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NCT02312258 · OUTCOME

Duration of Next-line Therapy

A Study of Oral Ixazomib Maintenance Therapy in Participants With Newly Diagnosed Multiple Myeloma (NDMM) Not Treated With Stem Cell Transplantation (SCT) · Source last updated 2023-09-21

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 until PD or death (up to 52 months)

What was measured

Duration of next-line therapy is defined as the time from the date of the first dose of the next line of antineoplastic therapy coming after study treatment to the date of the last dose.

Analysis population: ITT Population included all participants who were randomized and had post-randomization data. Overall number analyzed is the number of participants with data available for analyses.

Groups in this outcome

Placebo

Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 through 26.

Ixazomib

Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 to 4 that may have been escalated to 4 mg thereafter up to Cycle 26.

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

Analysis denominator · Participants

GroupSource count
Placebo164
Ixazomib215

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Placebo14.0Not reported10.4116.82Not reported
Ixazomib8.7Not reported7.8510.87Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.968
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.727
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    other Analysis Description
    Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant.
    param Type
    Hazard Ratio (HR)
    param Value
    1.293
Complete source fields
analyses
  1. ci Lower Limit
    0.968
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.727
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    other Analysis Description
    Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant.
    param Type
    Hazard Ratio (HR)
    param Value
    1.293
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        10.41
        upper Limit
        16.82
        value
        14.0
      2. group Id
        OG001
        lower Limit
        7.85
        upper Limit
        10.87
        value
        8.7
denoms
  1. counts
    1. group Id
      OG000
      value
      164
    2. group Id
      OG001
      value
      215
    units
    Participants
description
Duration of next-line therapy is defined as the time from the date of the first dose of the next line of antineoplastic therapy coming after study treatment to the date of the last dose.
dispersion Type
95% Confidence Interval
groups
  1. description
    Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 through 26.
    id
    OG000
    title
    Placebo
  2. description
    Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 to 4 that may have been escalated to 4 mg thereafter up to Cycle 26.
    id
    OG001
    title
    Ixazomib
param Type
MEDIAN
population Description
ITT Population included all participants who were randomized and had post-randomization data. Overall number analyzed is the number of participants with data available for analyses.
reporting Status
POSTED
time Frame
From randomization until PD or death (up to 52 months)
title
Duration of Next-line Therapy
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice