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NCT01850524 · OUTCOME

PFS in High-risk Population Carrying Del(17p), t(4;14), or t(14;16) Mutations

IXAZOMIB Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Newly Diagnosed Multiple Myeloma · Source last updated 2023-07-21

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
Up to approximately 9 years

What was measured

PFS was defined as the time from the date of randomization to the date of first documentation of progressive disease based on central laboratory results and IMWG criteria as evaluated by an independent review committee (IRC) or death due to any cause, whichever occurs first, as assessed in high-risk population carrying del(17p), t(4;14), or t(14;16) mutations.

Analysis population: ITT population included all participants who were randomized. Overall number of participants analyzed indicates the number of participants from the high-risk category.

Groups in this outcome

Placebo + LenDex

Participants who were randomly assigned to receive placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib matching placebo capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).

Ixazomib + LenDex

Participants who were randomly assigned to receive Ixazomib 4.0 mg capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 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
Placebo + LenDex63
Ixazomib + LenDex60

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Placebo + LenDex17.5Not reported12.1220.30Not reported
Ixazomib + LenDex22.4Not reported12.1642.84Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.466
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.240
    estimate Comment
    Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.
    group Description
    PFS in High-risk Population Carrying del(17p), t(4;14), or t(14;16) Mutations
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.271
    param Type
    Hazard Ratio (HR)
    param Value
    0.760
    statistical Comment
    Log-rank test is stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.466
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.240
    estimate Comment
    Hazard ratio is based on an unadjusted Cox's proportional hazard regression model stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.
    group Description
    PFS in High-risk Population Carrying del(17p), t(4;14), or t(14;16) Mutations
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.271
    param Type
    Hazard Ratio (HR)
    param Value
    0.760
    statistical Comment
    Log-rank test is stratified by age (\<75 years vs \>=75), ISS (stage I or II vs stage III), and BPI-SF worst pain score (\<4 vs \>=4) at screening.
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        12.12
        upper Limit
        20.30
        value
        17.5
      2. group Id
        OG001
        lower Limit
        12.16
        upper Limit
        42.84
        value
        22.4
denoms
  1. counts
    1. group Id
      OG000
      value
      63
    2. group Id
      OG001
      value
      60
    units
    Participants
description
PFS was defined as the time from the date of randomization to the date of first documentation of progressive disease based on central laboratory results and IMWG criteria as evaluated by an independent review committee (IRC) or death due to any cause, whichever occurs first, as assessed in high-risk population carrying del(17p), t(4;14), or t(14;16) mutations.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants who were randomly assigned to receive placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib matching placebo capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).
    id
    OG000
    title
    Placebo + LenDex
  2. description
    Participants who were randomly assigned to receive Ixazomib 4.0 mg capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).
    id
    OG001
    title
    Ixazomib + LenDex
param Type
MEDIAN
population Description
ITT population included all participants who were randomized. Overall number of participants analyzed indicates the number of participants from the high-risk category.
reporting Status
POSTED
time Frame
Up to approximately 9 years
title
PFS in High-risk Population Carrying Del(17p), t(4;14), or t(14;16) Mutations
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice