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NCT03110562 · OUTCOME

SVdX Arm: Overall Response Rate (ORR1) as Assessed by IRC During SVdX Treatment

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 first SVdX treatment until disease progression or initiating a new MM treatment (up to 33 months)

What was measured

ORR was defined as the percentage of the participants who achieved a confirmed partial response or better (i.e., PR, VGPR, CR, or sCR) based on the IRC's response outcome assessments, according to the IMWG response criteria. PR: \>=50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by \>=90% or \<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: CR as defined as Normal FLC ratio+ Absence of clonal cells in bone marrow biopsy by immunohistochemistry.

Analysis population: The SVdX population consisted of a subset of participants in the Vd arm of the safety population who crossed over from the Vd arm to SVdX treatment after IRC confirmation of PD on Vd and had received at least 1 dose of selinexor. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

Groups in this outcome

SVdX Arm: Selinexor + Bortezomib + Dexamethasone

Participants in the VD arm who had IRC-confirmed PD and were able to tolerate continued bortezomib treatment had crossed over to receive 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.

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

Analysis denominator · Participants

GroupSource count
SVdX Arm: Selinexor + Bortezomib + Dexamethasone63

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
SVdX Arm: Selinexor + Bortezomib + Dexamethasone19.0Not reported10.230.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        10.2
        upper Limit
        30.9
        value
        19.0
denoms
  1. counts
    1. group Id
      OG000
      value
      63
    units
    Participants
description
ORR was defined as the percentage of the participants who achieved a confirmed partial response or better (i.e., PR, VGPR, CR, or sCR) based on the IRC's response outcome assessments, according to the IMWG response criteria. PR: \>=50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by \>=90% or \<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: CR as defined as Normal FLC ratio+ Absence of clonal cells in bone marrow biopsy by immunohistochemistry.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants in the VD arm who had IRC-confirmed PD and were able to tolerate continued bortezomib treatment had crossed over to receive 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
    SVdX Arm: Selinexor + Bortezomib + Dexamethasone
param Type
NUMBER
population Description
The SVdX population consisted of a subset of participants in the Vd arm of the safety population who crossed over from the Vd arm to SVdX treatment after IRC confirmation of PD on Vd and had received at least 1 dose of selinexor. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.
reporting Status
POSTED
time Frame
From date of first SVdX treatment until disease progression or initiating a new MM treatment (up to 33 months)
title
SVdX Arm: Overall Response Rate (ORR1) as Assessed by IRC During SVdX Treatment
type
SECONDARY
unit Of Measure
Percentage of participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice