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NCT01080391 · OUTCOME

Overall Survival

Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed Multiple Myeloma · Source last updated 2022-09-21

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
From randomization through the data cutoff date of 28 April 2017 for the final analysis of overall survival; median follow up time was 67.1 months in each treatment group.

What was measured

Overall survival (OS) was defined as the duration from randomization to death due to any cause. Participants who were still alive were censored at the date when the participant was last known to be alive or the data cutoff date, whichever occurred earlier.

Analysis population: ITT analysis set comprised of all randomized participants

Groups in this outcome

Lenalidomide and Dexamethasone (Rd)

Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Lenalidomide 25 mg was administered orally on days 1 to 21 and dexamethasone 40 mg was administered orally or intravenously on days 1, 8, 15, and 22.

Carfilzomib, Lenalidomide, and Dexamethasone (CRd)

Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Carfilzomib 20 mg/m² was administered intravenously (IV) on days 1 and 2 of cycle 1, then escalated to 27 mg/m² on Days 8, 9, 15, and 16 of cycle 1 and continuing on days 1, 2, 8, 9, 15, and 16 of cycle 2 through cycle 12 and then from cycle 13 through cycle 18, 27 mg/m² on days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on days 1 to 21 of every cycle. Dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22 of every cycle.

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

Analysis denominator · Participants

GroupSource count
Lenalidomide and Dexamethasone (Rd)396
Carfilzomib, Lenalidomide, and Dexamethasone (CRd)396

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Lenalidomide and Dexamethasone (Rd)40.4Not reported33.644.4Not reported
Carfilzomib, Lenalidomide, and Dexamethasone (CRd)48.3Not reported42.452.8Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.667
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.945
    group Description
    The final analysis of OS was to be performed after 510 deaths occur. A total of 510 deaths would provide 85% power to detect, with a 1-sided significance level of 0.025, a hazard ratio of 0.765 corresponding to a 23.5% reduction in risk for death for CRd versus Rd (39.2 vs. 30.0 months, respectively).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    The stopping boundary for this analysis was 0.0231 based on 1-sided significance level (O'Brien-Fleming with Lan-DeMets spending function).
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0045
    param Type
    Hazard Ratio (HR)
    param Value
    0.794
    statistical Comment
    Analysis was stratified by β2 microglobulin levels (\< 2.5 mg/L vs. ≥ 2.5 mg/L), prior bortezomib (no vs. yes), and prior lenalidomide (no vs. yes).
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.667
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.945
    group Description
    The final analysis of OS was to be performed after 510 deaths occur. A total of 510 deaths would provide 85% power to detect, with a 1-sided significance level of 0.025, a hazard ratio of 0.765 corresponding to a 23.5% reduction in risk for death for CRd versus Rd (39.2 vs. 30.0 months, respectively).
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    The stopping boundary for this analysis was 0.0231 based on 1-sided significance level (O'Brien-Fleming with Lan-DeMets spending function).
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0045
    param Type
    Hazard Ratio (HR)
    param Value
    0.794
    statistical Comment
    Analysis was stratified by β2 microglobulin levels (\< 2.5 mg/L vs. ≥ 2.5 mg/L), prior bortezomib (no vs. yes), and prior lenalidomide (no vs. yes).
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        33.6
        upper Limit
        44.4
        value
        40.4
      2. group Id
        OG001
        lower Limit
        42.4
        upper Limit
        52.8
        value
        48.3
denoms
  1. counts
    1. group Id
      OG000
      value
      396
    2. group Id
      OG001
      value
      396
    units
    Participants
description
Overall survival (OS) was defined as the duration from randomization to death due to any cause. Participants who were still alive were censored at the date when the participant was last known to be alive or the data cutoff date, whichever occurred earlier.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Lenalidomide 25 mg was administered orally on days 1 to 21 and dexamethasone 40 mg was administered orally or intravenously on days 1, 8, 15, and 22.
    id
    OG000
    title
    Lenalidomide and Dexamethasone (Rd)
  2. description
    Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Carfilzomib 20 mg/m² was administered intravenously (IV) on days 1 and 2 of cycle 1, then escalated to 27 mg/m² on Days 8, 9, 15, and 16 of cycle 1 and continuing on days 1, 2, 8, 9, 15, and 16 of cycle 2 through cycle 12 and then from cycle 13 through cycle 18, 27 mg/m² on days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on days 1 to 21 of every cycle. Dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22 of every cycle.
    id
    OG001
    title
    Carfilzomib, Lenalidomide, and Dexamethasone (CRd)
param Type
MEDIAN
population Description
ITT analysis set comprised of all randomized participants
reporting Status
POSTED
time Frame
From randomization through the data cutoff date of 28 April 2017 for the final analysis of overall survival; median follow up time was 67.1 months in each treatment group.
title
Overall Survival
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice