A Study Evaluating Venetoclax (ABT-199) in Multiple Myeloma Subjects Who Are Receiving Bortezomib and Dexamethasone as Standard Therapy (Bellini)

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ClinicalTrials.gov Identifier: NCT02755597

Recruitment Status : Completed

First Posted : April 29, 2016

Results First Posted : August 22, 2023

Last Update Posted : August 22, 2023

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Sponsor:

Collaborator:

Genentech, Inc.

Information provided by (Responsible Party):

AbbVie

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition	Relapsed/Refractory Multiple Myeloma
Interventions	Drug: Venetoclax Drug: Bortezomib Drug: Dexamethasone Drug: Placebo for venetoclax
Enrollment	291

Participant Flow

Recruitment Details
Pre-assignment Details	Intent-To-Treat (ITT) analysis set: all randomized participants, analyzed by treatment group assignment given at the time of randomization


Arm/Group Title	Venetoclax + Bortezomib and Dexamethasone	Placebo + Bortezomib and Dexamethasone
Arm/Group Description	Cycles 1-8: Venetoclax 800 mg orall...	Cycles 1-8: Placebo (to match venet...
Arm/Group Description	Cycles 1-8: Venetoclax 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 4, 8 & 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 & 12; Cycles 9 and beyond: Venetoclax 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 and 23	Cycles 1-8: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 4, 8 & 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 & 12; Cycles 9 and beyond: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 & 23
Period Title: Overall Study
Started	194	97
Completed	0	0
Not Completed	194	97
Reason Not Completed
Withdrew consent	27	11
Lost to Follow-up	1	0
Death	78	36
Study terminated by Sponsor	67	47
Other, not specified	20	3
Participant missing reason for study discontinuation	1	0

Baseline Characteristics

Arm/Group Title		Venetoclax + Bortezomib and Dexamethasone	Placebo + Bortezomib and Dexamethasone	Total
Arm/Group Description		Cycles 1-8: Venetoclax 800 mg orall...	Cycles 1-8: Placebo (to match venet...	Total of all reporting groups
Arm/Group Description		Cycles 1-8: Venetoclax 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 4, 8 & 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 & 12; Cycles 9 and beyond: Venetoclax 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 and 23	Cycles 1-8: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 4, 8 & 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 & 12; Cycles 9 and beyond: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 & 23	Total of all reporting groups
Overall Number of Baseline Participants		194	97	291
Baseline Analysis Population Description		...
Baseline Analysis Population Description		Intent-To-Treat (ITT) analysis set: all randomized participants, analyzed by treatment group assignment given at the time of randomization
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	194 participants	97 participants	291 participants
		65.9 (9.41)	65.9 (7.81)	65.9 (8.90)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	194 participants	97 participants	291 participants
	Female	97	42	139
	Male	97	55	152
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	194 participants	97 participants	291 participants
	Hispanic or Latino	25	7	32
	Not Hispanic or Latino	169	90	259
	Unknown or Not Reported	0	0	0
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	194 participants	97 participants	291 participants
	American Indian or Alaska Native	0	0	0
	Asian	59	28	87
	Native Hawaiian or Other Pacific Islander	0	0	0
	Black or African American	9	3	12
	White	124	66	190
	More than one race	2	0	2
	Unknown or Not Reported	0	0	0
Time since diagnosis Median (Full Range) Unit of measure: Days
	Number Analyzed	194 participants	97 participants	291 participants
		1263.5 (62.0 to 8356.0)	1461.0 (195.0 to 4906.0)	1318.0 (62.0 to 8356.0)
Number of prior lines of therapy Median (Full Range) Unit of measure: Number of prior lines of therapy
	Number Analyzed	194 participants	97 participants	291 participants
		1.0 (1.0 to 3.0)	2.0 (1.0 to 3.0)	1.0 (1.0 to 3.0)
Number of prior lines of multiple myeloma therapy Measure Type: Count of Participants Unit of measure: Participants	Number Analyzed	194 participants	97 participants	291 participants
1 line		91	44	135
2-3 lines		103	53	156
Prior exposure to proteasome inhibitors (PI) Measure Type: Count of Participants Unit of measure: Participants	Number Analyzed	194 participants	97 participants	291 participants
Refractory		0	2	2
Sensitive		131	66	197
Naïve		61	28	89
Unknown		2	0	2
MISSING		0	1	1
Prior exposure to an immunomodulatory drug (IMID) Measure Type: Count of Participants Unit of measure: Participants	Number Analyzed	194 participants	97 participants	291 participants
Refractory		64	36	100
Sensitive		67	29	96
Naïve		63	30	93
Unknown		0	1	1
MISSING		0	1	1
Prior exposure to an anti-CD38 monoclonal antibody Measure Type: Count of Participants Unit of measure: Participants	Number Analyzed	194 participants	97 participants	291 participants
Refractory		5	1	6
Sensitive		0	0	0
Naïve		185	95	280
Unknown		0	0	0
MISSING		4	1	5
Multiple myeloma International Staging System(ISS) stage ^[1] Measure Type: Count of Participants Unit of measure: Participants	Number Analyzed	194 participants	97 participants	291 participants
Stage I		81	48	129
Stage II		69	32	101
Stage III		39	13	52
Not evaluable		5	3	8
MISSING		0	1	1
		[1] Measure Description: The International Staging System for multiple myeloma: Stage I: Serum β2 microglobulin (Sβ2M), < 3.5 mg/L; serum albumin ≥ 3.5 g/dL Stage II: Not ISS Stage I or III Stage III: Sβ2M > 5.5 mg/L Stage I represents the mildest form of multiple myeloma (best prognosis) and Stage III the most severe form (worst prognosis).
Chromosomal abnormality (CA) risk by fluorescent in situ hybridization (FISH) ^[1] Measure Type: Count of Participants Unit of measure: Participants	Number Analyzed	194 participants	97 participants	291 participants
High		31	18	49
Standard		141	72	213
Unknown		9	4	13
MISSING		13	3	16
		[1] Measure Description: A 4 mL bone marrow aspirate sample was collected for baseline assessment of chromosomal abnormalities, including t(11;14), t(4;14), t(14;16), del 17p, 5+, 9+, 15+
Prior stem cell transplant Measure Type: Count of Participants Unit of measure: Participants	Number Analyzed	194 participants	97 participants	291 participants
Autologous		114	57	171
Allogeneic		2	0	2
Syngeneic		0	0	0
MISSING		78	40	118

Outcome Measures

1.Primary Outcome


Title	Progression-free Survival (PFS)
Description	PFS is defined as the number of days from the date the participant was...
Description	PFS is defined as the number of days from the date the participant was randomized to the date of the first documented progressive disease (PD) as determined by an Independent Review Committee (IRC) or death due to any cause, whichever occurs first. PFS was analyzed by Kaplan-Meier methodology.
Time Frame	Median duration of follow-up was 28.6 months for the venetoclax group and 28.6 months for the placebo group

Outcome Measure Data

Analysis Population Description

Intent-To-Treat (ITT) analysis set: all randomized participants, analyzed by treatment group assignment given at the time of randomization


Arm/Group Title	Venetoclax + Bortezomib and Dexamethasone	Placebo + Bortezomib and Dexamethasone
Arm/Group Description:	Cycles 1-8: Venetoclax 800 mg orall...	Cycles 1-8: Placebo (to match venet...
Arm/Group Description:	Cycles 1-8: Venetoclax 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 4, 8 & 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 & 12; Cycles 9 and beyond: Venetoclax 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 and 23	Cycles 1-8: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 4, 8 & 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 & 12; Cycles 9 and beyond: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 & 23
Overall Number of Participants Analyzed	194	97
Median (95% Confidence Interval) Unit of Measure: months
	23.2 (15.3 to 27.5)	11.5 (9.6 to 15.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Venetoclax + Bortezomib and Dexamethasone, Placebo + Bortezomib and Dexamethasone
	Comments	Stratified Analysis; Stratification factors: Prior exposure to proteasome inhibitors (naïve versus sensitive), and number of prior lines of therapy (1 versus 2 or 3)
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	=0.012
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.656
	Confidence Interval	(2-Sided) 95% 0.471 to 0.913
	Estimation Comments	Hazard ratio was estimated by Cox proportional hazards model

2.Secondary Outcome


Title	Very Good Partial Response (VGPR) or Better Response Rate
Description	The percentage of participants with documented best overall response o...
Description	The percentage of participants with documented best overall response of Very Good Partial Response (VGPR) or better (VGPR, Complete response [CR], or Stringent complete response [sCR]) per 2016 standard International Myeloma Working Group (IMWG) criteria as determined by an Independent Review Committee (IRC) was computed.
Time Frame	Response was assessed at Cycle 1, Day 1, and on Day 1 of every cycle thereafter; median time on follow-up was 28.6 months for the venetoclax group and 28.6 months for the placebo group

Outcome Measure Data

Analysis Population Description

Intent-To-Treat (ITT) analysis set: all randomized participants, analyzed by treatment group assignment given at the time of randomization


Arm/Group Title	Venetoclax + Bortezomib and Dexamethasone	Placebo + Bortezomib and Dexamethasone
Arm/Group Description:	Cycles 1-8: Venetoclax 800 mg orall...	Cycles 1-8: Placebo (to match venet...
Arm/Group Description:	Cycles 1-8: Venetoclax 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 4, 8 & 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 & 12; Cycles 9 and beyond: Venetoclax 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 and 23	Cycles 1-8: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 4, 8 & 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 & 12; Cycles 9 and beyond: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 & 23
Overall Number of Participants Analyzed	194	97
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: percentage of participants
	60.3 (53.1 to 67.2)	38.1 (28.5 to 48.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Venetoclax + Bortezomib and Dexamethasone, Placebo + Bortezomib and Dexamethasone
	Comments	Stratified Analysis; Stratification factors: Prior exposure to proteasome inhibitors (naïve versus sensitive), and number of prior lines of therapy (1 versus 2 or 3)
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

3.Secondary Outcome


Title	Progression-Free Survival (PFS) in Participants With High B-cell Lymphoma 2 (BCL-2) Expression
Description	PFS is defined as the number of days from the date the participant was...
Description	PFS is defined as the number of days from the date the participant was randomized to the date of the first documented progressive disease (PD) per investigator assessment or death due to any cause, whichever occurs first. PFS was analyzed by Kaplan-Meier methodology. BCL-2 expression was determined through central laboratory testing by immunohistochemistry (IHC) and based on a pre-specified scoring algorithm. High clinical score of 2+: ≥50% of tumor cells with moderate or higher cytoplasmic staining but < 50% of tumor cells with strong staining intensity; high clinical score of 3+: ≥50% of tumor cells with strong cytoplasmic staining.
Time Frame	Median duration of follow-up was 28.6 months for the venetoclax group and 28.6 months for the placebo group

Outcome Measure Data

Analysis Population Description

Intent-To-Treat (ITT) analysis set: all randomized participants, analyzed by treatment group assignment given at the time of randomization who had high BCL-2 expression


Arm/Group Title	Venetoclax + Bortezomib and Dexamethasone	Placebo + Bortezomib and Dexamethasone
Arm/Group Description:	Cycles 1-8: Venetoclax 800 mg orall...	Cycles 1-8: Placebo (to match venet...
Arm/Group Description:	Cycles 1-8: Venetoclax 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 4, 8 & 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 & 12; Cycles 9 and beyond: Venetoclax 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 and 23	Cycles 1-8: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 4, 8 & 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 & 12; Cycles 9 and beyond: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 & 23
Overall Number of Participants Analyzed	93	47
Median (95% Confidence Interval) Unit of Measure: months
	23.8 (19.5 to 34.7)	11.4 (9.1 to 15.0)

4.Secondary Outcome


Title	Duration of Response (DOR)
Description	DOR is defined as the number of days from the participant's date of fi...
Description	DOR is defined as the number of days from the participant's date of first documented response (partial response [PR] or better) to the date of first documented progressive disease (PD) as determined by an Independent Review Committee (IRC) or death due to multiple myeloma, whichever occurs first. DOR was analyzed by Kaplan-Meier methodology.
Time Frame	Response was assessed at Cycle 1, Day 1, and on Day 1 of every cycle thereafter; median time on follow-up was 28.6 months for the venetoclax group and 28.6 months for the placebo group

Outcome Measure Data

Analysis Population Description

Intent-To-Treat (ITT) analysis set: all randomized participants, analyzed by treatment group assignment given at the time of randomization


Arm/Group Title	Venetoclax + Bortezomib and Dexamethasone	Placebo + Bortezomib and Dexamethasone
Arm/Group Description:	Cycles 1-8: Venetoclax 800 mg orall...	Cycles 1-8: Placebo (to match venet...
Arm/Group Description:	Cycles 1-8: Venetoclax 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 4, 8 & 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 & 12; Cycles 9 and beyond: Venetoclax 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 and 23	Cycles 1-8: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 4, 8 & 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 & 12; Cycles 9 and beyond: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 & 23
Overall Number of Participants Analyzed	158	67
Median (95% Confidence Interval) Unit of Measure: months
	NA ^[1] (22.8 to NA)	12.8 (10.6 to 15.5)

[1]

Not estimable/calculable due to low number of participants with events

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Venetoclax + Bortezomib and Dexamethasone, Placebo + Bortezomib and Dexamethasone
	Comments	Stratified Analysis; Stratification factors: Prior exposure to proteasome inhibitors (naïve versus sensitive), and number of prior lines of therapy (1 versus 2 or 3)
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.508
	Confidence Interval	(2-Sided) 95% 0.343 to 0.753
	Estimation Comments	Hazard ratio was estimated by Cox proportional hazards model

5.Secondary Outcome


Title	Mean Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF) Worst Pain
Description	The BPI-SF is a pain-specific measure developed to assess patient-repo...
Description	The BPI-SF is a pain-specific measure developed to assess patient-reported severity (or intensity) of pain (4 items) and the impact of pain on daily functioning (7 items) in patients with cancer pain. The four pain severity items assess pain at its "worst in last 24 hours," "least in last 24 hours," "average," and "now" (current pain). For these items, participants are asked to rate their pain on an 11-point numeric rating scale with anchors of 0 (no pain) and 10 (pain as bad as you can imagine). The Worst Pain scores range from 0 to 10, with higher scores indicating severe pain. Negative changes from baseline indicate improvement.
Time Frame	Baseline; Cycle 3 (Cycles 1 - 8 are 21 days, Cycles 9 and beyond are 35 days) through Cycle 47, collected on Day 1 of every other cycle and at the Treatment Completion Visit (TCV) while participant is on treatment

Outcome Measure Data

Analysis Population Description

Intent-To-Treat (ITT) analysis set: all randomized participants, analyzed by treatment group assignment given at the time of randomization; participants who have both baseline and post-baseline values are included in the analysis at each visit


Arm/Group Title		Venetoclax + Bortezomib and Dexamethasone	Placebo + Bortezomib and Dexamethasone
Arm/Group Description:		Cycles 1-8: Venetoclax 800 mg orall...	Cycles 1-8: Placebo (to match venet...
Arm/Group Description:		Cycles 1-8: Venetoclax 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 4, 8 & 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 & 12; Cycles 9 and beyond: Venetoclax 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 and 23	Cycles 1-8: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 4, 8 & 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 & 12; Cycles 9 and beyond: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 & 23
Overall Number of Participants Analyzed		184	92
Mean (Standard Deviation) Unit of Measure: units on a scale
Cycle 3, Day 1	Number Analyzed	162 participants	79 participants
Cycle 3, Day 1		-0.6 (2.59)	-0.5 (2.46)
Cycle 5, Day 1	Number Analyzed	140 participants	70 participants
Cycle 5, Day 1		0.0 (2.65)	-0.2 (3.15)
Cycle 7, Day 1	Number Analyzed	126 participants	70 participants
Cycle 7, Day 1		-0.1 (2.56)	0.2 (2.98)
Cycle 9, Day 1	Number Analyzed	113 participants	65 participants
Cycle 9, Day 1		-0.2 (3.11)	0.0 (2.88)
Cycle 11, Day 1	Number Analyzed	98 participants	55 participants
Cycle 11, Day 1		-0.4 (2.57)	0.1 (3.45)
Cycle 13, Day 1	Number Analyzed	82 participants	43 participants
Cycle 13, Day 1		-0.2 (2.71)	-0.1 (3.22)
Cycle 15, Day 1	Number Analyzed	76 participants	31 participants
Cycle 15, Day 1		-0.2 (2.92)	-0.0 (3.08)
Cycle 17, Day 1	Number Analyzed	66 participants	27 participants
Cycle 17, Day 1		-0.3 (2.54)	-0.1 (2.06)
Cycle 19, Day 1	Number Analyzed	67 participants	22 participants
Cycle 19, Day 1		-0.1 (2.59)	-0.2 (1.95)
Cycle 21, Day 1	Number Analyzed	59 participants	18 participants
Cycle 21, Day 1		-0.1 (2.39)	-0.3 (2.89)
Cycle 23, Day 1	Number Analyzed	55 participants	17 participants
Cycle 23, Day 1		-0.0 (3.20)	-0.2 (2.61)
Cycle 25, Day 1	Number Analyzed	47 participants	13 participants
Cycle 25, Day 1		0.4 (2.65)	0.2 (3.00)
Cycle 27, Day 1	Number Analyzed	37 participants	14 participants
Cycle 27, Day 1		0.2 (2.53)	0.1 (1.92)
Cycle 29, Day 1	Number Analyzed	40 participants	15 participants
Cycle 29, Day 1		-0.2 (2.83)	0.3 (2.15)
Cycle 31, Day 1	Number Analyzed	39 participants	9 participants
Cycle 31, Day 1		0.0 (3.11)	0.6 (1.33)
Cycle 33, Day 1	Number Analyzed	37 participants	7 participants
Cycle 33, Day 1		-0.2 (2.88)	0.4 (1.40)
Cycle 35, Day 1	Number Analyzed	34 participants	6 participants
Cycle 35, Day 1		0.1 (2.77)	-0.2 (1.33)
Cycle 37, Day 1	Number Analyzed	31 participants	4 participants
Cycle 37, Day 1		0.4 (2.78)	1.5 (2.65)
Cycle 39, Day 1	Number Analyzed	26 participants	3 participants
Cycle 39, Day 1		0.1 (2.70)	-0.3 (1.15)
Cycle 41, Day 1	Number Analyzed	21 participants	3 participants
Cycle 41, Day 1		0.1 (3.00)	0.3 (1.15)
Cycle 43, Day 1	Number Analyzed	17 participants	2 participants
Cycle 43, Day 1		-0.1 (3.07)	0.5 (0.71)
Cycle 45, Day 1	Number Analyzed	9 participants	2 participants
Cycle 45, Day 1		-0.7 (3.64)	1.0 (0.00)
Cycle 47, Day 1	Number Analyzed	4 participants	1 participants
Cycle 47, Day 1		-2.8 (3.77)	1.0
Final visit	Number Analyzed	175 participants	87 participants
Final visit		0.3 (3.28)	0.4 (3.55)

6.Secondary Outcome


Title	Mean Change From Baseline in Physical Functioning Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Description	The QLQ-C30 is a 30-item subject self-report questionnaire composed of...
Description	The QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including five functional scales (physical, role, emotional, social, and cognitive), three symptom scales (fatigue, nausea and vomiting, and pain), a global health status/quality of life scale, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). For the Physical Functioning scale, participants rate five items on a four-point scale, with 1 as "not at all" and 4 as "very much." The Physical Functioning Scale scores range from 0 to 100 and were calculated per the EORTC QLQ-C30 Scoring Manual (3rd edition), version 3.0. A high scale score represents high/healthy level of functioning. Positive changes from baseline indicate improvement.
Time Frame	Baseline; Cycle 3 (Cycles 1 - 8 are 21 days, Cycles 9 and beyond are 35 days) through Cycle 47, collected on Day 1 of every other cycle and at the Treatment Completion Visit (TCV) while participant is on treatment

Outcome Measure Data

Analysis Population Description


Arm/Group Title		Venetoclax + Bortezomib and Dexamethasone	Placebo + Bortezomib and Dexamethasone
Arm/Group Description:		Cycles 1-8: Venetoclax 800 mg orall...	Cycles 1-8: Placebo (to match venet...
Arm/Group Description:		Cycles 1-8: Venetoclax 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 4, 8 & 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 & 12; Cycles 9 and beyond: Venetoclax 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 and 23	Cycles 1-8: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 4, 8 & 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 & 12; Cycles 9 and beyond: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 & 23
Overall Number of Participants Analyzed		184	92
Mean (Standard Deviation) Unit of Measure: units on a scale
Cycle 3, Day 1	Number Analyzed	161 participants	79 participants
Cycle 3, Day 1		-5.0 (18.22)	-4.6 (19.50)
Cycle 5, Day 1	Number Analyzed	140 participants	70 participants
Cycle 5, Day 1		-3.9 (18.38)	-7.8 (21.50)
Cycle 7, Day 1	Number Analyzed	126 participants	70 participants
Cycle 7, Day 1		-6.1 (20.19)	-8.6 (19.76)
Cycle 9, Day 1	Number Analyzed	114 participants	65 participants
Cycle 9, Day 1		-3.5 (19.54)	-8.0 (20.01)
Cycle 11, Day 1	Number Analyzed	99 participants	55 participants
Cycle 11, Day 1		-1.5 (15.92)	-7.5 (18.46)
Cycle 13, Day 1	Number Analyzed	83 participants	43 participants
Cycle 13, Day 1		-3.2 (16.57)	-8.8 (22.85)
Cycle 15, Day 1	Number Analyzed	77 participants	31 participants
Cycle 15, Day 1		-2.3 (18.72)	-7.3 (22.27)
Cycle 17, Day 1	Number Analyzed	67 participants	27 participants
Cycle 17, Day 1		-1.8 (16.23)	-8.6 (19.90)
Cycle 19, Day 1	Number Analyzed	68 participants	22 participants
Cycle 19, Day 1		-2.5 (19.30)	-7.0 (19.35)
Cycle 21, Day 1	Number Analyzed	59 participants	18 participants
Cycle 21, Day 1		-1.5 (17.81)	-8.5 (20.43)
Cycle 23, Day 1	Number Analyzed	55 participants	17 participants
Cycle 23, Day 1		-3.4 (20.32)	-7.5 (20.53)
Cycle 25, Day 1	Number Analyzed	48 participants	13 participants
Cycle 25, Day 1		-3.8 (17.28)	0.5 (23.95)
Cycle 27, Day 1	Number Analyzed	38 participants	14 participants
Cycle 27, Day 1		-8.6 (21.69)	-3.3 (18.44)
Cycle 29, Day 1	Number Analyzed	40 participants	15 participants
Cycle 29, Day 1		-8.7 (21.25)	-4.0 (19.81)
Cycle 31, Day 1	Number Analyzed	40 participants	9 participants
Cycle 31, Day 1		-2.8 (17.98)	2.2 (18.56)
Cycle 33, Day 1	Number Analyzed	38 participants	7 participants
Cycle 33, Day 1		-4.0 (22.76)	-4.8 (23.64)
Cycle 35, Day 1	Number Analyzed	35 participants	6 participants
Cycle 35, Day 1		-7.0 (16.64)	4.4 (18.70)
Cycle 37, Day 1	Number Analyzed	31 participants	4 participants
Cycle 37, Day 1		-7.5 (22.49)	15.0 (14.78)
Cycle 39, Day 1	Number Analyzed	27 participants	3 participants
Cycle 39, Day 1		-10.1 (18.80)	8.9 (10.18)
Cycle 41, Day 1	Number Analyzed	22 participants	3 participants
Cycle 41, Day 1		-13.0 (25.65)	13.3 (23.09)
Cycle 43, Day 1	Number Analyzed	17 participants	2 participants
Cycle 43, Day 1		-7.8 (23.12)	13.3 (18.86)
Cycle 45, Day 1	Number Analyzed	10 participants	2 participants
Cycle 45, Day 1		-1.3 (10.33)	13.3 (18.86)
Cycle 47, Day 1	Number Analyzed	4 participants	1 participants
Cycle 47, Day 1		0.0 (14.40)	0.0
Final visit	Number Analyzed	175 participants	87 participants
Final visit		-11.8 (22.85)	-10.0 (21.52)

7.Secondary Outcome


Title	Mean Change From Baseline in Global Health Status/Quality of Life Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Description	The QLQ-C30 is a 30-item subject self-report questionnaire composed of...
Description	The QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including five functional scales (physical, role, emotional, social, and cognitive), three symptom scales (fatigue, nausea and vomiting, and pain), a global health status/quality of life scale, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). For the Global Health Status/Quality of Life scale, participants rate two items on a seven point scale, with 1 as "very poor" and 7 as "excellent." The Global Health Status/Quality of Life scale ranges from 0 to 100 and was calculated per the EORTC QLQ-C30 Scoring Manual (3rd edition), version 3.0. A high score for the global health status/QoL represents a high QoL. Positive changes from baseline indicate improvement.
Time Frame	Baseline; Cycle 3 (Cycles 1 - 8 are 21 days, Cycles 9 and beyond are 35 days) through Cycle 47, collected on Day 1 of every other cycle and at the Treatment Completion Visit (TCV) while participant is on treatment

Outcome Measure Data

Analysis Population Description


Arm/Group Title		Venetoclax + Bortezomib and Dexamethasone	Placebo + Bortezomib and Dexamethasone
Arm/Group Description:		Cycles 1-8: Venetoclax 800 mg orall...	Cycles 1-8: Placebo (to match venet...
Arm/Group Description:		Cycles 1-8: Venetoclax 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 4, 8 & 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 & 12; Cycles 9 and beyond: Venetoclax 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 and 23	Cycles 1-8: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 4, 8 & 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 & 12; Cycles 9 and beyond: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 & 23
Overall Number of Participants Analyzed		184	92
Mean (Standard Deviation) Unit of Measure: units on a scale
Cycle 3, Day 1	Number Analyzed	161 participants	79 participants
Cycle 3, Day 1		-1.9 (22.75)	-2.2 (22.63)
Cycle 5, Day 1	Number Analyzed	140 participants	70 participants
Cycle 5, Day 1		-5.1 (26.74)	-2.5 (23.54)
Cycle 7, Day 1	Number Analyzed	126 participants	70 participants
Cycle 7, Day 1		-8.3 (26.76)	-6.7 (24.56)
Cycle 9, Day 1	Number Analyzed	114 participants	65 participants
Cycle 9, Day 1		-6.9 (26.33)	-6.7 (24.22)
Cycle 11, Day 1	Number Analyzed	99 participants	55 participants
Cycle 11, Day 1		-0.5 (25.58)	-5.2 (25.38)
Cycle 13, Day 1	Number Analyzed	83 participants	43 participants
Cycle 13, Day 1		-1.0 (25.05)	-1.7 (22.24)
Cycle 15, Day 1	Number Analyzed	77 participants	31 participants
Cycle 15, Day 1		-4.9 (26.09)	0.5 (23.56)
Cycle 17, Day 1	Number Analyzed	67 participants	27 participants
Cycle 17, Day 1		-5.1 (24.91)	-7.7 (21.55)
Cycle 19, Day 1	Number Analyzed	68 participants	22 participants
Cycle 19, Day 1		-1.3 (19.51)	0.8 (26.09)
Cycle 21, Day 1	Number Analyzed	59 participants	18 participants
Cycle 21, Day 1		-6.6 (26.16)	-5.6 (20.01)
Cycle 23, Day 1	Number Analyzed	55 participants	17 participants
Cycle 23, Day 1		-2.9 (23.20)	-1.0 (22.99)
Cycle 25, Day 1	Number Analyzed	48 participants	13 participants
Cycle 25, Day 1		-4.7 (26.29)	-4.5 (24.68)
Cycle 27, Day 1	Number Analyzed	38 participants	14 participants
Cycle 27, Day 1		-9.0 (24.46)	4.2 (26.70)
Cycle 29, Day 1	Number Analyzed	40 participants	15 participants
Cycle 29, Day 1		-6.9 (24.67)	-1.1 (26.33)
Cycle 31, Day 1	Number Analyzed	40 participants	9 participants
Cycle 31, Day 1		-4.8 (26.48)	5.6 (35.36)
Cycle 33, Day 1	Number Analyzed	38 participants	7 participants
Cycle 33, Day 1		-7.7 (27.22)	-7.1 (22.79)
Cycle 35, Day 1	Number Analyzed	35 participants	6 participants
Cycle 35, Day 1		-3.8 (24.03)	4.2 (29.23)
Cycle 37, Day 1	Number Analyzed	31 participants	4 participants
Cycle 37, Day 1		-13.7 (29.86)	10.4 (12.50)
Cycle 39, Day 1	Number Analyzed	27 participants	3 participants
Cycle 39, Day 1		-9.3 (28.05)	0.0 (0.00)
Cycle 41, Day 1	Number Analyzed	22 participants	3 participants
Cycle 41, Day 1		-11.0 (30.47)	8.3 (8.33)
Cycle 43, Day 1	Number Analyzed	17 participants	2 participants
Cycle 43, Day 1		2.0 (28.95)	-8.3 (23.57)
Cycle 45, Day 1	Number Analyzed	10 participants	2 participants
Cycle 45, Day 1		-1.7 (33.75)	4.2 (5.89)
Cycle 47, Day 1	Number Analyzed	4 participants	1 participants
Cycle 47, Day 1		10.4 (22.95)	-8.3
Final visit	Number Analyzed	175 participants	87 participants
Final visit		-8.1 (26.40)	-6.7 (28.50)

8.Secondary Outcome


Title	Mean Change From Baseline in Patient Reported Outcomes Measurement Information System [PROMIS] Cancer Fatigue Short Form [SF] Score
Description	PROMIS Cancer Fatigue SF is a seven item questionnaire that assesses t...
Description	PROMIS Cancer Fatigue SF is a seven item questionnaire that assesses the impact and experience of fatigue over the past 7 days. All questions employ the following five response options: 1 = Not at all, 2 = A little bit, 3 = Somewhat, 4 = Quite a bit, and 5 = Very much. The total raw score is the sum of the responses to each question and is converted to a T-score. The T-score re-scales the total raw score to a standardized score with a mean of 50 and a standard deviation of 10. The [PROMIS] Cancer Fatigue Short Form [SF] 7a T-Scores range from 29.4 to 83.2, with higher scores indicating more fatigue. Negative changes from baseline indicate improvement.
Time Frame	Baseline; Cycle 3 (Cycles 1 - 8 are 21 days, Cycles 9 and beyond are 35 days) through Cycle 47, collected on Day 1 of every other cycle and at the Treatment Completion Visit (TCV) while participant is on treatment

Outcome Measure Data

Analysis Population Description


Arm/Group Title		Venetoclax + Bortezomib and Dexamethasone	Placebo + Bortezomib and Dexamethasone
Arm/Group Description:		Cycles 1-8: Venetoclax 800 mg orall...	Cycles 1-8: Placebo (to match venet...
Arm/Group Description:		Cycles 1-8: Venetoclax 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 4, 8 & 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 & 12; Cycles 9 and beyond: Venetoclax 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 and 23	Cycles 1-8: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 4, 8 & 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 & 12; Cycles 9 and beyond: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 & 23
Overall Number of Participants Analyzed		185	92
Mean (Standard Deviation) Unit of Measure: T-score
Cycle 3, Day 1	Number Analyzed	163 participants	79 participants
Cycle 3, Day 1		2.2 (9.54)	1.8 (8.12)
Cycle 5, Day 1	Number Analyzed	141 participants	70 participants
Cycle 5, Day 1		3.3 (9.25)	2.4 (10.34)
Cycle 7, Day 1	Number Analyzed	126 participants	70 participants
Cycle 7, Day 1		3.2 (9.28)	2.6 (9.70)
Cycle 9, Day 1	Number Analyzed	114 participants	65 participants
Cycle 9, Day 1		2.3 (8.90)	2.6 (8.67)
Cycle 11, Day 1	Number Analyzed	99 participants	55 participants
Cycle 11, Day 1		0.6 (8.54)	3.1 (8.98)
Cycle 13, Day 1	Number Analyzed	83 participants	43 participants
Cycle 13, Day 1		1.8 (8.03)	2.3 (6.97)
Cycle 15, Day 1	Number Analyzed	77 participants	31 participants
Cycle 15, Day 1		1.5 (8.84)	2.1 (7.66)
Cycle 17, Day 1	Number Analyzed	67 participants	27 participants
Cycle 17, Day 1		1.2 (8.11)	2.6 (8.05)
Cycle 19, Day 1	Number Analyzed	68 participants	22 participants
Cycle 19, Day 1		0.7 (8.52)	0.9 (9.32)
Cycle 21, Day 1	Number Analyzed	59 participants	18 participants
Cycle 21, Day 1		1.6 (8.58)	1.2 (7.66)
Cycle 23, Day 1	Number Analyzed	55 participants	17 participants
Cycle 23, Day 1		2.0 (8.08)	1.5 (8.83)
Cycle 25, Day 1	Number Analyzed	48 participants	13 participants
Cycle 25, Day 1		2.0 (8.59)	-0.1 (8.73)
Cycle 27, Day 1	Number Analyzed	38 participants	14 participants
Cycle 27, Day 1		3.4 (8.19)	-0.1 (9.59)
Cycle 29, Day 1	Number Analyzed	40 participants	15 participants
Cycle 29, Day 1		3.9 (8.07)	0.8 (8.51)
Cycle 31, Day 1	Number Analyzed	40 participants	9 participants
Cycle 31, Day 1		2.8 (8.43)	-0.3 (9.15)
Cycle 33, Day 1	Number Analyzed	38 participants	7 participants
Cycle 33, Day 1		2.0 (8.93)	3.7 (9.17)
Cycle 35, Day 1	Number Analyzed	35 participants	6 participants
Cycle 35, Day 1		3.4 (9.27)	1.1 (7.22)
Cycle 37, Day 1	Number Analyzed	31 participants	4 participants
Cycle 37, Day 1		4.1 (9.72)	-3.0 (11.72)
Cycle 39, Day 1	Number Analyzed	27 participants	3 participants
Cycle 39, Day 1		3.6 (8.12)	4.1 (2.82)
Cycle 41, Day 1	Number Analyzed	22 participants	3 participants
Cycle 41, Day 1		3.3 (8.69)	-0.7 (6.90)
Cycle 43, Day 1	Number Analyzed	17 participants	2 participants
Cycle 43, Day 1		5.3 (9.28)	4.4 (1.91)
Cycle 45, Day 1	Number Analyzed	10 participants	2 participants
Cycle 45, Day 1		-0.3 (7.99)	1.8 (0.28)
Cycle 47, Day 1	Number Analyzed	4 participants	1 participants
Cycle 47, Day 1		-2.5 (6.30)	0.0
Final visit	Number Analyzed	176 participants	87 participants
Final visit		5.0 (10.95)	2.9 (9.96)

9.Secondary Outcome


Title	Overall Survival (OS).
Description	OS is defined as the number of days from the date of randomization to ...
Description	OS is defined as the number of days from the date of randomization to the date of death due to any cause. All events of death were to be included, regardless of whether the event occurred while the participant was still taking study drug or after the participant discontinued study drug. If a participant is not known to have died, OS was censored at the date of last contact. The distribution of OS was estimated using Kaplan-Meier methodology.
Time Frame	Median duration of follow-up was 45.6 months for the venetoclax group and 45.6 months for the placebo group

Outcome Measure Data

Analysis Population Description

Intent-To-Treat (ITT) analysis set: all randomized participants, analyzed by treatment group assignment given at the time of randomization


Arm/Group Title	Venetoclax + Bortezomib and Dexamethasone	Placebo + Bortezomib and Dexamethasone
Arm/Group Description:	Cycles 1-8: Venetoclax 800 mg orall...	Cycles 1-8: Placebo (to match venet...
Arm/Group Description:	Cycles 1-8: Venetoclax 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 4, 8 & 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 & 12; Cycles 9 and beyond: Venetoclax 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 and 23	Cycles 1-8: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 4, 8 & 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 & 12; Cycles 9 and beyond: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 & 23
Overall Number of Participants Analyzed	194	97
Median (95% Confidence Interval) Unit of Measure: months
	NA ^[1] (44.4 to NA)	NA ^[1] (44.0 to NA)

[1]

Not estimable/calculable due to low number of participants with events

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Venetoclax + Bortezomib and Dexamethasone, Placebo + Bortezomib and Dexamethasone
	Comments	Stratified Analysis; Stratification factors: Prior exposure to proteasome inhibitors (naïve versus sensitive), and number of prior lines of therapy (1 versus 2 or 3)
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	=0.385
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.191
	Confidence Interval	(2-Sided) 95% 0.802 to 1.770
	Estimation Comments	Hazard ratio was estimated by Cox proportional hazards model

10.Secondary Outcome


Title	Time to Progression (TTP)
Description	TTP is defined as the number of days from the date of randomization to...
Description	TTP is defined as the number of days from the date of randomization to the date of first documented progressive disease (PD) as determined by an Independent Review Committee (IRC) or death due to multiple myeloma, whichever occurs first. TTP was analyzed by Kaplan-Meier methodology.
Time Frame	Median time on follow-up up was 28.6 months for the venetoclax group and 28.6 months for the placebo group

Outcome Measure Data

Analysis Population Description

Intent-To-Treat (ITT) analysis set: all randomized participants, analyzed by treatment group assignment given at the time of randomization


Arm/Group Title	Venetoclax + Bortezomib and Dexamethasone	Placebo + Bortezomib and Dexamethasone
Arm/Group Description:	Cycles 1-8: Venetoclax 800 mg orall...	Cycles 1-8: Placebo (to match venet...
Arm/Group Description:	Cycles 1-8: Venetoclax 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 4, 8 & 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 & 12; Cycles 9 and beyond: Venetoclax 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 and 23	Cycles 1-8: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 4, 8 & 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 & 12; Cycles 9 and beyond: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 & 23
Overall Number of Participants Analyzed	194	97
Median (95% Confidence Interval) Unit of Measure: months
	25.4 ^[1] (20.6 to NA)	12.2 (9.9 to 15.0)

[1]

Not estimable/calculable due to low number of participants with events

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Venetoclax + Bortezomib and Dexamethasone, Placebo + Bortezomib and Dexamethasone
	Comments	Stratified Analysis; Stratification factors: Prior exposure to proteasome inhibitors (naïve versus sensitive), and number of prior lines of therapy (1 versus 2 or 3)
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	=0.001
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.571
	Confidence Interval	(2-Sided) 95% 0.405 to 0.805
	Estimation Comments	Hazard ratio was estimated by Cox proportional hazards model

11.Secondary Outcome


Title	Overall Response Rate (ORR)
Description	Overall response rate is defined as the percentage of participants wit...
Description	Overall response rate is defined as the percentage of participants with documented best overall response of Partial Response (PR) or better (PR, Very good partial response [VGPR], Complete response [CR], or Stringent complete response [sCR]) per International Myeloma Working Group (IMWG) criteria as determined by an Independent Review Committee (IRC).
Time Frame	Response was assessed at Cycle 1, Day 1, and on Day 1 of every cycle thereafter; median time on follow-up was 28.6 months for the venetoclax group and 28.6 months for the placebo group

Outcome Measure Data

Analysis Population Description

Intent-To-Treat (ITT) analysis set: all randomized participants, analyzed by treatment group assignment given at the time of randomization


Arm/Group Title	Venetoclax + Bortezomib and Dexamethasone	Placebo + Bortezomib and Dexamethasone
Arm/Group Description:	Cycles 1-8: Venetoclax 800 mg orall...	Cycles 1-8: Placebo (to match venet...
Arm/Group Description:	Cycles 1-8: Venetoclax 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 4, 8 & 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 & 12; Cycles 9 and beyond: Venetoclax 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 and 23	Cycles 1-8: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 4, 8 & 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 & 12; Cycles 9 and beyond: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 & 23
Overall Number of Participants Analyzed	194	97
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: percentage of participants
	81.4 (75.2 to 86.7)	69.1 (58.9 to 78.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Venetoclax + Bortezomib and Dexamethasone, Placebo + Bortezomib and Dexamethasone
	Comments	Stratified Analysis; Stratification factors: Prior exposure to proteasome inhibitors (naïve versus sensitive), and number of prior lines of therapy (1 versus 2 or 3)
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	=0.019
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

12.Secondary Outcome


Title	Minimal Residual Disease (MRD) Negativity Rate
Description	MRD negativity rate is defined as the percentage of participants who h...
Description	MRD negativity rate is defined as the percentage of participants who have negative MRD by bone marrow aspirate at any time point after randomization and before progression or starting subsequent therapy. MRD negativity was defined at 10^-5 threshold (less than one residual myeloma cell per 10^5 total nucleated cells) as measured by centralized testing of bone marrow aspirate by Next Generation Sequencing (NGS). MRD positive participants include those of which all tested samples were found to be MRD positive or indeterminate. Participants with missing or unevaluable MRD status were considered as MRD positive.
Time Frame	Assessed at Screening; to confirm a stringent Complete Response (sCR) or Complete Response (CR); at 6 months and 12 months post-confirmed CR/sCR

Outcome Measure Data

Analysis Population Description

Intent-To-Treat (ITT) analysis set: all randomized participants, analyzed by treatment group assignment given at the time of randomization


Arm/Group Title	Venetoclax + Bortezomib and Dexamethasone	Placebo + Bortezomib and Dexamethasone
Arm/Group Description:	Cycles 1-8: Venetoclax 800 mg orall...	Cycles 1-8: Placebo (to match venet...
Arm/Group Description:	Cycles 1-8: Venetoclax 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 4, 8 & 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 & 12; Cycles 9 and beyond: Venetoclax 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 and 23	Cycles 1-8: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 4, 8 & 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 & 12; Cycles 9 and beyond: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 & 23
Overall Number of Participants Analyzed	194	97
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: percentage of participants
	15.5 (10.7 to 21.3)	2.1 (0.3 to 7.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Venetoclax + Bortezomib and Dexamethasone, Placebo + Bortezomib and Dexamethasone
	Comments	Stratified Analysis; Stratification factors: Prior exposure to proteasome inhibitors (naïve versus sensitive), and number of prior lines of therapy (1 versus 2 or 3)
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Adverse Events

Time Frame	All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days.
Adverse Event Reporting Description	All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.

Arm/Group Title	Venetoclax + Bortezomib and Dexamethasone		Placebo + Bortezomib and Dexamethasone
Arm/Group Description	Cycles 1-8: Venetoclax 800 mg orall...		Cycles 1-8: Placebo (to match venet...
Arm/Group Description	Cycles 1-8: Venetoclax 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 4, 8 & 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 & 12; Cycles 9 and beyond: Venetoclax 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 and 23		Cycles 1-8: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 4, 8 & 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 & 12; Cycles 9 and beyond: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 & 23
All-Cause Mortality
	Venetoclax + Bortezomib and Dexamethasone		Placebo + Bortezomib and Dexamethasone
	Affected / at Risk (%)		Affected / at Risk (%)
Total	81/194 (41.75%)		36/97 (37.11%)
Serious Adverse Events Serious Adverse Events
	Venetoclax + Bortezomib and Dexamethasone		Placebo + Bortezomib and Dexamethasone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	115/193 (59.59%)		53/96 (55.21%)
Blood and lymphatic system disorders
ANAEMIA ^† 1	4/193 (2.07%)	5	1/96 (1.04%)	1
FEBRILE NEUTROPENIA ^† 1	6/193 (3.11%)	6	0/96 (0.00%)	0
LYMPHOPENIA ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
NEUTROPENIA ^† 1	0/193 (0.00%)	0	1/96 (1.04%)	1
PANCYTOPENIA ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
THROMBOCYTOPENIA ^† 1	0/193 (0.00%)	0	1/96 (1.04%)	1
Cardiac disorders
ANGINA UNSTABLE ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
ATRIAL FIBRILLATION ^† 1	4/193 (2.07%)	6	0/96 (0.00%)	0
CARDIAC ARREST ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
CARDIAC FAILURE ^† 1	2/193 (1.04%)	2	0/96 (0.00%)	0
CARDIOMYOPATHY ^† 1	0/193 (0.00%)	0	1/96 (1.04%)	1
CORONARY ARTERY DISEASE ^† 1	0/193 (0.00%)	0	1/96 (1.04%)	1
MYOCARDIAL INFARCTION ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
TOXIC CARDIOMYOPATHY ^† 1	0/193 (0.00%)	0	1/96 (1.04%)	1
Eye disorders
CATARACT ^† 1	3/193 (1.55%)	3	3/96 (3.13%)	4
GLAUCOMA ^† 1	0/193 (0.00%)	0	1/96 (1.04%)	1
Gastrointestinal disorders
ABDOMINAL PAIN ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
COLITIS ^† 1	0/193 (0.00%)	0	1/96 (1.04%)	1
CONSTIPATION ^† 1	2/193 (1.04%)	2	1/96 (1.04%)	1
CROHN'S DISEASE ^† 1	0/193 (0.00%)	0	1/96 (1.04%)	1
DIARRHOEA ^† 1	2/193 (1.04%)	2	2/96 (2.08%)	2
DYSPEPSIA ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
ENTEROCOLITIS ^† 1	1/193 (0.52%)	2	0/96 (0.00%)	0
GASTRIC ULCER ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
ILEUS ^† 1	1/193 (0.52%)	1	2/96 (2.08%)	2
INCARCERATED INGUINAL HERNIA ^† 1	0/193 (0.00%)	0	1/96 (1.04%)	1
INTESTINAL OBSTRUCTION ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
INTESTINAL PSEUDO-OBSTRUCTION ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
LARGE INTESTINE POLYP ^† 1	0/193 (0.00%)	0	1/96 (1.04%)	1
SMALL INTESTINAL OBSTRUCTION ^† 1	3/193 (1.55%)	5	0/96 (0.00%)	0
VOMITING ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
General disorders
ASTHENIA ^† 1	0/193 (0.00%)	0	1/96 (1.04%)	1
DEATH ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
FATIGUE ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
MULTIPLE ORGAN DYSFUNCTION SYNDROME ^† 1	2/193 (1.04%)	2	1/96 (1.04%)	1
NON-CARDIAC CHEST PAIN ^† 1	0/193 (0.00%)	0	1/96 (1.04%)	1
PYREXIA ^† 1	1/193 (0.52%)	1	1/96 (1.04%)	1
Hepatobiliary disorders
BILIARY COLIC ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
CHOLECYSTITIS ACUTE ^† 1	2/193 (1.04%)	2	0/96 (0.00%)	0
Infections and infestations
ARTHRITIS BACTERIAL ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
ATYPICAL PNEUMONIA ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
BILIARY SEPSIS ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
BRONCHITIS ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
CELLULITIS ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
COVID-19 ^† 1	2/193 (1.04%)	2	0/96 (0.00%)	0
COVID-19 PNEUMONIA ^† 1	6/193 (3.11%)	9	1/96 (1.04%)	1
ENDOCARDITIS ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
ERYSIPELAS ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
GASTROENTERITIS ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
HAEMOPHILUS INFECTION ^† 1	0/193 (0.00%)	0	1/96 (1.04%)	1
HEPATITIS B REACTIVATION ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
HERPES ZOSTER ^† 1	3/193 (1.55%)	3	0/96 (0.00%)	0
INFECTION ^† 1	2/193 (1.04%)	2	0/96 (0.00%)	0
INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE ^† 1	0/193 (0.00%)	0	1/96 (1.04%)	2
INFLUENZA ^† 1	3/193 (1.55%)	3	4/96 (4.17%)	4
LARGE INTESTINE INFECTION ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
LISTERIOSIS ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
LOWER RESPIRATORY TRACT INFECTION ^† 1	4/193 (2.07%)	9	5/96 (5.21%)	7
MEDICAL DEVICE SITE INFECTION ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
METAPNEUMOVIRUS INFECTION ^† 1	0/193 (0.00%)	0	1/96 (1.04%)	1
NECROTISING FASCIITIS ^† 1	1/193 (0.52%)	2	0/96 (0.00%)	0
PARAINFLUENZAE VIRUS INFECTION ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
PERIODONTITIS ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
PERITONITIS ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
PNEUMOCYSTIS JIROVECII PNEUMONIA ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
PNEUMONIA ^† 1	35/193 (18.13%)	53	14/96 (14.58%)	19
PNEUMONIA ADENOVIRAL ^† 1	0/193 (0.00%)	0	1/96 (1.04%)	1
PNEUMONIA ASPIRATION ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
PNEUMONIA BACTERIAL ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
PNEUMONIA INFLUENZAL ^† 1	4/193 (2.07%)	4	0/96 (0.00%)	0
PNEUMONIA PNEUMOCOCCAL ^† 1	0/193 (0.00%)	0	1/96 (1.04%)	1
RESPIRATORY SYNCYTIAL VIRUS INFECTION ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
RESPIRATORY TRACT INFECTION ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
RHINOVIRUS INFECTION ^† 1	2/193 (1.04%)	2	0/96 (0.00%)	0
SEPSIS ^† 1	6/193 (3.11%)	8	0/96 (0.00%)	0
SEPTIC SHOCK ^† 1	1/193 (0.52%)	2	1/96 (1.04%)	1
STREPTOCOCCAL BACTERAEMIA ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
TONSILLITIS ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
UPPER RESPIRATORY TRACT INFECTION ^† 1	3/193 (1.55%)	3	1/96 (1.04%)	1
URINARY TRACT INFECTION ^† 1	2/193 (1.04%)	2	2/96 (2.08%)	2
Injury, poisoning and procedural complications
ANKLE FRACTURE ^† 1	0/193 (0.00%)	0	2/96 (2.08%)	2
FALL ^† 1	3/193 (1.55%)	3	0/96 (0.00%)	0
FEMUR FRACTURE ^† 1	3/193 (1.55%)	3	3/96 (3.13%)	3
FOREARM FRACTURE ^† 1	0/193 (0.00%)	0	1/96 (1.04%)	1
HIP FRACTURE ^† 1	2/193 (1.04%)	2	0/96 (0.00%)	0
HUMERUS FRACTURE ^† 1	2/193 (1.04%)	2	1/96 (1.04%)	1
JOINT DISLOCATION ^† 1	0/193 (0.00%)	0	1/96 (1.04%)	1
LIGAMENT SPRAIN ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
MULTIPLE FRACTURES ^† 1	0/193 (0.00%)	0	1/96 (1.04%)	1
PELVIC FRACTURE ^† 1	2/193 (1.04%)	2	0/96 (0.00%)	0
RADIUS FRACTURE ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
SOFT TISSUE INJURY ^† 1	0/193 (0.00%)	0	1/96 (1.04%)	1
SPINAL COMPRESSION FRACTURE ^† 1	2/193 (1.04%)	2	0/96 (0.00%)	0
Investigations
C-REACTIVE PROTEIN INCREASED ^† 1	1/193 (0.52%)	2	0/96 (0.00%)	0
INFLUENZA A VIRUS TEST POSITIVE ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
Metabolism and nutrition disorders
DEHYDRATION ^† 1	2/193 (1.04%)	2	0/96 (0.00%)	0
DIABETES MELLITUS ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
HYPERGLYCAEMIA ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
HYPERVOLAEMIA ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
HYPOGLYCAEMIA ^† 1	1/193 (0.52%)	1	1/96 (1.04%)	1
METABOLIC ACIDOSIS ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
Musculoskeletal and connective tissue disorders
BACK PAIN ^† 1	0/193 (0.00%)	0	2/96 (2.08%)	2
BONE LESION ^† 1	0/193 (0.00%)	0	1/96 (1.04%)	1
BONE PAIN ^† 1	2/193 (1.04%)	2	0/96 (0.00%)	0
CHONDROCALCINOSIS PYROPHOSPHATE ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
HAEMATOMA MUSCLE ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
MUSCULAR WEAKNESS ^† 1	2/193 (1.04%)	2	0/96 (0.00%)	0
OSTEOARTHRITIS ^† 1	1/193 (0.52%)	1	1/96 (1.04%)	1
OSTEONECROSIS OF JAW ^† 1	2/193 (1.04%)	2	0/96 (0.00%)	0
SACRAL PAIN ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
SPINAL PAIN ^† 1	0/193 (0.00%)	0	1/96 (1.04%)	1
VERTEBRAL WEDGING ^† 1	0/193 (0.00%)	0	1/96 (1.04%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER ^† 1	0/193 (0.00%)	0	1/96 (1.04%)	1
CHOLESTEATOMA ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
MALIGNANT MEDIASTINAL NEOPLASM ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
MALIGNANT NEOPLASM PROGRESSION ^† 1	0/193 (0.00%)	0	1/96 (1.04%)	1
NEUROENDOCRINE TUMOUR ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
NON-SMALL CELL LUNG CANCER METASTATIC ^† 1	0/193 (0.00%)	0	1/96 (1.04%)	1
SQUAMOUS CELL CARCINOMA OF LUNG ^† 1	0/193 (0.00%)	0	1/96 (1.04%)	1
SQUAMOUS CELL CARCINOMA OF SKIN ^† 1	0/193 (0.00%)	0	1/96 (1.04%)	1
TUMOUR PAIN ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
Nervous system disorders
AUTONOMIC NEUROPATHY ^† 1	2/193 (1.04%)	2	0/96 (0.00%)	0
BRAIN OEDEMA ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
COMA ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
EMBOLIC STROKE ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
HEADACHE ^† 1	0/193 (0.00%)	0	1/96 (1.04%)	1
NEUROPATHY PERIPHERAL ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
SYNCOPE ^† 1	4/193 (2.07%)	4	0/96 (0.00%)	0
Psychiatric disorders
CONFUSIONAL STATE ^† 1	2/193 (1.04%)	2	0/96 (0.00%)	0
SUICIDE ATTEMPT ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
Renal and urinary disorders
ACUTE KIDNEY INJURY ^† 1	3/193 (1.55%)	3	3/96 (3.13%)	4
POLLAKIURIA ^† 1	0/193 (0.00%)	0	1/96 (1.04%)	1
RENAL IMPAIRMENT ^† 1	0/193 (0.00%)	0	1/96 (1.04%)	1
Reproductive system and breast disorders
BENIGN PROSTATIC HYPERPLASIA ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
ENDOMETRIOSIS ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
CHRONIC OBSTRUCTIVE PULMONARY DISEASE ^† 1	1/193 (0.52%)	4	2/96 (2.08%)	3
DYSPNOEA ^† 1	3/193 (1.55%)	3	0/96 (0.00%)	0
EPISTAXIS ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
HYPOXIA ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
LUNG DISORDER ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
OROPHARYNGEAL PAIN ^† 1	0/193 (0.00%)	0	1/96 (1.04%)	1
PLEURAL EFFUSION ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
PNEUMONITIS ^† 1	1/193 (0.52%)	2	0/96 (0.00%)	0
PULMONARY CONGESTION ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
PULMONARY EMBOLISM ^† 1	3/193 (1.55%)	3	0/96 (0.00%)	0
PULMONARY HYPERTENSION ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
SINUS DISORDER ^† 1	0/193 (0.00%)	0	1/96 (1.04%)	1
Skin and subcutaneous tissue disorders
DRUG ERUPTION ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
Vascular disorders
DEEP VEIN THROMBOSIS ^† 1	2/193 (1.04%)	2	0/96 (0.00%)	0
EMBOLISM ^† 1	0/193 (0.00%)	0	1/96 (1.04%)	1
HYPOTENSION ^† 1	2/193 (1.04%)	3	0/96 (0.00%)	0
ORTHOSTATIC HYPOTENSION ^† 1	5/193 (2.59%)	5	2/96 (2.08%)	2
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE ^† 1	1/193 (0.52%)	1	0/96 (0.00%)	0
1 Term from vocabulary, MedDRA 25.0 † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Venetoclax + Bortezomib and Dexamethasone		Placebo + Bortezomib and Dexamethasone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	191/193 (98.96%)		95/96 (98.96%)
Blood and lymphatic system disorders
ANAEMIA ^† 1	48/193 (24.87%)	73	23/96 (23.96%)	31
LYMPHOPENIA ^† 1	19/193 (9.84%)	54	0/96 (0.00%)	0
NEUTROPENIA ^† 1	54/193 (27.98%)	183	9/96 (9.38%)	16
THROMBOCYTOPENIA ^† 1	53/193 (27.46%)	120	34/96 (35.42%)	78
Cardiac disorders
PALPITATIONS ^† 1	5/193 (2.59%)	6	6/96 (6.25%)	6
Eye disorders
CATARACT ^† 1	24/193 (12.44%)	33	11/96 (11.46%)	17
VISION BLURRED ^† 1	8/193 (4.15%)	9	5/96 (5.21%)	5
Gastrointestinal disorders
ABDOMINAL DISCOMFORT ^† 1	10/193 (5.18%)	12	1/96 (1.04%)	1
ABDOMINAL DISTENSION ^† 1	15/193 (7.77%)	17	3/96 (3.13%)	3
ABDOMINAL PAIN ^† 1	23/193 (11.92%)	38	8/96 (8.33%)	10
ABDOMINAL PAIN UPPER ^† 1	20/193 (10.36%)	26	7/96 (7.29%)	9
CONSTIPATION ^† 1	68/193 (35.23%)	89	29/96 (30.21%)	35
DIARRHOEA ^† 1	114/193 (59.07%)	282	46/96 (47.92%)	79
DYSPEPSIA ^† 1	24/193 (12.44%)	28	9/96 (9.38%)	10
FLATULENCE ^† 1	12/193 (6.22%)	13	2/96 (2.08%)	2
GASTRITIS ^† 1	10/193 (5.18%)	16	3/96 (3.13%)	4
NAUSEA ^† 1	73/193 (37.82%)	112	22/96 (22.92%)	28
STOMATITIS ^† 1	8/193 (4.15%)	9	5/96 (5.21%)	5
VOMITING ^† 1	38/193 (19.69%)	62	17/96 (17.71%)	27
General disorders
ASTHENIA ^† 1	30/193 (15.54%)	39	2/96 (2.08%)	2
FATIGUE ^† 1	63/193 (32.64%)	90	31/96 (32.29%)	43
INFLUENZA LIKE ILLNESS ^† 1	10/193 (5.18%)	20	7/96 (7.29%)	10
INJECTION SITE REACTION ^† 1	5/193 (2.59%)	6	5/96 (5.21%)	5
MALAISE ^† 1	10/193 (5.18%)	10	2/96 (2.08%)	3
OEDEMA PERIPHERAL ^† 1	38/193 (19.69%)	57	20/96 (20.83%)	25
PAIN ^† 1	4/193 (2.07%)	4	5/96 (5.21%)	5
PYREXIA ^† 1	31/193 (16.06%)	40	11/96 (11.46%)	13
Immune system disorders
HYPOGAMMAGLOBULINAEMIA ^† 1	11/193 (5.70%)	13	0/96 (0.00%)	0
Infections and infestations
BRONCHITIS ^† 1	30/193 (15.54%)	45	15/96 (15.63%)	20
CONJUNCTIVITIS ^† 1	22/193 (11.40%)	26	7/96 (7.29%)	8
INFLUENZA ^† 1	28/193 (14.51%)	38	4/96 (4.17%)	11
LOWER RESPIRATORY TRACT INFECTION ^† 1	15/193 (7.77%)	19	4/96 (4.17%)	4
NASOPHARYNGITIS ^† 1	35/193 (18.13%)	92	8/96 (8.33%)	15
PNEUMONIA ^† 1	14/193 (7.25%)	18	3/96 (3.13%)	3
SINUSITIS ^† 1	10/193 (5.18%)	14	0/96 (0.00%)	0
UPPER RESPIRATORY TRACT INFECTION ^† 1	55/193 (28.50%)	149	25/96 (26.04%)	46
URINARY TRACT INFECTION ^† 1	15/193 (7.77%)	16	4/96 (4.17%)	4
Injury, poisoning and procedural complications
CONTUSION ^† 1	12/193 (6.22%)	13	6/96 (6.25%)	7
FALL ^† 1	22/193 (11.40%)	25	8/96 (8.33%)	11
Investigations
ALANINE AMINOTRANSFERASE INCREASED ^† 1	15/193 (7.77%)	22	9/96 (9.38%)	13
ASPARTATE AMINOTRANSFERASE INCREASED ^† 1	17/193 (8.81%)	23	5/96 (5.21%)	7
BLOOD CREATININE INCREASED ^† 1	14/193 (7.25%)	18	2/96 (2.08%)	5
C-REACTIVE PROTEIN INCREASED ^† 1	13/193 (6.74%)	15	3/96 (3.13%)	5
NEUTROPHIL COUNT DECREASED ^† 1	21/193 (10.88%)	54	1/96 (1.04%)	1
PLATELET COUNT DECREASED ^† 1	33/193 (17.10%)	78	15/96 (15.63%)	50
WEIGHT DECREASED ^† 1	11/193 (5.70%)	15	2/96 (2.08%)	3
Metabolism and nutrition disorders
DECREASED APPETITE ^† 1	42/193 (21.76%)	60	13/96 (13.54%)	14
HYPERGLYCAEMIA ^† 1	20/193 (10.36%)	29	8/96 (8.33%)	12
HYPOCALCAEMIA ^† 1	16/193 (8.29%)	21	0/96 (0.00%)	0
HYPOKALAEMIA ^† 1	32/193 (16.58%)	49	8/96 (8.33%)	12
HYPOMAGNESAEMIA ^† 1	12/193 (6.22%)	14	4/96 (4.17%)	11
Musculoskeletal and connective tissue disorders
ARTHRALGIA ^† 1	27/193 (13.99%)	37	12/96 (12.50%)	13
BACK PAIN ^† 1	43/193 (22.28%)	48	17/96 (17.71%)	23
BONE PAIN ^† 1	15/193 (7.77%)	20	5/96 (5.21%)	5
MUSCLE SPASMS ^† 1	17/193 (8.81%)	22	8/96 (8.33%)	8
MUSCULAR WEAKNESS ^† 1	17/193 (8.81%)	19	10/96 (10.42%)	10
MUSCULOSKELETAL CHEST PAIN ^† 1	9/193 (4.66%)	12	6/96 (6.25%)	6
MUSCULOSKELETAL PAIN ^† 1	10/193 (5.18%)	11	3/96 (3.13%)	4
MYALGIA ^† 1	13/193 (6.74%)	13	4/96 (4.17%)	4
PAIN IN EXTREMITY ^† 1	25/193 (12.95%)	32	14/96 (14.58%)	15
Nervous system disorders
DIZZINESS ^† 1	34/193 (17.62%)	44	10/96 (10.42%)	11
DYSGEUSIA ^† 1	16/193 (8.29%)	18	5/96 (5.21%)	5
HEADACHE ^† 1	31/193 (16.06%)	50	16/96 (16.67%)	19
HYPOAESTHESIA ^† 1	14/193 (7.25%)	16	8/96 (8.33%)	12
NEUROPATHY PERIPHERAL ^† 1	59/193 (30.57%)	84	27/96 (28.13%)	35
PARAESTHESIA ^† 1	18/193 (9.33%)	24	5/96 (5.21%)	6
PERIPHERAL SENSORY NEUROPATHY ^† 1	36/193 (18.65%)	60	24/96 (25.00%)	36
Psychiatric disorders
INSOMNIA ^† 1	56/193 (29.02%)	73	29/96 (30.21%)	33
Respiratory, thoracic and mediastinal disorders
COUGH ^† 1	44/193 (22.80%)	65	20/96 (20.83%)	27
DYSPNOEA ^† 1	22/193 (11.40%)	33	15/96 (15.63%)	21
DYSPNOEA EXERTIONAL ^† 1	7/193 (3.63%)	7	6/96 (6.25%)	8
EPISTAXIS ^† 1	8/193 (4.15%)	8	7/96 (7.29%)	10
OROPHARYNGEAL PAIN ^† 1	18/193 (9.33%)	23	5/96 (5.21%)	8
PRODUCTIVE COUGH ^† 1	14/193 (7.25%)	25	4/96 (4.17%)	5
RHINORRHOEA ^† 1	6/193 (3.11%)	8	5/96 (5.21%)	6
Skin and subcutaneous tissue disorders
PRURITUS ^† 1	33/193 (17.10%)	47	8/96 (8.33%)	11
RASH ^† 1	25/193 (12.95%)	27	4/96 (4.17%)	5
URTICARIA ^† 1	2/193 (1.04%)	2	6/96 (6.25%)	6
Vascular disorders
HYPERTENSION ^† 1	20/193 (10.36%)	23	15/96 (15.63%)	18
HYPOTENSION ^† 1	23/193 (11.92%)	25	4/96 (4.17%)	5
ORTHOSTATIC HYPOTENSION ^† 1	13/193 (6.74%)	15	5/96 (5.21%)	6
1 Term from vocabulary, MedDRA 25.0 † 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.

AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.

Results Point of Contact

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Name/Title:	Global Medical Services
Organization:	AbbVie
Phone:	800-633-9110
EMail:	abbvieclinicaltrials@abbvie.com

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

Kumar SK, Harrison SJ, Cavo M, de la Rubia J, Popat R, Gasparetto C, Hungria V, Salwender H, Suzuki K, Kim I, Punnoose EA, Hong WJ, Freise KJ, Yang X, Sood A, Jalaluddin M, Ross JA, Ward JE, Maciag PC, Moreau P. Venetoclax or placebo in combination with bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma (BELLINI): a randomised, double-blind, multicentre, phase 3 trial. Lancet Oncol. 2020 Dec;21(12):1630-1642. doi: 10.1016/S1470-2045(20)30525-8. Epub 2020 Oct 29.

Layout table for additonal information

Responsible Party:	AbbVie
ClinicalTrials.gov Identifier:	NCT02755597
Other Study ID Numbers:	M14-031 2015-004411-20 ( EudraCT Number )
First Submitted:	April 20, 2016
First Posted:	April 29, 2016
Results First Submitted:	July 12, 2023
Results First Posted:	August 22, 2023
Last Update Posted:	August 22, 2023

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