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NCT03859427 · OUTCOME

Kaplan-Meier Estimate of Duration of Response (DOR)

A Study Comparing Once-weekly vs Twice-weekly Carfilzomib in Combination With Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma · Source last updated 2024-08-13

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
months
Interval / dispersion
Full Range
Time frame
Cycle 1 Day 1 up to approximately 12 months (cycle = 28 days); median treatment duration for the twice-weekly arm was 47.00 weeks and for the once-weekly arm was 47.14 weeks.

What was measured

For participants who achieved a PR or better, i.e., sCR, CR, VGPR, or PR per IMWG-URC, the DOR was defined as the time from the earliest date when a PR or better was first achieved, and subsequently confirmed, to the earliest date of confirmed PD or death due to any cause. Median DOR was estimated using the Kaplan-Meier method. 95% CIs were estimated using the method by Klein and Moeschberger (1997) with log-log transformation. For those alive and who had not experienced PD by analysis time, DOR was censored for participants who met any one of the following: 1. no baseline/no post-baseline disease assessments; 2. starting new anti-myeloma therapy before documentation of PD or death; 3. PD or death immediately after more than 1 consecutively missed disease assessment visit (PD or death immediately after \> 63 days without disease assessment visit); 4. alive without documentation of PD; 5. lost to follow-up or withdrawn consent.

Analysis population: The ITT population included all randomized participants. Data is presented for participants in the ITT population who achieved a confirmed response of PR or better.

Groups in this outcome

Twice-weekly KRd 20/27 mg/m^2

Carfilzomib was administered twice-weekly intravenously as a 10 ± 5 minute infusion using an infusion pump on Days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. The dose was 20 mg/m\^2 on Days 1 and 2 of Cycle 1 and 27 mg/m\^2 beginning on Day 8 of Cycle 1 and thereafter. Participants also received lenalidomide 25 mg daily orally on Days 1 to 21 of each cycle and dexamethasone 40 mg weekly orally or intravenously. Participants were treated for up to 12 28-day cycles.

Once-weekly KRd 20/56 mg/m^2

Carfilzomib was administered once-weekly intravenously as a 30 ± 5 minute infusion using an infusion pump on Days 1, 8, and 15 of each 28-day cycle. The dose was 20 mg/m\^2 on Day 1 of Cycle 1 and 56 mg/m\^2 beginning on Day 8 of Cycle 1 and thereafter. Participants also received lenalidomide 25 mg daily orally on Days 1 to 21 of each cycle and dexamethasone 40 mg weekly orally or intravenously. Participants were treated for up to 12 28-day cycles.

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

Analysis denominator · Participants

GroupSource count
Twice-weekly KRd 20/27 mg/m^2195
Once-weekly KRd 20/56 mg/m^2188

Reported measurements

Source class 1
Values in months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Twice-weekly KRd 20/27 mg/m^2NANot reportedNANAThe median and 95% CIs could not be estimated due to too few events.
Once-weekly KRd 20/56 mg/m^2NANot reportedNANAThe median and 95% CIs could not be estimated due to too few events.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        The median and 95% CIs could not be estimated due to too few events.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        The median and 95% CIs could not be estimated due to too few events.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      195
    2. group Id
      OG001
      value
      188
    units
    Participants
description
For participants who achieved a PR or better, i.e., sCR, CR, VGPR, or PR per IMWG-URC, the DOR was defined as the time from the earliest date when a PR or better was first achieved, and subsequently confirmed, to the earliest date of confirmed PD or death due to any cause. Median DOR was estimated using the Kaplan-Meier method. 95% CIs were estimated using the method by Klein and Moeschberger (1997) with log-log transformation. For those alive and who had not experienced PD by analysis time, DOR was censored for participants who met any one of the following: 1. no baseline/no post-baseline disease assessments; 2. starting new anti-myeloma therapy before documentation of PD or death; 3. PD or death immediately after more than 1 consecutively missed disease assessment visit (PD or death immediately after \> 63 days without disease assessment visit); 4. alive without documentation of PD; 5. lost to follow-up or withdrawn consent.
dispersion Type
Full Range
groups
  1. description
    Carfilzomib was administered twice-weekly intravenously as a 10 ± 5 minute infusion using an infusion pump on Days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. The dose was 20 mg/m\^2 on Days 1 and 2 of Cycle 1 and 27 mg/m\^2 beginning on Day 8 of Cycle 1 and thereafter. Participants also received lenalidomide 25 mg daily orally on Days 1 to 21 of each cycle and dexamethasone 40 mg weekly orally or intravenously. Participants were treated for up to 12 28-day cycles.
    id
    OG000
    title
    Twice-weekly KRd 20/27 mg/m^2
  2. description
    Carfilzomib was administered once-weekly intravenously as a 30 ± 5 minute infusion using an infusion pump on Days 1, 8, and 15 of each 28-day cycle. The dose was 20 mg/m\^2 on Day 1 of Cycle 1 and 56 mg/m\^2 beginning on Day 8 of Cycle 1 and thereafter. Participants also received lenalidomide 25 mg daily orally on Days 1 to 21 of each cycle and dexamethasone 40 mg weekly orally or intravenously. Participants were treated for up to 12 28-day cycles.
    id
    OG001
    title
    Once-weekly KRd 20/56 mg/m^2
param Type
MEDIAN
population Description
The ITT population included all randomized participants. Data is presented for participants in the ITT population who achieved a confirmed response of PR or better.
reporting Status
POSTED
time Frame
Cycle 1 Day 1 up to approximately 12 months (cycle = 28 days); median treatment duration for the twice-weekly arm was 47.00 weeks and for the once-weekly arm was 47.14 weeks.
title
Kaplan-Meier Estimate of Duration of Response (DOR)
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice