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NCT02181413 · OUTCOME

Time to Start of the Next Line of Therapy

A Study of Oral Ixazomib Citrate (MLN9708) Maintenance Therapy in Participants With Multiple Myeloma Following Autologous Stem Cell Transplant · Source last updated 2024-11-19

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
Randomization up to 107 months

What was measured

Time to start of the next line of therapy was defined as the time from the date of randomization to the date of initiation dose of the next line of antineoplastic therapy following study treatment or death due to any cause, whichever occurred first. Participants who never took antineoplastic therapy were censored at the date of last contact or death.

Analysis population: ITT population was defined as all participants who were randomized and had post randomization data.

Groups in this outcome

Placebo

Ixazomib citrate placebo-matching capsules, orally, once on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 26 until progressive disease (PD), unacceptable toxicity, or discontinuation for alternate reasons.

Ixazomib Citrate

Ixazomib citrate 3 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 4. Ixazomib citrate 4 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 5 through 26 until PD, unacceptable toxicity, or discontinuation for alternate reasons. Participants who had any dose reductions due to AEs were not dose escalated.

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

Analysis denominator · Participants

GroupSource count
Placebo261
Ixazomib Citrate395

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Placebo27.6Not reported24.4831.61Not reported
Ixazomib Citrate33.1Not reported29.1436.34Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.690
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.005
    estimate Comment
    Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.056
    param Type
    Hazard Ratio (HR)
    param Value
    0.833
    statistical Comment
    P-value was based on log-rank test stratified by pre-induction regimen, ISS stage and response after transplantation.
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.690
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.005
    estimate Comment
    Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by induction regimen, pre-induction ISS, and response after transplantation, comparing the hazard rate of Ixazomib arm over the hazard rate of Placebo arm.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.056
    param Type
    Hazard Ratio (HR)
    param Value
    0.833
    statistical Comment
    P-value was based on log-rank test stratified by pre-induction regimen, ISS stage and response after transplantation.
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        24.48
        upper Limit
        31.61
        value
        27.6
      2. group Id
        OG001
        lower Limit
        29.14
        upper Limit
        36.34
        value
        33.1
denoms
  1. counts
    1. group Id
      OG000
      value
      261
    2. group Id
      OG001
      value
      395
    units
    Participants
description
Time to start of the next line of therapy was defined as the time from the date of randomization to the date of initiation dose of the next line of antineoplastic therapy following study treatment or death due to any cause, whichever occurred first. Participants who never took antineoplastic therapy were censored at the date of last contact or death.
dispersion Type
95% Confidence Interval
groups
  1. description
    Ixazomib citrate placebo-matching capsules, orally, once on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 26 until progressive disease (PD), unacceptable toxicity, or discontinuation for alternate reasons.
    id
    OG000
    title
    Placebo
  2. description
    Ixazomib citrate 3 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 4. Ixazomib citrate 4 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 5 through 26 until PD, unacceptable toxicity, or discontinuation for alternate reasons. Participants who had any dose reductions due to AEs were not dose escalated.
    id
    OG001
    title
    Ixazomib Citrate
param Type
MEDIAN
population Description
ITT population was defined as all participants who were randomized and had post randomization data.
reporting Status
POSTED
time Frame
Randomization up to 107 months
title
Time to Start of the Next Line of Therapy
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice