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NCT03951220 · OUTCOME

Secondary Objective 3: Assess Participants' Quality of Life Throughout the Study

The Development and Pilot Testing of a New MR Imaging Protocol to Quantify Myeloma Disease Burden and Bone Loss · Source last updated 2025-08-19

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
At baseline and six months

What was measured

Secondary Objective 3: To assess how quality of life compares between groups and longitudinally in patients with myeloma, Monoclonal Gammopathy of Undetermined Significance (MGUS), and healthy volunteers. The EuroQol 5-Dimension (EQ-5D) assess the mobility, self-care, usual activities, pain/discomfort, anxiety and depression on a 5-point scale, in which a lower score represents better quality of life (1 = 'no problems', 5 = maximum problems, for each domain). The second part of the EQ-5D assess health on a scale where 100 is the best health and 0 is the worst health.

Analysis population: All participants from Groups 1, 2 and 3 were invited to complete EQ5D questionnaires at baseline and 6-month follow-up visits. The total number of patients analysed for each EQ5D question varied slightly depending on how many responses were received from the questionnaires.

Groups in this outcome

Group 1- Myeloma

Participants recruited with myeloma

Group 2- MGUS

Participants recruited with MGUS

Group 3- Healthy Volunteers

Participants recruited as healthy volunteers

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

Analysis denominator · Participants

GroupSource count
Group 1- Myeloma41
Group 2- MGUS14
Group 3- Healthy Volunteers12

Reported measurements

Baseline: Mobility

Analysis denominator · Participants

GroupSource count
Group 1- Myeloma38
Group 2- MGUS13
Group 3- Healthy Volunteers12
Values in Scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Group 1- Myeloma1.290.46Not reportedNot reportedNot reported
Group 2- MGUS1.230.44Not reportedNot reportedNot reported
Group 3- Healthy Volunteers1.000.00Not reportedNot reportedNot reported
Baseline: Self-Care

Analysis denominator · Participants

GroupSource count
Group 1- Myeloma38
Group 2- MGUS13
Group 3- Healthy Volunteers12
Values in Scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Group 1- Myeloma1.110.31Not reportedNot reportedNot reported
Group 2- MGUS1.080.28Not reportedNot reportedNot reported
Group 3- Healthy Volunteers1.000.00Not reportedNot reportedNot reported
Baseline: Usual Activities

Analysis denominator · Participants

GroupSource count
Group 1- Myeloma38
Group 2- MGUS13
Group 3- Healthy Volunteers12
Values in Scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Group 1- Myeloma1.450.65Not reportedNot reportedNot reported
Group 2- MGUS1.150.38Not reportedNot reportedNot reported
Group 3- Healthy Volunteers1.000.00Not reportedNot reportedNot reported
Baseline: Pain/Discomfort

Analysis denominator · Participants

GroupSource count
Group 1- Myeloma38
Group 2- MGUS13
Group 3- Healthy Volunteers12
Values in Scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Group 1- Myeloma1.630.63Not reportedNot reportedNot reported
Group 2- MGUS1.540.52Not reportedNot reportedNot reported
Group 3- Healthy Volunteers1.080.29Not reportedNot reportedNot reported
Baseline: Anxiety/Depression

Analysis denominator · Participants

GroupSource count
Group 1- Myeloma38
Group 2- MGUS13
Group 3- Healthy Volunteers12
Values in Scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Group 1- Myeloma1.110.31Not reportedNot reportedNot reported
Group 2- MGUS1.080.28Not reportedNot reportedNot reported
Group 3- Healthy Volunteers1.000.00Not reportedNot reportedNot reported
Baseline: Health Score

Analysis denominator · Participants

GroupSource count
Group 1- Myeloma36
Group 2- MGUS12
Group 3- Healthy Volunteers12
Values in Scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Group 1- Myeloma72.822.6Not reportedNot reportedNot reported
Group 2- MGUS83.97.7Not reportedNot reportedNot reported
Group 3- Healthy Volunteers87.95.9Not reportedNot reportedNot reported
Follow-Up: Mobility

Analysis denominator · Participants

GroupSource count
Group 1- Myeloma29
Group 2- MGUS12
Group 3- Healthy Volunteers0
Values in Scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Group 1- Myeloma1.340.48Not reportedNot reportedNot reported
Group 2- MGUS1.330.49Not reportedNot reportedNot reported
Follow-Up: Self-Care

Analysis denominator · Participants

GroupSource count
Group 1- Myeloma29
Group 2- MGUS12
Group 3- Healthy Volunteers0
Values in Scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Group 1- Myeloma1.070.26Not reportedNot reportedNot reported
Group 2- MGUS1.170.39Not reportedNot reportedNot reported
Follow-Up: Usual Activities

Analysis denominator · Participants

GroupSource count
Group 1- Myeloma29
Group 2- MGUS12
Group 3- Healthy Volunteers0
Values in Scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Group 1- Myeloma1.380.49Not reportedNot reportedNot reported
Group 2- MGUS1.250.45Not reportedNot reportedNot reported
Follow-Up: Pain/Discomfort

Analysis denominator · Participants

GroupSource count
Group 1- Myeloma29
Group 2- MGUS12
Group 3- Healthy Volunteers0
Values in Scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Group 1- Myeloma1.590.63Not reportedNot reportedNot reported
Group 2- MGUS1.420.51Not reportedNot reportedNot reported
Follow-Up: Anxiety/Depression

Analysis denominator · Participants

GroupSource count
Group 1- Myeloma29
Group 2- MGUS12
Group 3- Healthy Volunteers0
Values in Scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Group 1- Myeloma1.210.41Not reportedNot reportedNot reported
Group 2- MGUS1.080.29Not reportedNot reportedNot reported
Follow-Up: Health Score

Analysis denominator · Participants

GroupSource count
Group 1- Myeloma29
Group 2- MGUS12
Group 3- Healthy Volunteers0
Values in Scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Group 1- Myeloma75.120.5Not reportedNot reportedNot reported
Group 2- MGUS79.015.6Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.46
        value
        1.29
      2. group Id
        OG001
        spread
        0.44
        value
        1.23
      3. group Id
        OG002
        spread
        0.00
        value
        1.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        38
      2. group Id
        OG001
        value
        13
      3. group Id
        OG002
        value
        12
      units
      Participants
    title
    Baseline: Mobility
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.31
        value
        1.11
      2. group Id
        OG001
        spread
        0.28
        value
        1.08
      3. group Id
        OG002
        spread
        0.00
        value
        1.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        38
      2. group Id
        OG001
        value
        13
      3. group Id
        OG002
        value
        12
      units
      Participants
    title
    Baseline: Self-Care
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.65
        value
        1.45
      2. group Id
        OG001
        spread
        0.38
        value
        1.15
      3. group Id
        OG002
        spread
        0.00
        value
        1.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        38
      2. group Id
        OG001
        value
        13
      3. group Id
        OG002
        value
        12
      units
      Participants
    title
    Baseline: Usual Activities
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.63
        value
        1.63
      2. group Id
        OG001
        spread
        0.52
        value
        1.54
      3. group Id
        OG002
        spread
        0.29
        value
        1.08
    denoms
    1. counts
      1. group Id
        OG000
        value
        38
      2. group Id
        OG001
        value
        13
      3. group Id
        OG002
        value
        12
      units
      Participants
    title
    Baseline: Pain/Discomfort
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.31
        value
        1.11
      2. group Id
        OG001
        spread
        0.28
        value
        1.08
      3. group Id
        OG002
        spread
        0.00
        value
        1.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        38
      2. group Id
        OG001
        value
        13
      3. group Id
        OG002
        value
        12
      units
      Participants
    title
    Baseline: Anxiety/Depression
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.6
        value
        72.8
      2. group Id
        OG001
        spread
        7.7
        value
        83.9
      3. group Id
        OG002
        spread
        5.9
        value
        87.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        36
      2. group Id
        OG001
        value
        12
      3. group Id
        OG002
        value
        12
      units
      Participants
    title
    Baseline: Health Score
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.48
        value
        1.34
      2. group Id
        OG001
        spread
        0.49
        value
        1.33
    denoms
    1. counts
      1. group Id
        OG000
        value
        29
      2. group Id
        OG001
        value
        12
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    Follow-Up: Mobility
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.26
        value
        1.07
      2. group Id
        OG001
        spread
        0.39
        value
        1.17
    denoms
    1. counts
      1. group Id
        OG000
        value
        29
      2. group Id
        OG001
        value
        12
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    Follow-Up: Self-Care
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.49
        value
        1.38
      2. group Id
        OG001
        spread
        0.45
        value
        1.25
    denoms
    1. counts
      1. group Id
        OG000
        value
        29
      2. group Id
        OG001
        value
        12
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    Follow-Up: Usual Activities
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.63
        value
        1.59
      2. group Id
        OG001
        spread
        0.51
        value
        1.42
    denoms
    1. counts
      1. group Id
        OG000
        value
        29
      2. group Id
        OG001
        value
        12
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    Follow-Up: Pain/Discomfort
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.41
        value
        1.21
      2. group Id
        OG001
        spread
        0.29
        value
        1.08
    denoms
    1. counts
      1. group Id
        OG000
        value
        29
      2. group Id
        OG001
        value
        12
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    Follow-Up: Anxiety/Depression
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.5
        value
        75.1
      2. group Id
        OG001
        spread
        15.6
        value
        79.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        29
      2. group Id
        OG001
        value
        12
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    Follow-Up: Health Score
denoms
  1. counts
    1. group Id
      OG000
      value
      41
    2. group Id
      OG001
      value
      14
    3. group Id
      OG002
      value
      12
    units
    Participants
description
Secondary Objective 3: To assess how quality of life compares between groups and longitudinally in patients with myeloma, Monoclonal Gammopathy of Undetermined Significance (MGUS), and healthy volunteers. The EuroQol 5-Dimension (EQ-5D) assess the mobility, self-care, usual activities, pain/discomfort, anxiety and depression on a 5-point scale, in which a lower score represents better quality of life (1 = 'no problems', 5 = maximum problems, for each domain). The second part of the EQ-5D assess health on a scale where 100 is the best health and 0 is the worst health.
dispersion Type
Standard Deviation
groups
  1. description
    Participants recruited with myeloma
    id
    OG000
    title
    Group 1- Myeloma
  2. description
    Participants recruited with MGUS
    id
    OG001
    title
    Group 2- MGUS
  3. description
    Participants recruited as healthy volunteers
    id
    OG002
    title
    Group 3- Healthy Volunteers
param Type
MEAN
population Description
All participants from Groups 1, 2 and 3 were invited to complete EQ5D questionnaires at baseline and 6-month follow-up visits. The total number of patients analysed for each EQ5D question varied slightly depending on how many responses were received from the questionnaires.
reporting Status
POSTED
time Frame
At baseline and six months
title
Secondary Objective 3: Assess Participants' Quality of Life Throughout the Study
type
SECONDARY
unit Of Measure
Scores on a scale

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

Preserved source evidence · Not medical advice