Change From Baseline in EORTC QLQ-C30: Emotional Functioning
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
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical \[5 items\], role \[2 items\], emotional \[4 items\], cognitive \[2 items\], social \[2 items\]), symptom scales (fatigue \[3 items\], nausea \& vomiting \[2 items\], pain \[2 items\]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For functional scales: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score and a positive change from baseline represents a better level of emotional functioning. 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
188
Isa-SC + Pd
200
Reported measurements
Cycle 2 Day 1
Analysis denominator · Participants
Group
Source count
Isa-IV + Pd
188
Isa-SC + Pd
200
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
-1.29
17.92
Not reported
Not reported
Not reported
Isa-SC + Pd
2.50
17.94
Not reported
Not reported
Not reported
Cycle 3 Day 15
Analysis denominator · Participants
Group
Source count
Isa-IV + Pd
165
Isa-SC + Pd
178
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
0.71
14.50
Not reported
Not reported
Not reported
Isa-SC + Pd
1.31
19.12
Not reported
Not reported
Not reported
Cycle 4 Day 15
Analysis denominator · Participants
Group
Source count
Isa-IV + Pd
156
Isa-SC + Pd
172
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
-0.27
17.52
Not reported
Not reported
Not reported
Isa-SC + Pd
3.39
20.33
Not reported
Not reported
Not reported
Cycle 5 Day 15
Analysis denominator · Participants
Group
Source count
Isa-IV + Pd
166
Isa-SC + Pd
164
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
0.35
17.39
Not reported
Not reported
Not reported
Isa-SC + Pd
1.78
18.53
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
1.83
17.22
Not reported
Not reported
Not reported
Isa-SC + Pd
1.78
19.08
Not reported
Not reported
Not reported
Cycle 7 Day 15
Analysis denominator · Participants
Group
Source count
Isa-IV + Pd
144
Isa-SC + Pd
143
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
1.10
19.17
Not reported
Not reported
Not reported
Isa-SC + Pd
2.51
19.73
Not reported
Not reported
Not reported
Cycle 8 Day 15
Analysis denominator · Participants
Group
Source count
Isa-IV + Pd
133
Isa-SC + Pd
135
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
2.01
17.23
Not reported
Not reported
Not reported
Isa-SC + Pd
2.41
19.71
Not reported
Not reported
Not reported
Cycle 9 Day 15
Analysis denominator · Participants
Group
Source count
Isa-IV + Pd
130
Isa-SC + Pd
118
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
-0.64
18.08
Not reported
Not reported
Not reported
Isa-SC + Pd
3.53
22.84
Not reported
Not reported
Not reported
Cycle 10 Day 15
Analysis denominator · Participants
Group
Source count
Isa-IV + Pd
121
Isa-SC + Pd
123
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
0.28
16.73
Not reported
Not reported
Not reported
Isa-SC + Pd
2.10
19.60
Not reported
Not reported
Not reported
Cycle 11 Day 15
Analysis denominator · Participants
Group
Source count
Isa-IV + Pd
121
Isa-SC + Pd
118
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
1.31
17.61
Not reported
Not reported
Not reported
Isa-SC + Pd
1.41
22.55
Not reported
Not reported
Not reported
Cycle 12 Day 15
Analysis denominator · Participants
Group
Source count
Isa-IV + Pd
107
Isa-SC + Pd
113
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
1.25
17.28
Not reported
Not reported
Not reported
Isa-SC + Pd
1.33
21.49
Not reported
Not reported
Not reported
Cycle 13 Day 15
Analysis denominator · Participants
Group
Source count
Isa-IV + Pd
103
Isa-SC + Pd
99
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
0.81
17.13
Not reported
Not reported
Not reported
Isa-SC + Pd
0.51
20.54
Not reported
Not reported
Not reported
Cycle 14 Day 15
Analysis denominator · Participants
Group
Source count
Isa-IV + Pd
99
Isa-SC + Pd
105
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
1.26
17.55
Not reported
Not reported
Not reported
Isa-SC + Pd
0.16
19.68
Not reported
Not reported
Not reported
Cycle 15 Day 15
Analysis denominator · Participants
Group
Source count
Isa-IV + Pd
96
Isa-SC + Pd
100
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
0.61
18.86
Not reported
Not reported
Not reported
Isa-SC + Pd
-0.50
20.34
Not reported
Not reported
Not reported
Cycle 16 Day 15
Analysis denominator · Participants
Group
Source count
Isa-IV + Pd
85
Isa-SC + Pd
93
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
-0.39
17.05
Not reported
Not reported
Not reported
Isa-SC + Pd
-0.90
18.69
Not reported
Not reported
Not reported
Cycle 17 Day 15
Analysis denominator · Participants
Group
Source count
Isa-IV + Pd
79
Isa-SC + Pd
84
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
0.21
16.23
Not reported
Not reported
Not reported
Isa-SC + Pd
-3.27
21.06
Not reported
Not reported
Not reported
Cycle 18 Day 15
Analysis denominator · Participants
Group
Source count
Isa-IV + Pd
68
Isa-SC + Pd
70
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
-2.57
16.31
Not reported
Not reported
Not reported
Isa-SC + Pd
-1.19
22.31
Not reported
Not reported
Not reported
Cycle 19 Day 15
Analysis denominator · Participants
Group
Source count
Isa-IV + Pd
62
Isa-SC + Pd
59
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
-2.15
15.16
Not reported
Not reported
Not reported
Isa-SC + Pd
-1.27
22.31
Not reported
Not reported
Not reported
Cycle 20 Day 15
Analysis denominator · Participants
Group
Source count
Isa-IV + Pd
53
Isa-SC + Pd
46
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
0.63
14.79
Not reported
Not reported
Not reported
Isa-SC + Pd
-1.81
24.27
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
-0.82
15.57
Not reported
Not reported
Not reported
Isa-SC + Pd
1.54
22.99
Not reported
Not reported
Not reported
Cycle 22 Day 15
Analysis denominator · Participants
Group
Source count
Isa-IV + Pd
46
Isa-SC + Pd
33
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
1.09
15.48
Not reported
Not reported
Not reported
Isa-SC + Pd
3.54
24.30
Not reported
Not reported
Not reported
Cycle 23 Day 15
Analysis denominator · Participants
Group
Source count
Isa-IV + Pd
36
Isa-SC + Pd
29
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
-2.31
15.64
Not reported
Not reported
Not reported
Isa-SC + Pd
0.57
28.17
Not reported
Not reported
Not reported
Cycle 24 Day 15
Analysis denominator · Participants
Group
Source count
Isa-IV + Pd
38
Isa-SC + Pd
24
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
-1.10
17.78
Not reported
Not reported
Not reported
Isa-SC + Pd
4.17
27.58
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
4.84
15.03
Not reported
Not reported
Not reported
Isa-SC + Pd
-7.08
29.90
Not reported
Not reported
Not reported
Cycle 26 Day 15
Analysis denominator · Participants
Group
Source count
Isa-IV + Pd
24
Isa-SC + Pd
19
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
3.13
20.97
Not reported
Not reported
Not reported
Isa-SC + Pd
-1.75
31.98
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
5.83
17.54
Not reported
Not reported
Not reported
Isa-SC + Pd
8.97
16.83
Not reported
Not reported
Not reported
Cycle 28 Day 15
Analysis denominator · Participants
Group
Source count
Isa-IV + Pd
15
Isa-SC + Pd
10
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
12.78
24.77
Not reported
Not reported
Not reported
Isa-SC + Pd
4.17
14.30
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
5.95
15.82
Not reported
Not reported
Not reported
Isa-SC + Pd
10.00
9.46
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
9.03
24.74
Not reported
Not reported
Not reported
Isa-SC + Pd
9.52
15.54
Not reported
Not reported
Not reported
EOT
Analysis denominator · Participants
Group
Source count
Isa-IV + Pd
89
Isa-SC + Pd
100
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Isa-IV + Pd
-6.37
17.23
Not reported
Not reported
Not reported
Isa-SC + Pd
-3.25
19.85
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
spread
17.92
value
-1.29
group Id
OG001
spread
17.94
value
2.50
denoms
counts
group Id
OG000
value
188
group Id
OG001
value
200
units
Participants
title
Cycle 2 Day 1
categories
measurements
group Id
OG000
spread
14.50
value
0.71
group Id
OG001
spread
19.12
value
1.31
denoms
counts
group Id
OG000
value
165
group Id
OG001
value
178
units
Participants
title
Cycle 3 Day 15
categories
measurements
group Id
OG000
spread
17.52
value
-0.27
group Id
OG001
spread
20.33
value
3.39
denoms
counts
group Id
OG000
value
156
group Id
OG001
value
172
units
Participants
title
Cycle 4 Day 15
categories
measurements
group Id
OG000
spread
17.39
value
0.35
group Id
OG001
spread
18.53
value
1.78
denoms
counts
group Id
OG000
value
166
group Id
OG001
value
164
units
Participants
title
Cycle 5 Day 15
categories
measurements
group Id
OG000
spread
17.22
value
1.83
group Id
OG001
spread
19.08
value
1.78
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
19.17
value
1.10
group Id
OG001
spread
19.73
value
2.51
denoms
counts
group Id
OG000
value
144
group Id
OG001
value
143
units
Participants
title
Cycle 7 Day 15
categories
measurements
group Id
OG000
spread
17.23
value
2.01
group Id
OG001
spread
19.71
value
2.41
denoms
counts
group Id
OG000
value
133
group Id
OG001
value
135
units
Participants
title
Cycle 8 Day 15
categories
measurements
group Id
OG000
spread
18.08
value
-0.64
group Id
OG001
spread
22.84
value
3.53
denoms
counts
group Id
OG000
value
130
group Id
OG001
value
118
units
Participants
title
Cycle 9 Day 15
categories
measurements
group Id
OG000
spread
16.73
value
0.28
group Id
OG001
spread
19.60
value
2.10
denoms
counts
group Id
OG000
value
121
group Id
OG001
value
123
units
Participants
title
Cycle 10 Day 15
categories
measurements
group Id
OG000
spread
17.61
value
1.31
group Id
OG001
spread
22.55
value
1.41
denoms
counts
group Id
OG000
value
121
group Id
OG001
value
118
units
Participants
title
Cycle 11 Day 15
categories
measurements
group Id
OG000
spread
17.28
value
1.25
group Id
OG001
spread
21.49
value
1.33
denoms
counts
group Id
OG000
value
107
group Id
OG001
value
113
units
Participants
title
Cycle 12 Day 15
categories
measurements
group Id
OG000
spread
17.13
value
0.81
group Id
OG001
spread
20.54
value
0.51
denoms
counts
group Id
OG000
value
103
group Id
OG001
value
99
units
Participants
title
Cycle 13 Day 15
denoms
counts
group Id
OG000
value
188
group Id
OG001
value
200
units
Participants
description
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical \[5 items\], role \[2 items\], emotional \[4 items\], cognitive \[2 items\], social \[2 items\]), symptom scales (fatigue \[3 items\], nausea \& vomiting \[2 items\], pain \[2 items\]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For functional scales: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score and a positive change from baseline represents a better level of emotional functioning. 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-C30: Emotional Functioning
Triangle