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NCT03859427 · OUTCOME

Patient-reported Treatment Satisfaction as Measured by the Cancer Therapy Satisfaction Questionnaire (CTSQ)

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
LEAST_SQUARES_MEAN
Unit
Score on a scale
Interval / dispersion
Standard Error
Time frame
Cycle 5 Day 1, Cycle 12 Day 1, and safety follow-up (30 days after last dose)

What was measured

The CTSQ measures treatment satisfaction in individuals with cancer and includes a domain for satisfaction with therapy. The satisfaction with therapy scores ranges from 0 to 100 points, with 100 points indicating greatest satisfaction. Analysis was based on ANCOVA model. The dependent variable of the models were the scale scores measured at each visit. The model included effects of intercept, scale score measured at cycle 2 day 1 visit, treatment arm, and randomization stratification factors.

Analysis population: The ITT population included all randomized participants. Participants with data available at each time point are presented.

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^2169
Once-weekly KRd 20/56 mg/m^2165

Reported measurements

Cycle 5 Day 1

Analysis denominator · Participants

GroupSource count
Twice-weekly KRd 20/27 mg/m^2169
Once-weekly KRd 20/56 mg/m^2165
Values in Score on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Twice-weekly KRd 20/27 mg/m^275.731.78Not reportedNot reportedNot reported
Once-weekly KRd 20/56 mg/m^275.471.76Not reportedNot reportedNot reported
Cycle 12 Day 1

Analysis denominator · Participants

GroupSource count
Twice-weekly KRd 20/27 mg/m^2128
Once-weekly KRd 20/56 mg/m^2122
Values in Score on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Twice-weekly KRd 20/27 mg/m^278.392.40Not reportedNot reportedNot reported
Once-weekly KRd 20/56 mg/m^277.912.40Not reportedNot reportedNot reported
Safety follow-up

Analysis denominator · Participants

GroupSource count
Twice-weekly KRd 20/27 mg/m^2138
Once-weekly KRd 20/56 mg/m^2134
Values in Score on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Twice-weekly KRd 20/27 mg/m^274.552.58Not reportedNot reportedNot reported
Once-weekly KRd 20/56 mg/m^275.992.49Not reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    -2.54
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.03
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    1.16
    estimate Comment
    Treatment difference at Cycle 5
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    param Type
    LS Mean difference
    param Value
    -0.26
  2. ci Lower Limit
    -3.24
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.28
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    1.40
    estimate Comment
    Treatment difference at Cycle 12
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    param Type
    LS Mean difference
    param Value
    -0.48
  3. ci Lower Limit
    -1.69
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    4.58
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    1.59
    estimate Comment
    Treatment difference at safety follow-up
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    param Type
    LS Mean difference
    param Value
    1.44
Complete source fields
analyses
  1. ci Lower Limit
    -2.54
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.03
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    1.16
    estimate Comment
    Treatment difference at Cycle 5
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    param Type
    LS Mean difference
    param Value
    -0.26
  2. ci Lower Limit
    -3.24
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.28
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    1.40
    estimate Comment
    Treatment difference at Cycle 12
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    param Type
    LS Mean difference
    param Value
    -0.48
  3. ci Lower Limit
    -1.69
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    4.58
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    1.59
    estimate Comment
    Treatment difference at safety follow-up
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    param Type
    LS Mean difference
    param Value
    1.44
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.78
        value
        75.73
      2. group Id
        OG001
        spread
        1.76
        value
        75.47
    denoms
    1. counts
      1. group Id
        OG000
        value
        169
      2. group Id
        OG001
        value
        165
      units
      Participants
    title
    Cycle 5 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.40
        value
        78.39
      2. group Id
        OG001
        spread
        2.40
        value
        77.91
    denoms
    1. counts
      1. group Id
        OG000
        value
        128
      2. group Id
        OG001
        value
        122
      units
      Participants
    title
    Cycle 12 Day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.58
        value
        74.55
      2. group Id
        OG001
        spread
        2.49
        value
        75.99
    denoms
    1. counts
      1. group Id
        OG000
        value
        138
      2. group Id
        OG001
        value
        134
      units
      Participants
    title
    Safety follow-up
denoms
  1. counts
    1. group Id
      OG000
      value
      169
    2. group Id
      OG001
      value
      165
    units
    Participants
description
The CTSQ measures treatment satisfaction in individuals with cancer and includes a domain for satisfaction with therapy. The satisfaction with therapy scores ranges from 0 to 100 points, with 100 points indicating greatest satisfaction. Analysis was based on ANCOVA model. The dependent variable of the models were the scale scores measured at each visit. The model included effects of intercept, scale score measured at cycle 2 day 1 visit, treatment arm, and randomization stratification factors.
dispersion Type
Standard Error
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
LEAST_SQUARES_MEAN
population Description
The ITT population included all randomized participants. Participants with data available at each time point are presented.
reporting Status
POSTED
time Frame
Cycle 5 Day 1, Cycle 12 Day 1, and safety follow-up (30 days after last dose)
title
Patient-reported Treatment Satisfaction as Measured by the Cancer Therapy Satisfaction Questionnaire (CTSQ)
type
SECONDARY
unit Of Measure
Score on a scale

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

Preserved source evidence · Not medical advice