Safety and Efficacy of Pomalidomide, Bortezomib and Low-dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma (OPTIMISMM)

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ClinicalTrials.gov Identifier: NCT01734928

Recruitment Status : Completed

First Posted : November 28, 2012

Results First Posted : June 6, 2023

Last Update Posted : June 6, 2023

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Sponsor:

Information provided by (Responsible Party):

Celgene

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Multiple Myeloma
Interventions	Drug: Pomalidomide Drug: Bortezomib Drug: Dexamethasone
Enrollment	559

Participant Flow

Recruitment Details
Pre-assignment Details	548 participants treated


Arm/Group Title	Treatment 1: POM+BTZ+LD-DEX	Treatment 2: BTZ+LD-DEX
Arm/Group Description	POM (Pomalidomide) ...	BTZ ((Bortezomib) ...
Arm/Group Description	POM (Pomalidomide) 4 mg/day on Days 1 to 14 of each 21-day treatment cycle BTZ (Bortezomib) For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone) For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle. For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.	BTZ ((Bortezomib) For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone) For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle. For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.
Period Title: Randomization
Started	281	278
Completed	278	270
Not Completed	3	8
Reason Not Completed
Physician Decision	0	1
clinical progression	0	1
progressive disease	0	2
Withdrew informed consent	0	4
Death	1	0
Randomization error	1	0
Lost to Follow-up	1	0
Period Title: Treatment Period
Started	278	270
Completed	0	0
Not Completed	278	270
Reason Not Completed
Lost to Follow-up	0	2
Progressive Disease	167	165
Adverse Event	39	52
Withdrawal of Consent	25	22
Death	20	9
Other Reasons	27	19
Pregnancy	0	1

Baseline Characteristics

Arm/Group Title		Treatment 1: POM+BTZ+LD-DEX	Treatment 2: BTZ+LD-DEX	Total
Arm/Group Description		POM (Pomalidomide) ...	BTZ ((Bortezomib) ...	Total of all reporting groups
Arm/Group Description		POM (Pomalidomide) 4 mg/day on Days 1 to 14 of each 21-day treatment cycle BTZ (Bortezomib) For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone) For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle. For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.	BTZ ((Bortezomib) For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone) For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle. For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.	Total of all reporting groups
Overall Number of Baseline Participants		281	278	559
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	281 participants	278 participants	559 participants
		65.9 (10.13)	66.1 (10.16)	66.0 (10.14)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	281 participants	278 participants	559 participants
	Female	126 44.8%	131 47.1%	257 46.0%
	Male	155 55.2%	147 52.9%	302 54.0%
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	281 participants	278 participants	559 participants
	Hispanic or Latino	17 6.0%	14 5.0%	31 5.5%
	Not Hispanic or Latino	244 86.8%	241 86.7%	485 86.8%
	Unknown or Not Reported	20 7.1%	23 8.3%	43 7.7%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	281 participants	278 participants	559 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	14 5.0%	8 2.9%	22 3.9%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	8 2.8%	13 4.7%	21 3.8%
	White	237 84.3%	234 84.2%	471 84.3%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	22 7.8%	23 8.3%	45 8.1%

Outcome Measures

1.Primary Outcome


Title	Progression Free Survival by Independent Response Adjudication Committee (IRAC)
Description	Progression free survival (PFS) will be calculated as the time between...
Description	Progression free survival (PFS) will be calculated as the time between the randomization and progressive disease (PD) or death. Progressive Disease is defined as an Increase of ≥ 25% from nadir in: Serum M-component and/or (the absolute increase must be ≥ 0.5 g/dL)g Urine M-component and/or (the absolute increase must be ≥ 200 mg/24 hours) In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels, the absolute increase must be > 100 mg/dL. Bone marrow plasma cell percentage, the absolute % must be ≥ 10%h Definite development of new bone lesions or soft tissue plasmacytomas increase in the size of existing bone lesions or soft tissue plasmacytomas. -Development of hypercalcemia (corrected serum calcium > 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder.
Time Frame	From randomization to progressive disease or death during the IRAC assessment period, up to approximately 42 months

Outcome Measure Data

Analysis Population Description

All randomized participants


Arm/Group Title	Treatment 1: POM+BTZ+LD-DEX	Treatment 2: BTZ+LD-DEX
Arm/Group Description:	POM (Pomalidomide) ...	BTZ ((Bortezomib) ...
Arm/Group Description:	POM (Pomalidomide) 4 mg/day on Days 1 to 14 of each 21-day treatment cycle BTZ (Bortezomib) For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone) For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle. For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.	BTZ ((Bortezomib) For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone) For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle. For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.
Overall Number of Participants Analyzed	281	278
Median (95% Confidence Interval) Unit of Measure: Months
	11.20 (9.66 to 13.73)	7.10 (5.88 to 8.48)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Treatment 1: POM+BTZ+LD-DEX, Treatment 2: BTZ+LD-DEX
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.001
	Comments	[Not Specified]
	Method	Based on Cox proportional hazards model
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.61
	Confidence Interval	(2-Sided) 95% 0.49 to 0.77
	Estimation Comments	[Not Specified]

2.Secondary Outcome


Title	Overall Survival (OS)
Description	Overall survival (OS) is calculated as the time from randomization to ...
Description	Overall survival (OS) is calculated as the time from randomization to death from any cause.
Time Frame	From randomization to date of death, up to approximately 65 months

Outcome Measure Data

Analysis Population Description

All randomized participants


Arm/Group Title	Treatment 1: POM+BTZ+LD-DEX	Treatment 2: BTZ+LD-DEX
Arm/Group Description:	POM (Pomalidomide) ...	BTZ ((Bortezomib) ...
Arm/Group Description:	POM (Pomalidomide) 4 mg/day on Days 1 to 14 of each 21-day treatment cycle BTZ (Bortezomib) For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone) For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle. For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.	BTZ ((Bortezomib) For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone) For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle. For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.
Overall Number of Participants Analyzed	281	278
Median (95% Confidence Interval) Unit of Measure: Months
	35.58 (28.55 to 41.20)	31.61 (26.05 to 37.16)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Treatment 1: POM+BTZ+LD-DEX, Treatment 2: BTZ+LD-DEX
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.571
	Comments	[Not Specified]
	Method	Log Rank
	Comments	The p-value is based on a stratified log-rank test with stratification factors as above Cox model.

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.94
	Confidence Interval	(2-Sided) 95% 0.77 to 1.15
	Estimation Comments	Based on Cox proportional hazards model, comparing the hazard functions associated with treatment groups, stratified by age, prior number of anti-myeloma regimens, and beta-2 macroglobulin at Screening.

3.Secondary Outcome


Title	Overall Response Rate by Independent Response Adjudication Committee (IRAC)
Description	The ORR together with the relative proportions in each response catego...
Description	The ORR together with the relative proportions in each response category (ie, stringent CR [sCR], CR, very good PR [VGPR], PR, SD, and PD) by treatment using the IMWG criteria will be examined. Complete Response: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow SCR: CR+ Normal FLC ratio and Absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine Mprotein level < 100 mg per 24 hours PR: ≥ 50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by ≥ 90% or to < 200 mg per 24 hours Progressive Disease: Please refer to Primary outcome measure for definition SD: Not meeting criteria for CR, VGPR, PR, or progressive disease
Time Frame	From randomization to progressive disease or death during the IRAC assessment period, up to approximately 42 months

Outcome Measure Data

Analysis Population Description

All randomized participants


Arm/Group Title	Treatment 1: POM+BTZ+LD-DEX	Treatment 2: BTZ+LD-DEX
Arm/Group Description:	POM (Pomalidomide) ...	BTZ ((Bortezomib) ...
Arm/Group Description:	POM (Pomalidomide) 4 mg/day on Days 1 to 14 of each 21-day treatment cycle BTZ (Bortezomib) For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone) For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle. For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.	BTZ ((Bortezomib) For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone) For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle. For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.
Overall Number of Participants Analyzed	281	278
Measure Type: Count of Participants Unit of Measure: Participants
Stringent complete response	9 3.2%	2 0.7%
Complete Reponse	35 12.5%	9 3.2%
Very Good Partial Response	104 37.0%	40 14.4%
Partial Response	83 29.5%	88 31.7%
Stable Disease	32 11.4%	106 38.1%
Progressive Disease	11 3.9%	16 5.8%
Not Evaluable	7 2.5%	17 6.1%

4.Secondary Outcome


Title	Duration of Response by Independent Response Adjudication Committee (IRAC)
Description	Duration of myeloma response is defined as the duration from the time ...
Description	Duration of myeloma response is defined as the duration from the time when the IMWG response criteria are first met for sCR or CR or VGPR or PR until the first date the response criteria are met for PD or until the subject died from any cause, whichever occurs first. Complete Response: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow SCR: CR+ Normal FLC ratio and Absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine Mprotein level < 100 mg per 24 hours PR: ≥ 50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by ≥ 90% or to < 200 mg per 24 hours Progressive Disease: Please refer to Primary outcome measure for definition SD: Not meeting criteria for CR, VGPR, PR, or progressive disease
Time Frame	From randomization to progressive disease or death during the IRAC assessment period, up to approximately 42 months

Outcome Measure Data

Analysis Population Description

All randomized participants with a response (sCR or CR or VGPR or PR)


Arm/Group Title	Treatment 1: POM+BTZ+LD-DEX	Treatment 2: BTZ+LD-DEX
Arm/Group Description:	POM (Pomalidomide) ...	BTZ ((Bortezomib) ...
Arm/Group Description:	POM (Pomalidomide) 4 mg/day on Days 1 to 14 of each 21-day treatment cycle BTZ (Bortezomib) For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone) For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle. For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.	BTZ ((Bortezomib) For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone) For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle. For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.
Overall Number of Participants Analyzed	231	139
Median (95% Confidence Interval) Unit of Measure: Months
	13.70 (10.94 to 18.10)	10.94 (8.11 to 14.78)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Treatment 1: POM+BTZ+LD-DEX, Treatment 2: BTZ+LD-DEX
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.064
	Comments	[Not Specified]
	Method	Unstratified log-rank test
	Comments	The p-value is based on an unstratified log-rank test.

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.76
	Confidence Interval	(2-Sided) 95% 0.56 to 1.02
	Estimation Comments	Based on Cox proportional hazards model comparing the hazard functions associated with treatment groups

5.Secondary Outcome


Title	Number of Participants With Grade 3-4 Treatment Emergent Adverse Events (TEAE)
Description	Treatment-emergent adverse events (TEAEs) are defined as any AE occurr...
Description	Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first dose date of the study treatment and within 28 days after the last dose date.
Time Frame	From first dose to 28 days after the last dose (up to approximately 44 months

Outcome Measure Data

Analysis Population Description

All Treated Participants


Arm/Group Title	Treatment 1: POM+BTZ+LD-DEX	Treatment 2: BTZ+LD-DEX
Arm/Group Description:	POM (Pomalidomide) ...	BTZ ((Bortezomib) ...
Arm/Group Description:	POM (Pomalidomide) 4 mg/day on Days 1 to 14 of each 21-day treatment cycle BTZ (Bortezomib) For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone) For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle. For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.	BTZ ((Bortezomib) For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone) For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle. For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.
Overall Number of Participants Analyzed	278	270
Measure Type: Count of Participants Unit of Measure: Participants
	259 93.2%	194 71.9%

6.Secondary Outcome


Title	Number of Participants With Grade 5 Treatment Emergent Adverse Events (TEAE)
Description	Treatment-emergent adverse events (TEAEs) are defined as any AE occurr...
Description	Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first dose date of the study treatment and within 28 days after the last dose date.
Time Frame	From first dose to 28 days after the last dose (up to approximately 44 months

Outcome Measure Data

Analysis Population Description

All Treated Participants


Arm/Group Title	Treatment 1: POM+BTZ+LD-DEX	Treatment 2: BTZ+LD-DEX
Arm/Group Description:	POM (Pomalidomide) ...	BTZ ((Bortezomib) ...
Arm/Group Description:	POM (Pomalidomide) 4 mg/day on Days 1 to 14 of each 21-day treatment cycle BTZ (Bortezomib) For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone) For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle. For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.	BTZ ((Bortezomib) For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone) For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle. For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.
Overall Number of Participants Analyzed	278	270
Measure Type: Count of Participants Unit of Measure: Participants
	29 10.4%	12 4.4%

Adverse Events

Time Frame	AEs and SAEs: From first treatment to 28 days after last dose, up to approximately 44 months on average of 10 months. All-Cause mortality: from randomization to end of the study, approximately 65 months.
Adverse Event Reporting Description	The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication

Arm/Group Title	Treatment 1: POM + BTZ + LD-DEX	Treatment 2: BTZ + LD-DEX
Arm/Group Description	POM (Pomalidomide) ...	BTZ ((Bortezomib) ...
Arm/Group Description	POM (Pomalidomide) 4 mg/day on Days 1 to 14 of each 21-day treatment cycle BTZ (Bortezomib) For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone) For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle. For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.	BTZ ((Bortezomib) For Cycles 1 - 8: 1.3 mg/m2/dose on Days 1, 4, 8, and 11 of a 21-day cycle For Cycles 9 onwards: 1.3 mg/m2/dose on Days 1 and 8 of a 21-day cycle DEX (Dexamethasone) For Cycles 1 to 8, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle. For Cycles 9 and onward, 20 mg/day (≤ 75 years old) or 10 mg/day (> 75 years old) on Days 1, 2, 8, and 9 of a 21-day cycle.
All-Cause Mortality
	Treatment 1: POM + BTZ + LD-DEX	Treatment 2: BTZ + LD-DEX
	Affected / at Risk (%)	Affected / at Risk (%)
Total	197/281 (70.11%)	193/278 (69.42%)
Serious Adverse Events Serious Adverse Events
	Treatment 1: POM + BTZ + LD-DEX	Treatment 2: BTZ + LD-DEX
	Affected / at Risk (%)	Affected / at Risk (%)
Total	177/278 (63.67%)	119/270 (44.07%)
Blood and lymphatic system disorders
Anaemia ^† 1	4/278 (1.44%)	5/270 (1.85%)
Febrile neutropenia ^† 1	5/278 (1.80%)	1/270 (0.37%)
Hyperviscosity syndrome ^† 1	0/278 (0.00%)	3/270 (1.11%)
Lymphopenia ^† 1	1/278 (0.36%)	0/270 (0.00%)
Neutropenia ^† 1	1/278 (0.36%)	0/270 (0.00%)
Thrombocytopenia ^† 1	2/278 (0.72%)	3/270 (1.11%)
Cardiac disorders
Acute coronary syndrome ^† 1	2/278 (0.72%)	0/270 (0.00%)
Acute myocardial infarction ^† 1	1/278 (0.36%)	1/270 (0.37%)
Angina pectoris ^† 1	1/278 (0.36%)	0/270 (0.00%)
Angina unstable ^† 1	2/278 (0.72%)	0/270 (0.00%)
Atrial fibrillation ^† 1	9/278 (3.24%)	2/270 (0.74%)
Atrial flutter ^† 1	2/278 (0.72%)	1/270 (0.37%)
Atrial thrombosis ^† 1	1/278 (0.36%)	0/270 (0.00%)
Atrioventricular block complete ^† 1	0/278 (0.00%)	1/270 (0.37%)
Atrioventricular block second degree ^† 1	1/278 (0.36%)	0/270 (0.00%)
Bradycardia ^† 1	1/278 (0.36%)	0/270 (0.00%)
Bundle branch block left ^† 1	1/278 (0.36%)	0/270 (0.00%)
Cardiac arrest ^† 1	2/278 (0.72%)	0/270 (0.00%)
Cardiac failure ^† 1	3/278 (1.08%)	2/270 (0.74%)
Cardiac failure congestive ^† 1	3/278 (1.08%)	2/270 (0.74%)
Cardio-respiratory arrest ^† 1	1/278 (0.36%)	0/270 (0.00%)
Coronary artery disease ^† 1	2/278 (0.72%)	0/270 (0.00%)
Left ventricular dysfunction ^† 1	0/278 (0.00%)	1/270 (0.37%)
Left ventricular failure ^† 1	0/278 (0.00%)	1/270 (0.37%)
Myocardial infarction ^† 1	1/278 (0.36%)	1/270 (0.37%)
Pericardial effusion ^† 1	0/278 (0.00%)	1/270 (0.37%)
Pericarditis ^† 1	1/278 (0.36%)	0/270 (0.00%)
Restrictive cardiomyopathy ^† 1	0/278 (0.00%)	1/270 (0.37%)
Sinus bradycardia ^† 1	1/278 (0.36%)	0/270 (0.00%)
Sinus node dysfunction ^† 1	2/278 (0.72%)	0/270 (0.00%)
Supraventricular tachycardia ^† 1	0/278 (0.00%)	1/270 (0.37%)
Ear and labyrinth disorders
Vertigo ^† 1	1/278 (0.36%)	0/270 (0.00%)
Endocrine disorders
Hyperthyroidism ^† 1	0/278 (0.00%)	1/270 (0.37%)
Eye disorders
Cataract ^† 1	1/278 (0.36%)	0/270 (0.00%)
Retinal detachment ^† 1	1/278 (0.36%)	0/270 (0.00%)
Retinal vein thrombosis ^† 1	1/278 (0.36%)	0/270 (0.00%)
Gastrointestinal disorders
Abdominal pain ^† 1	2/278 (0.72%)	1/270 (0.37%)
Abdominal pain upper ^† 1	2/278 (0.72%)	0/270 (0.00%)
Colonic fistula ^† 1	1/278 (0.36%)	0/270 (0.00%)
Constipation ^† 1	2/278 (0.72%)	2/270 (0.74%)
Diarrhoea ^† 1	5/278 (1.80%)	6/270 (2.22%)
Enterocolitis ^† 1	1/278 (0.36%)	0/270 (0.00%)
Food poisoning ^† 1	0/278 (0.00%)	1/270 (0.37%)
Gastric haemorrhage ^† 1	1/278 (0.36%)	0/270 (0.00%)
Gastric ulcer haemorrhage ^† 1	1/278 (0.36%)	0/270 (0.00%)
Gastric volvulus ^† 1	1/278 (0.36%)	0/270 (0.00%)
Gastrointestinal haemorrhage ^† 1	0/278 (0.00%)	1/270 (0.37%)
Haemorrhoidal haemorrhage ^† 1	1/278 (0.36%)	1/270 (0.37%)
Ileus ^† 1	1/278 (0.36%)	1/270 (0.37%)
Intestinal obstruction ^† 1	1/278 (0.36%)	0/270 (0.00%)
Lower gastrointestinal haemorrhage ^† 1	0/278 (0.00%)	1/270 (0.37%)
Nausea ^† 1	1/278 (0.36%)	3/270 (1.11%)
Pancreatitis acute ^† 1	1/278 (0.36%)	0/270 (0.00%)
Parotid gland enlargement ^† 1	1/278 (0.36%)	0/270 (0.00%)
Retroperitoneal haematoma ^† 1	1/278 (0.36%)	0/270 (0.00%)
Retroperitoneal haemorrhage ^† 1	0/278 (0.00%)	1/270 (0.37%)
Umbilical hernia ^† 1	0/278 (0.00%)	1/270 (0.37%)
Upper gastrointestinal haemorrhage ^† 1	1/278 (0.36%)	0/270 (0.00%)
Vomiting ^† 1	1/278 (0.36%)	3/270 (1.11%)
General disorders
Death ^† 1	4/278 (1.44%)	0/270 (0.00%)
Fatigue ^† 1	1/278 (0.36%)	0/270 (0.00%)
Gait disturbance ^† 1	0/278 (0.00%)	2/270 (0.74%)
General physical health deterioration ^† 1	5/278 (1.80%)	9/270 (3.33%)
Influenza like illness ^† 1	1/278 (0.36%)	0/270 (0.00%)
Malaise ^† 1	0/278 (0.00%)	2/270 (0.74%)
Multiple organ dysfunction syndrome ^† 1	1/278 (0.36%)	0/270 (0.00%)
Non-cardiac chest pain ^† 1	3/278 (1.08%)	2/270 (0.74%)
Pain ^† 1	1/278 (0.36%)	1/270 (0.37%)
Pyrexia ^† 1	12/278 (4.32%)	5/270 (1.85%)
Systemic inflammatory response syndrome ^† 1	0/278 (0.00%)	1/270 (0.37%)
Hepatobiliary disorders
Cholecystitis ^† 1	1/278 (0.36%)	0/270 (0.00%)
Cholecystitis acute ^† 1	1/278 (0.36%)	0/270 (0.00%)
Cholecystitis chronic ^† 1	0/278 (0.00%)	1/270 (0.37%)
Hepatitis acute ^† 1	0/278 (0.00%)	1/270 (0.37%)
Hepatotoxicity ^† 1	0/278 (0.00%)	1/270 (0.37%)
Hyperbilirubinaemia ^† 1	1/278 (0.36%)	0/270 (0.00%)
Infections and infestations
Abscess limb ^† 1	1/278 (0.36%)	0/270 (0.00%)
Acute hepatitis B ^† 1	0/278 (0.00%)	1/270 (0.37%)
Atypical pneumonia ^† 1	0/278 (0.00%)	1/270 (0.37%)
Bacterial sepsis ^† 1	1/278 (0.36%)	0/270 (0.00%)
Bronchiolitis ^† 1	1/278 (0.36%)	0/270 (0.00%)
Bronchitis ^† 1	3/278 (1.08%)	2/270 (0.74%)
Bronchitis bacterial ^† 1	1/278 (0.36%)	0/270 (0.00%)
Bronchitis pneumococcal ^† 1	1/278 (0.36%)	0/270 (0.00%)
Bronchopulmonary aspergillosis ^† 1	0/278 (0.00%)	1/270 (0.37%)
Catheter site infection ^† 1	1/278 (0.36%)	0/270 (0.00%)
Cellulitis ^† 1	2/278 (0.72%)	1/270 (0.37%)
Clostridium difficile colitis ^† 1	4/278 (1.44%)	0/270 (0.00%)
Clostridium difficile infection ^† 1	1/278 (0.36%)	0/270 (0.00%)
Device related infection ^† 1	0/278 (0.00%)	1/270 (0.37%)
Diverticulitis ^† 1	1/278 (0.36%)	0/270 (0.00%)
Endocarditis ^† 1	0/278 (0.00%)	1/270 (0.37%)
Enterobacter pneumonia ^† 1	1/278 (0.36%)	1/270 (0.37%)
Enterococcal sepsis ^† 1	0/278 (0.00%)	1/270 (0.37%)
Epididymitis ^† 1	0/278 (0.00%)	1/270 (0.37%)
Erysipelas ^† 1	2/278 (0.72%)	0/270 (0.00%)
Escherichia bacteraemia ^† 1	0/278 (0.00%)	1/270 (0.37%)
Escherichia sepsis ^† 1	1/278 (0.36%)	1/270 (0.37%)
Escherichia urinary tract infection ^† 1	3/278 (1.08%)	1/270 (0.37%)
Gastroenteritis ^† 1	0/278 (0.00%)	1/270 (0.37%)
Gastroenteritis salmonella ^† 1	2/278 (0.72%)	0/270 (0.00%)
H1N1 influenza ^† 1	1/278 (0.36%)	1/270 (0.37%)
Haemophilus infection ^† 1	0/278 (0.00%)	1/270 (0.37%)
Herpes oesophagitis ^† 1	1/278 (0.36%)	0/270 (0.00%)
Herpes zoster ^† 1	1/278 (0.36%)	0/270 (0.00%)
Hordeolum ^† 1	0/278 (0.00%)	1/270 (0.37%)
Infection ^† 1	3/278 (1.08%)	1/270 (0.37%)
Influenza ^† 1	10/278 (3.60%)	4/270 (1.48%)
Leishmaniasis ^† 1	1/278 (0.36%)	0/270 (0.00%)
Localised infection ^† 1	0/278 (0.00%)	1/270 (0.37%)
Lower respiratory tract infection ^† 1	10/278 (3.60%)	5/270 (1.85%)
Lung infection ^† 1	2/278 (0.72%)	2/270 (0.74%)
Mastoiditis ^† 1	0/278 (0.00%)	1/270 (0.37%)
Meningitis listeria ^† 1	1/278 (0.36%)	0/270 (0.00%)
Meningococcal infection ^† 1	0/278 (0.00%)	1/270 (0.37%)
Muscle abscess ^† 1	1/278 (0.36%)	0/270 (0.00%)
Neutropenic sepsis ^† 1	1/278 (0.36%)	0/270 (0.00%)
Oesophageal candidiasis ^† 1	1/278 (0.36%)	0/270 (0.00%)
Osteomyelitis ^† 1	1/278 (0.36%)	0/270 (0.00%)
Periorbital cellulitis ^† 1	0/278 (0.00%)	1/270 (0.37%)
Pharyngitis ^† 1	1/278 (0.36%)	0/270 (0.00%)
Pharyngotonsillitis ^† 1	0/278 (0.00%)	1/270 (0.37%)
Pneumococcal sepsis ^† 1	1/278 (0.36%)	0/270 (0.00%)
Pneumocystis jirovecii pneumonia ^† 1	1/278 (0.36%)	0/270 (0.00%)
Pneumonia ^† 1	34/278 (12.23%)	17/270 (6.30%)
Pneumonia bacterial ^† 1	2/278 (0.72%)	1/270 (0.37%)
Pneumonia haemophilus ^† 1	0/278 (0.00%)	1/270 (0.37%)
Pneumonia influenzal ^† 1	2/278 (0.72%)	0/270 (0.00%)
Pneumonia legionella ^† 1	2/278 (0.72%)	0/270 (0.00%)
Pneumonia moraxella ^† 1	1/278 (0.36%)	0/270 (0.00%)
Pneumonia parainfluenzae viral ^† 1	1/278 (0.36%)	0/270 (0.00%)
Pneumonia pneumococcal ^† 1	1/278 (0.36%)	2/270 (0.74%)
Pneumonia respiratory syncytial viral ^† 1	1/278 (0.36%)	0/270 (0.00%)
Pneumonia staphylococcal ^† 1	2/278 (0.72%)	0/270 (0.00%)
Pneumonia streptococcal ^† 1	1/278 (0.36%)	2/270 (0.74%)
Pulmonary sepsis ^† 1	2/278 (0.72%)	0/270 (0.00%)
Respiratory syncytial virus bronchiolitis ^† 1	1/278 (0.36%)	0/270 (0.00%)
Respiratory syncytial virus infection ^† 1	2/278 (0.72%)	0/270 (0.00%)
Respiratory tract infection ^† 1	5/278 (1.80%)	0/270 (0.00%)
Respiratory tract infection bacterial ^† 1	1/278 (0.36%)	0/270 (0.00%)
Respiratory tract infection viral ^† 1	1/278 (0.36%)	0/270 (0.00%)
Rhinovirus infection ^† 1	1/278 (0.36%)	0/270 (0.00%)
Sepsis ^† 1	5/278 (1.80%)	1/270 (0.37%)
Septic shock ^† 1	6/278 (2.16%)	0/270 (0.00%)
Sinusitis ^† 1	2/278 (0.72%)	0/270 (0.00%)
Skin infection ^† 1	2/278 (0.72%)	0/270 (0.00%)
Staphylococcal bacteraemia ^† 1	1/278 (0.36%)	0/270 (0.00%)
Staphylococcal sepsis ^† 1	1/278 (0.36%)	1/270 (0.37%)
Streptococcal sepsis ^† 1	1/278 (0.36%)	0/270 (0.00%)
Upper respiratory tract infection ^† 1	3/278 (1.08%)	3/270 (1.11%)
Urinary tract infection ^† 1	3/278 (1.08%)	0/270 (0.00%)
Urinary tract infection bacterial ^† 1	1/278 (0.36%)	1/270 (0.37%)
Urinary tract infection staphylococcal ^† 1	1/278 (0.36%)	0/270 (0.00%)
Urosepsis ^† 1	1/278 (0.36%)	2/270 (0.74%)
Injury, poisoning and procedural complications
Cervical vertebral fracture ^† 1	0/278 (0.00%)	1/270 (0.37%)
Femoral neck fracture ^† 1	1/278 (0.36%)	0/270 (0.00%)
Femur fracture ^† 1	1/278 (0.36%)	3/270 (1.11%)
Head injury ^† 1	0/278 (0.00%)	1/270 (0.37%)
Humerus fracture ^† 1	2/278 (0.72%)	1/270 (0.37%)
Infusion related reaction ^† 1	1/278 (0.36%)	0/270 (0.00%)
Overdose ^† 1	0/278 (0.00%)	1/270 (0.37%)
Post procedural haemorrhage ^† 1	0/278 (0.00%)	1/270 (0.37%)
Rib fracture ^† 1	1/278 (0.36%)	1/270 (0.37%)
Spinal fracture ^† 1	0/278 (0.00%)	1/270 (0.37%)
Subcutaneous haematoma ^† 1	0/278 (0.00%)	1/270 (0.37%)
Investigations
Alanine aminotransferase increased ^† 1	1/278 (0.36%)	0/270 (0.00%)
Aspartate aminotransferase increased ^† 1	1/278 (0.36%)	0/270 (0.00%)
Blood alkaline phosphatase increased ^† 1	1/278 (0.36%)	0/270 (0.00%)
Blood creatinine increased ^† 1	1/278 (0.36%)	1/270 (0.37%)
Chest X-ray abnormal ^† 1	0/278 (0.00%)	1/270 (0.37%)
Coronavirus test positive ^† 1	1/278 (0.36%)	0/270 (0.00%)
General physical condition abnormal ^† 1	1/278 (0.36%)	0/270 (0.00%)
International normalised ratio increased ^† 1	1/278 (0.36%)	0/270 (0.00%)
Neutrophil count decreased ^† 1	1/278 (0.36%)	0/270 (0.00%)
Metabolism and nutrition disorders
Dehydration ^† 1	3/278 (1.08%)	2/270 (0.74%)
Diabetes mellitus ^† 1	0/278 (0.00%)	1/270 (0.37%)
Hypercalcaemia ^† 1	1/278 (0.36%)	0/270 (0.00%)
Hyperglycaemia ^† 1	3/278 (1.08%)	1/270 (0.37%)
Hypoalbuminaemia ^† 1	1/278 (0.36%)	0/270 (0.00%)
Hypomagnesaemia ^† 1	0/278 (0.00%)	1/270 (0.37%)
Hyponatraemia ^† 1	2/278 (0.72%)	0/270 (0.00%)
Hypovolaemia ^† 1	1/278 (0.36%)	0/270 (0.00%)
Malnutrition ^† 1	0/278 (0.00%)	1/270 (0.37%)
Metabolic acidosis ^† 1	0/278 (0.00%)	1/270 (0.37%)
Tumour lysis syndrome ^† 1	1/278 (0.36%)	0/270 (0.00%)
Type 2 diabetes mellitus ^† 1	0/278 (0.00%)	1/270 (0.37%)
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	1/278 (0.36%)	0/270 (0.00%)
Arthritis ^† 1	1/278 (0.36%)	0/270 (0.00%)
Back pain ^† 1	3/278 (1.08%)	1/270 (0.37%)
Bone pain ^† 1	1/278 (0.36%)	1/270 (0.37%)
Cervical spinal stenosis ^† 1	0/278 (0.00%)	1/270 (0.37%)
Muscular weakness ^† 1	1/278 (0.36%)	1/270 (0.37%)
Musculoskeletal chest pain ^† 1	1/278 (0.36%)	0/270 (0.00%)
Musculoskeletal pain ^† 1	0/278 (0.00%)	1/270 (0.37%)
Osteorrhagia ^† 1	0/278 (0.00%)	1/270 (0.37%)
Pain in extremity ^† 1	0/278 (0.00%)	2/270 (0.74%)
Pathological fracture ^† 1	2/278 (0.72%)	0/270 (0.00%)
Spinal pain ^† 1	1/278 (0.36%)	0/270 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia ^† 1	1/278 (0.36%)	0/270 (0.00%)
Basal cell carcinoma ^† 1	6/278 (2.16%)	1/270 (0.37%)
Basosquamous carcinoma ^† 1	1/278 (0.36%)	0/270 (0.00%)
Bowen's disease ^† 1	2/278 (0.72%)	0/270 (0.00%)
Bronchial carcinoma ^† 1	0/278 (0.00%)	1/270 (0.37%)
Keratoacanthoma ^† 1	1/278 (0.36%)	0/270 (0.00%)
Metastases to meninges ^† 1	0/278 (0.00%)	1/270 (0.37%)
Plasma cell leukaemia ^† 1	1/278 (0.36%)	0/270 (0.00%)
Plasmacytoma ^† 1	1/278 (0.36%)	1/270 (0.37%)
Porocarcinoma ^† 1	0/278 (0.00%)	1/270 (0.37%)
Prostate cancer ^† 1	1/278 (0.36%)	0/270 (0.00%)
Renal cell carcinoma ^† 1	0/278 (0.00%)	1/270 (0.37%)
Scrotal cancer ^† 1	1/278 (0.36%)	0/270 (0.00%)
Squamous cell carcinoma ^† 1	1/278 (0.36%)	1/270 (0.37%)
Squamous cell carcinoma of skin ^† 1	4/278 (1.44%)	2/270 (0.74%)
Nervous system disorders
Altered state of consciousness ^† 1	0/278 (0.00%)	1/270 (0.37%)
Amnesia ^† 1	0/278 (0.00%)	1/270 (0.37%)
Aphasia ^† 1	1/278 (0.36%)	0/270 (0.00%)
Cerebral haemorrhage ^† 1	1/278 (0.36%)	0/270 (0.00%)
Cerebrovascular accident ^† 1	2/278 (0.72%)	0/270 (0.00%)
Cognitive disorder ^† 1	1/278 (0.36%)	1/270 (0.37%)
Depressed level of consciousness ^† 1	0/278 (0.00%)	1/270 (0.37%)
Disturbance in attention ^† 1	0/278 (0.00%)	1/270 (0.37%)
Dizziness ^† 1	0/278 (0.00%)	1/270 (0.37%)
Encephalopathy ^† 1	1/278 (0.36%)	0/270 (0.00%)
Epilepsy ^† 1	1/278 (0.36%)	0/270 (0.00%)
Generalised tonic-clonic seizure ^† 1	1/278 (0.36%)	0/270 (0.00%)
Guillain-Barre syndrome ^† 1	1/278 (0.36%)	0/270 (0.00%)
Hepatic encephalopathy ^† 1	0/278 (0.00%)	1/270 (0.37%)
Hypoxic-ischaemic encephalopathy ^† 1	1/278 (0.36%)	0/270 (0.00%)
Ischaemic cerebral infarction ^† 1	1/278 (0.36%)	0/270 (0.00%)
Ischaemic stroke ^† 1	0/278 (0.00%)	1/270 (0.37%)
Loss of consciousness ^† 1	0/278 (0.00%)	1/270 (0.37%)
Lumbar radiculopathy ^† 1	0/278 (0.00%)	1/270 (0.37%)
Motor dysfunction ^† 1	1/278 (0.36%)	0/270 (0.00%)
Nerve root compression ^† 1	1/278 (0.36%)	0/270 (0.00%)
Paraparesis ^† 1	1/278 (0.36%)	0/270 (0.00%)
Paraplegia ^† 1	1/278 (0.36%)	0/270 (0.00%)
Peripheral motor neuropathy ^† 1	1/278 (0.36%)	0/270 (0.00%)
Peripheral sensory neuropathy ^† 1	0/278 (0.00%)	1/270 (0.37%)
Presyncope ^† 1	1/278 (0.36%)	1/270 (0.37%)
Spinal cord compression ^† 1	1/278 (0.36%)	2/270 (0.74%)
Syncope ^† 1	6/278 (2.16%)	5/270 (1.85%)
Transient ischaemic attack ^† 1	1/278 (0.36%)	0/270 (0.00%)
Trigeminal neuralgia ^† 1	1/278 (0.36%)	0/270 (0.00%)
Pregnancy, puerperium and perinatal conditions
Pregnancy ^† 1	0/278 (0.00%)	1/270 (0.37%)
Psychiatric disorders
Anxiety ^† 1	1/278 (0.36%)	0/270 (0.00%)
Confusional state ^† 1	1/278 (0.36%)	0/270 (0.00%)
Depression ^† 1	1/278 (0.36%)	0/270 (0.00%)
Mental status changes ^† 1	0/278 (0.00%)	1/270 (0.37%)
Renal and urinary disorders
Acute kidney injury ^† 1	8/278 (2.88%)	6/270 (2.22%)
Anuria ^† 1	1/278 (0.36%)	0/270 (0.00%)
Chronic kidney disease ^† 1	1/278 (0.36%)	0/270 (0.00%)
Nephrolithiasis ^† 1	1/278 (0.36%)	0/270 (0.00%)
Renal colic ^† 1	1/278 (0.36%)	0/270 (0.00%)
Urinary bladder haemorrhage ^† 1	1/278 (0.36%)	0/270 (0.00%)
Urinary retention ^† 1	1/278 (0.36%)	0/270 (0.00%)
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema ^† 1	1/278 (0.36%)	0/270 (0.00%)
Acute respiratory failure ^† 1	3/278 (1.08%)	0/270 (0.00%)
Chronic obstructive pulmonary disease ^† 1	0/278 (0.00%)	1/270 (0.37%)
Dyspnoea ^† 1	4/278 (1.44%)	1/270 (0.37%)
Dyspnoea exertional ^† 1	1/278 (0.36%)	0/270 (0.00%)
Haemothorax ^† 1	0/278 (0.00%)	1/270 (0.37%)
Hypoxia ^† 1	2/278 (0.72%)	1/270 (0.37%)
Interstitial lung disease ^† 1	0/278 (0.00%)	1/270 (0.37%)
Pleural effusion ^† 1	3/278 (1.08%)	3/270 (1.11%)
Pneumonitis ^† 1	0/278 (0.00%)	1/270 (0.37%)
Pulmonary embolism ^† 1	9/278 (3.24%)	1/270 (0.37%)
Respiratory acidosis ^† 1	1/278 (0.36%)	0/270 (0.00%)
Respiratory alkalosis ^† 1	1/278 (0.36%)	0/270 (0.00%)
Respiratory failure ^† 1	2/278 (0.72%)	2/270 (0.74%)
Skin and subcutaneous tissue disorders
Rash ^† 1	1/278 (0.36%)	0/270 (0.00%)
Skin disorder ^† 1	1/278 (0.36%)	0/270 (0.00%)
Vascular disorders
Circulatory collapse ^† 1	0/278 (0.00%)	1/270 (0.37%)
Deep vein thrombosis ^† 1	4/278 (1.44%)	4/270 (1.48%)
Hypertension ^† 1	1/278 (0.36%)	0/270 (0.00%)
Hypotension ^† 1	3/278 (1.08%)	1/270 (0.37%)
Orthostatic hypotension ^† 1	1/278 (0.36%)	1/270 (0.37%)
Peripheral arterial occlusive disease ^† 1	1/278 (0.36%)	0/270 (0.00%)
1 Term from vocabulary, 20.0 † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Treatment 1: POM + BTZ + LD-DEX	Treatment 2: BTZ + LD-DEX
	Affected / at Risk (%)	Affected / at Risk (%)
Total	276/278 (99.28%)	260/270 (96.30%)
Blood and lymphatic system disorders
Anaemia ^† 1	87/278 (31.29%)	72/270 (26.67%)
Leukopenia ^† 1	37/278 (13.31%)	9/270 (3.33%)
Lymphopenia ^† 1	14/278 (5.04%)	9/270 (3.33%)
Neutropenia ^† 1	150/278 (53.96%)	29/270 (10.74%)
Thrombocytopenia ^† 1	110/278 (39.57%)	105/270 (38.89%)
Cardiac disorders
Atrial fibrillation ^† 1	26/278 (9.35%)	5/270 (1.85%)
Eye disorders
Cataract ^† 1	22/278 (7.91%)	3/270 (1.11%)
Vision blurred ^† 1	14/278 (5.04%)	9/270 (3.33%)
Gastrointestinal disorders
Abdominal distension ^† 1	17/278 (6.12%)	6/270 (2.22%)
Abdominal pain ^† 1	30/278 (10.79%)	19/270 (7.04%)
Abdominal pain upper ^† 1	23/278 (8.27%)	16/270 (5.93%)
Constipation ^† 1	106/278 (38.13%)	65/270 (24.07%)
Diarrhoea ^† 1	102/278 (36.69%)	82/270 (30.37%)
Dry mouth ^† 1	19/278 (6.83%)	11/270 (4.07%)
Dyspepsia ^† 1	22/278 (7.91%)	25/270 (9.26%)
Nausea ^† 1	52/278 (18.71%)	56/270 (20.74%)
Stomatitis ^† 1	17/278 (6.12%)	1/270 (0.37%)
Vomiting ^† 1	35/278 (12.59%)	27/270 (10.00%)
General disorders
Asthenia ^† 1	52/278 (18.71%)	48/270 (17.78%)
Fatigue ^† 1	107/278 (38.49%)	72/270 (26.67%)
Influenza like illness ^† 1	15/278 (5.40%)	9/270 (3.33%)
Oedema peripheral ^† 1	101/278 (36.33%)	54/270 (20.00%)
Pyrexia ^† 1	72/278 (25.90%)	33/270 (12.22%)
Infections and infestations
Bronchitis ^† 1	43/278 (15.47%)	20/270 (7.41%)
Conjunctivitis ^† 1	26/278 (9.35%)	16/270 (5.93%)
Influenza ^† 1	27/278 (9.71%)	13/270 (4.81%)
Lower respiratory tract infection ^† 1	17/278 (6.12%)	8/270 (2.96%)
Pneumonia ^† 1	26/278 (9.35%)	21/270 (7.78%)
Respiratory tract infection ^† 1	21/278 (7.55%)	16/270 (5.93%)
Upper respiratory tract infection ^† 1	71/278 (25.54%)	51/270 (18.89%)
Urinary tract infection ^† 1	36/278 (12.95%)	28/270 (10.37%)
Viral upper respiratory tract infection ^† 1	36/278 (12.95%)	18/270 (6.67%)
Injury, poisoning and procedural complications
Accidental overdose ^† 1	35/278 (12.59%)	11/270 (4.07%)
Fall ^† 1	20/278 (7.19%)	11/270 (4.07%)
Investigations
Alanine aminotransferase increased ^† 1	14/278 (5.04%)	3/270 (1.11%)
Weight decreased ^† 1	20/278 (7.19%)	18/270 (6.67%)
Weight increased ^† 1	19/278 (6.83%)	19/270 (7.04%)
Metabolism and nutrition disorders
Decreased appetite ^† 1	29/278 (10.43%)	26/270 (9.63%)
Hyperglycaemia ^† 1	43/278 (15.47%)	28/270 (10.37%)
Hypocalcaemia ^† 1	20/278 (7.19%)	10/270 (3.70%)
Hypokalaemia ^† 1	45/278 (16.19%)	31/270 (11.48%)
Hypomagnesaemia ^† 1	20/278 (7.19%)	7/270 (2.59%)
Hypophosphataemia ^† 1	20/278 (7.19%)	10/270 (3.70%)
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	39/278 (14.03%)	32/270 (11.85%)
Back pain ^† 1	61/278 (21.94%)	38/270 (14.07%)
Bone pain ^† 1	25/278 (8.99%)	14/270 (5.19%)
Muscle spasms ^† 1	30/278 (10.79%)	16/270 (5.93%)
Muscular weakness ^† 1	41/278 (14.75%)	12/270 (4.44%)
Musculoskeletal pain ^† 1	23/278 (8.27%)	17/270 (6.30%)
Myalgia ^† 1	15/278 (5.40%)	11/270 (4.07%)
Pain in extremity ^† 1	42/278 (15.11%)	38/270 (14.07%)
Nervous system disorders
Dizziness ^† 1	49/278 (17.63%)	29/270 (10.74%)
Dysgeusia ^† 1	18/278 (6.47%)	8/270 (2.96%)
Headache ^† 1	35/278 (12.59%)	25/270 (9.26%)
Hypoaesthesia ^† 1	7/278 (2.52%)	15/270 (5.56%)
Paraesthesia ^† 1	18/278 (6.47%)	5/270 (1.85%)
Peripheral sensorimotor neuropathy ^† 1	18/278 (6.47%)	12/270 (4.44%)
Peripheral sensory neuropathy ^† 1	134/278 (48.20%)	103/270 (38.15%)
Syncope ^† 1	14/278 (5.04%)	6/270 (2.22%)
Tremor ^† 1	32/278 (11.51%)	8/270 (2.96%)
Psychiatric disorders
Anxiety ^† 1	13/278 (4.68%)	17/270 (6.30%)
Depression ^† 1	16/278 (5.76%)	7/270 (2.59%)
Insomnia ^† 1	49/278 (17.63%)	54/270 (20.00%)
Respiratory, thoracic and mediastinal disorders
Cough ^† 1	66/278 (23.74%)	45/270 (16.67%)
Dyspnoea ^† 1	62/278 (22.30%)	32/270 (11.85%)
Oropharyngeal pain ^† 1	17/278 (6.12%)	16/270 (5.93%)
Productive cough ^† 1	17/278 (6.12%)	13/270 (4.81%)
Skin and subcutaneous tissue disorders
Rash ^† 1	31/278 (11.15%)	11/270 (4.07%)
Vascular disorders
Hypertension ^† 1	24/278 (8.63%)	22/270 (8.15%)
Hypotension ^† 1	26/278 (9.35%)	13/270 (4.81%)
1 Term from vocabulary, 20.0 † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

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Name/Title:	Bristol-Myers Squibb Study Director
Organization:	Bristol-Myers Squibb
Phone:	Please Email
EMail:	Clinical.Trials@bms.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Richardson PG, Oriol A, Beksac M, Liberati AM, Galli M, Schjesvold F, Lindsay J, Weisel K, White D, Facon T, San Miguel J, Sunami K, O'Gorman P, Sonneveld P, Robak P, Semochkin S, Schey S, Yu X, Doerr T, Bensmaine A, Biyukov T, Peluso T, Zaki M, Anderson K, Dimopoulos M; OPTIMISMM trial investigators. Pomalidomide, bortezomib, and dexamethasone for patients with relapsed or refractory multiple myeloma previously treated with lenalidomide (OPTIMISMM): a randomised, open-label, phase 3 trial. Lancet Oncol. 2019 Jun;20(6):781-794. doi: 10.1016/S1470-2045(19)30152-4. Epub 2019 May 13.

Richardson PG, Hofmeister CC, Raje NS, Siegel DS, Lonial S, Laubach J, Efebera YA, Vesole DH, Nooka AK, Rosenblatt J, Doss D, Zaki MH, Bensmaine A, Herring J, Li Y, Watkins L, Chen MS, Anderson KC. Pomalidomide, bortezomib and low-dose dexamethasone in lenalidomide-refractory and proteasome inhibitor-exposed myeloma. Leukemia. 2017 Dec;31(12):2695-2701. doi: 10.1038/leu.2017.173. Epub 2017 Jun 2. Erratum In: Leukemia. 2018 Oct;32(10):2305.

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Responsible Party:	Celgene
ClinicalTrials.gov Identifier:	NCT01734928
Other Study ID Numbers:	CC-4047-MM-007
First Submitted:	November 23, 2012
First Posted:	November 28, 2012
Results First Submitted:	May 9, 2023
Results First Posted:	June 6, 2023
Last Update Posted:	June 6, 2023

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