NCT03110562 · OUTCOME

SVd/Vd Arm: Overall Survival (OS)

Bortezomib, Selinexor, and Dexamethasone in Patients With Multiple Myeloma · Source last updated 2024-08-21

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: From date of randomization to the date of death or censored date, whichever occurred first (up to 45 months)

What was measured

OS was defined as the time from the date of randomization until either the date of death due to any cause or until the participant is lost to follow-up, for all participants.

Analysis population: ITT population consisted of all participants who were randomized to the study treatment, regardless of whether or not they received the study treatment. Data was not planned to be reported for SVdx arm and Sdx arm.

Groups in this outcome

SVd Arm: Selinexor + Bortezomib + Dexamethasone

Participants received a fixed oral dose of 100 milligrams (mg) selinexor tablets (5 tablets of 20 mg each) once weekly (QW) on Days 1, 8, 15, 22, and 29 of each 35-day cycle, along with subcutaneous (SC) injection of 1.3 milligrams per square meter (mg/m\^2) bortezomib QW on Days 1, 8, 15, and 22 of each 35-day cycle, and an oral dose of 20 mg of dexamethasone twice weekly (BIW) on Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle until PD confirmed by the IRC, investigator or participant decision to discontinue study treatment, pregnancy, unacceptable AEs or toxicity that could not be managed by supportive care, withdrawal of consent, death, or sponsor decision to terminate the study.

Vd Arm: Bortezomib + Dexamethasone

Participants received SC injection of 1.3 mg/m\^2 bortezomib on Days 1, 4, 8, and 11 of each 21-day cycle for the first 8 cycles, followed by \>= 9 cycles on Days 1, 8, 15, and 22 of each 35-day cycle, and received oral dose of 20 mg dexamethasone BIW on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle for the first 8 cycles and for cycles \>= 9 on Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle until PD confirmed by the IRC, investigator or participant decision to discontinue study treatment, pregnancy, unacceptable AEs or toxicity that could not be managed by supportive care, withdrawal of consent, death, or sponsor decision to terminate the study.

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
SVd Arm: Selinexor + Bortezomib + Dexamethasone	195
Vd Arm: Bortezomib + Dexamethasone	207

Reported measurements

Source class 1

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
SVd Arm: Selinexor + Bortezomib + Dexamethasone	36.67	Not reported	30.19	NA	The 95% CI was not available due to insufficient numbers of participants with events.
Vd Arm: Bortezomib + Dexamethasone	32.76	Not reported	27.83	NA	The 95% CI was not available due to insufficient numbers of participants with events.

Source statistical analyses

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

ci Lower Limit
0.6313
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.2168
estimate Comment
Based on stratified Cox Proportional Hazard model with Efron's Method of handling ties.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.2152
p Value Comment
One Sided P-value
param Type
Hazard Ratio (HR)
param Value
0.8764
statistical Comment
Stratified for prior PI therapies, number of prior anti-MM regimens and R-ISS Stage at screening.
statistical Method
Stratified log-rank test

Complete source fields

analyses

ci Lower Limit
0.6313
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.2168
estimate Comment
Based on stratified Cox Proportional Hazard model with Efron's Method of handling ties.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.2152
p Value Comment
One Sided P-value
param Type
Hazard Ratio (HR)
param Value
0.8764
statistical Comment
Stratified for prior PI therapies, number of prior anti-MM regimens and R-ISS Stage at screening.
statistical Method
Stratified log-rank test

classes

categories
measurements
comment
The 95% CI was not available due to insufficient numbers of participants with events.
group Id
OG000
lower Limit
30.19
upper Limit
NA
value
36.67
comment
The 95% CI was not available due to insufficient numbers of participants with events.
group Id
OG001
lower Limit
27.83
upper Limit
NA
value
32.76

denoms

counts
group Id
OG000
value
195
group Id
OG001
value
207
units
Participants

description

OS was defined as the time from the date of randomization until either the date of death due to any cause or until the participant is lost to follow-up, for all participants.

dispersion Type

95% Confidence Interval

groups

description
Participants received a fixed oral dose of 100 milligrams (mg) selinexor tablets (5 tablets of 20 mg each) once weekly (QW) on Days 1, 8, 15, 22, and 29 of each 35-day cycle, along with subcutaneous (SC) injection of 1.3 milligrams per square meter (mg/m\^2) bortezomib QW on Days 1, 8, 15, and 22 of each 35-day cycle, and an oral dose of 20 mg of dexamethasone twice weekly (BIW) on Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle until PD confirmed by the IRC, investigator or participant decision to discontinue study treatment, pregnancy, unacceptable AEs or toxicity that could not be managed by supportive care, withdrawal of consent, death, or sponsor decision to terminate the study.
id
OG000
title
SVd Arm: Selinexor + Bortezomib + Dexamethasone
description
Participants received SC injection of 1.3 mg/m\^2 bortezomib on Days 1, 4, 8, and 11 of each 21-day cycle for the first 8 cycles, followed by \>= 9 cycles on Days 1, 8, 15, and 22 of each 35-day cycle, and received oral dose of 20 mg dexamethasone BIW on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle for the first 8 cycles and for cycles \>= 9 on Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle until PD confirmed by the IRC, investigator or participant decision to discontinue study treatment, pregnancy, unacceptable AEs or toxicity that could not be managed by supportive care, withdrawal of consent, death, or sponsor decision to terminate the study.
id
OG001
title
Vd Arm: Bortezomib + Dexamethasone

param Type

MEDIAN

population Description

ITT population consisted of all participants who were randomized to the study treatment, regardless of whether or not they received the study treatment. Data was not planned to be reported for SVdx arm and Sdx arm.

reporting Status

POSTED

time Frame

From date of randomization to the date of death or censored date, whichever occurred first (up to 45 months)

title

SVd/Vd Arm: Overall Survival (OS)

type

SECONDARY

unit Of Measure

Months

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Preserved source evidence · Not medical advice