Change From Baseline in EORTC QLQ-MY20: Side Effects of Treatment
SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM · Source last updated 2026-09-02
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 (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
What was measured
The EORTC QLQ-MY20 was used in conjunction with the EORTC QLQ-C30 to assess symptoms and side effects due to the treatment or the disease which impacts health related QoL in participants with MM. It contains 20 items, 4 independent subscales covering 2 functional domains: symptom scales which include disease symptoms (6 items) and side-effects of treatment (10 items) and function scale which include future perspective (3 items) and body image (1 item). Scores for each subscale are based on the 4-point Likert scale ranging from (1: not at all to 4: very much) and transformed from raw scores to linear scales ranging from 0 to 100; mean is presented here. A higher score for side effects of treatment and a positive change from baseline represents more side effects, worse QoL. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Analysis population: The ITT population included all randomized population. Only those participants with data collected at specified timepoints are reported.
Groups in this outcome
Isa-IV + Pd
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
Isa-SC + Pd
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
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
Isa-IV + Pd
185
Isa-SC + Pd
193
Reported measurements
Cycle 2 Day 1
Analysis denominator · Participants
Group
Source count
Isa-IV + Pd
185
Isa-SC + Pd
193
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
1.94
11.34
Not reported
Not reported
Not reported
Isa-SC + Pd
0.23
12.22
Not reported
Not reported
Not reported
Cycle 3 Day 15
Analysis denominator · Participants
Group
Source count
Isa-IV + Pd
160
Isa-SC + Pd
172
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
1.68
11.26
Not reported
Not reported
Not reported
Isa-SC + Pd
0.45
13.29
Not reported
Not reported
Not reported
Cycle 4 Day 15
Analysis denominator · Participants
Group
Source count
Isa-IV + Pd
152
Isa-SC + Pd
161
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
2.23
12.34
Not reported
Not reported
Not reported
Isa-SC + Pd
0.04
14.86
Not reported
Not reported
Not reported
Cycle 5 Day 15
Analysis denominator · Participants
Group
Source count
Isa-IV + Pd
165
Isa-SC + Pd
161
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
2.51
12.18
Not reported
Not reported
Not reported
Isa-SC + Pd
1.75
15.06
Not reported
Not reported
Not reported
Cycle 6 Day 15
Analysis denominator · Participants
Group
Source count
Isa-IV + Pd
146
Isa-SC + Pd
150
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
1.18
13.17
Not reported
Not reported
Not reported
Isa-SC + Pd
-0.76
13.28
Not reported
Not reported
Not reported
Cycle 7 Day 15
Analysis denominator · Participants
Group
Source count
Isa-IV + Pd
143
Isa-SC + Pd
143
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
1.47
13.01
Not reported
Not reported
Not reported
Isa-SC + Pd
-0.42
15.12
Not reported
Not reported
Not reported
Cycle 8 Day 15
Analysis denominator · Participants
Group
Source count
Isa-IV + Pd
133
Isa-SC + Pd
133
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
0.97
12.86
Not reported
Not reported
Not reported
Isa-SC + Pd
0.34
14.70
Not reported
Not reported
Not reported
Cycle 9 Day 15
Analysis denominator · Participants
Group
Source count
Isa-IV + Pd
129
Isa-SC + Pd
116
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
2.03
13.58
Not reported
Not reported
Not reported
Isa-SC + Pd
-0.05
14.70
Not reported
Not reported
Not reported
Cycle 10 Day 15
Analysis denominator · Participants
Group
Source count
Isa-IV + Pd
121
Isa-SC + Pd
121
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
3.64
13.04
Not reported
Not reported
Not reported
Isa-SC + Pd
1.00
14.46
Not reported
Not reported
Not reported
Cycle 11 Day 15
Analysis denominator · Participants
Group
Source count
Isa-IV + Pd
121
Isa-SC + Pd
116
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
2.27
13.49
Not reported
Not reported
Not reported
Isa-SC + Pd
1.03
14.77
Not reported
Not reported
Not reported
Cycle 12 Day 15
Analysis denominator · Participants
Group
Source count
Isa-IV + Pd
107
Isa-SC + Pd
112
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
2.08
12.78
Not reported
Not reported
Not reported
Isa-SC + Pd
0.49
15.06
Not reported
Not reported
Not reported
Cycle 13 Day 15
Analysis denominator · Participants
Group
Source count
Isa-IV + Pd
103
Isa-SC + Pd
98
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
2.41
13.79
Not reported
Not reported
Not reported
Isa-SC + Pd
0.31
13.51
Not reported
Not reported
Not reported
Cycle 14 Day 15
Analysis denominator · Participants
Group
Source count
Isa-IV + Pd
99
Isa-SC + Pd
104
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
4.18
13.64
Not reported
Not reported
Not reported
Isa-SC + Pd
1.24
15.14
Not reported
Not reported
Not reported
Cycle 15 Day 15
Analysis denominator · Participants
Group
Source count
Isa-IV + Pd
96
Isa-SC + Pd
99
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
3.50
12.13
Not reported
Not reported
Not reported
Isa-SC + Pd
0.71
14.03
Not reported
Not reported
Not reported
Cycle 16 Day 15
Analysis denominator · Participants
Group
Source count
Isa-IV + Pd
85
Isa-SC + Pd
92
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
3.72
13.10
Not reported
Not reported
Not reported
Isa-SC + Pd
1.79
14.73
Not reported
Not reported
Not reported
Cycle 17 Day 15
Analysis denominator · Participants
Group
Source count
Isa-IV + Pd
79
Isa-SC + Pd
83
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
3.85
10.71
Not reported
Not reported
Not reported
Isa-SC + Pd
2.06
15.14
Not reported
Not reported
Not reported
Cycle 18 Day 15
Analysis denominator · Participants
Group
Source count
Isa-IV + Pd
67
Isa-SC + Pd
69
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
3.99
13.15
Not reported
Not reported
Not reported
Isa-SC + Pd
0.37
13.34
Not reported
Not reported
Not reported
Cycle 19 Day 15
Analysis denominator · Participants
Group
Source count
Isa-IV + Pd
62
Isa-SC + Pd
58
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
4.93
13.54
Not reported
Not reported
Not reported
Isa-SC + Pd
0.94
12.65
Not reported
Not reported
Not reported
Cycle 20 Day 15
Analysis denominator · Participants
Group
Source count
Isa-IV + Pd
53
Isa-SC + Pd
45
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
3.87
12.74
Not reported
Not reported
Not reported
Isa-SC + Pd
0.84
16.03
Not reported
Not reported
Not reported
Cycle 21 Day 15
Analysis denominator · Participants
Group
Source count
Isa-IV + Pd
51
Isa-SC + Pd
38
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
3.22
12.70
Not reported
Not reported
Not reported
Isa-SC + Pd
-0.99
15.09
Not reported
Not reported
Not reported
Cycle 22 Day 15
Analysis denominator · Participants
Group
Source count
Isa-IV + Pd
46
Isa-SC + Pd
32
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
2.10
11.26
Not reported
Not reported
Not reported
Isa-SC + Pd
-0.88
18.18
Not reported
Not reported
Not reported
Cycle 23 Day 15
Analysis denominator · Participants
Group
Source count
Isa-IV + Pd
36
Isa-SC + Pd
28
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
1.10
11.83
Not reported
Not reported
Not reported
Isa-SC + Pd
-1.32
17.03
Not reported
Not reported
Not reported
Cycle 24 Day 15
Analysis denominator · Participants
Group
Source count
Isa-IV + Pd
38
Isa-SC + Pd
23
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
0.56
11.39
Not reported
Not reported
Not reported
Isa-SC + Pd
-3.17
16.57
Not reported
Not reported
Not reported
Cycle 25 Day 15
Analysis denominator · Participants
Group
Source count
Isa-IV + Pd
31
Isa-SC + Pd
20
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
3.24
13.69
Not reported
Not reported
Not reported
Isa-SC + Pd
-1.30
19.03
Not reported
Not reported
Not reported
Cycle 26 Day 15
Analysis denominator · Participants
Group
Source count
Isa-IV + Pd
24
Isa-SC + Pd
18
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
1.88
15.40
Not reported
Not reported
Not reported
Isa-SC + Pd
-2.10
15.04
Not reported
Not reported
Not reported
Cycle 27 Day 15
Analysis denominator · Participants
Group
Source count
Isa-IV + Pd
20
Isa-SC + Pd
13
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
0.98
14.42
Not reported
Not reported
Not reported
Isa-SC + Pd
-3.33
18.51
Not reported
Not reported
Not reported
Cycle 28 Day 15
Analysis denominator · Participants
Group
Source count
Isa-IV + Pd
15
Isa-SC + Pd
9
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
-0.27
16.41
Not reported
Not reported
Not reported
Isa-SC + Pd
-2.18
14.63
Not reported
Not reported
Not reported
Cycle 29 Day 15
Analysis denominator · Participants
Group
Source count
Isa-IV + Pd
14
Isa-SC + Pd
10
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
1.75
13.47
Not reported
Not reported
Not reported
Isa-SC + Pd
-3.78
13.95
Not reported
Not reported
Not reported
Cycle 30 Day 15
Analysis denominator · Participants
Group
Source count
Isa-IV + Pd
12
Isa-SC + Pd
7
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
-2.69
20.07
Not reported
Not reported
Not reported
Isa-SC + Pd
-4.02
12.18
Not reported
Not reported
Not reported
EOT
Analysis denominator · Participants
Group
Source count
Isa-IV + Pd
88
Isa-SC + Pd
99
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
2.95
13.99
Not reported
Not reported
Not reported
Isa-SC + Pd
0.69
13.93
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
spread
11.34
value
1.94
group Id
OG001
spread
12.22
value
0.23
denoms
counts
group Id
OG000
value
185
group Id
OG001
value
193
units
Participants
title
Cycle 2 Day 1
categories
measurements
group Id
OG000
spread
11.26
value
1.68
group Id
OG001
spread
13.29
value
0.45
denoms
counts
group Id
OG000
value
160
group Id
OG001
value
172
units
Participants
title
Cycle 3 Day 15
categories
measurements
group Id
OG000
spread
12.34
value
2.23
group Id
OG001
spread
14.86
value
0.04
denoms
counts
group Id
OG000
value
152
group Id
OG001
value
161
units
Participants
title
Cycle 4 Day 15
categories
measurements
group Id
OG000
spread
12.18
value
2.51
group Id
OG001
spread
15.06
value
1.75
denoms
counts
group Id
OG000
value
165
group Id
OG001
value
161
units
Participants
title
Cycle 5 Day 15
categories
measurements
group Id
OG000
spread
13.17
value
1.18
group Id
OG001
spread
13.28
value
-0.76
denoms
counts
group Id
OG000
value
146
group Id
OG001
value
150
units
Participants
title
Cycle 6 Day 15
categories
measurements
group Id
OG000
spread
13.01
value
1.47
group Id
OG001
spread
15.12
value
-0.42
denoms
counts
group Id
OG000
value
143
group Id
OG001
value
143
units
Participants
title
Cycle 7 Day 15
categories
measurements
group Id
OG000
spread
12.86
value
0.97
group Id
OG001
spread
14.70
value
0.34
denoms
counts
group Id
OG000
value
133
group Id
OG001
value
133
units
Participants
title
Cycle 8 Day 15
categories
measurements
group Id
OG000
spread
13.58
value
2.03
group Id
OG001
spread
14.70
value
-0.05
denoms
counts
group Id
OG000
value
129
group Id
OG001
value
116
units
Participants
title
Cycle 9 Day 15
categories
measurements
group Id
OG000
spread
13.04
value
3.64
group Id
OG001
spread
14.46
value
1.00
denoms
counts
group Id
OG000
value
121
group Id
OG001
value
121
units
Participants
title
Cycle 10 Day 15
categories
measurements
group Id
OG000
spread
13.49
value
2.27
group Id
OG001
spread
14.77
value
1.03
denoms
counts
group Id
OG000
value
121
group Id
OG001
value
116
units
Participants
title
Cycle 11 Day 15
categories
measurements
group Id
OG000
spread
12.78
value
2.08
group Id
OG001
spread
15.06
value
0.49
denoms
counts
group Id
OG000
value
107
group Id
OG001
value
112
units
Participants
title
Cycle 12 Day 15
categories
measurements
group Id
OG000
spread
13.79
value
2.41
group Id
OG001
spread
13.51
value
0.31
denoms
counts
group Id
OG000
value
103
group Id
OG001
value
98
units
Participants
title
Cycle 13 Day 15
denoms
counts
group Id
OG000
value
185
group Id
OG001
value
193
units
Participants
description
The EORTC QLQ-MY20 was used in conjunction with the EORTC QLQ-C30 to assess symptoms and side effects due to the treatment or the disease which impacts health related QoL in participants with MM. It contains 20 items, 4 independent subscales covering 2 functional domains: symptom scales which include disease symptoms (6 items) and side-effects of treatment (10 items) and function scale which include future perspective (3 items) and body image (1 item). Scores for each subscale are based on the 4-point Likert scale ranging from (1: not at all to 4: very much) and transformed from raw scores to linear scales ranging from 0 to 100; mean is presented here. A higher score for side effects of treatment and a positive change from baseline represents more side effects, worse QoL. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
dispersion Type
Standard Deviation
groups
description
Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
id
OG000
title
Isa-IV + Pd
description
Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
id
OG001
title
Isa-SC + Pd
param Type
MEAN
population Description
The ITT population included all randomized population. Only those participants with data collected at specified timepoints are reported.
reporting Status
POSTED
time Frame
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
title
Change From Baseline in EORTC QLQ-MY20: Side Effects of Treatment
Triangle