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NCT01564537 · OUTCOME

PFS in High-Risk Participants

A Phase 3 Study Comparing Oral Ixazomib Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma · Source last updated 2023-03-10

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 date of randomization until disease progression or death up to approximately 38 months (approximate median follow-up 15 months)

What was measured

Progression Free Survival (PFS) is defined as the time from the date of randomization to the date of first documentation of disease progression or death due to any cause, whichever occurs first. Response was assessed by independent review committee (IRC) using IMWG response criteria. High-risk participants are defined as participants carrying cytogenic abnormalities: del(17), translocation t(4;14), or t(14;16) as reported by the central laboratory combined with those cases that lacked a central laboratory result but with known del (17), t(4;14), or t(14;16) by local laboratory. Cytogenetic abnormalities of del(13) and +1q are not included in the analysis.

Analysis population: Participants from the ITT population, all randomized participants, with cytogenic abnormalities. Overall number analyzed is the number of participants available for analysis.

Groups in this outcome

Ixazomib+ Lenalidomide + Dexamethasone

Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until PD or unacceptable toxicity, whichever occurred first up to EOT (up to approximately 42.9 months).

Placebo + Lenalidomide + Dexamethasone

Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until PD or unacceptable toxicity, whichever occurred first (up to approximately 41 months).

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

Analysis denominator · Participants

GroupSource count
Ixazomib+ Lenalidomide + Dexamethasone75
Placebo + Lenalidomide + Dexamethasone62

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ixazomib+ Lenalidomide + Dexamethasone18.7Not reported13.24NAThe upper limit of CI was not estimable due to insufficient number of participants with events.
Placebo + Lenalidomide + Dexamethasone9.3Not reported7.3615.70Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        The upper limit of CI was not estimable due to insufficient number of participants with events.
        group Id
        OG000
        lower Limit
        13.24
        upper Limit
        NA
        value
        18.7
      2. group Id
        OG001
        lower Limit
        7.36
        upper Limit
        15.70
        value
        9.3
denoms
  1. counts
    1. group Id
      OG000
      value
      75
    2. group Id
      OG001
      value
      62
    units
    Participants
description
Progression Free Survival (PFS) is defined as the time from the date of randomization to the date of first documentation of disease progression or death due to any cause, whichever occurs first. Response was assessed by independent review committee (IRC) using IMWG response criteria. High-risk participants are defined as participants carrying cytogenic abnormalities: del(17), translocation t(4;14), or t(14;16) as reported by the central laboratory combined with those cases that lacked a central laboratory result but with known del (17), t(4;14), or t(14;16) by local laboratory. Cytogenetic abnormalities of del(13) and +1q are not included in the analysis.
dispersion Type
95% Confidence Interval
groups
  1. description
    Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until PD or unacceptable toxicity, whichever occurred first up to EOT (up to approximately 42.9 months).
    id
    OG000
    title
    Ixazomib+ Lenalidomide + Dexamethasone
  2. description
    Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until PD or unacceptable toxicity, whichever occurred first (up to approximately 41 months).
    id
    OG001
    title
    Placebo + Lenalidomide + Dexamethasone
param Type
MEDIAN
population Description
Participants from the ITT population, all randomized participants, with cytogenic abnormalities. Overall number analyzed is the number of participants available for analysis.
reporting Status
POSTED
time Frame
From date of randomization until disease progression or death up to approximately 38 months (approximate median follow-up 15 months)
title
PFS in High-Risk Participants
type
SECONDARY
unit Of Measure
months

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice