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NCT03416374 · OUTCOME

Patient-Reported Outcome Health-Related Quality of Life (HRQoL) Based on Global Health Status Scale of European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (EORTC QLQ-C30)

A Study to Evaluate the Efficacy and Safety of Ixazomib in Combination With Lenalidomide and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma Initially Treated With an Injection of Proteasome Inhibitor-Based Therapy · Source last updated 2022-09-27

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 and End of Treatment (Up to 23 cycles for VRd Group, Up to 32 cycles for KRd and Overall Group, each cycle was of 28 days)

What was measured

EORTC QLQ-C30 contains 30 items across 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status/QOL scale (Global Health Status). EORTC QLQ-C30 contains 28 questions (4-point scale where 1=Not at all \[best\] to 4=Very Much \[worst\]) and 2 questions (7-point scale where 1=Very poor \[worst\] to 7= Excellent \[best\]). Raw scores are converted into scale scores ranging from 0 to 100. For the functional scales and the global health status/QOL scale, higher scores represent better QOL; for the symptom scales, lower scores represent better QOL.

Analysis population: Full Analysis Set (FAS): all participants who were enrolled in Treatment Period I and who receive at least one dose of any therapy during the Treatment Period.

Groups in this outcome

[VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy

Bortezomib + Lenalidomide + Dexamethasone, standard recommended dose according to the package insert of each drug (Treatment Period I), followed by Ixazomib (4.0 mg) on Days 1, 8 and 15, plus Lenalidomide (25 mg) on Days 1 to 21, and Dexamethasone (40 mg) on Days 1, 8, 15 and 22, of a 28-day cycle (Treatment Period II)

[KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy

Carfilzomib + Lenalidomide + Dexamethasone, standard recommended dose according to the package insert of each drug (Treatment Period I), followed by Ixazomib (4.0 mg) on Days 1, 8 and 15, plus Lenalidomide (25 mg) on Days 1 to 21, and Dexamethasone (40 mg) on Days 1, 8, 15 and 22, of a 28-day cycle (Treatment Period II)

[Overall]; Combination Therapy + Ixazomib Therapy

Bortezomib + Lenalidomide + Dexamethasone, or Carfilzomib + Lenalidomide + Dexamethasone, standard recommended dose according to the package insert of each drug (Treatment Period I), followed by Ixazomib (4.0 mg) on Days 1, 8 and 15, plus Lenalidomide (25 mg) on Days 1 to 21, and Dexamethasone (40 mg) on Days 1, 8, 15 and 22, of a 28-day cycle (Treatment Period II)

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

Analysis denominator · Participants

GroupSource count
[VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy6
[KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy39
[Overall]; Combination Therapy + Ixazomib Therapy45

Reported measurements

Baseline

Analysis denominator · Participants

GroupSource count
[VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy6
[KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy39
[Overall]; Combination Therapy + Ixazomib Therapy45
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
[VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy44.4440.369Not reportedNot reportedNot reported
[KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy63.2524.085Not reportedNot reportedNot reported
[Overall]; Combination Therapy + Ixazomib Therapy60.7426.981Not reportedNot reportedNot reported
Cycle 23

Analysis denominator · Participants

GroupSource count
[VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy1
[KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy6
[Overall]; Combination Therapy + Ixazomib Therapy7
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
[VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy0NANot reportedNot reportedNA: data not available due to below the level of detection and insufficient number of participants with events.
[KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy54.178.740Not reportedNot reportedNot reported
[Overall]; Combination Therapy + Ixazomib Therapy46.4321.973Not reportedNot reportedNot reported
Cycle 32

Analysis denominator · Participants

GroupSource count
[VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy0
[KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy2
[Overall]; Combination Therapy + Ixazomib Therapy2
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
[KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy50.0023.750Not reportedNot reportedNot reported
[Overall]; Combination Therapy + Ixazomib Therapy50.0023.750Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        40.369
        value
        44.44
      2. group Id
        OG001
        spread
        24.085
        value
        63.25
      3. group Id
        OG002
        spread
        26.981
        value
        60.74
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        39
      3. group Id
        OG002
        value
        45
      units
      Participants
    title
    Baseline
  2. categories
    1. measurements
      1. comment
        NA: data not available due to below the level of detection and insufficient number of participants with events.
        group Id
        OG000
        spread
        NA
        value
        0
      2. group Id
        OG001
        spread
        8.740
        value
        54.17
      3. group Id
        OG002
        spread
        21.973
        value
        46.43
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        7
      units
      Participants
    title
    Cycle 23
  3. categories
    1. measurements
      1. group Id
        OG001
        spread
        23.750
        value
        50.00
      2. group Id
        OG002
        spread
        23.750
        value
        50.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        2
      units
      Participants
    title
    Cycle 32
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      39
    3. group Id
      OG002
      value
      45
    units
    Participants
description
EORTC QLQ-C30 contains 30 items across 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status/QOL scale (Global Health Status). EORTC QLQ-C30 contains 28 questions (4-point scale where 1=Not at all \[best\] to 4=Very Much \[worst\]) and 2 questions (7-point scale where 1=Very poor \[worst\] to 7= Excellent \[best\]). Raw scores are converted into scale scores ranging from 0 to 100. For the functional scales and the global health status/QOL scale, higher scores represent better QOL; for the symptom scales, lower scores represent better QOL.
dispersion Type
Standard Deviation
groups
  1. description
    Bortezomib + Lenalidomide + Dexamethasone, standard recommended dose according to the package insert of each drug (Treatment Period I), followed by Ixazomib (4.0 mg) on Days 1, 8 and 15, plus Lenalidomide (25 mg) on Days 1 to 21, and Dexamethasone (40 mg) on Days 1, 8, 15 and 22, of a 28-day cycle (Treatment Period II)
    id
    OG000
    title
    [VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy
  2. description
    Carfilzomib + Lenalidomide + Dexamethasone, standard recommended dose according to the package insert of each drug (Treatment Period I), followed by Ixazomib (4.0 mg) on Days 1, 8 and 15, plus Lenalidomide (25 mg) on Days 1 to 21, and Dexamethasone (40 mg) on Days 1, 8, 15 and 22, of a 28-day cycle (Treatment Period II)
    id
    OG001
    title
    [KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy
  3. description
    Bortezomib + Lenalidomide + Dexamethasone, or Carfilzomib + Lenalidomide + Dexamethasone, standard recommended dose according to the package insert of each drug (Treatment Period I), followed by Ixazomib (4.0 mg) on Days 1, 8 and 15, plus Lenalidomide (25 mg) on Days 1 to 21, and Dexamethasone (40 mg) on Days 1, 8, 15 and 22, of a 28-day cycle (Treatment Period II)
    id
    OG002
    title
    [Overall]; Combination Therapy + Ixazomib Therapy
param Type
MEAN
population Description
Full Analysis Set (FAS): all participants who were enrolled in Treatment Period I and who receive at least one dose of any therapy during the Treatment Period.
reporting Status
POSTED
time Frame
Baseline and End of Treatment (Up to 23 cycles for VRd Group, Up to 32 cycles for KRd and Overall Group, each cycle was of 28 days)
title
Patient-Reported Outcome Health-Related Quality of Life (HRQoL) Based on Global Health Status Scale of European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
type
SECONDARY
unit Of Measure
Score on a Scale

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

Preserved source evidence · Not medical advice