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NCT01849783 · OUTCOME

Mean Change in Quality-Of-Life Indicators Post-Transplant

Autologous Stem Cell Transplant Followed By Maintenance Therapy in Treating Elderly Patients With Multiple Myeloma · Source last updated 2022-05-11

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
95% Confidence Interval
Time frame
Pre-DPACE, Pre-maintenance, every 6 months for up to 2 years during maintenance. Up to 6 years.

What was measured

Measured using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) and Multiple Myeloma module (QLQ-MY20). The EORTC QLQ-C30 includes functional scales (physical, role, emotional, cognitive, and social) and global health status. The EORTC QLQ-MY20 includes disease symptoms and treatment side effects scales. Scores are averaged and transformed to 0-100 scale. For functional and global health status, a positive change from baseline (pre-DPACE) indicates improvement whereas for the symptom scales a negative change from baseline (pre-DPACE) indicates improvement.

Analysis population: Participants who received at least one day of study treatment. Globally, there were 37 patients who were included in at least one of the estimated mean change scores being reported. Four patients were not included due to not completing the baseline questionnaire making it impossible to calculate change from baseline (n=3) or did not complete the questionnaire at any time point (n=1).

Groups in this outcome

Autologous Stem Cell Transplant

Induction : DPACE(dexamethasone,cisplatin,doxorubicin,cyclophosphamide,etoposide) chemotherapy plus stem cell collection. Additional stem cell collection and/or chemotherapy may be required. After collection, participants will receive dexamethasone x 4 days every 14 days. Transplant: The transplant preparative regimen will be bortezomib/thalidomide/dexamethasone/melphalan. Once recovered, participants start thalidomide daily and dexamethasone x 4 days every 21 days. Consolidation (if administered): VDT-PACE(bortezomib,dexamethasone,thalidomide,cisplatin,doxorubicin,cyclophosphamide, etoposide) Maintenance: Year 1 - VTD (bortezomib, thalidomide, dexamethasone) cycles. Year 2 - VCD (bortezomib, cyclophosphamide, dexamethasone)cycles. dexamethasone: Given PO cisplatin: Given IV doxorubicin: Given IV cyclophosphamide: Given IV or PO etoposide: Given IV bortezomib: Given IV thalidomide: Given PO melphalan: Given IV autologous stem cell transplant

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

Analysis denominator · Participants

GroupSource count
Autologous Stem Cell Transplant37

Reported measurements

Change in Physical Functioning at Pre-Maintenance

Analysis denominator · Participants

GroupSource count
Autologous Stem Cell Transplant30
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Autologous Stem Cell Transplant1.3Not reported-5.27.9Not reported
Change in Physical Functioning at Maintenance Cycle 6

Analysis denominator · Participants

GroupSource count
Autologous Stem Cell Transplant31
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Autologous Stem Cell Transplant-0.6Not reported-7.15.9Not reported
Change in Physical Functioning at Maintenance Cycle 12

Analysis denominator · Participants

GroupSource count
Autologous Stem Cell Transplant26
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Autologous Stem Cell Transplant1.1Not reported-5.67.8Not reported
Change in Physical Functioning at Maintenance Cycle 18

Analysis denominator · Participants

GroupSource count
Autologous Stem Cell Transplant24
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Autologous Stem Cell Transplant5.4Not reported-1.512.3Not reported
Change in Physical Functioning at Maintenance Cycle 24

Analysis denominator · Participants

GroupSource count
Autologous Stem Cell Transplant22
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Autologous Stem Cell Transplant4.6Not reported-2.611.7Not reported
Change in Role Functioning at Pre-Maintenance

Analysis denominator · Participants

GroupSource count
Autologous Stem Cell Transplant28
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Autologous Stem Cell Transplant7.4Not reported-5.520.4Not reported
Change in Role Functioning at Maintenance Cycle 6

Analysis denominator · Participants

GroupSource count
Autologous Stem Cell Transplant30
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Autologous Stem Cell Transplant8.7Not reported-4.021.5Not reported
Change in Role Functioning at Maintenance Cycle 12

Analysis denominator · Participants

GroupSource count
Autologous Stem Cell Transplant26
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Autologous Stem Cell Transplant4.4Not reported-8.717.5Not reported
Change in Role Functioning at Maintenance Cycle 18

Analysis denominator · Participants

GroupSource count
Autologous Stem Cell Transplant23
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Autologous Stem Cell Transplant7.0Not reported-6.620.5Not reported
Change in Role Functioning at Maintenance Cycle 24

Analysis denominator · Participants

GroupSource count
Autologous Stem Cell Transplant22
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Autologous Stem Cell Transplant6.0Not reported-8.020.0Not reported
Change in Emotional Functioning at Pre-Maintenance

Analysis denominator · Participants

GroupSource count
Autologous Stem Cell Transplant31
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Autologous Stem Cell Transplant8.7Not reported2.514.9Not reported
Change in Emotional Functioning at Maintenance Cycle 6

Analysis denominator · Participants

GroupSource count
Autologous Stem Cell Transplant32
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Autologous Stem Cell Transplant5.5Not reported-0.611.6Not reported
Change in Emotional Functioning at Maintenance Cycle 12

Analysis denominator · Participants

GroupSource count
Autologous Stem Cell Transplant28
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Autologous Stem Cell Transplant1.4Not reported-4.97.7Not reported
Change in Emotional Functioning at Maintenance Cycle 18

Analysis denominator · Participants

GroupSource count
Autologous Stem Cell Transplant24
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Autologous Stem Cell Transplant5.8Not reported-1.012.5Not reported
Change in Emotional Functioning at Maintenance Cycle 24

Analysis denominator · Participants

GroupSource count
Autologous Stem Cell Transplant24
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Autologous Stem Cell Transplant8.3Not reported1.315.2Not reported
Change in Cognitive Functioning at Pre-Maintenance

Analysis denominator · Participants

GroupSource count
Autologous Stem Cell Transplant31
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Autologous Stem Cell Transplant0.4Not reported-7.17.9Not reported
Change in Cognitive Functioning at Maintenance Cycle 6

Analysis denominator · Participants

GroupSource count
Autologous Stem Cell Transplant31
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Autologous Stem Cell Transplant-4.6Not reported-12.02.9Not reported
Change in Cognitive Functioning at Maintenance Cycle 12

Analysis denominator · Participants

GroupSource count
Autologous Stem Cell Transplant28
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Autologous Stem Cell Transplant-5.1Not reported-12.82.5Not reported
Change in Cognitive Functioning at Maintenance Cycle 18

Analysis denominator · Participants

GroupSource count
Autologous Stem Cell Transplant25
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Autologous Stem Cell Transplant-6.0Not reported-14.02.1Not reported
Change in Cognitive Functioning at Maintenance Cycle 24

Analysis denominator · Participants

GroupSource count
Autologous Stem Cell Transplant24
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Autologous Stem Cell Transplant-3.6Not reported-11.94.7Not reported
Change in Social Functioning at Pre-Maintenance

Analysis denominator · Participants

GroupSource count
Autologous Stem Cell Transplant30
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Autologous Stem Cell Transplant-1.0Not reported-11.09.1Not reported
Change in Social Functioning at Maintenance Cycle 6

Analysis denominator · Participants

GroupSource count
Autologous Stem Cell Transplant31
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Autologous Stem Cell Transplant2.7Not reported-7.212.6Not reported
Change in Social Functioning at Maintenance Cycle 12

Analysis denominator · Participants

GroupSource count
Autologous Stem Cell Transplant25
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Autologous Stem Cell Transplant-4.9Not reported-15.35.6Not reported
Change in Social Functioning at Maintenance Cycle 18

Analysis denominator · Participants

GroupSource count
Autologous Stem Cell Transplant24
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Autologous Stem Cell Transplant0.8Not reported-9.911.6Not reported
Change in Social Functioning at Maintenance Cycle 24

Analysis denominator · Participants

GroupSource count
Autologous Stem Cell Transplant23
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Autologous Stem Cell Transplant-1.5Not reported-12.79.7Not reported
Change in Global Health Status at Pre-Maintenance

Analysis denominator · Participants

GroupSource count
Autologous Stem Cell Transplant31
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Autologous Stem Cell Transplant5.4Not reported-2.713.5Not reported
Change in Global Health Status at Maintenance Cycle 6

Analysis denominator · Participants

GroupSource count
Autologous Stem Cell Transplant32
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Autologous Stem Cell Transplant0.2Not reported-7.88.3Not reported
Change in Global Health Status at Maintenance Cycle 12

Analysis denominator · Participants

GroupSource count
Autologous Stem Cell Transplant28
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Autologous Stem Cell Transplant-3.1Not reported-11.45.1Not reported
Change in Global Health Status at Maintenance Cycle 18

Analysis denominator · Participants

GroupSource count
Autologous Stem Cell Transplant25
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Autologous Stem Cell Transplant-0.1Not reported-8.88.5Not reported
Change in Global Health Status at Maintenance Cycle 24

Analysis denominator · Participants

GroupSource count
Autologous Stem Cell Transplant24
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Autologous Stem Cell Transplant3.4Not reported-5.612.3Not reported
Change in Distress Symptoms at Pre-Maintenance

Analysis denominator · Participants

GroupSource count
Autologous Stem Cell Transplant32
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Autologous Stem Cell Transplant6.2Not reported1.211.2Not reported
Change in Distress Symptoms at Maintenance Cycle 6

Analysis denominator · Participants

GroupSource count
Autologous Stem Cell Transplant32
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Autologous Stem Cell Transplant5.9Not reported0.910.8Not reported
Change in Distress Symptoms at Maintenance Cycle 12

Analysis denominator · Participants

GroupSource count
Autologous Stem Cell Transplant28
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Autologous Stem Cell Transplant5.7Not reported0.510.9Not reported
Change in Distress Symptoms at Maintenance Cycle 18

Analysis denominator · Participants

GroupSource count
Autologous Stem Cell Transplant25
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Autologous Stem Cell Transplant3.8Not reported-1.79.3Not reported
Change in Distress Symptoms at Maintenance Cycle 24

Analysis denominator · Participants

GroupSource count
Autologous Stem Cell Transplant24
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Autologous Stem Cell Transplant5.3Not reported-0.411.0Not reported
Change in Side Effects of Treatment at Pre-Maintenance

Analysis denominator · Participants

GroupSource count
Autologous Stem Cell Transplant32
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Autologous Stem Cell Transplant-3.3Not reported-8.01.3Not reported
Change in Side Effects of Treatment at Maintenance Cycle 6

Analysis denominator · Participants

GroupSource count
Autologous Stem Cell Transplant32
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Autologous Stem Cell Transplant-0.7Not reported-5.33.9Not reported
Change in Side Effects of Treatment at Maintenance Cycle 12

Analysis denominator · Participants

GroupSource count
Autologous Stem Cell Transplant28
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Autologous Stem Cell Transplant-5.1Not reported-9.8-0.3Not reported
Change in Side Effects of Treatment at Maintenance Cycle 18

Analysis denominator · Participants

GroupSource count
Autologous Stem Cell Transplant25
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Autologous Stem Cell Transplant-2.4Not reported-7.42.5Not reported
Change in Side Effects of Treatment at Maintenance Cycle 24

Analysis denominator · Participants

GroupSource count
Autologous Stem Cell Transplant24
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Autologous Stem Cell Transplant-2.7Not reported-7.82.4Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -5.2
        upper Limit
        7.9
        value
        1.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        30
      units
      Participants
    title
    Change in Physical Functioning at Pre-Maintenance
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -7.1
        upper Limit
        5.9
        value
        -0.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        31
      units
      Participants
    title
    Change in Physical Functioning at Maintenance Cycle 6
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -5.6
        upper Limit
        7.8
        value
        1.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        26
      units
      Participants
    title
    Change in Physical Functioning at Maintenance Cycle 12
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -1.5
        upper Limit
        12.3
        value
        5.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        24
      units
      Participants
    title
    Change in Physical Functioning at Maintenance Cycle 18
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -2.6
        upper Limit
        11.7
        value
        4.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        22
      units
      Participants
    title
    Change in Physical Functioning at Maintenance Cycle 24
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -5.5
        upper Limit
        20.4
        value
        7.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        28
      units
      Participants
    title
    Change in Role Functioning at Pre-Maintenance
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -4.0
        upper Limit
        21.5
        value
        8.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        30
      units
      Participants
    title
    Change in Role Functioning at Maintenance Cycle 6
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -8.7
        upper Limit
        17.5
        value
        4.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        26
      units
      Participants
    title
    Change in Role Functioning at Maintenance Cycle 12
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -6.6
        upper Limit
        20.5
        value
        7.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        23
      units
      Participants
    title
    Change in Role Functioning at Maintenance Cycle 18
  10. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -8.0
        upper Limit
        20.0
        value
        6.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        22
      units
      Participants
    title
    Change in Role Functioning at Maintenance Cycle 24
  11. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.5
        upper Limit
        14.9
        value
        8.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        31
      units
      Participants
    title
    Change in Emotional Functioning at Pre-Maintenance
  12. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -0.6
        upper Limit
        11.6
        value
        5.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        32
      units
      Participants
    title
    Change in Emotional Functioning at Maintenance Cycle 6
denoms
  1. counts
    1. group Id
      OG000
      value
      37
    units
    Participants
description
Measured using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) and Multiple Myeloma module (QLQ-MY20). The EORTC QLQ-C30 includes functional scales (physical, role, emotional, cognitive, and social) and global health status. The EORTC QLQ-MY20 includes disease symptoms and treatment side effects scales. Scores are averaged and transformed to 0-100 scale. For functional and global health status, a positive change from baseline (pre-DPACE) indicates improvement whereas for the symptom scales a negative change from baseline (pre-DPACE) indicates improvement.
dispersion Type
95% Confidence Interval
groups
  1. description
    Induction : DPACE(dexamethasone,cisplatin,doxorubicin,cyclophosphamide,etoposide) chemotherapy plus stem cell collection. Additional stem cell collection and/or chemotherapy may be required. After collection, participants will receive dexamethasone x 4 days every 14 days. Transplant: The transplant preparative regimen will be bortezomib/thalidomide/dexamethasone/melphalan. Once recovered, participants start thalidomide daily and dexamethasone x 4 days every 21 days. Consolidation (if administered): VDT-PACE(bortezomib,dexamethasone,thalidomide,cisplatin,doxorubicin,cyclophosphamide, etoposide) Maintenance: Year 1 - VTD (bortezomib, thalidomide, dexamethasone) cycles. Year 2 - VCD (bortezomib, cyclophosphamide, dexamethasone)cycles. dexamethasone: Given PO cisplatin: Given IV doxorubicin: Given IV cyclophosphamide: Given IV or PO etoposide: Given IV bortezomib: Given IV thalidomide: Given PO melphalan: Given IV autologous stem cell transplant
    id
    OG000
    title
    Autologous Stem Cell Transplant
param Type
MEAN
population Description
Participants who received at least one day of study treatment. Globally, there were 37 patients who were included in at least one of the estimated mean change scores being reported. Four patients were not included due to not completing the baseline questionnaire making it impossible to calculate change from baseline (n=3) or did not complete the questionnaire at any time point (n=1).
reporting Status
POSTED
time Frame
Pre-DPACE, Pre-maintenance, every 6 months for up to 2 years during maintenance. Up to 6 years.
title
Mean Change in Quality-Of-Life Indicators Post-Transplant
type
SECONDARY
unit Of Measure
score on a scale

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

Preserved source evidence · Not medical advice