Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02312258 · OUTCOME

OS in a High-risk Population

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 the date of randomization and every 12 weeks after PD on next-line therapy until death (up to 88 months)

What was measured

High-risk population included but not be limited to participants carrying cytogenetic deletion (del)17, translocation \[t\](4;14), t(14;16). OS was measured as the time from the date of randomization to the date of death.

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

Groups in this outcome

Placebo

Ixazomib placebo-matching 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
Placebo48
Ixazomib74

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Placebo48.3Not reported29.7074.48Not reported
Ixazomib37.3Not reported26.0547.44Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        29.70
        upper Limit
        74.48
        value
        48.3
      2. group Id
        OG001
        lower Limit
        26.05
        upper Limit
        47.44
        value
        37.3
denoms
  1. counts
    1. group Id
      OG000
      value
      48
    2. group Id
      OG001
      value
      74
    units
    Participants
description
High-risk population included but not be limited to participants carrying cytogenetic deletion (del)17, translocation \[t\](4;14), t(14;16). 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 placebo-matching 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 of participants analyzed is the number of participants present in the high-risk group.
reporting Status
POSTED
time Frame
From the date of randomization and every 12 weeks after PD on next-line therapy until death (up to 88 months)
title
OS 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