NCT02755597 · OUTCOME

Overall Survival (OS).

A Study Evaluating Venetoclax (ABT-199) in Multiple Myeloma Subjects Who Are Receiving Bortezomib and Dexamethasone as Standard Therapy · Source last updated 2023-08-22

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: MEDIAN
Unit: months
Interval / dispersion: 95% Confidence Interval
Time frame: Median duration of follow-up was 45.6 months for the venetoclax group and 45.6 months for the placebo group

What was measured

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.

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

Groups in this outcome

Venetoclax + Bortezomib and Dexamethasone

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

Placebo + Bortezomib and Dexamethasone

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

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Venetoclax + Bortezomib and Dexamethasone	194
Placebo + Bortezomib and Dexamethasone	97

Reported measurements

Source class 1

Values in months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Venetoclax + Bortezomib and Dexamethasone	NA	Not reported	44.4	NA	Not estimable/calculable due to low number of participants with events
Placebo + Bortezomib and Dexamethasone	NA	Not reported	44.0	NA	Not estimable/calculable due to low number of participants with events

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

ci Lower Limit
0.802
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.770
estimate Comment
Hazard ratio was estimated by Cox proportional hazards model
group Description
Stratified Analysis; Stratification factors: Prior exposure to proteasome inhibitors (naïve versus sensitive), and number of prior lines of therapy (1 versus 2 or 3)
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
=0.385
param Type
Hazard Ratio (HR)
param Value
1.191
statistical Method
Log Rank

Complete source fields

analyses

ci Lower Limit
0.802
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.770
estimate Comment
Hazard ratio was estimated by Cox proportional hazards model
group Description
Stratified Analysis; Stratification factors: Prior exposure to proteasome inhibitors (naïve versus sensitive), and number of prior lines of therapy (1 versus 2 or 3)
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
=0.385
param Type
Hazard Ratio (HR)
param Value
1.191
statistical Method
Log Rank

classes

categories
measurements
comment
Not estimable/calculable due to low number of participants with events
group Id
OG000
lower Limit
44.4
upper Limit
NA
value
NA
comment
Not estimable/calculable due to low number of participants with events
group Id
OG001
lower Limit
44.0
upper Limit
NA
value
NA

denoms

counts
group Id
OG000
value
194
group Id
OG001
value
97
units
Participants

description

dispersion Type

95% Confidence Interval

groups

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
id
OG000
title
Venetoclax + Bortezomib and Dexamethasone
description
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
id
OG001
title
Placebo + Bortezomib and Dexamethasone

param Type

MEDIAN

population Description

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

reporting Status

POSTED

time Frame

Median duration of follow-up was 45.6 months for the venetoclax group and 45.6 months for the placebo group

title

Overall Survival (OS).

type

SECONDARY

unit Of Measure

months

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Preserved source evidence · Not medical advice