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NCT03512353 · OUTCOME

Change From Baseline to Last Cycle of Treatment in European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ)-Core 30 (C30)

A Study of Carfilzomib Plus Dexamethasone in Adults With Relapsed or Refractory Multiple Myeloma at US Community Oncology Centers · Source last updated 2021-01-08

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

Measure
MEAN
Unit
scores on a scale
Interval / dispersion
Standard Deviation
Time frame
Baseline (cycle 1 day 1) to cycle 12 day 1

What was measured

The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) is a 30-item questionnaire used to assess the overall quality of life in cancer patients. EORTC QLQ-C30 was administered on day 1 of each treatment cycle. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Insomnia, Appetite Loss, Constipation, Diarrhea, Financial Impact). For each of these scales, scores range from 0 to 100. For the GHS and 5 functional scales a high score indicates better global health status/functioning and a positive change from baseline indicates improvement. For the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms.

Analysis population: All enrolled and treated participants

Groups in this outcome

Carfilzomib Plus Dexamethasone

Participants received carfilzomib administered as an intravenous (IV) infusion twice-weekly for up to six 28-day cycles followed by once-weekly for another six 28-day cycles. The carfilzomib dose was 20 mg/m² on days 1 and 2 of cycle 1, 56 mg/m² for the remaining days of cycle 1 (days 8, 9, 15, and 16) and then on days 1, 2, 8, 9, 15, and 16 of each cycle for cycles 2 to 6, and 70 mg/m² on days 1, 8, and 15 of each cycle for cycles 7 to 12. Participants also received dexamethasone either orally or by IV infusion at a dose of 20 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 of cycles 1 to 6 and at a dose 40 mg once daily on days 1, 8, 15 of cycles 7 to 12.

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

Analysis denominator · Participants

GroupSource count
Carfilzomib Plus Dexamethasone6

Reported measurements

Physical Functioning
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Carfilzomib Plus Dexamethasone-15.615.6Not reportedNot reportedNot reported
Role Functioning
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Carfilzomib Plus Dexamethasone-16.725.8Not reportedNot reportedNot reported
Emotional Functioning
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Carfilzomib Plus Dexamethasone-5.615.5Not reportedNot reportedNot reported
Cognitive Functioning
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Carfilzomib Plus Dexamethasone2.812.6Not reportedNot reportedNot reported
Social Functioning
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Carfilzomib Plus Dexamethasone-19.419.5Not reportedNot reportedNot reported
Fatigue
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Carfilzomib Plus Dexamethasone9.310.9Not reportedNot reportedNot reported
Pain
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Carfilzomib Plus Dexamethasone-8.325.3Not reportedNot reportedNot reported
Nausea and Vomiting
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Carfilzomib Plus Dexamethasone0.010.5Not reportedNot reportedNot reported
Global Health Status
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Carfilzomib Plus Dexamethasone-5.610.1Not reportedNot reportedNot reported
Dyspnoea
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Carfilzomib Plus Dexamethasone22.227.2Not reportedNot reportedNot reported
Appetite Loss
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Carfilzomib Plus Dexamethasone5.613.6Not reportedNot reportedNot reported
Insomnia
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Carfilzomib Plus Dexamethasone-5.613.6Not reportedNot reportedNot reported
Constipation
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Carfilzomib Plus Dexamethasone11.127.2Not reportedNot reportedNot reported
Diarrhoea
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Carfilzomib Plus Dexamethasone-5.625.1Not reportedNot reportedNot reported
Financial Difficulties
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Carfilzomib Plus Dexamethasone5.613.6Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.6
        value
        -15.6
    title
    Physical Functioning
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        25.8
        value
        -16.7
    title
    Role Functioning
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.5
        value
        -5.6
    title
    Emotional Functioning
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        12.6
        value
        2.8
    title
    Cognitive Functioning
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.5
        value
        -19.4
    title
    Social Functioning
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        10.9
        value
        9.3
    title
    Fatigue
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        25.3
        value
        -8.3
    title
    Pain
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        10.5
        value
        0.0
    title
    Nausea and Vomiting
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        10.1
        value
        -5.6
    title
    Global Health Status
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        27.2
        value
        22.2
    title
    Dyspnoea
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.6
        value
        5.6
    title
    Appetite Loss
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.6
        value
        -5.6
    title
    Insomnia
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    units
    Participants
description
The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) is a 30-item questionnaire used to assess the overall quality of life in cancer patients. EORTC QLQ-C30 was administered on day 1 of each treatment cycle. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Insomnia, Appetite Loss, Constipation, Diarrhea, Financial Impact). For each of these scales, scores range from 0 to 100. For the GHS and 5 functional scales a high score indicates better global health status/functioning and a positive change from baseline indicates improvement. For the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms.
dispersion Type
Standard Deviation
groups
  1. description
    Participants received carfilzomib administered as an intravenous (IV) infusion twice-weekly for up to six 28-day cycles followed by once-weekly for another six 28-day cycles. The carfilzomib dose was 20 mg/m² on days 1 and 2 of cycle 1, 56 mg/m² for the remaining days of cycle 1 (days 8, 9, 15, and 16) and then on days 1, 2, 8, 9, 15, and 16 of each cycle for cycles 2 to 6, and 70 mg/m² on days 1, 8, and 15 of each cycle for cycles 7 to 12. Participants also received dexamethasone either orally or by IV infusion at a dose of 20 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 of cycles 1 to 6 and at a dose 40 mg once daily on days 1, 8, 15 of cycles 7 to 12.
    id
    OG000
    title
    Carfilzomib Plus Dexamethasone
param Type
MEAN
population Description
All enrolled and treated participants
reporting Status
POSTED
time Frame
Baseline (cycle 1 day 1) to cycle 12 day 1
title
Change From Baseline to Last Cycle of Treatment in European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire (EORTC QLQ)-Core 30 (C30)
type
SECONDARY
unit Of Measure
scores on a scale

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

Preserved source evidence · Not medical advice