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NCT03110562 · OUTCOME

SVd/Vd Arm: Percentage of Participants With Response Rate of Very Good Partial Response (VGPR) or Better Based on IRC Assessment

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
NUMBER
Unit
Percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
From date of randomization until confirmed PD or initiating a new MM treatment (up to 33 months)

What was measured

Response rate was defined as percentage of participants with responses of VGPR, at any time prior to IRC-confirmed PD or initiating a new MM treatment. VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \< 100 mg per 24 hours.

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

GroupSource count
SVd Arm: Selinexor + Bortezomib + Dexamethasone195
Vd Arm: Bortezomib + Dexamethasone207

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
SVd Arm: Selinexor + Bortezomib + Dexamethasone44.6Not reported37.551.9Not reported
Vd Arm: Bortezomib + Dexamethasone32.4Not reported26.039.2Not reported

Source statistical analyses

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

  1. ci Lower Limit
    1.0993
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.5049
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0082
    p Value Comment
    One Sided P-value
    param Type
    Odds Ratio (OR)
    param Value
    1.6594
    statistical Comment
    Analysis using Cochran-Mantel-Haenszel test stratified by region, prior PI therapies, number of prior anti-MM regimens, and R-ISS stage at screening.
    statistical Method
    Cochran-Mantel-Haenszel
Complete source fields
analyses
  1. ci Lower Limit
    1.0993
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.5049
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0082
    p Value Comment
    One Sided P-value
    param Type
    Odds Ratio (OR)
    param Value
    1.6594
    statistical Comment
    Analysis using Cochran-Mantel-Haenszel test stratified by region, prior PI therapies, number of prior anti-MM regimens, and R-ISS stage at screening.
    statistical Method
    Cochran-Mantel-Haenszel
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        37.5
        upper Limit
        51.9
        value
        44.6
      2. group Id
        OG001
        lower Limit
        26.0
        upper Limit
        39.2
        value
        32.4
denoms
  1. counts
    1. group Id
      OG000
      value
      195
    2. group Id
      OG001
      value
      207
    units
    Participants
description
Response rate was defined as percentage of participants with responses of VGPR, at any time prior to IRC-confirmed PD or initiating a new MM treatment. VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \< 100 mg per 24 hours.
dispersion Type
95% Confidence Interval
groups
  1. 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
  2. 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
NUMBER
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 until confirmed PD or initiating a new MM treatment (up to 33 months)
title
SVd/Vd Arm: Percentage of Participants With Response Rate of Very Good Partial Response (VGPR) or Better Based on IRC Assessment
type
SECONDARY
unit Of Measure
Percentage of participants

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Preserved source evidence · Not medical advice