Trial Outcomes & Findings for A Study of Daratumumab Plus Lenalidomide Versus Lenalidomide Alone as Maintenance Treatment in Participants With Newly Diagnosed Multiple Myeloma Who Are Minimal Residual Disease Positive After Frontline Autologous Stem Cell Transplant (NCT NCT03901963)

NCT ID: NCT03901963

Last Updated: 2025-11-13

Results Overview

Percentage of participants who achieved MRD negative (MRD conversion) status from baseline to 12 months after maintenance treatment was defined as percentage of participants who were MRD positive at baseline (randomization) and achieved MRD negative status (at 10\^-5) during the time period from randomization to 12 months plus 2 months window, but prior to progressive disease (PD) and subsequent anti-myeloma therapy.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE3
• Target enrollment: 200 participants
• Primary outcome timeframe: From randomization up to 12 months
• Results posted on: 2025-11-13

Participant Flow

Currently, results posted till interim data cutoff date of 04-April-2024 (primary completion date).

Participant milestones

Measure	Daratumumab + Lenalidomide Participants received daratumumab 1800 milligrams (mg) subcutaneous (SC) injection weekly during Cycle 1 and Cycle 2 (that is, on Day 1, Day 8, Day 15 and Day 22 of each Cycle), followed by every-2-week dosing from Cycle 3 to Cycle 6 (that is, on Weeks 9, 11, 13, 15, 17, 19, and 21) and then every-4-week dosing from Cycle 7 onwards (that is, from Week 25). In addition, participants received maintenance therapy with lenalidomide 10 mg capsule orally (PO) from Day 1 to 28 in each treatment cycle. Participants received study treatment until confirmed disease progression (PD), unacceptable toxicity, or until end of study treatment, whichever occurred first. After Cycle 3, if lenalidomide was well tolerated, dose might be increased to 15 mg at the discretion of the investigator. Each treatment cycle was of 28 days.	Lenalidomide Participants received lenalidomide 10 mg capsule PO as maintenance therapy from Day 1 to Day 28 of each 28-day treatment cycle until confirmed PD, unacceptable toxicity, or the end of the study treatment, whichever occurred first. After Cycle 3, if lenalidomide was well tolerated, dose might be increased to 15 mg at the discretion of the investigator.
Overall Study STARTED	99	101
Overall Study Treated	96	98
Overall Study COMPLETED	5	10
Overall Study NOT COMPLETED	94	91

Reasons for withdrawal

Measure	Daratumumab + Lenalidomide Participants received daratumumab 1800 milligrams (mg) subcutaneous (SC) injection weekly during Cycle 1 and Cycle 2 (that is, on Day 1, Day 8, Day 15 and Day 22 of each Cycle), followed by every-2-week dosing from Cycle 3 to Cycle 6 (that is, on Weeks 9, 11, 13, 15, 17, 19, and 21) and then every-4-week dosing from Cycle 7 onwards (that is, from Week 25). In addition, participants received maintenance therapy with lenalidomide 10 mg capsule orally (PO) from Day 1 to 28 in each treatment cycle. Participants received study treatment until confirmed disease progression (PD), unacceptable toxicity, or until end of study treatment, whichever occurred first. After Cycle 3, if lenalidomide was well tolerated, dose might be increased to 15 mg at the discretion of the investigator. Each treatment cycle was of 28 days.	Lenalidomide Participants received lenalidomide 10 mg capsule PO as maintenance therapy from Day 1 to Day 28 of each 28-day treatment cycle until confirmed PD, unacceptable toxicity, or the end of the study treatment, whichever occurred first. After Cycle 3, if lenalidomide was well tolerated, dose might be increased to 15 mg at the discretion of the investigator.
Overall Study Physician Decision	1	2
Overall Study Protocol Violation	1	1
Overall Study Lost to Follow-up	1	1
Overall Study Withdrawal by Subject	4	11
Overall Study Ongoing	84	73
Overall Study Randomized but not treated	3	3

Baseline Characteristics

A Study of Daratumumab Plus Lenalidomide Versus Lenalidomide Alone as Maintenance Treatment in Participants With Newly Diagnosed Multiple Myeloma Who Are Minimal Residual Disease Positive After Frontline Autologous Stem Cell Transplant

Baseline characteristics by cohort

Measure	Daratumumab + Lenalidomide n=99 Participants Participants received daratumumab 1800 milligrams (mg) subcutaneous (SC) injection weekly during Cycle 1 and Cycle 2 (that is, on Day 1, Day 8, Day 15 and Day 22 of each Cycle), followed by every-2-week dosing from Cycle 3 to Cycle 6 (that is, on Weeks 9, 11, 13, 15, 17, 19, and 21) and then every-4-week dosing from Cycle 7 onwards (that is, from Week 25). In addition, participants received maintenance therapy with lenalidomide 10 mg capsule orally (PO) from Day 1 to 28 in each treatment cycle. Participants received study treatment until confirmed disease progression (PD), unacceptable toxicity, or until end of study treatment, whichever occurred first. After Cycle 3, if lenalidomide was well tolerated, dose might be increased to 15 mg at the discretion of the investigator. Each treatment cycle was of 28 days.	Lenalidomide n=101 Participants Participants received lenalidomide 10 mg capsule PO as maintenance therapy from Day 1 to Day 28 of each 28-day treatment cycle until confirmed PD, unacceptable toxicity, or the end of the study treatment, whichever occurred first. After Cycle 3, if lenalidomide was well tolerated, dose might be increased to 15 mg at the discretion of the investigator.	Total n=200 Participants Total of all reporting groups
Age, Continuous	61.3 years STANDARD_DEVIATION 8.12 • n=10 Participants	60.8 years STANDARD_DEVIATION 9.54 • n=10 Participants	61 years STANDARD_DEVIATION 8.84 • n=20 Participants
Sex: Female, Male Female	38 Participants n=10 Participants	43 Participants n=10 Participants	81 Participants n=20 Participants
Sex: Female, Male Male	61 Participants n=10 Participants	58 Participants n=10 Participants	119 Participants n=20 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=10 Participants	6 Participants n=10 Participants	15 Participants n=20 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	81 Participants n=10 Participants	89 Participants n=10 Participants	170 Participants n=20 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	9 Participants n=10 Participants	6 Participants n=10 Participants	15 Participants n=20 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=10 Participants	1 Participants n=10 Participants	1 Participants n=20 Participants
Race/Ethnicity, Customized Asian	5 Participants n=10 Participants	1 Participants n=10 Participants	6 Participants n=20 Participants
Race/Ethnicity, Customized Black or African American	20 Participants n=10 Participants	24 Participants n=10 Participants	44 Participants n=20 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants
Race/Ethnicity, Customized White	67 Participants n=10 Participants	68 Participants n=10 Participants	135 Participants n=20 Participants
Race/Ethnicity, Customized More than one race	1 Participants n=10 Participants	1 Participants n=10 Participants	2 Participants n=20 Participants
Race/Ethnicity, Customized Unknown or Not Reported	2 Participants n=10 Participants	2 Participants n=10 Participants	4 Participants n=20 Participants
Race/Ethnicity, Customized Other	4 Participants n=10 Participants	4 Participants n=10 Participants	8 Participants n=20 Participants
Region of Enrollment Canada	2 Participants n=10 Participants	0 Participants n=10 Participants	2 Participants n=20 Participants
Region of Enrollment United States	97 Participants n=10 Participants	101 Participants n=10 Participants	198 Participants n=20 Participants

PRIMARY outcome

Timeframe: From randomization up to 12 months

Population: The full analysis set (FAS) which included all participants randomly assigned to daratumumab in combination with lenalidomide or the lenalidomide alone.

Percentage of participants who achieved MRD negative (MRD conversion) status from baseline to 12 months after maintenance treatment was defined as percentage of participants who were MRD positive at baseline (randomization) and achieved MRD negative status (at 10^-5) during the time period from randomization to 12 months plus 2 months window, but prior to progressive disease (PD) and subsequent anti-myeloma therapy.

Outcome measures

Measure	Daratumumab + Lenalidomide n=99 Participants Participants received daratumumab 1800 milligrams (mg) subcutaneous (SC) injection weekly during Cycle 1 and Cycle 2 (that is, on Day 1, Day 8, Day 15 and Day 22 of each Cycle), followed by every-2-week dosing from Cycle 3 to Cycle 6 (that is, on Weeks 9, 11, 13, 15, 17, 19, and 21) and then every-4-week dosing from Cycle 7 onwards (that is, from Week 25). In addition, participants received maintenance therapy with lenalidomide 10 mg capsule orally (PO) from Day 1 to 28 in each treatment cycle. Participants received study treatment until confirmed disease progression (PD), unacceptable toxicity, or until end of study treatment, whichever occurred first. After Cycle 3, if lenalidomide was well tolerated, dose might be increased to 15 mg at the discretion of the investigator. Each treatment cycle was of 28 days.	Lenalidomide n=101 Participants Participants received lenalidomide 10 mg capsule PO as maintenance therapy from Day 1 to Day 28 of each 28-day treatment cycle until confirmed PD, unacceptable toxicity, or the end of the study treatment, whichever occurred first. After Cycle 3, if lenalidomide was well tolerated, dose might be increased to 15 mg at the discretion of the investigator.
Percentage of Participants Who Had Minimal Residual Disease (MRD) Conversion From Baseline to 12 Months After Start of Maintenance Treatment as Determined by Next Generation Sequencing (NGS)	50.5 percentage of participants Interval 40.3 to 60.7	18.8 percentage of participants Interval 11.7 to 27.8

SECONDARY outcome

Timeframe: From randomization to either disease progression or death (up to 7.1 years)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From randomization up to 30 days after last dose of study treatment or disease progression or initiation of subsequent therapy, whichever occurs first (up to 3 years)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From randomization up to 30 days after last dose of study treatment or disease progression or initiation of subsequent therapy, whichever occurs first (up to 3 years)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From randomization up to 30 days after last dose of study treatment or disease progression or initiation of subsequent therapy, whichever occurs first (up to 3 years)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From randomization up to 7.1 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of initial documentation of CR or sCR up to first documented disease progression or death due to disease progression whichever occurs first (up to 7.1 years)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From baseline (Cycle 1 Day 1) up to 7.1 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From baseline (Cycle 1 Day 1) up to 7.1 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From baseline (Cycle 1 Day 1) up to 7.1 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 7.1 years)

Outcome measures

Outcome data not reported

Adverse Events

Daratumumab + Lenalidomide

Serious events: 29 serious events

Other events: 95 other events

Deaths: 5 deaths

Lenalidomide

Serious events: 22 serious events

Other events: 97 other events

Deaths: 9 deaths

Serious adverse events

Measure	Daratumumab + Lenalidomide n=96 participants at risk Participants received daratumumab 1800 milligrams (mg) subcutaneous (SC) injection weekly during Cycle 1 and Cycle 2 (that is, on Day 1, Day 8, Day 15 and Day 22 of each Cycle), followed by every-2-week dosing from Cycle 3 to Cycle 6 (that is, on Weeks 9, 11, 13, 15, 17, 19, and 21) and then every-4-week dosing from Cycle 7 onwards (that is, from Week 25). In addition, participants received maintenance therapy with lenalidomide 10 mg capsule orally (PO) from Day 1 to 28 in each treatment cycle. Participants received study treatment until confirmed disease progression (PD), unacceptable toxicity, or until end of study treatment, whichever occurred first. After Cycle 3, if lenalidomide was well tolerated, dose might be increased to 15 mg at the discretion of the investigator. Each treatment cycle was of 28 days.	Lenalidomide n=98 participants at risk Participants received lenalidomide 10 mg capsule PO as maintenance therapy from Day 1 to Day 28 of each 28-day treatment cycle until confirmed PD, unacceptable toxicity, or the end of the study treatment, whichever occurred first. After Cycle 3, if lenalidomide was well tolerated, dose might be increased to 15 mg at the discretion of the investigator.
Blood and lymphatic system disorders Anaemia	1.0% 1/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Blood and lymphatic system disorders Haemolytic Anaemia	0.00% 0/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Blood and lymphatic system disorders Leukopenia	0.00% 0/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Blood and lymphatic system disorders Neutropenia	1.0% 1/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Cardiac disorders Angina Pectoris	1.0% 1/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Cardiac disorders Aortic Valve Stenosis	1.0% 1/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Cardiac disorders Atrial Fibrillation	1.0% 1/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Cardiac disorders Sinus Bradycardia	1.0% 1/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Cardiac disorders Sinus Tachycardia	1.0% 1/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Eye disorders Retinal Artery Embolism	1.0% 1/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Gastrointestinal disorders Inguinal Hernia	1.0% 1/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Gastrointestinal disorders Lower Gastrointestinal Haemorrhage	0.00% 0/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Gastrointestinal disorders Pancreatitis	0.00% 0/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Gastrointestinal disorders Upper Gastrointestinal Haemorrhage	1.0% 1/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
General disorders Complication Associated with Device	1.0% 1/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
General disorders Non-Cardiac Chest Pain	0.00% 0/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
General disorders Pyrexia	3.1% 3/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Hepatobiliary disorders Acute Hepatic Failure	1.0% 1/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Hepatobiliary disorders Cholelithiasis	0.00% 0/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Infections and infestations Appendicitis	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Infections and infestations Arthritis Infective	0.00% 0/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Infections and infestations Bronchitis	0.00% 0/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Infections and infestations Clostridium Difficile Infection	1.0% 1/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Infections and infestations Covid-19	1.0% 1/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Infections and infestations Covid-19 Pneumonia	1.0% 1/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	2.0% 2/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Infections and infestations Diverticulitis	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Infections and infestations Enterocolitis Infectious	1.0% 1/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Infections and infestations Escherichia Infection	0.00% 0/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Infections and infestations Escherichia Urinary Tract Infection	0.00% 0/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Infections and infestations Gastroenteritis Salmonella	1.0% 1/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Infections and infestations Kidney Infection	1.0% 1/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Infections and infestations Meningitis Cryptococcal	0.00% 0/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Infections and infestations Pneumonia	4.2% 4/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	4.1% 4/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Infections and infestations Pneumonia Legionella	1.0% 1/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Infections and infestations Pneumonia Parainfluenzae Viral	1.0% 1/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Infections and infestations Pneumonia Respiratory Syncytial Viral	1.0% 1/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Infections and infestations Respiratory Syncytial Virus Infection	1.0% 1/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Infections and infestations Sepsis	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Infections and infestations Septic Shock	1.0% 1/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Injury, poisoning and procedural complications Hip Fracture	1.0% 1/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Injury, poisoning and procedural complications Overdose	0.00% 0/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Injury, poisoning and procedural complications Rib Fracture	0.00% 0/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Injury, poisoning and procedural complications Thoracic Vertebral Fracture	1.0% 1/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	2.0% 2/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Metabolism and nutrition disorders Hypokalaemia	1.0% 1/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	2.0% 2/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Musculoskeletal and connective tissue disorders Osteolysis	0.00% 0/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of Colon	1.0% 1/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-Cell Type Acute Leukaemia	0.00% 0/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Melanoma	1.0% 1/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic Syndrome	0.00% 0/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neurilemmoma Benign	0.00% 0/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal Cell Carcinoma	1.0% 1/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Nervous system disorders Cerebrovascular Accident	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Nervous system disorders Dizziness	1.0% 1/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Nervous system disorders Presyncope	0.00% 0/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Nervous system disorders Syncope	1.0% 1/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Psychiatric disorders Alcohol Abuse	1.0% 1/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Renal and urinary disorders Acute Kidney Injury	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	1.0% 1/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Respiratory, thoracic and mediastinal disorders Pneumonitis	1.0% 1/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Skin and subcutaneous tissue disorders Dermatitis Allergic	1.0% 1/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Skin and subcutaneous tissue disorders Melanocytic Hyperplasia	1.0% 1/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Vascular disorders Aortic Aneurysm	1.0% 1/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Vascular disorders Haemorrhage	1.0% 1/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Vascular disorders Hypotension	0.00% 0/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.

Other adverse events

Measure	Daratumumab + Lenalidomide n=96 participants at risk Participants received daratumumab 1800 milligrams (mg) subcutaneous (SC) injection weekly during Cycle 1 and Cycle 2 (that is, on Day 1, Day 8, Day 15 and Day 22 of each Cycle), followed by every-2-week dosing from Cycle 3 to Cycle 6 (that is, on Weeks 9, 11, 13, 15, 17, 19, and 21) and then every-4-week dosing from Cycle 7 onwards (that is, from Week 25). In addition, participants received maintenance therapy with lenalidomide 10 mg capsule orally (PO) from Day 1 to 28 in each treatment cycle. Participants received study treatment until confirmed disease progression (PD), unacceptable toxicity, or until end of study treatment, whichever occurred first. After Cycle 3, if lenalidomide was well tolerated, dose might be increased to 15 mg at the discretion of the investigator. Each treatment cycle was of 28 days.	Lenalidomide n=98 participants at risk Participants received lenalidomide 10 mg capsule PO as maintenance therapy from Day 1 to Day 28 of each 28-day treatment cycle until confirmed PD, unacceptable toxicity, or the end of the study treatment, whichever occurred first. After Cycle 3, if lenalidomide was well tolerated, dose might be increased to 15 mg at the discretion of the investigator.
Blood and lymphatic system disorders Anaemia	21.9% 21/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	17.3% 17/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Blood and lymphatic system disorders Eosinophilia	3.1% 3/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	2.0% 2/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Blood and lymphatic system disorders Increased Tendency to Bruise	5.2% 5/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Blood and lymphatic system disorders Leukopenia	26.0% 25/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	28.6% 28/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Blood and lymphatic system disorders Lymphopenia	24.0% 23/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	13.3% 13/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Blood and lymphatic system disorders Neutropenia	64.6% 62/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	61.2% 60/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Blood and lymphatic system disorders Thrombocytopenia	24.0% 23/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	27.6% 27/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Cardiac disorders Atrial Fibrillation	4.2% 4/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Cardiac disorders Atrial Flutter	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Cardiac disorders Bradycardia	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	4.1% 4/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Cardiac disorders Palpitations	3.1% 3/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	3.1% 3/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Cardiac disorders Sinus Bradycardia	3.1% 3/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	7.1% 7/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Cardiac disorders Sinus Tachycardia	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Cardiac disorders Tachycardia	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	2.0% 2/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Ear and labyrinth disorders Ear Discomfort	0.00% 0/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	2.0% 2/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Ear and labyrinth disorders Ear Pain	6.2% 6/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	3.1% 3/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Ear and labyrinth disorders Hypoacusis	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Ear and labyrinth disorders Tinnitus	1.0% 1/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	4.1% 4/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Ear and labyrinth disorders Vertigo	0.00% 0/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	4.1% 4/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Endocrine disorders Androgen Deficiency	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Endocrine disorders Hypothyroidism	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Eye disorders Blepharitis	0.00% 0/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	3.1% 3/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Eye disorders Cataract	4.2% 4/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Eye disorders Dry Eye	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	3.1% 3/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Eye disorders Vision Blurred	7.3% 7/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	3.1% 3/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Eye disorders Visual Impairment	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Gastrointestinal disorders Abdominal Distension	6.2% 6/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	2.0% 2/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Gastrointestinal disorders Abdominal Pain	17.7% 17/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	11.2% 11/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Gastrointestinal disorders Abdominal Pain Upper	8.3% 8/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	2.0% 2/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Gastrointestinal disorders Colitis	3.1% 3/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Gastrointestinal disorders Constipation	22.9% 22/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	26.5% 26/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Gastrointestinal disorders Dental Caries	3.1% 3/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	4.1% 4/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Gastrointestinal disorders Diarrhoea	61.5% 59/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	55.1% 54/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Gastrointestinal disorders Diverticulum	0.00% 0/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	2.0% 2/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Gastrointestinal disorders Dry Mouth	4.2% 4/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	5.1% 5/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Gastrointestinal disorders Dyspepsia	13.5% 13/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	5.1% 5/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Gastrointestinal disorders Faeces Discoloured	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Gastrointestinal disorders Flatulence	4.2% 4/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	3.1% 3/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Gastrointestinal disorders Gastritis	1.0% 1/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	2.0% 2/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Gastrointestinal disorders Gastrooesophageal Reflux Disease	4.2% 4/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	4.1% 4/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Gastrointestinal disorders Haematochezia	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Gastrointestinal disorders Nausea	27.1% 26/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	26.5% 26/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Gastrointestinal disorders Oesophagitis	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Gastrointestinal disorders Oral Pain	0.00% 0/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	2.0% 2/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Gastrointestinal disorders Rectal Haemorrhage	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Gastrointestinal disorders Stomatitis	7.3% 7/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	5.1% 5/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Gastrointestinal disorders Toothache	3.1% 3/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	3.1% 3/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Gastrointestinal disorders Vomiting	17.7% 17/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	11.2% 11/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
General disorders Asthenia	3.1% 3/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
General disorders Chest Pain	5.2% 5/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	2.0% 2/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
General disorders Chills	6.2% 6/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	4.1% 4/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
General disorders Face Oedema	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	2.0% 2/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
General disorders Facial Pain	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
General disorders Fatigue	45.8% 44/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	46.9% 46/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
General disorders Gait Disturbance	1.0% 1/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	3.1% 3/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
General disorders Generalised Oedema	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
General disorders Influenza Like Illness	12.5% 12/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	14.3% 14/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
General disorders Injection Site Bruising	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
General disorders Injection Site Erythema	6.2% 6/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
General disorders Injection Site Pain	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
General disorders Injection Site Reaction	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
General disorders Localised Oedema	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
General disorders Malaise	3.1% 3/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	2.0% 2/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
General disorders Non-Cardiac Chest Pain	7.3% 7/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	7.1% 7/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
General disorders Oedema Peripheral	12.5% 12/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	14.3% 14/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
General disorders Pain	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
General disorders Peripheral Swelling	6.2% 6/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
General disorders Pyrexia	16.7% 16/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	16.3% 16/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
General disorders Temperature Intolerance	5.2% 5/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Hepatobiliary disorders Cholelithiasis	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Hepatobiliary disorders Hyperbilirubinaemia	1.0% 1/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	8.2% 8/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Immune system disorders Hypogammaglobulinaemia	9.4% 9/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Infections and infestations Bronchitis	5.2% 5/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	8.2% 8/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Infections and infestations Cellulitis	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	2.0% 2/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Infections and infestations Clostridium Difficile Infection	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Infections and infestations Conjunctivitis	4.2% 4/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	4.1% 4/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Infections and infestations Covid-19	28.1% 27/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	26.5% 26/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Infections and infestations Covid-19 Pneumonia	1.0% 1/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	2.0% 2/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Infections and infestations Diverticulitis	3.1% 3/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Infections and infestations Ear Infection	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Infections and infestations Enterocolitis Infectious	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Infections and infestations Escherichia Infection	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Infections and infestations Folliculitis	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Infections and infestations Herpes Zoster	5.2% 5/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	2.0% 2/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Infections and infestations Influenza	1.0% 1/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	5.1% 5/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Infections and infestations Nasopharyngitis	8.3% 8/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	2.0% 2/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Infections and infestations Onychomycosis	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Infections and infestations Oral Candidiasis	0.00% 0/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	2.0% 2/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Infections and infestations Otitis Externa	1.0% 1/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	2.0% 2/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Infections and infestations Otitis Media	3.1% 3/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Infections and infestations Parainfluenzae Virus Infection	3.1% 3/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Infections and infestations Pharyngitis	0.00% 0/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	2.0% 2/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Infections and infestations Pneumonia	7.3% 7/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	12.2% 12/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Infections and infestations Rash Pustular	0.00% 0/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	3.1% 3/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Infections and infestations Respiratory Syncytial Virus Infection	1.0% 1/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	4.1% 4/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Infections and infestations Rhinovirus Infection	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Infections and infestations Sinusitis	8.3% 8/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	9.2% 9/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Infections and infestations Skin Infection	3.1% 3/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	2.0% 2/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Infections and infestations Tinea Pedis	3.1% 3/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Infections and infestations Tooth Abscess	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Infections and infestations Tooth Infection	3.1% 3/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	5.1% 5/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Infections and infestations Upper Respiratory Tract Infection	41.7% 40/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	26.5% 26/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Infections and infestations Urinary Tract Infection	10.4% 10/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	3.1% 3/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Infections and infestations Viral Upper Respiratory Tract Infection	0.00% 0/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	2.0% 2/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Injury, poisoning and procedural complications Contusion	12.5% 12/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	8.2% 8/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Injury, poisoning and procedural complications Epicondylitis	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Injury, poisoning and procedural complications Fall	4.2% 4/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	10.2% 10/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Injury, poisoning and procedural complications Ligament Sprain	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	2.0% 2/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Injury, poisoning and procedural complications Limb Injury	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Injury, poisoning and procedural complications Muscle Strain	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Injury, poisoning and procedural complications Rib Fracture	0.00% 0/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	2.0% 2/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Injury, poisoning and procedural complications Tooth Fracture	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	3.1% 3/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Investigations Alanine Aminotransferase Increased	16.7% 16/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	13.3% 13/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Investigations Aspartate Aminotransferase Increased	14.6% 14/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	13.3% 13/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Investigations Blood Alkaline Phosphatase Increased	7.3% 7/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	8.2% 8/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Investigations Blood Bicarbonate Decreased	1.0% 1/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	2.0% 2/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Investigations Blood Creatinine Decreased	0.00% 0/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	2.0% 2/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Investigations Blood Creatinine Increased	13.5% 13/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	11.2% 11/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Investigations Blood Lactate Dehydrogenase Increased	3.1% 3/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	2.0% 2/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Investigations Blood Urea Increased	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Investigations Human Rhinovirus Test Positive	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Investigations Weight Decreased	8.3% 8/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	5.1% 5/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Investigations Weight Increased	5.2% 5/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	6.1% 6/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Metabolism and nutrition disorders Decreased Appetite	10.4% 10/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	10.2% 10/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Metabolism and nutrition disorders Dehydration	3.1% 3/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	6.1% 6/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Metabolism and nutrition disorders Gout	0.00% 0/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	2.0% 2/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Metabolism and nutrition disorders Hypercalcaemia	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Metabolism and nutrition disorders Hypercholesterolaemia	3.1% 3/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Metabolism and nutrition disorders Hyperglycaemia	16.7% 16/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	10.2% 10/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Metabolism and nutrition disorders Hyperkalaemia	4.2% 4/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Metabolism and nutrition disorders Hyperlipidaemia	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Metabolism and nutrition disorders Hypernatraemia	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Metabolism and nutrition disorders Hypocalcaemia	12.5% 12/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	12.2% 12/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Metabolism and nutrition disorders Hypoglycaemia	4.2% 4/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	7.1% 7/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Metabolism and nutrition disorders Hypokalaemia	34.4% 33/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	36.7% 36/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Metabolism and nutrition disorders Hypomagnesaemia	7.3% 7/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	5.1% 5/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Metabolism and nutrition disorders Hyponatraemia	6.2% 6/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	7.1% 7/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Metabolism and nutrition disorders Hypophosphataemia	6.2% 6/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	3.1% 3/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Metabolism and nutrition disorders Polydipsia	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Metabolism and nutrition disorders Vitamin B12 Deficiency	1.0% 1/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	2.0% 2/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Metabolism and nutrition disorders Vitamin D Deficiency	4.2% 4/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	2.0% 2/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Musculoskeletal and connective tissue disorders Arthralgia	33.3% 32/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	36.7% 36/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Musculoskeletal and connective tissue disorders Back Pain	32.3% 31/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	20.4% 20/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Musculoskeletal and connective tissue disorders Bone Pain	7.3% 7/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	6.1% 6/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Musculoskeletal and connective tissue disorders Flank Pain	4.2% 4/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	6.1% 6/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Musculoskeletal and connective tissue disorders Joint Swelling	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Musculoskeletal and connective tissue disorders Muscle Spasms	22.9% 22/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	21.4% 21/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Musculoskeletal and connective tissue disorders Muscular Weakness	4.2% 4/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	4.1% 4/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Musculoskeletal and connective tissue disorders Musculoskeletal Chest Pain	9.4% 9/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	8.2% 8/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	2.0% 2/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Musculoskeletal and connective tissue disorders Musculoskeletal Stiffness	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Musculoskeletal and connective tissue disorders Myalgia	10.4% 10/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	10.2% 10/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Musculoskeletal and connective tissue disorders Neck Pain	7.3% 7/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	8.2% 8/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Musculoskeletal and connective tissue disorders Osteoarthritis	3.1% 3/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Musculoskeletal and connective tissue disorders Osteonecrosis of Jaw	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	3.1% 3/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Musculoskeletal and connective tissue disorders Pain in Extremity	22.9% 22/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	17.3% 17/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Musculoskeletal and connective tissue disorders Pain in Jaw	5.2% 5/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Musculoskeletal and connective tissue disorders Plantar Fasciitis	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Musculoskeletal and connective tissue disorders Spinal Osteoarthritis	3.1% 3/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Musculoskeletal and connective tissue disorders Spinal Pain	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanocytic Naevus	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic Syndrome	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Seborrhoeic Keratosis	3.1% 3/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Nervous system disorders Ageusia	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Nervous system disorders Amnesia	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Nervous system disorders Carotid Artery Stenosis	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Nervous system disorders Disturbance in Attention	3.1% 3/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Nervous system disorders Dizziness	18.8% 18/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	16.3% 16/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Nervous system disorders Dysgeusia	5.2% 5/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	4.1% 4/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Nervous system disorders Headache	25.0% 24/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	17.3% 17/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Nervous system disorders Hypoaesthesia	9.4% 9/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	3.1% 3/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Nervous system disorders Memory Impairment	4.2% 4/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	2.0% 2/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Nervous system disorders Migraine	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	3.1% 3/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Nervous system disorders Neuralgia	4.2% 4/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	2.0% 2/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Nervous system disorders Neuropathy Peripheral	1.0% 1/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	2.0% 2/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Nervous system disorders Paraesthesia	7.3% 7/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	9.2% 9/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Nervous system disorders Parosmia	0.00% 0/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	2.0% 2/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Nervous system disorders Peripheral Motor Neuropathy	1.0% 1/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	2.0% 2/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Nervous system disorders Peripheral Sensory Neuropathy	12.5% 12/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	13.3% 13/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Nervous system disorders Syncope	0.00% 0/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	4.1% 4/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Nervous system disorders Tremor	4.2% 4/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Psychiatric disorders Affect Lability	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Psychiatric disorders Anxiety	6.2% 6/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	3.1% 3/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Psychiatric disorders Depression	7.3% 7/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	7.1% 7/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Psychiatric disorders Insomnia	15.6% 15/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	8.2% 8/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Psychiatric disorders Libido Decreased	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Psychiatric disorders Sleep Disorder	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Renal and urinary disorders Chronic Kidney Disease	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Renal and urinary disorders Dysuria	1.0% 1/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	2.0% 2/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Renal and urinary disorders Haematuria	3.1% 3/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Renal and urinary disorders Pollakiuria	5.2% 5/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Renal and urinary disorders Renal Cyst	1.0% 1/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	2.0% 2/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Renal and urinary disorders Renal Impairment	3.1% 3/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Renal and urinary disorders Urinary Retention	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	2.0% 2/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Reproductive system and breast disorders Breast Pain	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Reproductive system and breast disorders Erectile Dysfunction	5.2% 5/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	2.0% 2/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Reproductive system and breast disorders Pelvic Pain	3.1% 3/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Respiratory, thoracic and mediastinal disorders Cough	38.5% 37/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	36.7% 36/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Respiratory, thoracic and mediastinal disorders Dysphonia	3.1% 3/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	2.0% 2/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Respiratory, thoracic and mediastinal disorders Dyspnoea	8.3% 8/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	15.3% 15/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Respiratory, thoracic and mediastinal disorders Dyspnoea Exertional	4.2% 4/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	2.0% 2/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Respiratory, thoracic and mediastinal disorders Epistaxis	1.0% 1/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	4.1% 4/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Respiratory, thoracic and mediastinal disorders Haemoptysis	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Respiratory, thoracic and mediastinal disorders Hiccups	3.1% 3/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	26.0% 25/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	19.4% 19/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	16.7% 16/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	11.2% 11/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Respiratory, thoracic and mediastinal disorders Productive Cough	9.4% 9/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	8.2% 8/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Respiratory, thoracic and mediastinal disorders Pulmonary Mass	0.00% 0/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	2.0% 2/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Respiratory, thoracic and mediastinal disorders Rhinitis Allergic	4.2% 4/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	3.1% 3/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	15.6% 15/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	7.1% 7/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Respiratory, thoracic and mediastinal disorders Sinus Congestion	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Respiratory, thoracic and mediastinal disorders Sleep Apnoea Syndrome	0.00% 0/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	3.1% 3/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Respiratory, thoracic and mediastinal disorders Sneezing	5.2% 5/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Respiratory, thoracic and mediastinal disorders Throat Irritation	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Respiratory, thoracic and mediastinal disorders Upper-Airway Cough Syndrome	10.4% 10/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	4.1% 4/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Respiratory, thoracic and mediastinal disorders Wheezing	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	2.0% 2/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Skin and subcutaneous tissue disorders Actinic Keratosis	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	2.0% 2/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Skin and subcutaneous tissue disorders Dermatitis Acneiform	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Skin and subcutaneous tissue disorders Dermatitis Contact	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Skin and subcutaneous tissue disorders Dry Skin	12.5% 12/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	11.2% 11/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Skin and subcutaneous tissue disorders Eczema	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Skin and subcutaneous tissue disorders Erythema	19.8% 19/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	2.0% 2/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Skin and subcutaneous tissue disorders Hyperhidrosis	3.1% 3/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	6.1% 6/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Skin and subcutaneous tissue disorders Hyperkeratosis	0.00% 0/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	2.0% 2/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Skin and subcutaneous tissue disorders Night Sweats	3.1% 3/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	5.1% 5/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Skin and subcutaneous tissue disorders Pain of Skin	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Skin and subcutaneous tissue disorders Perioral Dermatitis	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Skin and subcutaneous tissue disorders Pruritus	11.5% 11/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	9.2% 9/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Skin and subcutaneous tissue disorders Rash	9.4% 9/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	12.2% 12/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Skin and subcutaneous tissue disorders Rash Erythematous	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Skin and subcutaneous tissue disorders Rash Macular	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Skin and subcutaneous tissue disorders Rash Maculo-Papular	21.9% 21/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	17.3% 17/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Skin and subcutaneous tissue disorders Rash Papular	3.1% 3/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Skin and subcutaneous tissue disorders Rash Pruritic	4.2% 4/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Skin and subcutaneous tissue disorders Sensitive Skin	4.2% 4/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Skin and subcutaneous tissue disorders Skin Discolouration	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Skin and subcutaneous tissue disorders Skin Lesion	1.0% 1/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	3.1% 3/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Skin and subcutaneous tissue disorders Urticaria	4.2% 4/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Vascular disorders Embolism Venous	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	3.1% 3/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Vascular disorders Flushing	4.2% 4/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	1.0% 1/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Vascular disorders Hot Flush	3.1% 3/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Vascular disorders Hypertension	14.6% 14/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	10.2% 10/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Vascular disorders Hypotension	6.2% 6/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	6.1% 6/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.
Vascular disorders Superficial Vein Thrombosis	2.1% 2/96 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.	0.00% 0/98 • From Cycle 1 Day 1 up to 30 days after the last study treatment or day prior to start of subsequent antimyeloma therapy (up to 4.9 years) Serious adverse events and Other adverse events were analyzed on safety analysis set which included all randomized participants who received at least 1 dose of study agent. All-cause mortality was assessed on all randomized participants.

Additional Information

Director Clinical Research Scientist

Janssen Research & Development

Phone: 844-434-4210

Email: ClinicalTrialDisclosure@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
• Publication restrictions are in place

Restriction type: OTHER