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NCT03110562 · OUTCOME

SVd/Vd Arm: Time To Response (TTR) in Participants Randomized to the SVd and Vd Arm

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 randomization to the date of first IRC-confirmed PR or better (i.e., PR, VGPR, CR, or sCR), whichever occurred first (up to 33 months)

What was measured

TTR was defined as duration from randomization to the date of first IRC-confirmed PR or better (i.e., PR, VGPR, CR, or sCR) before IRC-confirmed PD or initiating a new MM treatment per IMWG response criteria. The participants who do not achieve IRC-confirmed PR or better response will be censored at the date of last disease assessment on or before database cutoff date. PR: \>= 50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by \>= 90% or to \< 200 mg per 24 hours; 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; CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \<= 5% plasma cells in bone marrow; or sCR: Normal free light chain (FLC) ratio + Absence of clonal cells by immunohistochemistry.

Analysis population: The ITT population consisted of all patients who were randomized to the study treatment, regardless of whether or not they received the study treatment. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. 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 mg selinexor tablets (5 tablets of 20 mg each) QW on Days 1, 8, 15, 22, and 29 of each 35-day cycle, along with SC injection of 1.3 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 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 + Dexamethasone149
Vd Arm: Bortezomib + Dexamethasone129

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
SVd Arm: Selinexor + Bortezomib + Dexamethasone1.41Not reported1.351.51Not reported
Vd Arm: Bortezomib + Dexamethasone1.61Not reported1.512.14Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.35
        upper Limit
        1.51
        value
        1.41
      2. group Id
        OG001
        lower Limit
        1.51
        upper Limit
        2.14
        value
        1.61
denoms
  1. counts
    1. group Id
      OG000
      value
      149
    2. group Id
      OG001
      value
      129
    units
    Participants
description
TTR was defined as duration from randomization to the date of first IRC-confirmed PR or better (i.e., PR, VGPR, CR, or sCR) before IRC-confirmed PD or initiating a new MM treatment per IMWG response criteria. The participants who do not achieve IRC-confirmed PR or better response will be censored at the date of last disease assessment on or before database cutoff date. PR: \>= 50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by \>= 90% or to \< 200 mg per 24 hours; 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; CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \<= 5% plasma cells in bone marrow; or sCR: Normal free light chain (FLC) ratio + Absence of clonal cells by immunohistochemistry.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received a fixed oral dose of 100 mg selinexor tablets (5 tablets of 20 mg each) QW on Days 1, 8, 15, 22, and 29 of each 35-day cycle, along with SC injection of 1.3 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 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
MEDIAN
population Description
The ITT population consisted of all patients who were randomized to the study treatment, regardless of whether or not they received the study treatment. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. Data was not planned to be reported for SVdx arm and Sdx arm.
reporting Status
POSTED
time Frame
From randomization to the date of first IRC-confirmed PR or better (i.e., PR, VGPR, CR, or sCR), whichever occurred first (up to 33 months)
title
SVd/Vd Arm: Time To Response (TTR) in Participants Randomized to the SVd and Vd Arm
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice