Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03859427 · OUTCOME

Change From Baseline in European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire (EORTC QLQ)-Core 30 (C30) Physical Functioning Scale

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
MEAN
Unit
Score on a scale
Interval / dispersion
Standard Deviation
Time frame
Baseline (Cycle 1 Day 1), Cycle 3 Day 1, Cycle 5 Day 1, Cycle 7 Day 1, Cycle 9 Day 1, Cycle 12 Day 1, and safety follow-up (30 days after last dose)

What was measured

The QLQ-C30 physical function is one of the functional domains of the EORTC QLQ-C30 self-reported instrument and the physical functioning score score ranges from 0-100 points, with 100 points indicating the best possible functioning. A positive change from baseline indicated an improvement in functioning.

Analysis population: The ITT population included all randomized participants. Participants with data available at each time point are presented. All participants in the overall number of participants analyzed contributed to the data in the endpoint.

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^2226
Once-weekly KRd 20/56 mg/m^2228

Reported measurements

Cycle 3 Day 1

Analysis denominator · Participants

GroupSource count
Twice-weekly KRd 20/27 mg/m^2186
Once-weekly KRd 20/56 mg/m^2182
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Twice-weekly KRd 20/27 mg/m^2-2.7616.84Not reportedNot reportedNot reported
Once-weekly KRd 20/56 mg/m^2-0.7714.95Not reportedNot reportedNot reported
Cycle 5 Day 1

Analysis denominator · Participants

GroupSource count
Twice-weekly KRd 20/27 mg/m^2181
Once-weekly KRd 20/56 mg/m^2177
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Twice-weekly KRd 20/27 mg/m^2-2.6515.76Not reportedNot reportedNot reported
Once-weekly KRd 20/56 mg/m^20.2615.59Not reportedNot reportedNot reported
Cycle 7 Day 1

Analysis denominator · Participants

GroupSource count
Twice-weekly KRd 20/27 mg/m^2162
Once-weekly KRd 20/56 mg/m^2161
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Twice-weekly KRd 20/27 mg/m^2-0.8216.59Not reportedNot reportedNot reported
Once-weekly KRd 20/56 mg/m^20.1714.62Not reportedNot reportedNot reported
Cycle 9 Day 1

Analysis denominator · Participants

GroupSource count
Twice-weekly KRd 20/27 mg/m^2152
Once-weekly KRd 20/56 mg/m^2148
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Twice-weekly KRd 20/27 mg/m^2-1.0515.59Not reportedNot reportedNot reported
Once-weekly KRd 20/56 mg/m^22.0314.75Not reportedNot reportedNot reported
Cycle 12 Day 1

Analysis denominator · Participants

GroupSource count
Twice-weekly KRd 20/27 mg/m^2134
Once-weekly KRd 20/56 mg/m^2132
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Twice-weekly KRd 20/27 mg/m^2-1.8915.15Not reportedNot reportedNot reported
Once-weekly KRd 20/56 mg/m^21.0615.63Not reportedNot reportedNot reported
Safety Follow-up

Analysis denominator · Participants

GroupSource count
Twice-weekly KRd 20/27 mg/m^2146
Once-weekly KRd 20/56 mg/m^2145
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Twice-weekly KRd 20/27 mg/m^2-1.5516.31Not reportedNot reportedNot reported
Once-weekly KRd 20/56 mg/m^22.1118.27Not reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    0.38
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    4.69
    estimate Comment
    Analysis was based on repeated measures analysis of covariance (ANCOVA) model, including arm, baseline scale score, randomization stratification factors and visit as repeated measure.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    param Type
    Least Squares (LS) Mean Difference
    param Value
    2.53
Complete source fields
analyses
  1. ci Lower Limit
    0.38
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    4.69
    estimate Comment
    Analysis was based on repeated measures analysis of covariance (ANCOVA) model, including arm, baseline scale score, randomization stratification factors and visit as repeated measure.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    param Type
    Least Squares (LS) Mean Difference
    param Value
    2.53
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.84
        value
        -2.76
      2. group Id
        OG001
        spread
        14.95
        value
        -0.77
    denoms
    1. counts
      1. group Id
        OG000
        value
        186
      2. group Id
        OG001
        value
        182
      units
      Participants
    title
    Cycle 3 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.76
        value
        -2.65
      2. group Id
        OG001
        spread
        15.59
        value
        0.26
    denoms
    1. counts
      1. group Id
        OG000
        value
        181
      2. group Id
        OG001
        value
        177
      units
      Participants
    title
    Cycle 5 Day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.59
        value
        -0.82
      2. group Id
        OG001
        spread
        14.62
        value
        0.17
    denoms
    1. counts
      1. group Id
        OG000
        value
        162
      2. group Id
        OG001
        value
        161
      units
      Participants
    title
    Cycle 7 Day 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.59
        value
        -1.05
      2. group Id
        OG001
        spread
        14.75
        value
        2.03
    denoms
    1. counts
      1. group Id
        OG000
        value
        152
      2. group Id
        OG001
        value
        148
      units
      Participants
    title
    Cycle 9 Day 1
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.15
        value
        -1.89
      2. group Id
        OG001
        spread
        15.63
        value
        1.06
    denoms
    1. counts
      1. group Id
        OG000
        value
        134
      2. group Id
        OG001
        value
        132
      units
      Participants
    title
    Cycle 12 Day 1
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.31
        value
        -1.55
      2. group Id
        OG001
        spread
        18.27
        value
        2.11
    denoms
    1. counts
      1. group Id
        OG000
        value
        146
      2. group Id
        OG001
        value
        145
      units
      Participants
    title
    Safety Follow-up
denoms
  1. counts
    1. group Id
      OG000
      value
      226
    2. group Id
      OG001
      value
      228
    units
    Participants
description
The QLQ-C30 physical function is one of the functional domains of the EORTC QLQ-C30 self-reported instrument and the physical functioning score score ranges from 0-100 points, with 100 points indicating the best possible functioning. A positive change from baseline indicated an improvement in functioning.
dispersion Type
Standard Deviation
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
MEAN
population Description
The ITT population included all randomized participants. Participants with data available at each time point are presented. All participants in the overall number of participants analyzed contributed to the data in the endpoint.
reporting Status
POSTED
time Frame
Baseline (Cycle 1 Day 1), Cycle 3 Day 1, Cycle 5 Day 1, Cycle 7 Day 1, Cycle 9 Day 1, Cycle 12 Day 1, and safety follow-up (30 days after last dose)
title
Change From Baseline in European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire (EORTC QLQ)-Core 30 (C30) Physical Functioning Scale
type
SECONDARY
unit Of Measure
Score on a scale

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

Preserved source evidence · Not medical advice