HRQL: Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Score: Visual Analogic Scale (VAS) at Specified Timepoints: Primary Analysis
Multinational Clinical Study Comparing Isatuximab, Carfilzomib And Dexamethasone To Carfilzomib And Dexamethasone In Relapse And/Or Refractory Multiple Myeloma Patients · Source last updated 2026-02-09
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, Day 1 of each cycle (Cycle 2 to Cycle 25), at the End of Treatment visit (any day up to 114 weeks)
What was measured
The EQ-5D-5L is a standardized measure of health status that provides a general assessment of health utility and consist of 2 sections; descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and a VAS. The VAS records the respondent's self-rated health on a 20 centimeter (cm) vertical VAS; the scale went from 0 (worst imaginable health state) to 100 (best imaginable health state). This information can be used as a quantitative measure of health as judged by the individual respondents.
Analysis population: Analysis was performed on ITT population. Here, 'Number analyzed' signifies participants with available data for each specified category.
Groups in this outcome
Carfilzomib + Dexamethasone (Kd)
Participants received carfilzomib 20 mg/m\^2, IV infusion on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle along with dexamethasone 20 mg, PO or IV on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 114 weeks).
Isatuximab + Carfilzomib + Dexamethasone (IKd)
Participants received isatuximab 10 mg/kg, IV infusion on Days 1, 8, 15 and 22 in Cycle 1, and then on Days 1 and Day 15 of each 28-day treatment cycle plus carfilzomib 20 mg/m\^2, IV on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle and dexamethasone 20 mg, PO or IV on Day 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 111 weeks).
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
Carfilzomib + Dexamethasone (Kd)
123
Isatuximab + Carfilzomib + Dexamethasone (IKd)
179
Reported measurements
Cycle 2 Day 1
Analysis denominator · Participants
Group
Source count
Carfilzomib + Dexamethasone (Kd)
99
Isatuximab + Carfilzomib + Dexamethasone (IKd)
151
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Carfilzomib + Dexamethasone (Kd)
2.42
17.04
Not reported
Not reported
Not reported
Isatuximab + Carfilzomib + Dexamethasone (IKd)
0.60
15.23
Not reported
Not reported
Not reported
Cycle 3 Day 1
Analysis denominator · Participants
Group
Source count
Carfilzomib + Dexamethasone (Kd)
98
Isatuximab + Carfilzomib + Dexamethasone (IKd)
150
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Carfilzomib + Dexamethasone (Kd)
4.70
16.13
Not reported
Not reported
Not reported
Isatuximab + Carfilzomib + Dexamethasone (IKd)
3.47
17.80
Not reported
Not reported
Not reported
Cycle 4 Day 1
Analysis denominator · Participants
Group
Source count
Carfilzomib + Dexamethasone (Kd)
99
Isatuximab + Carfilzomib + Dexamethasone (IKd)
147
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Carfilzomib + Dexamethasone (Kd)
6.03
16.73
Not reported
Not reported
Not reported
Isatuximab + Carfilzomib + Dexamethasone (IKd)
2.29
18.69
Not reported
Not reported
Not reported
Cycle 5 Day 1
Analysis denominator · Participants
Group
Source count
Carfilzomib + Dexamethasone (Kd)
94
Isatuximab + Carfilzomib + Dexamethasone (IKd)
144
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Carfilzomib + Dexamethasone (Kd)
3.40
16.89
Not reported
Not reported
Not reported
Isatuximab + Carfilzomib + Dexamethasone (IKd)
2.35
19.73
Not reported
Not reported
Not reported
Cycle 6 Day 1
Analysis denominator · Participants
Group
Source count
Carfilzomib + Dexamethasone (Kd)
88
Isatuximab + Carfilzomib + Dexamethasone (IKd)
141
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Carfilzomib + Dexamethasone (Kd)
2.80
18.56
Not reported
Not reported
Not reported
Isatuximab + Carfilzomib + Dexamethasone (IKd)
1.24
19.11
Not reported
Not reported
Not reported
Cycle 7 Day 1
Analysis denominator · Participants
Group
Source count
Carfilzomib + Dexamethasone (Kd)
84
Isatuximab + Carfilzomib + Dexamethasone (IKd)
139
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Carfilzomib + Dexamethasone (Kd)
0.64
21.69
Not reported
Not reported
Not reported
Isatuximab + Carfilzomib + Dexamethasone (IKd)
2.24
18.85
Not reported
Not reported
Not reported
Cycle 8 Day 1
Analysis denominator · Participants
Group
Source count
Carfilzomib + Dexamethasone (Kd)
81
Isatuximab + Carfilzomib + Dexamethasone (IKd)
132
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Carfilzomib + Dexamethasone (Kd)
1.48
17.11
Not reported
Not reported
Not reported
Isatuximab + Carfilzomib + Dexamethasone (IKd)
2.40
18.87
Not reported
Not reported
Not reported
Cycle 9 Day 1
Analysis denominator · Participants
Group
Source count
Carfilzomib + Dexamethasone (Kd)
77
Isatuximab + Carfilzomib + Dexamethasone (IKd)
124
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Carfilzomib + Dexamethasone (Kd)
-0.14
17.46
Not reported
Not reported
Not reported
Isatuximab + Carfilzomib + Dexamethasone (IKd)
2.93
19.04
Not reported
Not reported
Not reported
Cycle 10 Day 1
Analysis denominator · Participants
Group
Source count
Carfilzomib + Dexamethasone (Kd)
71
Isatuximab + Carfilzomib + Dexamethasone (IKd)
120
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Carfilzomib + Dexamethasone (Kd)
2.76
17.41
Not reported
Not reported
Not reported
Isatuximab + Carfilzomib + Dexamethasone (IKd)
2.82
18.35
Not reported
Not reported
Not reported
Cycle 11 Day 1
Analysis denominator · Participants
Group
Source count
Carfilzomib + Dexamethasone (Kd)
69
Isatuximab + Carfilzomib + Dexamethasone (IKd)
118
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Carfilzomib + Dexamethasone (Kd)
3.86
20.07
Not reported
Not reported
Not reported
Isatuximab + Carfilzomib + Dexamethasone (IKd)
3.77
18.51
Not reported
Not reported
Not reported
Cycle 12 Day 1
Analysis denominator · Participants
Group
Source count
Carfilzomib + Dexamethasone (Kd)
63
Isatuximab + Carfilzomib + Dexamethasone (IKd)
115
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Carfilzomib + Dexamethasone (Kd)
5.29
18.51
Not reported
Not reported
Not reported
Isatuximab + Carfilzomib + Dexamethasone (IKd)
3.63
19.34
Not reported
Not reported
Not reported
Cycle 13 Day 1
Analysis denominator · Participants
Group
Source count
Carfilzomib + Dexamethasone (Kd)
59
Isatuximab + Carfilzomib + Dexamethasone (IKd)
109
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Carfilzomib + Dexamethasone (Kd)
6.81
19.57
Not reported
Not reported
Not reported
Isatuximab + Carfilzomib + Dexamethasone (IKd)
4.94
18.41
Not reported
Not reported
Not reported
Cycle 14 Day 1
Analysis denominator · Participants
Group
Source count
Carfilzomib + Dexamethasone (Kd)
58
Isatuximab + Carfilzomib + Dexamethasone (IKd)
109
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Carfilzomib + Dexamethasone (Kd)
7.95
18.12
Not reported
Not reported
Not reported
Isatuximab + Carfilzomib + Dexamethasone (IKd)
4.72
17.67
Not reported
Not reported
Not reported
Cycle 15 Day 1
Analysis denominator · Participants
Group
Source count
Carfilzomib + Dexamethasone (Kd)
57
Isatuximab + Carfilzomib + Dexamethasone (IKd)
101
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Carfilzomib + Dexamethasone (Kd)
4.96
18.92
Not reported
Not reported
Not reported
Isatuximab + Carfilzomib + Dexamethasone (IKd)
3.23
18.87
Not reported
Not reported
Not reported
Cycle 16 Day 1
Analysis denominator · Participants
Group
Source count
Carfilzomib + Dexamethasone (Kd)
50
Isatuximab + Carfilzomib + Dexamethasone (IKd)
98
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Carfilzomib + Dexamethasone (Kd)
3.94
18.78
Not reported
Not reported
Not reported
Isatuximab + Carfilzomib + Dexamethasone (IKd)
4.56
18.88
Not reported
Not reported
Not reported
Cycle 17 Day 1
Analysis denominator · Participants
Group
Source count
Carfilzomib + Dexamethasone (Kd)
46
Isatuximab + Carfilzomib + Dexamethasone (IKd)
97
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Carfilzomib + Dexamethasone (Kd)
5.04
17.93
Not reported
Not reported
Not reported
Isatuximab + Carfilzomib + Dexamethasone (IKd)
4.97
18.55
Not reported
Not reported
Not reported
Cycle 18 Day 1
Analysis denominator · Participants
Group
Source count
Carfilzomib + Dexamethasone (Kd)
45
Isatuximab + Carfilzomib + Dexamethasone (IKd)
90
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Carfilzomib + Dexamethasone (Kd)
3.71
19.08
Not reported
Not reported
Not reported
Isatuximab + Carfilzomib + Dexamethasone (IKd)
3.83
18.46
Not reported
Not reported
Not reported
Cycle 19 Day 1
Analysis denominator · Participants
Group
Source count
Carfilzomib + Dexamethasone (Kd)
41
Isatuximab + Carfilzomib + Dexamethasone (IKd)
86
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Carfilzomib + Dexamethasone (Kd)
7.44
18.73
Not reported
Not reported
Not reported
Isatuximab + Carfilzomib + Dexamethasone (IKd)
3.69
18.37
Not reported
Not reported
Not reported
Cycle 20 Day 1
Analysis denominator · Participants
Group
Source count
Carfilzomib + Dexamethasone (Kd)
34
Isatuximab + Carfilzomib + Dexamethasone (IKd)
85
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Carfilzomib + Dexamethasone (Kd)
6.18
18.43
Not reported
Not reported
Not reported
Isatuximab + Carfilzomib + Dexamethasone (IKd)
4.20
17.20
Not reported
Not reported
Not reported
Cycle 21 Day 1
Analysis denominator · Participants
Group
Source count
Carfilzomib + Dexamethasone (Kd)
28
Isatuximab + Carfilzomib + Dexamethasone (IKd)
70
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Carfilzomib + Dexamethasone (Kd)
7.25
23.46
Not reported
Not reported
Not reported
Isatuximab + Carfilzomib + Dexamethasone (IKd)
3.26
18.97
Not reported
Not reported
Not reported
Cycle 22 Day 1
Analysis denominator · Participants
Group
Source count
Carfilzomib + Dexamethasone (Kd)
19
Isatuximab + Carfilzomib + Dexamethasone (IKd)
52
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Carfilzomib + Dexamethasone (Kd)
5.58
24.06
Not reported
Not reported
Not reported
Isatuximab + Carfilzomib + Dexamethasone (IKd)
2.35
18.62
Not reported
Not reported
Not reported
Cycle 23 Day 1
Analysis denominator · Participants
Group
Source count
Carfilzomib + Dexamethasone (Kd)
15
Isatuximab + Carfilzomib + Dexamethasone (IKd)
36
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Carfilzomib + Dexamethasone (Kd)
6.33
18.73
Not reported
Not reported
Not reported
Isatuximab + Carfilzomib + Dexamethasone (IKd)
6.44
18.34
Not reported
Not reported
Not reported
Cycle 24 Day 1
Analysis denominator · Participants
Group
Source count
Carfilzomib + Dexamethasone (Kd)
9
Isatuximab + Carfilzomib + Dexamethasone (IKd)
22
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Carfilzomib + Dexamethasone (Kd)
5.11
17.93
Not reported
Not reported
Not reported
Isatuximab + Carfilzomib + Dexamethasone (IKd)
4.50
18.31
Not reported
Not reported
Not reported
Cycle 25 Day 1
Analysis denominator · Participants
Group
Source count
Carfilzomib + Dexamethasone (Kd)
5
Isatuximab + Carfilzomib + Dexamethasone (IKd)
16
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Carfilzomib + Dexamethasone (Kd)
9.20
21.48
Not reported
Not reported
Not reported
Isatuximab + Carfilzomib + Dexamethasone (IKd)
5.00
18.83
Not reported
Not reported
Not reported
End of Treatment
Analysis denominator · Participants
Group
Source count
Carfilzomib + Dexamethasone (Kd)
57
Isatuximab + Carfilzomib + Dexamethasone (IKd)
56
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Carfilzomib + Dexamethasone (Kd)
-4.40
18.66
Not reported
Not reported
Not reported
Isatuximab + Carfilzomib + Dexamethasone (IKd)
-7.80
21.08
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
spread
17.04
value
2.42
group Id
OG001
spread
15.23
value
0.60
denoms
counts
group Id
OG000
value
99
group Id
OG001
value
151
units
Participants
title
Cycle 2 Day 1
categories
measurements
group Id
OG000
spread
16.13
value
4.70
group Id
OG001
spread
17.80
value
3.47
denoms
counts
group Id
OG000
value
98
group Id
OG001
value
150
units
Participants
title
Cycle 3 Day 1
categories
measurements
group Id
OG000
spread
16.73
value
6.03
group Id
OG001
spread
18.69
value
2.29
denoms
counts
group Id
OG000
value
99
group Id
OG001
value
147
units
Participants
title
Cycle 4 Day 1
categories
measurements
group Id
OG000
spread
16.89
value
3.40
group Id
OG001
spread
19.73
value
2.35
denoms
counts
group Id
OG000
value
94
group Id
OG001
value
144
units
Participants
title
Cycle 5 Day 1
categories
measurements
group Id
OG000
spread
18.56
value
2.80
group Id
OG001
spread
19.11
value
1.24
denoms
counts
group Id
OG000
value
88
group Id
OG001
value
141
units
Participants
title
Cycle 6 Day 1
categories
measurements
group Id
OG000
spread
21.69
value
0.64
group Id
OG001
spread
18.85
value
2.24
denoms
counts
group Id
OG000
value
84
group Id
OG001
value
139
units
Participants
title
Cycle 7 Day 1
categories
measurements
group Id
OG000
spread
17.11
value
1.48
group Id
OG001
spread
18.87
value
2.40
denoms
counts
group Id
OG000
value
81
group Id
OG001
value
132
units
Participants
title
Cycle 8 Day 1
categories
measurements
group Id
OG000
spread
17.46
value
-0.14
group Id
OG001
spread
19.04
value
2.93
denoms
counts
group Id
OG000
value
77
group Id
OG001
value
124
units
Participants
title
Cycle 9 Day 1
categories
measurements
group Id
OG000
spread
17.41
value
2.76
group Id
OG001
spread
18.35
value
2.82
denoms
counts
group Id
OG000
value
71
group Id
OG001
value
120
units
Participants
title
Cycle 10 Day 1
categories
measurements
group Id
OG000
spread
20.07
value
3.86
group Id
OG001
spread
18.51
value
3.77
denoms
counts
group Id
OG000
value
69
group Id
OG001
value
118
units
Participants
title
Cycle 11 Day 1
categories
measurements
group Id
OG000
spread
18.51
value
5.29
group Id
OG001
spread
19.34
value
3.63
denoms
counts
group Id
OG000
value
63
group Id
OG001
value
115
units
Participants
title
Cycle 12 Day 1
categories
measurements
group Id
OG000
spread
19.57
value
6.81
group Id
OG001
spread
18.41
value
4.94
denoms
counts
group Id
OG000
value
59
group Id
OG001
value
109
units
Participants
title
Cycle 13 Day 1
denoms
counts
group Id
OG000
value
123
group Id
OG001
value
179
units
Participants
description
The EQ-5D-5L is a standardized measure of health status that provides a general assessment of health utility and consist of 2 sections; descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and a VAS. The VAS records the respondent's self-rated health on a 20 centimeter (cm) vertical VAS; the scale went from 0 (worst imaginable health state) to 100 (best imaginable health state). This information can be used as a quantitative measure of health as judged by the individual respondents.
dispersion Type
Standard Deviation
groups
description
Participants received carfilzomib 20 mg/m\^2, IV infusion on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle along with dexamethasone 20 mg, PO or IV on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 114 weeks).
id
OG000
title
Carfilzomib + Dexamethasone (Kd)
description
Participants received isatuximab 10 mg/kg, IV infusion on Days 1, 8, 15 and 22 in Cycle 1, and then on Days 1 and Day 15 of each 28-day treatment cycle plus carfilzomib 20 mg/m\^2, IV on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle and dexamethasone 20 mg, PO or IV on Day 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 111 weeks).
id
OG001
title
Isatuximab + Carfilzomib + Dexamethasone (IKd)
param Type
MEAN
population Description
Analysis was performed on ITT population. Here, 'Number analyzed' signifies participants with available data for each specified category.
reporting Status
POSTED
time Frame
Baseline, Day 1 of each cycle (Cycle 2 to Cycle 25), at the End of Treatment visit (any day up to 114 weeks)
title
HRQL: Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Score: Visual Analogic Scale (VAS) at Specified Timepoints: Primary Analysis
Triangle