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NCT02181413 · OUTCOME

OS Benefits in a High-Risk Population

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

High-risk population included but was not limited to participants carrying deletion (del)17, t(4:14), t(14:16), amplification (ampl) 1q, del13, or del1p. OS was measured as the time from the date of randomization to the date of death.

Analysis population: ITT population was defined as all participants who were randomized and had post randomization data. Overall number analyzed is the number of participants present in the high-risk group.

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
Placebo54
Ixazomib Citrate61

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Placebo69.0Not reported33.2592.98Not reported
Ixazomib Citrate64.2Not reported40.97NAUpper limit of 95% CI was not estimable due to low number of participants with events.

Source statistical analyses

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

  1. ci Lower Limit
    0.583
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.613
    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
    0.905
    p Value Comment
    P-value was based on log-rank test stratified by pre-induction regimen, ISS stage and response after transplantation.
    param Type
    Hazard Ratio (HR)
    param Value
    0.97
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.583
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.613
    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
    0.905
    p Value Comment
    P-value was based on log-rank test stratified by pre-induction regimen, ISS stage and response after transplantation.
    param Type
    Hazard Ratio (HR)
    param Value
    0.97
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        33.25
        upper Limit
        92.98
        value
        69.0
      2. comment
        Upper limit of 95% CI was not estimable due to low number of participants with events.
        group Id
        OG001
        lower Limit
        40.97
        upper Limit
        NA
        value
        64.2
denoms
  1. counts
    1. group Id
      OG000
      value
      54
    2. group Id
      OG001
      value
      61
    units
    Participants
description
High-risk population included but was not limited to participants carrying deletion (del)17, t(4:14), t(14:16), amplification (ampl) 1q, del13, or del1p. OS was measured as the time from the date of randomization to the date of 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. Overall number analyzed is the number of participants present in the high-risk group.
reporting Status
POSTED
time Frame
Randomization up to 107 months
title
OS Benefits in a High-Risk Population
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice