 Score on scale
Interval 0.41 to 3.94
|
|
Change From Baseline in the Short Form Health Survey, Version 2, the Mental Component Summary, (SF-36v2 MCS)
Week 52
|
0.69 Score on scale
Interval -2.57 to 3.94
|
1.33 Score on scale
Interval -1.73 to 4.39
|
|
Change From Baseline in the Short Form Health Survey, Version 2, the Mental Component Summary, (SF-36v2 MCS)
Week 56
|
-0.35 Score on scale
Interval -3.83 to 3.13
|
0.91 Score on scale
Interval -0.88 to 2.71
|
|
Change From Baseline in the Short Form Health Survey, Version 2, the Mental Component Summary, (SF-36v2 MCS)
Week 60
|
2.20 Score on scale
Interval -1.39 to 5.79
|
1.32 Score on scale
Interval -1.64 to 4.28
|
|
Change From Baseline in the Short Form Health Survey, Version 2, the Mental Component Summary, (SF-36v2 MCS)
Week 64
|
-2.00 Score on scale
Interval -6.28 to 2.28
|
2.74 Score on scale
Interval 0.9 to 4.58
|
|
Change From Baseline in the Short Form Health Survey, Version 2, the Mental Component Summary, (SF-36v2 MCS)
Week 68
|
0.68 Score on scale
Interval -3.81 to 5.17
|
1.25 Score on scale
Interval -1.32 to 3.83
|
|
Change From Baseline in the Short Form Health Survey, Version 2, the Mental Component Summary, (SF-36v2 MCS)
Week 72
|
-1.21 Score on scale
Interval -4.26 to 1.84
|
2.03 Score on scale
Interval 0.14 to 3.92
|
|
Change From Baseline in the Short Form Health Survey, Version 2, the Mental Component Summary, (SF-36v2 MCS)
Week 76
|
1.05 Score on scale
Interval -3.07 to 5.17
|
0.12 Score on scale
Interval -2.56 to 2.8
|
|
Change From Baseline in the Short Form Health Survey, Version 2, the Mental Component Summary, (SF-36v2 MCS)
Week 80
|
0.47 Score on scale
Interval -2.58 to 3.52
|
2.32 Score on scale
Interval 0.44 to 4.2
|
|
Change From Baseline in the Short Form Health Survey, Version 2, the Mental Component Summary, (SF-36v2 MCS)
Week 84
|
3.21 Score on scale
Interval -1.77 to 8.19
|
1.56 Score on scale
Interval -1.12 to 4.25
|
|
Change From Baseline in the Short Form Health Survey, Version 2, the Mental Component Summary, (SF-36v2 MCS)
Week 88
|
2.12 Score on scale
Interval -2.35 to 6.59
|
2.57 Score on scale
Interval 0.72 to 4.42
|
|
Change From Baseline in the Short Form Health Survey, Version 2, the Mental Component Summary, (SF-36v2 MCS)
Week 92
|
-2.50 Score on scale
Interval -7.78 to 2.78
|
1.31 Score on scale
Interval -1.4 to 4.02
|
|
Change From Baseline in the Short Form Health Survey, Version 2, the Mental Component Summary, (SF-36v2 MCS)
Week 96
|
-0.03 Score on scale
Interval -3.61 to 3.55
|
2.96 Score on scale
Interval 0.96 to 4.96
|
SECONDARY outcome
Timeframe: Baseline (Day -28), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92 and 96Population: The intent to treat analysis set included all randomized participants. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. Here 'n' (number analyzed) signifies number of participants analyzed at specified timepoints. Data for this outcome measure was planned to be collected and analyzed for specified arms only.
The EORTC-QLQ-C30 a 30-question tool was used to assess the overall QoL in cancer patients. It included 30 items resulting in 5 functional scales (physical, role, emotional, cognitive, and social functioning), 1 GHS scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single 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 were transformed to a 0 to 100 scale, with higher scores representing better GHS, better functioning, and more symptoms.
Outcome measures
| Measure |
CyBorD
n=178 Participants
Participants received dexamethasone (40 mg weekly dose)starting from cycle 1 day1 in every 28-day cycle followed by cyclophosphamide 300 mg/m\^2 orally or IV maximum weekly dose 500 mg and then bortezomib 1.3 mg/m\^2 SC injection once weekly up to 7.33 months. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
|
Daratumumab Plus CyBorD
n=179 Participants
Participants received combination therapy for six cycles of 28 days each, daratumumab 1800 mg SC weekly starting from cycles 1 day 1 and cycle 2, every 2 weeks in cycles 3 through 6, dexamethasone 40 mg weekly (on days of daratumumab dosing, dexamethasone was split, 20 mg as premedication and 20 mg as post daratumumab dosing), cyclophosphamide 300 mg/m\^2 orally or IV maximum weekly dose 500 mg, bortezomib 1.3 mg/m\^2 SC injection once weekly. After 6 cycles, participants continued to receive daratumumab SC monotherapy until disease progression, start of subsequent therapy or up to 26.71 months from the first dose of study treatment. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
|
|---|---|---|
|
Change From Baseline in EORTC QLQ-C30 Global Health Status Score
Week 4
|
-3.02 Score on scale
Interval -5.89 to -0.14
|
-2.72 Score on scale
Interval -5.59 to 0.16
|
|
Change From Baseline in EORTC QLQ-C30 Global Health Status Score
Week 8
|
-4.15 Score on scale
Interval -7.09 to -1.21
|
-3.83 Score on scale
Interval -6.73 to -0.93
|
|
Change From Baseline in EORTC QLQ-C30 Global Health Status Score
Week 12
|
-6.00 Score on scale
Interval -9.01 to -3.0
|
-1.70 Score on scale
Interval -4.7 to 1.29
|
|
Change From Baseline in EORTC QLQ-C30 Global Health Status Score
Week 16
|
-7.17 Score on scale
Interval -10.23 to -4.11
|
-2.75 Score on scale
Interval -5.78 to 0.28
|
|
Change From Baseline in EORTC QLQ-C30 Global Health Status Score
Week 20
|
-5.46 Score on scale
Interval -8.65 to -2.27
|
-2.53 Score on scale
Interval -5.52 to 0.47
|
|
Change From Baseline in EORTC QLQ-C30 Global Health Status Score
Week 24
|
-4.26 Score on scale
Interval -9.43 to 0.92
|
-0.76 Score on scale
Interval -3.83 to 2.31
|
|
Change From Baseline in EORTC QLQ-C30 Global Health Status Score
Week 28
|
-3.81 Score on scale
Interval -7.34 to -0.29
|
-1.96 Score on scale
Interval -7.53 to 3.61
|
|
Change From Baseline in EORTC QLQ-C30 Global Health Status Score
Week 32
|
3.03 Score on scale
Interval -4.33 to 10.39
|
1.36 Score on scale
Interval -1.9 to 4.62
|
|
Change From Baseline in EORTC QLQ-C30 Global Health Status Score
Week 36
|
2.97 Score on scale
Interval -7.02 to 12.97
|
3.09 Score on scale
Interval -3.27 to 9.45
|
|
Change From Baseline in EORTC QLQ-C30 Global Health Status Score
Week 40
|
-6.13 Score on scale
Interval -14.31 to 2.05
|
5.10 Score on scale
Interval 1.79 to 8.41
|
|
Change From Baseline in EORTC QLQ-C30 Global Health Status Score
Week 44
|
-1.37 Score on scale
Interval -10.79 to 8.05
|
0.16 Score on scale
Interval -6.36 to 6.68
|
|
Change From Baseline in EORTC QLQ-C30 Global Health Status Score
Week 48
|
-0.71 Score on scale
Interval -5.94 to 4.52
|
6.79 Score on scale
Interval 3.4 to 10.17
|
|
Change From Baseline in EORTC QLQ-C30 Global Health Status Score
Week 52
|
-0.17 Score on scale
Interval -6.63 to 6.3
|
8.61 Score on scale
Interval 2.64 to 14.59
|
|
Change From Baseline in EORTC QLQ-C30 Global Health Status Score
Week 56
|
3.62 Score on scale
Interval -3.3 to 10.54
|
4.02 Score on scale
Interval 0.56 to 7.49
|
|
Change From Baseline in EORTC QLQ-C30 Global Health Status Score
Week 60
|
2.33 Score on scale
Interval -4.8 to 9.47
|
5.85 Score on scale
Interval -0.02 to 11.71
|
|
Change From Baseline in EORTC QLQ-C30 Global Health Status Score
Week 64
|
-5.49 Score on scale
Interval -13.67 to 2.7
|
8.27 Score on scale
Interval 4.7 to 11.83
|
|
Change From Baseline in EORTC QLQ-C30 Global Health Status Score
Week 68
|
6.19 Score on scale
Interval -2.75 to 15.14
|
4.95 Score on scale
Interval -0.08 to 9.99
|
|
Change From Baseline in EORTC QLQ-C30 Global Health Status Score
Week 72
|
-4.26 Score on scale
Interval -10.31 to 1.79
|
8.94 Score on scale
Interval 5.27 to 12.6
|
|
Change From Baseline in EORTC QLQ-C30 Global Health Status Score
Week 76
|
2.00 Score on scale
Interval -6.19 to 10.19
|
10.34 Score on scale
Interval 5.11 to 15.57
|
|
Change From Baseline in EORTC QLQ-C30 Global Health Status Score
Week 80
|
4.13 Score on scale
Interval -1.79 to 10.06
|
7.05 Score on scale
Interval 3.45 to 10.65
|
|
Change From Baseline in EORTC QLQ-C30 Global Health Status Score
Week 84
|
3.69 Score on scale
Interval -6.26 to 13.64
|
6.85 Score on scale
Interval 1.54 to 12.15
|
|
Change From Baseline in EORTC QLQ-C30 Global Health Status Score
Week 88
|
-2.95 Score on scale
Interval -11.16 to 5.26
|
7.59 Score on scale
Interval 4.01 to 11.16
|
|
Change From Baseline in EORTC QLQ-C30 Global Health Status Score
Week 92
|
3.18 Score on scale
Interval -7.39 to 13.74
|
8.08 Score on scale
Interval 2.7 to 13.45
|
|
Change From Baseline in EORTC QLQ-C30 Global Health Status Score
Week 96
|
6.54 Score on scale
Interval -0.38 to 13.47
|
8.03 Score on scale
Interval 4.15 to 11.91
|
Adverse Events
Run-In: Daratumumab Plus CyBorD
CyBorD
Daratumumab Plus CyBorD
Serious adverse events
| Measure |
Run-In: Daratumumab Plus CyBorD
n=28 participants at risk
Participants received the combination therapy during Run-in phase starting with 20 milligrams (mg) dexamethasone as premedication followed by daratumumab 1800 mg on Day 1 Cycle 1, then cyclophosphamide 300 milligram per meter square (mg/m\^2) orally or intravenous (IV) maximum weekly dose 500 mg, followed by bortezomib 1.3 mg/m\^2 subcutaneous (SC) injection once every week and dexamethasone remaining 20 mg post daratumumab dosing for up to 1 cycle (28 Days) to assess the safety before randomizing participants in CyBorD or daratumumab plus CyBorD arms. However, participants also continued daratumumab plus CyBorD for up to 6 cycles and then daratumumab monotherapy for up to 24 months from the start of treatment. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
|
CyBorD
n=188 participants at risk
Participants received dexamethasone (40 mg weekly dose)starting from cycle 1 day1 in every 28-day cycle followed by cyclophosphamide 300 mg/m\^2 orally or IV maximum weekly dose 500 mg and then bortezomib 1.3 mg/m\^2 SC injection once weekly up to 7.33 months. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
|
Daratumumab Plus CyBorD
n=193 participants at risk
Participants received combination therapy for six cycles of 28 days each, daratumumab 1800 mg SC weekly starting from cycles 1 day 1 and cycle 2, every 2 weeks in cycles 3 through 6, dexamethasone 40 mg weekly (on days of daratumumab dosing, dexamethasone was split, 20 mg as premedication and 20 mg as post daratumumab dosing), cyclophosphamide 300 mg/m\^2 orally or IV maximum weekly dose 500 mg, bortezomib 1.3 mg/m\^2 SC injection once weekly. After 6 cycles, participants continued to receive daratumumab SC monotherapy until disease progression, start of subsequent therapy or up to 26.71 months from the first dose of study treatment. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.6%
1/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.53%
1/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Blood and lymphatic system disorders
Haemorrhagic Diathesis
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.53%
1/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Cardiac disorders
Acute Left Ventricular Failure
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.53%
1/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.53%
1/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.53%
1/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
1.0%
2/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
1.1%
2/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Cardiac disorders
Arteriospasm Coronary
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
1.1%
2/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
3.1%
6/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
1.0%
2/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Cardiac disorders
Atrial Tachycardia
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.53%
1/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Cardiac disorders
Atrial Thrombosis
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.53%
1/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Cardiac disorders
Bradyarrhythmia
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
1.6%
3/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
4.1%
8/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Cardiac disorders
Cardiac Failure
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
4.3%
8/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
7.3%
14/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Cardiac disorders
Cardiac Failure Congestive
|
3.6%
1/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
1.1%
2/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Cardiac disorders
Cardiogenic Shock
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.53%
1/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Cardiac disorders
Cardiovascular Insufficiency
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Cardiac disorders
Left Ventricular Dysfunction
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Cardiac disorders
Mitral Valve Incompetence
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.53%
1/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
1.1%
2/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Cardiac disorders
Sinus Bradycardia
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.53%
1/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Cardiac disorders
Sinus Node Dysfunction
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.53%
1/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Cardiac disorders
Sinus Tachycardia
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.53%
1/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Congenital, familial and genetic disorders
Hereditary Haemorrhagic Telangiectasia
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Eye disorders
Amaurosis Fugax
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.53%
1/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Gastrointestinal disorders
Colitis Ischaemic
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Gastrointestinal disorders
Diarrhoea
|
3.6%
1/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
2.1%
4/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
1.6%
3/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Gastrointestinal disorders
Gastric Haemorrhage
|
3.6%
1/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.53%
1/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
1.1%
2/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
General disorders
Asthenia
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
1.6%
3/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
General disorders
Chest Pain
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.53%
1/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
General disorders
Fatigue
|
3.6%
1/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.53%
1/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
General disorders
General Physical Health Deterioration
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.53%
1/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
General disorders
Malaise
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.53%
1/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
General disorders
Multiple Organ Dysfunction Syndrome
|
3.6%
1/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.53%
1/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
General disorders
Oedema
|
3.6%
1/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
General disorders
Oedema Peripheral
|
3.6%
1/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
1.1%
2/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
1.6%
3/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
General disorders
Peripheral Swelling
|
3.6%
1/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
General disorders
Pyrexia
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.53%
1/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
General disorders
Sudden Cardiac Death
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.53%
1/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
General disorders
Sudden Death
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
1.6%
3/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
3.1%
6/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Hepatobiliary disorders
Bile Duct Stone
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Infections and infestations
Adenovirus Infection
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Infections and infestations
Biliary Sepsis
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.53%
1/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Infections and infestations
Candida Sepsis
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Infections and infestations
Cellulitis
|
7.1%
2/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.53%
1/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
1.0%
2/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Infections and infestations
Escherichia Bacteraemia
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Infections and infestations
Gastrointestinal Infection
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.53%
1/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.53%
1/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Infections and infestations
Influenza
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
1.1%
2/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
1.6%
3/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Infections and infestations
Lower Respiratory Tract Infection Viral
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Infections and infestations
Neutropenic Sepsis
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Infections and infestations
Orchitis
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Infections and infestations
Peritonitis
|
3.6%
1/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Infections and infestations
Pneumonia
|
7.1%
2/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
4.8%
9/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
7.3%
14/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Infections and infestations
Pneumonia Pneumococcal
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.53%
1/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Infections and infestations
Pulmonary Sepsis
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Infections and infestations
Pyelonephritis Acute
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Infections and infestations
Respiratory Syncytial Virus Infection
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Infections and infestations
Respiratory Tract Infection
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Infections and infestations
Respiratory Tract Infection Viral
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Infections and infestations
Rhinovirus Infection
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Infections and infestations
Sepsis
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
3.6%
7/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Infections and infestations
Septic Shock
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.53%
1/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
1.0%
2/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
3.6%
1/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.53%
1/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
2.1%
4/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Infections and infestations
Wound Infection
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Injury, poisoning and procedural complications
Delayed Engraftment
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Injury, poisoning and procedural complications
Fall
|
10.7%
3/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.53%
1/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.53%
1/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Injury, poisoning and procedural complications
Traumatic Liver Injury
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.53%
1/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Investigations
Influenza A Virus Test Positive
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Investigations
Weight Decreased
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.53%
1/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Metabolism and nutrition disorders
Dehydration
|
3.6%
1/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
1.1%
2/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
1.0%
2/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Metabolism and nutrition disorders
Failure to Thrive
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Metabolism and nutrition disorders
Fluid Overload
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
2.7%
5/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Metabolism and nutrition disorders
Hyperglycaemic Hyperosmolar Nonketotic Syndrome
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
1.0%
2/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.53%
1/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.6%
1/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
1.6%
3/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
3.6%
1/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Musculoskeletal and connective tissue disorders
Connective Tissue Inflammation
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
3.6%
1/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.53%
1/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
1.0%
2/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Cancer
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Melanoma
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.53%
1/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Nervous system disorders
Facial Paralysis
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Nervous system disorders
Ischaemic Stroke
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.53%
1/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Nervous system disorders
Peripheral Sensorimotor Neuropathy
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Nervous system disorders
Status Epilepticus
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.53%
1/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Nervous system disorders
Syncope
|
3.6%
1/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
3.2%
6/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
2.1%
4/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
1.1%
2/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Psychiatric disorders
Delirium
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Psychiatric disorders
Depressed Mood
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Psychiatric disorders
Depression
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.53%
1/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Psychiatric disorders
Mental Status Changes
|
3.6%
1/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Psychiatric disorders
Suicide Attempt
|
3.6%
1/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Renal and urinary disorders
Acute Kidney Injury
|
10.7%
3/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.53%
1/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
1.6%
3/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Renal and urinary disorders
Chronic Kidney Disease
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.53%
1/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Renal and urinary disorders
Nephrolithiasis
|
3.6%
1/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Renal and urinary disorders
Nephropathy
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Renal and urinary disorders
Nephrotic Syndrome
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
1.1%
2/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Renal and urinary disorders
Renal Impairment
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.53%
1/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Reproductive system and breast disorders
Female Genital Tract Fistula
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Respiratory, thoracic and mediastinal disorders
Acute Pulmonary Oedema
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.53%
1/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.53%
1/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.53%
1/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
1.6%
3/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
2.1%
4/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.53%
1/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Respiratory, thoracic and mediastinal disorders
Lung Disorder
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.53%
1/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
2.1%
4/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.53%
1/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
1.0%
2/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.53%
1/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Haemorrhage
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
3.6%
1/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
1.1%
2/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Skin and subcutaneous tissue disorders
Skin Mass
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Surgical and medical procedures
Elective Surgery
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Vascular disorders
Circulatory Collapse
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.53%
1/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Vascular disorders
Hypotension
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.53%
1/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Vascular disorders
Orthostatic Hypotension
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Vascular disorders
Thrombosis
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
Other adverse events
| Measure |
Run-In: Daratumumab Plus CyBorD
n=28 participants at risk
Participants received the combination therapy during Run-in phase starting with 20 milligrams (mg) dexamethasone as premedication followed by daratumumab 1800 mg on Day 1 Cycle 1, then cyclophosphamide 300 milligram per meter square (mg/m\^2) orally or intravenous (IV) maximum weekly dose 500 mg, followed by bortezomib 1.3 mg/m\^2 subcutaneous (SC) injection once every week and dexamethasone remaining 20 mg post daratumumab dosing for up to 1 cycle (28 Days) to assess the safety before randomizing participants in CyBorD or daratumumab plus CyBorD arms. However, participants also continued daratumumab plus CyBorD for up to 6 cycles and then daratumumab monotherapy for up to 24 months from the start of treatment. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
|
CyBorD
n=188 participants at risk
Participants received dexamethasone (40 mg weekly dose)starting from cycle 1 day1 in every 28-day cycle followed by cyclophosphamide 300 mg/m\^2 orally or IV maximum weekly dose 500 mg and then bortezomib 1.3 mg/m\^2 SC injection once weekly up to 7.33 months. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
|
Daratumumab Plus CyBorD
n=193 participants at risk
Participants received combination therapy for six cycles of 28 days each, daratumumab 1800 mg SC weekly starting from cycles 1 day 1 and cycle 2, every 2 weeks in cycles 3 through 6, dexamethasone 40 mg weekly (on days of daratumumab dosing, dexamethasone was split, 20 mg as premedication and 20 mg as post daratumumab dosing), cyclophosphamide 300 mg/m\^2 orally or IV maximum weekly dose 500 mg, bortezomib 1.3 mg/m\^2 SC injection once weekly. After 6 cycles, participants continued to receive daratumumab SC monotherapy until disease progression, start of subsequent therapy or up to 26.71 months from the first dose of study treatment. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
46.4%
13/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
23.4%
44/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
25.4%
49/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Blood and lymphatic system disorders
Eosinopenia
|
7.1%
2/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Blood and lymphatic system disorders
Leukocytosis
|
7.1%
2/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.53%
1/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Blood and lymphatic system disorders
Leukopenia
|
17.9%
5/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
3.7%
7/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
5.7%
11/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Blood and lymphatic system disorders
Lymphopenia
|
42.9%
12/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
14.9%
28/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
19.2%
37/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Blood and lymphatic system disorders
Neutropenia
|
10.7%
3/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
6.4%
12/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
10.9%
21/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
25.0%
7/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
11.2%
21/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
17.6%
34/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Cardiac disorders
Palpitations
|
3.6%
1/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
3.2%
6/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
6.2%
12/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Ear and labyrinth disorders
Tinnitus
|
7.1%
2/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
2.1%
4/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Eye disorders
Dry Eye
|
14.3%
4/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
1.1%
2/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
2.6%
5/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Eye disorders
Ocular Hyperaemia
|
7.1%
2/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
1.1%
2/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
1.0%
2/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Eye disorders
Vision Blurred
|
17.9%
5/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
4.3%
8/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
6.7%
13/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Gastrointestinal disorders
Abdominal Distension
|
10.7%
3/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
6.4%
12/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
7.8%
15/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Gastrointestinal disorders
Abdominal Pain
|
17.9%
5/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
9.0%
17/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
10.9%
21/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
3.6%
1/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
6.9%
13/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
9.3%
18/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Gastrointestinal disorders
Ascites
|
7.1%
2/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
1.1%
2/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
2.1%
4/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Gastrointestinal disorders
Constipation
|
42.9%
12/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
28.7%
54/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
36.3%
70/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Gastrointestinal disorders
Diarrhoea
|
67.9%
19/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
29.3%
55/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
35.8%
69/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Gastrointestinal disorders
Dry Mouth
|
7.1%
2/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
3.2%
6/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
2.6%
5/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Gastrointestinal disorders
Dyspepsia
|
3.6%
1/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
6.4%
12/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
4.1%
8/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Gastrointestinal disorders
Flatulence
|
7.1%
2/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
3.6%
7/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Gastrointestinal disorders
Gastrointestinal Pain
|
7.1%
2/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.53%
1/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Gastrointestinal disorders
Nausea
|
42.9%
12/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
27.1%
51/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
28.5%
55/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Gastrointestinal disorders
Stomatitis
|
10.7%
3/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
2.7%
5/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
2.1%
4/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Gastrointestinal disorders
Vomiting
|
17.9%
5/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
11.2%
21/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
15.0%
29/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
General disorders
Asthenia
|
7.1%
2/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
10.6%
20/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
16.1%
31/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
General disorders
Chills
|
3.6%
1/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
2.1%
4/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
5.2%
10/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
General disorders
Fatigue
|
57.1%
16/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
27.7%
52/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
28.5%
55/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
General disorders
Injection Site Bruising
|
7.1%
2/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
2.1%
4/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
General disorders
Injection Site Discolouration
|
7.1%
2/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.53%
1/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
1.0%
2/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
General disorders
Injection Site Erythema
|
17.9%
5/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
11.2%
21/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
9.3%
18/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
General disorders
Non-Cardiac Chest Pain
|
7.1%
2/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
4.3%
8/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
1.6%
3/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
General disorders
Oedema Peripheral
|
50.0%
14/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
35.1%
66/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
36.8%
71/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
General disorders
Pyrexia
|
10.7%
3/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
8.0%
15/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
13.5%
26/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
17.9%
5/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
4.8%
9/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
2.1%
4/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Infections and infestations
Bronchitis
|
14.3%
4/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
2.7%
5/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
5.7%
11/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Infections and infestations
Cellulitis
|
7.1%
2/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
2.1%
4/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
1.6%
3/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Infections and infestations
Conjunctivitis
|
3.6%
1/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
2.7%
5/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
6.2%
12/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
6.4%
12/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
6.7%
13/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Infections and infestations
Hordeolum
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
5.9%
11/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
4.7%
9/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
5.9%
11/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
10.4%
20/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Infections and infestations
Pneumonia
|
3.6%
1/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
3.2%
6/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
6.7%
13/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Infections and infestations
Rhinitis
|
3.6%
1/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
1.1%
2/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
5.2%
10/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Infections and infestations
Sinusitis
|
10.7%
3/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
1.1%
2/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
3.1%
6/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Infections and infestations
Tooth Infection
|
7.1%
2/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.53%
1/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
2.1%
4/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
35.7%
10/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
11.2%
21/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
25.9%
50/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Infections and infestations
Urinary Tract Infection
|
3.6%
1/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
3.2%
6/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
7.3%
14/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Injury, poisoning and procedural complications
Contusion
|
21.4%
6/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
3.2%
6/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
7.8%
15/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Injury, poisoning and procedural complications
Fall
|
14.3%
4/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
4.3%
8/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
7.8%
15/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
10.7%
3/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
1.6%
3/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
2.1%
4/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Investigations
Alanine Aminotransferase Increased
|
21.4%
6/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
5.3%
10/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
10.9%
21/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Investigations
Aspartate Aminotransferase Increased
|
25.0%
7/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
4.3%
8/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
10.4%
20/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Investigations
Basophil Count Increased
|
7.1%
2/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
17.9%
5/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
5.9%
11/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
5.2%
10/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Investigations
Blood Creatinine Increased
|
25.0%
7/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
8.5%
16/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
10.4%
20/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Investigations
Gamma-Glutamyltransferase Increased
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
5.9%
11/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
6.7%
13/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Investigations
Hepatic Enzyme Increased
|
7.1%
2/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Investigations
Monocyte Count Increased
|
10.7%
3/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Investigations
Weight Decreased
|
3.6%
1/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
3.2%
6/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
5.7%
11/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Investigations
Weight Increased
|
14.3%
4/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
3.2%
6/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
4.7%
9/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
17.9%
5/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
11.7%
22/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
10.9%
21/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
10.7%
3/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
1.1%
2/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
1.0%
2/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
35.7%
10/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
3.7%
7/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
6.2%
12/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
10.7%
3/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
3.7%
7/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
7.3%
14/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
3.6%
1/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
4.3%
8/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
7.3%
14/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
25.0%
7/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
5.9%
11/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
4.7%
9/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
21.4%
6/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
4.8%
9/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
6.7%
13/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
21.4%
6/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
1.6%
3/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
3.6%
7/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
25.0%
7/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
14.9%
28/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
13.5%
26/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
10.7%
3/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
1.6%
3/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
3.1%
6/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
25.0%
7/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
3.2%
6/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
8.3%
16/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.7%
3/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
4.8%
9/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
11.9%
23/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
10.7%
3/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
5.9%
11/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
14.5%
28/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
7.1%
2/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
1.0%
2/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
5.3%
10/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
9.8%
19/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
17.9%
5/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
5.9%
11/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
8.3%
16/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
7.1%
2/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
1.1%
2/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
3.6%
7/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
17.9%
5/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
3.7%
7/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
8.8%
17/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
10.7%
3/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.53%
1/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
1.6%
3/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
17.9%
5/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
4.8%
9/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
12.4%
24/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Nervous system disorders
Dizziness
|
46.4%
13/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
13.8%
26/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
16.1%
31/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Nervous system disorders
Dysgeusia
|
21.4%
6/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
5.9%
11/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
7.8%
15/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Nervous system disorders
Headache
|
21.4%
6/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
9.6%
18/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
15.5%
30/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Nervous system disorders
Hypoaesthesia
|
17.9%
5/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
1.6%
3/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
3.6%
7/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Nervous system disorders
Memory Impairment
|
7.1%
2/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
1.1%
2/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
2.7%
5/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
5.2%
10/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Nervous system disorders
Paraesthesia
|
17.9%
5/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
6.4%
12/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
8.8%
17/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
17.9%
5/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
19.7%
37/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
33.7%
65/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Nervous system disorders
Syncope
|
3.6%
1/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
4.8%
9/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
7.3%
14/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Nervous system disorders
Tremor
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
1.1%
2/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
6.2%
12/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
5.9%
11/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
6.2%
12/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Psychiatric disorders
Confusional State
|
10.7%
3/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.53%
1/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
1.0%
2/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Psychiatric disorders
Depression
|
10.7%
3/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
3.2%
6/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
4.7%
9/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Psychiatric disorders
Insomnia
|
32.1%
9/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
25.0%
47/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
25.4%
49/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Renal and urinary disorders
Haematuria
|
7.1%
2/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
3.1%
6/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Renal and urinary disorders
Pollakiuria
|
17.9%
5/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
2.1%
4/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
1.6%
3/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Renal and urinary disorders
Renal Impairment
|
7.1%
2/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
5.9%
11/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
5.2%
10/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Renal and urinary disorders
Urinary Incontinence
|
7.1%
2/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.52%
1/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Renal and urinary disorders
Urinary Retention
|
7.1%
2/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
2.6%
5/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
28.6%
8/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
10.1%
19/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
18.1%
35/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
32.1%
9/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
15.4%
29/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
23.8%
46/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
14.3%
4/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
3.2%
6/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
4.1%
8/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
1.6%
3/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
5.2%
10/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
7.1%
2/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
1.1%
2/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
6.2%
12/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
17.9%
5/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
2.7%
5/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
7.8%
15/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
7.1%
2/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.53%
1/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
6.7%
13/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
10.7%
3/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.00%
0/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
1.0%
2/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
17.9%
5/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
1.1%
2/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
6.2%
12/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
14.3%
4/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
1.6%
3/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
6.2%
12/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.6%
1/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
4.3%
8/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
8.3%
16/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.3%
4/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
6.9%
13/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
9.8%
19/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
17.9%
5/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
1.1%
2/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
4.1%
8/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Skin and subcutaneous tissue disorders
Rash Pruritic
|
7.1%
2/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.53%
1/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
1.0%
2/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Vascular disorders
Flushing
|
7.1%
2/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
1.6%
3/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
1.0%
2/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Vascular disorders
Hot Flush
|
7.1%
2/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
0.53%
1/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
1.6%
3/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Vascular disorders
Hypertension
|
7.1%
2/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
1.6%
3/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
7.3%
14/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Vascular disorders
Hypotension
|
21.4%
6/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
11.2%
21/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
15.5%
30/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
|
Vascular disorders
Orthostatic Hypotension
|
3.6%
1/28 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
5.9%
11/188 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
4.7%
9/193 • All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER