A Study of Ixazomib, Given With Dexamethasone in Adults With Multiple Myeloma · Source last updated 2022-12-20
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
Standard Deviation
Time frame
Baseline and End of Treatment (Up to 28 cycles, each cycle was of 28 days)
What was measured
The EORTC QLQ-C30 contains 30 items across 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial difficulties) and a QOL scale. Most of the 30 items had 4 response levels (not at all, a little, quite a bit, and very much), with 2 questions relying on a 7-point numeric rating scale. Each subscale raw score were linearly transformed to a total score between 0 to 100. For the functional scales and the global health status/QOL scale, higher scores represent better QOL; for the symptom scales, lower scores represent better QOL. The Physical domain of the functional subscale is reported in the secondary outcome measure 7.
Analysis population: ITT PRO Population included participants with a measurement at study entry and at least one post study entry measurement for at least 1 subscale on all 3 questionnaires (EORTC QLQ-C30, EORTC QLQ-MY20 and EQ-5D-5L). Number analyzed are the number of participants with data available for analyses at the given timepoint.
Groups in this outcome
Pomalidomide 4 mg + Dexamethasone 40 mg
Pomalidomide 4 mg, capsules, orally, once daily on Days 1 to 21 of each 28-day cycle, plus dexamethasone 40 mg, (or 20 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.
Ixazomib 4 mg + Dexamethasone 20 mg
Ixazomib 4 mg as starting dose, capsules, orally, once daily on Days 1, 8, and 15 of each 28-day cycle, with escalation to 5.5 mg at the start of Cycle 2 for participants who tolerated the 4 mg dose in Cycle 1, plus dexamethasone 20 mg (or 10 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 2, 8, 9, 15, 16, 22, and 23 of every 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group
Source count
Pomalidomide 4 mg + Dexamethasone 40 mg
45
Ixazomib 4 mg + Dexamethasone 20 mg
70
Reported measurements
Global Health Status/QoL: Baseline
Analysis denominator · Participants
Group
Source count
Pomalidomide 4 mg + Dexamethasone 40 mg
45
Ixazomib 4 mg + Dexamethasone 20 mg
70
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide 4 mg + Dexamethasone 40 mg
57.0
20.72
Not reported
Not reported
Not reported
Ixazomib 4 mg + Dexamethasone 20 mg
60.8
21.16
Not reported
Not reported
Not reported
Global Health Status/QoL: End of Treatment
Analysis denominator · Participants
Group
Source count
Pomalidomide 4 mg + Dexamethasone 40 mg
27
Ixazomib 4 mg + Dexamethasone 20 mg
42
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide 4 mg + Dexamethasone 40 mg
47.8
19.56
Not reported
Not reported
Not reported
Ixazomib 4 mg + Dexamethasone 20 mg
48.2
19.61
Not reported
Not reported
Not reported
Role (Functional Scale): Baseline
Analysis denominator · Participants
Group
Source count
Pomalidomide 4 mg + Dexamethasone 40 mg
45
Ixazomib 4 mg + Dexamethasone 20 mg
70
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide 4 mg + Dexamethasone 40 mg
67.4
28.42
Not reported
Not reported
Not reported
Ixazomib 4 mg + Dexamethasone 20 mg
67.9
29.67
Not reported
Not reported
Not reported
Role (Functional Scale): End of Treatment
Analysis denominator · Participants
Group
Source count
Pomalidomide 4 mg + Dexamethasone 40 mg
28
Ixazomib 4 mg + Dexamethasone 20 mg
42
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide 4 mg + Dexamethasone 40 mg
47.6
27.86
Not reported
Not reported
Not reported
Ixazomib 4 mg + Dexamethasone 20 mg
49.2
27.04
Not reported
Not reported
Not reported
Emotional (Functional Scale): Baseline
Analysis denominator · Participants
Group
Source count
Pomalidomide 4 mg + Dexamethasone 40 mg
45
Ixazomib 4 mg + Dexamethasone 20 mg
70
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide 4 mg + Dexamethasone 40 mg
74.9
21.19
Not reported
Not reported
Not reported
Ixazomib 4 mg + Dexamethasone 20 mg
83.1
21.70
Not reported
Not reported
Not reported
Emotional (Functional Scale): End of Treatment
Analysis denominator · Participants
Group
Source count
Pomalidomide 4 mg + Dexamethasone 40 mg
28
Ixazomib 4 mg + Dexamethasone 20 mg
42
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide 4 mg + Dexamethasone 40 mg
67.6
25.19
Not reported
Not reported
Not reported
Ixazomib 4 mg + Dexamethasone 20 mg
72.8
22.62
Not reported
Not reported
Not reported
Cognitive(Functional Scale): Baseline
Analysis denominator · Participants
Group
Source count
Pomalidomide 4 mg + Dexamethasone 40 mg
45
Ixazomib 4 mg + Dexamethasone 20 mg
70
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide 4 mg + Dexamethasone 40 mg
79.6
20.38
Not reported
Not reported
Not reported
Ixazomib 4 mg + Dexamethasone 20 mg
84.0
20.74
Not reported
Not reported
Not reported
Cognitive (Functional Scale): End of Treatment
Analysis denominator · Participants
Group
Source count
Pomalidomide 4 mg + Dexamethasone 40 mg
28
Ixazomib 4 mg + Dexamethasone 20 mg
42
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide 4 mg + Dexamethasone 40 mg
69.6
27.61
Not reported
Not reported
Not reported
Ixazomib 4 mg + Dexamethasone 20 mg
77.4
22.64
Not reported
Not reported
Not reported
Social (Functional Scale): Baseline
Analysis denominator · Participants
Group
Source count
Pomalidomide 4 mg + Dexamethasone 40 mg
45
Ixazomib 4 mg + Dexamethasone 20 mg
70
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide 4 mg + Dexamethasone 40 mg
72.2
29.94
Not reported
Not reported
Not reported
Ixazomib 4 mg + Dexamethasone 20 mg
75.7
27.02
Not reported
Not reported
Not reported
Social (Functional Scale): End of Treatment
Analysis denominator · Participants
Group
Source count
Pomalidomide 4 mg + Dexamethasone 40 mg
28
Ixazomib 4 mg + Dexamethasone 20 mg
42
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide 4 mg + Dexamethasone 40 mg
63.1
27.35
Not reported
Not reported
Not reported
Ixazomib 4 mg + Dexamethasone 20 mg
69.8
24.76
Not reported
Not reported
Not reported
Fatigue (Symptom Scale): Baseline
Analysis denominator · Participants
Group
Source count
Pomalidomide 4 mg + Dexamethasone 40 mg
45
Ixazomib 4 mg + Dexamethasone 20 mg
70
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide 4 mg + Dexamethasone 40 mg
60.0
22.89
Not reported
Not reported
Not reported
Ixazomib 4 mg + Dexamethasone 20 mg
61.0
23.07
Not reported
Not reported
Not reported
Fatigue (Symptom Scale): End of Treatment
Analysis denominator · Participants
Group
Source count
Pomalidomide 4 mg + Dexamethasone 40 mg
28
Ixazomib 4 mg + Dexamethasone 20 mg
42
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide 4 mg + Dexamethasone 40 mg
50.8
25.02
Not reported
Not reported
Not reported
Ixazomib 4 mg + Dexamethasone 20 mg
50.3
25.77
Not reported
Not reported
Not reported
Nausea/Vomiting (Symptom Scale): Baseline
Analysis denominator · Participants
Group
Source count
Pomalidomide 4 mg + Dexamethasone 40 mg
45
Ixazomib 4 mg + Dexamethasone 20 mg
70
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide 4 mg + Dexamethasone 40 mg
96.7
8.41
Not reported
Not reported
Not reported
Ixazomib 4 mg + Dexamethasone 20 mg
94.8
11.54
Not reported
Not reported
Not reported
Nausea/Vomiting (Symptom Scale): End of Treatment
Analysis denominator · Participants
Group
Source count
Pomalidomide 4 mg + Dexamethasone 40 mg
28
Ixazomib 4 mg + Dexamethasone 20 mg
42
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide 4 mg + Dexamethasone 40 mg
88.7
15.75
Not reported
Not reported
Not reported
Ixazomib 4 mg + Dexamethasone 20 mg
92.9
16.52
Not reported
Not reported
Not reported
Pain (Symptom Scale): Baseline
Analysis denominator · Participants
Group
Source count
Pomalidomide 4 mg + Dexamethasone 40 mg
45
Ixazomib 4 mg + Dexamethasone 20 mg
70
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide 4 mg + Dexamethasone 40 mg
61.1
30.77
Not reported
Not reported
Not reported
Ixazomib 4 mg + Dexamethasone 20 mg
65.2
24.70
Not reported
Not reported
Not reported
Pain (Symptom Scale): End of Treatment
Analysis denominator · Participants
Group
Source count
Pomalidomide 4 mg + Dexamethasone 40 mg
28
Ixazomib 4 mg + Dexamethasone 20 mg
42
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide 4 mg + Dexamethasone 40 mg
51.2
26.42
Not reported
Not reported
Not reported
Ixazomib 4 mg + Dexamethasone 20 mg
53.2
28.33
Not reported
Not reported
Not reported
Dyspnea (Symptom Scale): Baseline
Analysis denominator · Participants
Group
Source count
Pomalidomide 4 mg + Dexamethasone 40 mg
45
Ixazomib 4 mg + Dexamethasone 20 mg
70
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide 4 mg + Dexamethasone 40 mg
25.2
28.56
Not reported
Not reported
Not reported
Ixazomib 4 mg + Dexamethasone 20 mg
19.0
25.74
Not reported
Not reported
Not reported
Dyspnea (Symptom Scale): End of Treatment
Analysis denominator · Participants
Group
Source count
Pomalidomide 4 mg + Dexamethasone 40 mg
28
Ixazomib 4 mg + Dexamethasone 20 mg
42
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide 4 mg + Dexamethasone 40 mg
40.5
30.57
Not reported
Not reported
Not reported
Ixazomib 4 mg + Dexamethasone 20 mg
24.6
26.61
Not reported
Not reported
Not reported
Insomnia (Symptom Scale): Baseline
Analysis denominator · Participants
Group
Source count
Pomalidomide 4 mg + Dexamethasone 40 mg
45
Ixazomib 4 mg + Dexamethasone 20 mg
70
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide 4 mg + Dexamethasone 40 mg
32.6
29.72
Not reported
Not reported
Not reported
Ixazomib 4 mg + Dexamethasone 20 mg
29.5
31.87
Not reported
Not reported
Not reported
Insomnia (Symptom Scale): End of Treatment
Analysis denominator · Participants
Group
Source count
Pomalidomide 4 mg + Dexamethasone 40 mg
28
Ixazomib 4 mg + Dexamethasone 20 mg
42
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide 4 mg + Dexamethasone 40 mg
36.9
34.35
Not reported
Not reported
Not reported
Ixazomib 4 mg + Dexamethasone 20 mg
29.4
34.69
Not reported
Not reported
Not reported
Appetite Loss (Symptom Scale): Baseline
Analysis denominator · Participants
Group
Source count
Pomalidomide 4 mg + Dexamethasone 40 mg
45
Ixazomib 4 mg + Dexamethasone 20 mg
70
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide 4 mg + Dexamethasone 40 mg
22.2
27.52
Not reported
Not reported
Not reported
Ixazomib 4 mg + Dexamethasone 20 mg
14.3
22.39
Not reported
Not reported
Not reported
Appetite Loss (Symptom Scale): End of Treatment
Analysis denominator · Participants
Group
Source count
Pomalidomide 4 mg + Dexamethasone 40 mg
28
Ixazomib 4 mg + Dexamethasone 20 mg
42
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide 4 mg + Dexamethasone 40 mg
34.5
34.52
Not reported
Not reported
Not reported
Ixazomib 4 mg + Dexamethasone 20 mg
23.0
28.02
Not reported
Not reported
Not reported
Constipation (Symptom Scale): Baseline
Analysis denominator · Participants
Group
Source count
Pomalidomide 4 mg + Dexamethasone 40 mg
45
Ixazomib 4 mg + Dexamethasone 20 mg
70
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide 4 mg + Dexamethasone 40 mg
13.3
23.99
Not reported
Not reported
Not reported
Ixazomib 4 mg + Dexamethasone 20 mg
11.4
20.37
Not reported
Not reported
Not reported
Constipation (Symptom Scale): End of Treatment
Analysis denominator · Participants
Group
Source count
Pomalidomide 4 mg + Dexamethasone 40 mg
28
Ixazomib 4 mg + Dexamethasone 20 mg
42
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide 4 mg + Dexamethasone 40 mg
25.0
34.69
Not reported
Not reported
Not reported
Ixazomib 4 mg + Dexamethasone 20 mg
19.8
29.50
Not reported
Not reported
Not reported
Diarrhea (Symptom Scale): Baseline
Analysis denominator · Participants
Group
Source count
Pomalidomide 4 mg + Dexamethasone 40 mg
45
Ixazomib 4 mg + Dexamethasone 20 mg
70
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide 4 mg + Dexamethasone 40 mg
17.8
23.14
Not reported
Not reported
Not reported
Ixazomib 4 mg + Dexamethasone 20 mg
16.7
23.23
Not reported
Not reported
Not reported
Diarrhea (Symptom Scale): End of Treatment
Analysis denominator · Participants
Group
Source count
Pomalidomide 4 mg + Dexamethasone 40 mg
28
Ixazomib 4 mg + Dexamethasone 20 mg
41
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide 4 mg + Dexamethasone 40 mg
19.0
26.34
Not reported
Not reported
Not reported
Ixazomib 4 mg + Dexamethasone 20 mg
16.3
25.95
Not reported
Not reported
Not reported
Financial Difficulties (Symptom Scale): Baseline
Analysis denominator · Participants
Group
Source count
Pomalidomide 4 mg + Dexamethasone 40 mg
45
Ixazomib 4 mg + Dexamethasone 20 mg
70
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide 4 mg + Dexamethasone 40 mg
22.2
27.52
Not reported
Not reported
Not reported
Ixazomib 4 mg + Dexamethasone 20 mg
17.1
25.85
Not reported
Not reported
Not reported
Financial Difficulties (Symptom Scale): End of Treatment
Analysis denominator · Participants
Group
Source count
Pomalidomide 4 mg + Dexamethasone 40 mg
28
Ixazomib 4 mg + Dexamethasone 20 mg
42
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Pomalidomide 4 mg + Dexamethasone 40 mg
16.7
21.28
Not reported
Not reported
Not reported
Ixazomib 4 mg + Dexamethasone 20 mg
12.7
22.03
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
spread
20.72
value
57.0
group Id
OG001
spread
21.16
value
60.8
denoms
counts
group Id
OG000
value
45
group Id
OG001
value
70
units
Participants
title
Global Health Status/QoL: Baseline
categories
measurements
group Id
OG000
spread
19.56
value
47.8
group Id
OG001
spread
19.61
value
48.2
denoms
counts
group Id
OG000
value
27
group Id
OG001
value
42
units
Participants
title
Global Health Status/QoL: End of Treatment
categories
measurements
group Id
OG000
spread
28.42
value
67.4
group Id
OG001
spread
29.67
value
67.9
denoms
counts
group Id
OG000
value
45
group Id
OG001
value
70
units
Participants
title
Role (Functional Scale): Baseline
categories
measurements
group Id
OG000
spread
27.86
value
47.6
group Id
OG001
spread
27.04
value
49.2
denoms
counts
group Id
OG000
value
28
group Id
OG001
value
42
units
Participants
title
Role (Functional Scale): End of Treatment
categories
measurements
group Id
OG000
spread
21.19
value
74.9
group Id
OG001
spread
21.70
value
83.1
denoms
counts
group Id
OG000
value
45
group Id
OG001
value
70
units
Participants
title
Emotional (Functional Scale): Baseline
categories
measurements
group Id
OG000
spread
25.19
value
67.6
group Id
OG001
spread
22.62
value
72.8
denoms
counts
group Id
OG000
value
28
group Id
OG001
value
42
units
Participants
title
Emotional (Functional Scale): End of Treatment
categories
measurements
group Id
OG000
spread
20.38
value
79.6
group Id
OG001
spread
20.74
value
84.0
denoms
counts
group Id
OG000
value
45
group Id
OG001
value
70
units
Participants
title
Cognitive(Functional Scale): Baseline
categories
measurements
group Id
OG000
spread
27.61
value
69.6
group Id
OG001
spread
22.64
value
77.4
denoms
counts
group Id
OG000
value
28
group Id
OG001
value
42
units
Participants
title
Cognitive (Functional Scale): End of Treatment
categories
measurements
group Id
OG000
spread
29.94
value
72.2
group Id
OG001
spread
27.02
value
75.7
denoms
counts
group Id
OG000
value
45
group Id
OG001
value
70
units
Participants
title
Social (Functional Scale): Baseline
categories
measurements
group Id
OG000
spread
27.35
value
63.1
group Id
OG001
spread
24.76
value
69.8
denoms
counts
group Id
OG000
value
28
group Id
OG001
value
42
units
Participants
title
Social (Functional Scale): End of Treatment
categories
measurements
group Id
OG000
spread
22.89
value
60.0
group Id
OG001
spread
23.07
value
61.0
denoms
counts
group Id
OG000
value
45
group Id
OG001
value
70
units
Participants
title
Fatigue (Symptom Scale): Baseline
categories
measurements
group Id
OG000
spread
25.02
value
50.8
group Id
OG001
spread
25.77
value
50.3
denoms
counts
group Id
OG000
value
28
group Id
OG001
value
42
units
Participants
title
Fatigue (Symptom Scale): End of Treatment
denoms
counts
group Id
OG000
value
45
group Id
OG001
value
70
units
Participants
description
The EORTC QLQ-C30 contains 30 items across 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial difficulties) and a QOL scale. Most of the 30 items had 4 response levels (not at all, a little, quite a bit, and very much), with 2 questions relying on a 7-point numeric rating scale. Each subscale raw score were linearly transformed to a total score between 0 to 100. For the functional scales and the global health status/QOL scale, higher scores represent better QOL; for the symptom scales, lower scores represent better QOL. The Physical domain of the functional subscale is reported in the secondary outcome measure 7.
dispersion Type
Standard Deviation
groups
description
Pomalidomide 4 mg, capsules, orally, once daily on Days 1 to 21 of each 28-day cycle, plus dexamethasone 40 mg, (or 20 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.
id
OG000
title
Pomalidomide 4 mg + Dexamethasone 40 mg
description
Ixazomib 4 mg as starting dose, capsules, orally, once daily on Days 1, 8, and 15 of each 28-day cycle, with escalation to 5.5 mg at the start of Cycle 2 for participants who tolerated the 4 mg dose in Cycle 1, plus dexamethasone 20 mg (or 10 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 2, 8, 9, 15, 16, 22, and 23 of every 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.
id
OG001
title
Ixazomib 4 mg + Dexamethasone 20 mg
param Type
MEAN
population Description
ITT PRO Population included participants with a measurement at study entry and at least one post study entry measurement for at least 1 subscale on all 3 questionnaires (EORTC QLQ-C30, EORTC QLQ-MY20 and EQ-5D-5L). Number analyzed are the number of participants with data available for analyses at the given timepoint.
reporting Status
POSTED
time Frame
Baseline and End of Treatment (Up to 28 cycles, each cycle was of 28 days)
Triangle