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NCT02902965 · OUTCOME

Median Progression-Free Survival (PFS)

Study of Ibrutinib in Combination With Bortezomib and Dexamethasone in Subjects With Relapsed/Relapsed and Refractory Multiple Myeloma · Source last updated 2020-03-16

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
The median time on study was 19.6 months (range: 0.16+, 24.64). Participants were evaluated for Progression-Free Survival (PFS) during their entire time on the study.

What was measured

The primary efficacy endpoint of this study is mPFS. Progression free survival is defined as the time from the date of first dose of study treatment to confirmed disease progression or death from any cause, whichever occurs first.

Analysis population: All participant received: see description on Arm/Group description. Following implementation of Amendment 4, dexamethasone administration was reduced to Days 1, 4, 8 and 11 during each 21-day cycle (Cycles 1-8) and on Days 1, 8, 22 and 29 on each 42-day cycle (Cycles 9-12) and unchanged thereafter.

Groups in this outcome

Ibrutinib+ Bortezomib+ Dexamethasone

Ibrutinib (I): I 840 mg orally, once daily continuously starting day 1 of Cycle (C) 1 until confirmed disease progression, unacceptable toxicity or other protocol specified reason for discontinuation Bortezomib (B): C 1-8: (21-day C): B 1.3 mg/m\^2 sub-cutaneously on days 1, 4, 8, and 11 of each C C 9-12: (42-day C): B 1.3 mg/m\^2 sub-cutaneously on days 1, 8, 22 and 29 of each C Dexamethasone (D): C 1-8: (21-day C): D 20 mg orally on days 1, 2, 4, 5, 8, 9, 11 and 12 of each C C 9-12: (42-day C): D 20 mg orally on days 1, 2, 8, 9, 22, 23, 29 and 30 of each C C 13+ (28-day C): D 40 mg orally once weekly Dose adjustment of D to 10 mg on days specified during C 1-12 and 20 mg weekly during C 13+ is recommended for subjects \>75 years of age. Following implementation of Protocol Amendment 4, D administration was reduced to Days 1, 4, 8, and 11 during each 21-day C (C 1-8) and on Days 1, 8, 22 and 29 on each 42-day C (C 9-12) and unchanged thereafter

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

Analysis denominator · Participants

GroupSource count
Ibrutinib+ Bortezomib+ Dexamethasone74

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ibrutinib+ Bortezomib+ Dexamethasone8.5Not reported6.210.8Not reported

Source statistical analyses

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

  1. ci Lower Limit
    6.2
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    10.8
    estimate Comment
    Kaplan-Meier estimates for median PFS and its associated 95% confidence intervals using log-log transformed Greenwood variance estimate were calculated.
    group Ids
    1. OG000
    non Inferiority Type
    OTHER
    param Type
    median PFS
    param Value
    8.5
Complete source fields
analyses
  1. ci Lower Limit
    6.2
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    10.8
    estimate Comment
    Kaplan-Meier estimates for median PFS and its associated 95% confidence intervals using log-log transformed Greenwood variance estimate were calculated.
    group Ids
    1. OG000
    non Inferiority Type
    OTHER
    param Type
    median PFS
    param Value
    8.5
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.2
        upper Limit
        10.8
        value
        8.5
denoms
  1. counts
    1. group Id
      OG000
      value
      74
    units
    Participants
description
The primary efficacy endpoint of this study is mPFS. Progression free survival is defined as the time from the date of first dose of study treatment to confirmed disease progression or death from any cause, whichever occurs first.
dispersion Type
95% Confidence Interval
groups
  1. description
    Ibrutinib (I): I 840 mg orally, once daily continuously starting day 1 of Cycle (C) 1 until confirmed disease progression, unacceptable toxicity or other protocol specified reason for discontinuation Bortezomib (B): C 1-8: (21-day C): B 1.3 mg/m\^2 sub-cutaneously on days 1, 4, 8, and 11 of each C C 9-12: (42-day C): B 1.3 mg/m\^2 sub-cutaneously on days 1, 8, 22 and 29 of each C Dexamethasone (D): C 1-8: (21-day C): D 20 mg orally on days 1, 2, 4, 5, 8, 9, 11 and 12 of each C C 9-12: (42-day C): D 20 mg orally on days 1, 2, 8, 9, 22, 23, 29 and 30 of each C C 13+ (28-day C): D 40 mg orally once weekly Dose adjustment of D to 10 mg on days specified during C 1-12 and 20 mg weekly during C 13+ is recommended for subjects \>75 years of age. Following implementation of Protocol Amendment 4, D administration was reduced to Days 1, 4, 8, and 11 during each 21-day C (C 1-8) and on Days 1, 8, 22 and 29 on each 42-day C (C 9-12) and unchanged thereafter
    id
    OG000
    title
    Ibrutinib+ Bortezomib+ Dexamethasone
param Type
MEDIAN
population Description
All participant received: see description on Arm/Group description. Following implementation of Amendment 4, dexamethasone administration was reduced to Days 1, 4, 8 and 11 during each 21-day cycle (Cycles 1-8) and on Days 1, 8, 22 and 29 on each 42-day cycle (Cycles 9-12) and unchanged thereafter.
reporting Status
POSTED
time Frame
The median time on study was 19.6 months (range: 0.16+, 24.64). Participants were evaluated for Progression-Free Survival (PFS) during their entire time on the study.
title
Median Progression-Free Survival (PFS)
type
PRIMARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice