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NCT00405756 · OUTCOME

Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Side Effects of Treatment Scale

A Study to Compare MPR With MP in Newly Diagnosed Multiple Myeloma Subjects 65 Years Old or Older. · Source last updated 2017-01-11

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
Baseline (Day 0), Months 4, 7, 10, 13, 16

What was measured

Data as of 11 May 2010 cutoff. EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale; higher score for the side effects scale = higher level of symptomatology.

Analysis population: Intent to treat population

Groups in this outcome

MPR+R

Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.

MPR+p

Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.

MPp+p

Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.

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

Analysis denominator · Participants

GroupSource count
MPR+R152
MPR+p153
MPp+p154

Reported measurements

Cycle 4 - approximately Month 4 (n=113,120,125)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
MPR+R1.313.37Not reportedNot reportedNot reported
MPR+p0.113.28Not reportedNot reportedNot reported
MPp+p0.612.67Not reportedNot reportedNot reported
Cycle 7 - approximately Month 7 (n=95,108,111)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
MPR+R0.415.22Not reportedNot reportedNot reported
MPR+p-1.714.27Not reportedNot reportedNot reported
MPp+p1.812.94Not reportedNot reportedNot reported
Cycle 10 - approximately Month 10 (n=85,89,94)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
MPR+R-1.614.46Not reportedNot reportedNot reported
MPR+p0.015.99Not reportedNot reportedNot reported
MPp+p0.312.61Not reportedNot reportedNot reported
Cycle 13 - approximately Month 13 (n=72,72,81)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
MPR+R-3.815.61Not reportedNot reportedNot reported
MPR+p-1.014.59Not reportedNot reportedNot reported
MPp+p0.312.60Not reportedNot reportedNot reported
Cycle 16 - approximately Month 16 (n=62,50,61)
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
MPR+R-2.114.95Not reportedNot reportedNot reported
MPR+p-2.914.16Not reportedNot reportedNot reported
MPp+p-0.912.23Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.37
        value
        1.3
      2. group Id
        OG001
        spread
        13.28
        value
        0.1
      3. group Id
        OG002
        spread
        12.67
        value
        0.6
    title
    Cycle 4 - approximately Month 4 (n=113,120,125)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.22
        value
        0.4
      2. group Id
        OG001
        spread
        14.27
        value
        -1.7
      3. group Id
        OG002
        spread
        12.94
        value
        1.8
    title
    Cycle 7 - approximately Month 7 (n=95,108,111)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        14.46
        value
        -1.6
      2. group Id
        OG001
        spread
        15.99
        value
        0.0
      3. group Id
        OG002
        spread
        12.61
        value
        0.3
    title
    Cycle 10 - approximately Month 10 (n=85,89,94)
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.61
        value
        -3.8
      2. group Id
        OG001
        spread
        14.59
        value
        -1.0
      3. group Id
        OG002
        spread
        12.60
        value
        0.3
    title
    Cycle 13 - approximately Month 13 (n=72,72,81)
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        14.95
        value
        -2.1
      2. group Id
        OG001
        spread
        14.16
        value
        -2.9
      3. group Id
        OG002
        spread
        12.23
        value
        -0.9
    title
    Cycle 16 - approximately Month 16 (n=62,50,61)
denoms
  1. counts
    1. group Id
      OG000
      value
      152
    2. group Id
      OG001
      value
      153
    3. group Id
      OG002
      value
      154
    units
    Participants
description
Data as of 11 May 2010 cutoff. EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale; higher score for the side effects scale = higher level of symptomatology.
dispersion Type
Standard Deviation
groups
  1. description
    Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
    id
    OG000
    title
    MPR+R
  2. description
    Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
    id
    OG001
    title
    MPR+p
  3. description
    Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
    id
    OG002
    title
    MPp+p
param Type
MEAN
population Description
Intent to treat population
reporting Status
POSTED
time Frame
Baseline (Day 0), Months 4, 7, 10, 13, 16
title
Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Side Effects of Treatment Scale
type
SECONDARY
unit Of Measure
units on a scale

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

Preserved source evidence · Not medical advice