Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01311687 · OUTCOME

Change From Baseline in the European Organization for Research and Treatment of Cancer QoL Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms

A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Pomalidomide in Combination With Low-Dose Dexamethasone Versus High-Dose Dexamethasone in Subjects With Refractory Multiple Myeloma or Relapsed and Refractory Multiple Myeloma and Companion Study · Source last updated 2018-10-24

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
units on a scale
Interval / dispersion
Standard Deviation
Time frame
Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6

What was measured

The European Organization for Research and Treatment of Cancer QoL Questionnaire for Patients with Multiple Myeloma (EORTC QLQ-MY20) is a 20-question tool used in clinical research to assess health-related quality of life in multiple myeloma patients. The QLQ-MY20 includes four domains (Disease Symptoms, Side-Effects of Treatment, Body Image and Future Perspective). The EORTC QLQ-MY20 Disease Symptoms Scale is scored between 0 and 100, with a high score reflecting a higher level of symptoms. Negative change from Baseline values indicate reduction (i.e. improvement) in symptoms and positive values indicate increase (i.e. worsening) of symptoms.

Analysis population: PRO population with available data at Baseline and each time point.

Groups in this outcome

Pomalidomide Plus Low-Dose Dexamethasone

Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.

High-Dose Dexamethasone

Participants received 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.

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 Plus Low-Dose Dexamethasone289
High-Dose Dexamethasone144

Reported measurements

Cycle 2, Day 1

Analysis denominator · Participants

GroupSource count
Pomalidomide Plus Low-Dose Dexamethasone218
High-Dose Dexamethasone99
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pomalidomide Plus Low-Dose Dexamethasone-0.5016.51Not reportedNot reportedNot reported
High-Dose Dexamethasone-1.0717.78Not reportedNot reportedNot reported
Cycle 3, Day 1

Analysis denominator · Participants

GroupSource count
Pomalidomide Plus Low-Dose Dexamethasone180
High-Dose Dexamethasone56
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pomalidomide Plus Low-Dose Dexamethasone-1.3619.51Not reportedNot reportedNot reported
High-Dose Dexamethasone0.9719.93Not reportedNot reportedNot reported
Cycle 4, Day 1

Analysis denominator · Participants

GroupSource count
Pomalidomide Plus Low-Dose Dexamethasone161
High-Dose Dexamethasone37
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pomalidomide Plus Low-Dose Dexamethasone-1.1519.54Not reportedNot reportedNot reported
High-Dose Dexamethasone1.3516.94Not reportedNot reportedNot reported
Cycle 5 Day 1

Analysis denominator · Participants

GroupSource count
Pomalidomide Plus Low-Dose Dexamethasone135
High-Dose Dexamethasone30
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pomalidomide Plus Low-Dose Dexamethasone-0.5317.39Not reportedNot reportedNot reported
High-Dose Dexamethasone1.4817.56Not reportedNot reportedNot reported
Cycle 6, Day 1

Analysis denominator · Participants

GroupSource count
Pomalidomide Plus Low-Dose Dexamethasone115
High-Dose Dexamethasone21
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Pomalidomide Plus Low-Dose Dexamethasone0.6019.64Not reportedNot reportedNot reported
High-Dose Dexamethasone2.1213.43Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.51
        value
        -0.50
      2. group Id
        OG001
        spread
        17.78
        value
        -1.07
    denoms
    1. counts
      1. group Id
        OG000
        value
        218
      2. group Id
        OG001
        value
        99
      units
      Participants
    title
    Cycle 2, Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.51
        value
        -1.36
      2. group Id
        OG001
        spread
        19.93
        value
        0.97
    denoms
    1. counts
      1. group Id
        OG000
        value
        180
      2. group Id
        OG001
        value
        56
      units
      Participants
    title
    Cycle 3, Day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.54
        value
        -1.15
      2. group Id
        OG001
        spread
        16.94
        value
        1.35
    denoms
    1. counts
      1. group Id
        OG000
        value
        161
      2. group Id
        OG001
        value
        37
      units
      Participants
    title
    Cycle 4, Day 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.39
        value
        -0.53
      2. group Id
        OG001
        spread
        17.56
        value
        1.48
    denoms
    1. counts
      1. group Id
        OG000
        value
        135
      2. group Id
        OG001
        value
        30
      units
      Participants
    title
    Cycle 5 Day 1
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.64
        value
        0.60
      2. group Id
        OG001
        spread
        13.43
        value
        2.12
    denoms
    1. counts
      1. group Id
        OG000
        value
        115
      2. group Id
        OG001
        value
        21
      units
      Participants
    title
    Cycle 6, Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      289
    2. group Id
      OG001
      value
      144
    units
    Participants
description
The European Organization for Research and Treatment of Cancer QoL Questionnaire for Patients with Multiple Myeloma (EORTC QLQ-MY20) is a 20-question tool used in clinical research to assess health-related quality of life in multiple myeloma patients. The QLQ-MY20 includes four domains (Disease Symptoms, Side-Effects of Treatment, Body Image and Future Perspective). The EORTC QLQ-MY20 Disease Symptoms Scale is scored between 0 and 100, with a high score reflecting a higher level of symptoms. Negative change from Baseline values indicate reduction (i.e. improvement) in symptoms and positive values indicate increase (i.e. worsening) of symptoms.
dispersion Type
Standard Deviation
groups
  1. description
    Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
    id
    OG000
    title
    Pomalidomide Plus Low-Dose Dexamethasone
  2. description
    Participants received 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
    id
    OG001
    title
    High-Dose Dexamethasone
param Type
MEAN
population Description
PRO population with available data at Baseline and each time point.
reporting Status
POSTED
time Frame
Day 1 of Cycle 1 (Baseline), and Day 1 of Cycles 2, 3, 4, 5 and 6
title
Change From Baseline in the European Organization for Research and Treatment of Cancer QoL Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms
type
SECONDARY
unit Of Measure
units on a scale

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

Preserved source evidence · Not medical advice