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NCT01564537 · OUTCOME

Duration of Response (DOR)

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
Day 1 of each cycle (every 4 weeks) until disease progression up to approximately 38 months

What was measured

DOR was measured as the time in months from the date of first documentation of a confirmed response of PR or better (CR \[including sCR\] + PR+ VGPR) to the date of the first documented disease progression (PD) among participants who responded to the treatment. Response was assessed by the investigator using International Myeloma Working Group (IMWG) Criteria.

Analysis population: Response-Evaluable population included all participants who received at least 1 dose of study drug, had measurable disease at baseline, and at least 1 post-baseline response assessment. 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 + Dexamethasone281
Placebo + Lenalidomide + Dexamethasone252

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ixazomib+ Lenalidomide + Dexamethasone26.0Not reported22.51NAThe upper limit of CI was not estimable due to insufficient number of participants with events.
Placebo + Lenalidomide + Dexamethasone21.7Not reported17.77NAThe upper limit of CI was not estimable due to insufficient number of participants with events.
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
        22.51
        upper Limit
        NA
        value
        26.0
      2. comment
        The upper limit of CI was not estimable due to insufficient number of participants with events.
        group Id
        OG001
        lower Limit
        17.77
        upper Limit
        NA
        value
        21.7
denoms
  1. counts
    1. group Id
      OG000
      value
      281
    2. group Id
      OG001
      value
      252
    units
    Participants
description
DOR was measured as the time in months from the date of first documentation of a confirmed response of PR or better (CR \[including sCR\] + PR+ VGPR) to the date of the first documented disease progression (PD) among participants who responded to the treatment. Response was assessed by the investigator using International Myeloma Working Group (IMWG) Criteria.
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
Response-Evaluable population included all participants who received at least 1 dose of study drug, had measurable disease at baseline, and at least 1 post-baseline response assessment. Overall number analyzed is the number of participants available for analysis.
reporting Status
POSTED
time Frame
Day 1 of each cycle (every 4 weeks) until disease progression up to approximately 38 months
title
Duration of Response (DOR)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice