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NCT03170882 · OUTCOME

HRQOL Based on EORTC Multiple Myeloma Module 20 (EORTC QLQ-MY20) Score

A Study of Ixazomib, Given With Dexamethasone in Adults With Multiple Myeloma · Source last updated 2022-12-20

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 28 cycles, each cycle was of 28 days)

What was measured

The EORTC QLQ-MY20 has 20 items across 4 independent subscales, 2 symptoms scales (disease symptoms, side effects of treatment), and 2 functional subscales (body image, future perspective). Scores were averaged and transformed to 0-100 scale. Higher scores for the future perspective scale indicate better perspective of the future, for the body image scale indicate better body image and for the disease symptoms scale indicate higher level of symptomatology.

Analysis population: ITT PRO Population included participants with a measurement at study entry and at least one post study entry measurement for at least 1 subscale on all 3 questionnaires (EORTC QLQ-C30, EORTC QLQ-MY20 and EQ-5D-5L). Number analyzed are the number of participants with data available for analyses at the given timepoint.

Groups in this outcome

Pomalidomide 4 mg + Dexamethasone 40 mg

Pomalidomide 4 mg, capsules, orally, once daily on Days 1 to 21 of each 28-day cycle, plus dexamethasone 40 mg, (or 20 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.

Ixazomib 4 mg + Dexamethasone 20 mg

Ixazomib 4 mg as starting dose, capsules, orally, once daily on Days 1, 8, and 15 of each 28-day cycle, with escalation to 5.5 mg at the start of Cycle 2 for participants who tolerated the 4 mg dose in Cycle 1, plus dexamethasone 20 mg (or 10 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 2, 8, 9, 15, 16, 22, and 23 of every 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.

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

Analysis denominator · Participants

GroupSource count
Pomalidomide 4 mg + Dexamethasone 40 mg45
Ixazomib 4 mg + Dexamethasone 20 mg70

Reported measurements

Disease Symptoms: Baseline

Analysis denominator · Participants

GroupSource count
Pomalidomide 4 mg + Dexamethasone 40 mg45
Ixazomib 4 mg + Dexamethasone 20 mg70
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pomalidomide 4 mg + Dexamethasone 40 mg73.217.06Not reportedNot reportedNot reported
Ixazomib 4 mg + Dexamethasone 20 mg72.421.31Not reportedNot reportedNot reported
Disease Symptoms: End of Treatment

Analysis denominator · Participants

GroupSource count
Pomalidomide 4 mg + Dexamethasone 40 mg28
Ixazomib 4 mg + Dexamethasone 20 mg41
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pomalidomide 4 mg + Dexamethasone 40 mg73.517.75Not reportedNot reportedNot reported
Ixazomib 4 mg + Dexamethasone 20 mg68.923.09Not reportedNot reportedNot reported
Side Effects of Treatment: Baseline

Analysis denominator · Participants

GroupSource count
Pomalidomide 4 mg + Dexamethasone 40 mg45
Ixazomib 4 mg + Dexamethasone 20 mg70
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pomalidomide 4 mg + Dexamethasone 40 mg81.013.45Not reportedNot reportedNot reported
Ixazomib 4 mg + Dexamethasone 20 mg81.413.30Not reportedNot reportedNot reported
Side Effects of Treatment: End of Treatment

Analysis denominator · Participants

GroupSource count
Pomalidomide 4 mg + Dexamethasone 40 mg28
Ixazomib 4 mg + Dexamethasone 20 mg41
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pomalidomide 4 mg + Dexamethasone 40 mg74.417.84Not reportedNot reportedNot reported
Ixazomib 4 mg + Dexamethasone 20 mg77.814.47Not reportedNot reportedNot reported
Body Image: Baseline

Analysis denominator · Participants

GroupSource count
Pomalidomide 4 mg + Dexamethasone 40 mg45
Ixazomib 4 mg + Dexamethasone 20 mg70
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pomalidomide 4 mg + Dexamethasone 40 mg81.523.09Not reportedNot reportedNot reported
Ixazomib 4 mg + Dexamethasone 20 mg82.923.90Not reportedNot reportedNot reported
Body Image: End of Treatment

Analysis denominator · Participants

GroupSource count
Pomalidomide 4 mg + Dexamethasone 40 mg28
Ixazomib 4 mg + Dexamethasone 20 mg41
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pomalidomide 4 mg + Dexamethasone 40 mg75.030.93Not reportedNot reportedNot reported
Ixazomib 4 mg + Dexamethasone 20 mg83.723.71Not reportedNot reportedNot reported
Future Perspective: Baseline

Analysis denominator · Participants

GroupSource count
Pomalidomide 4 mg + Dexamethasone 40 mg45
Ixazomib 4 mg + Dexamethasone 20 mg70
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pomalidomide 4 mg + Dexamethasone 40 mg58.823.29Not reportedNot reportedNot reported
Ixazomib 4 mg + Dexamethasone 20 mg67.524.03Not reportedNot reportedNot reported
Future Perspective: End of Treatment

Analysis denominator · Participants

GroupSource count
Pomalidomide 4 mg + Dexamethasone 40 mg28
Ixazomib 4 mg + Dexamethasone 20 mg41
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pomalidomide 4 mg + Dexamethasone 40 mg57.928.26Not reportedNot reportedNot reported
Ixazomib 4 mg + Dexamethasone 20 mg64.019.21Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.06
        value
        73.2
      2. group Id
        OG001
        spread
        21.31
        value
        72.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        45
      2. group Id
        OG001
        value
        70
      units
      Participants
    title
    Disease Symptoms: Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.75
        value
        73.5
      2. group Id
        OG001
        spread
        23.09
        value
        68.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        28
      2. group Id
        OG001
        value
        41
      units
      Participants
    title
    Disease Symptoms: End of Treatment
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.45
        value
        81.0
      2. group Id
        OG001
        spread
        13.30
        value
        81.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        45
      2. group Id
        OG001
        value
        70
      units
      Participants
    title
    Side Effects of Treatment: Baseline
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.84
        value
        74.4
      2. group Id
        OG001
        spread
        14.47
        value
        77.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        28
      2. group Id
        OG001
        value
        41
      units
      Participants
    title
    Side Effects of Treatment: End of Treatment
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        23.09
        value
        81.5
      2. group Id
        OG001
        spread
        23.90
        value
        82.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        45
      2. group Id
        OG001
        value
        70
      units
      Participants
    title
    Body Image: Baseline
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        30.93
        value
        75.0
      2. group Id
        OG001
        spread
        23.71
        value
        83.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        28
      2. group Id
        OG001
        value
        41
      units
      Participants
    title
    Body Image: End of Treatment
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        23.29
        value
        58.8
      2. group Id
        OG001
        spread
        24.03
        value
        67.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        45
      2. group Id
        OG001
        value
        70
      units
      Participants
    title
    Future Perspective: Baseline
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        28.26
        value
        57.9
      2. group Id
        OG001
        spread
        19.21
        value
        64.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        28
      2. group Id
        OG001
        value
        41
      units
      Participants
    title
    Future Perspective: End of Treatment
denoms
  1. counts
    1. group Id
      OG000
      value
      45
    2. group Id
      OG001
      value
      70
    units
    Participants
description
The EORTC QLQ-MY20 has 20 items across 4 independent subscales, 2 symptoms scales (disease symptoms, side effects of treatment), and 2 functional subscales (body image, future perspective). Scores were averaged and transformed to 0-100 scale. Higher scores for the future perspective scale indicate better perspective of the future, for the body image scale indicate better body image and for the disease symptoms scale indicate higher level of symptomatology.
dispersion Type
Standard Deviation
groups
  1. description
    Pomalidomide 4 mg, capsules, orally, once daily on Days 1 to 21 of each 28-day cycle, plus dexamethasone 40 mg, (or 20 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.
    id
    OG000
    title
    Pomalidomide 4 mg + Dexamethasone 40 mg
  2. description
    Ixazomib 4 mg as starting dose, capsules, orally, once daily on Days 1, 8, and 15 of each 28-day cycle, with escalation to 5.5 mg at the start of Cycle 2 for participants who tolerated the 4 mg dose in Cycle 1, plus dexamethasone 20 mg (or 10 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 2, 8, 9, 15, 16, 22, and 23 of every 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.
    id
    OG001
    title
    Ixazomib 4 mg + Dexamethasone 20 mg
param Type
MEAN
population Description
ITT PRO Population included participants with a measurement at study entry and at least one post study entry measurement for at least 1 subscale on all 3 questionnaires (EORTC QLQ-C30, EORTC QLQ-MY20 and EQ-5D-5L). Number analyzed are the number of participants with data available for analyses at the given timepoint.
reporting Status
POSTED
time Frame
Baseline and End of Treatment (Up to 28 cycles, each cycle was of 28 days)
title
HRQOL Based on EORTC Multiple Myeloma Module 20 (EORTC QLQ-MY20) Score
type
SECONDARY
unit Of Measure
score on a scale

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

Preserved source evidence · Not medical advice