HRQL: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Side Effects of Treatment 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
EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in participants with multiple myeloma. Side effects of treatment domain is one of the four domain scores. Side effects of treatment domain consists of 10 questions and the score uses a 4-point scale (1 'Not at All' to 4 'Very Much'). Side Effects of Treatment Score (MYSE) is calculated as (\[{Q37+Q38+Q39+Q40+Q41+Q42+Q43+Q44+Q45+Q46}/10\]-1)/3\*100. Scores are averaged, and transformed to 0-100 scale, where higher scores = more side effects and lower HRQL and lower scores = less side effects and better HRQL.
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)
103
Isatuximab + Carfilzomib + Dexamethasone (IKd)
157
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Carfilzomib + Dexamethasone (Kd)
1.23
11.56
Not reported
Not reported
Not reported
Isatuximab + Carfilzomib + Dexamethasone (IKd)
1.41
11.71
Not reported
Not reported
Not reported
Cycle 3 Day 1
Analysis denominator · Participants
Group
Source count
Carfilzomib + Dexamethasone (Kd)
102
Isatuximab + Carfilzomib + Dexamethasone (IKd)
158
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Carfilzomib + Dexamethasone (Kd)
0.44
10.11
Not reported
Not reported
Not reported
Isatuximab + Carfilzomib + Dexamethasone (IKd)
0.84
12.00
Not reported
Not reported
Not reported
Cycle 4 Day 1
Analysis denominator · Participants
Group
Source count
Carfilzomib + Dexamethasone (Kd)
102
Isatuximab + Carfilzomib + Dexamethasone (IKd)
152
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Carfilzomib + Dexamethasone (Kd)
0.83
11.38
Not reported
Not reported
Not reported
Isatuximab + Carfilzomib + Dexamethasone (IKd)
0.99
11.89
Not reported
Not reported
Not reported
Cycle 5 Day 1
Analysis denominator · Participants
Group
Source count
Carfilzomib + Dexamethasone (Kd)
97
Isatuximab + Carfilzomib + Dexamethasone (IKd)
150
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Carfilzomib + Dexamethasone (Kd)
1.91
11.36
Not reported
Not reported
Not reported
Isatuximab + Carfilzomib + Dexamethasone (IKd)
2.36
11.94
Not reported
Not reported
Not reported
Cycle 6 Day 1
Analysis denominator · Participants
Group
Source count
Carfilzomib + Dexamethasone (Kd)
91
Isatuximab + Carfilzomib + Dexamethasone (IKd)
146
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Carfilzomib + Dexamethasone (Kd)
2.08
11.81
Not reported
Not reported
Not reported
Isatuximab + Carfilzomib + Dexamethasone (IKd)
1.61
12.32
Not reported
Not reported
Not reported
Cycle 7 Day 1
Analysis denominator · Participants
Group
Source count
Carfilzomib + Dexamethasone (Kd)
87
Isatuximab + Carfilzomib + Dexamethasone (IKd)
143
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Carfilzomib + Dexamethasone (Kd)
1.47
12.14
Not reported
Not reported
Not reported
Isatuximab + Carfilzomib + Dexamethasone (IKd)
2.14
10.76
Not reported
Not reported
Not reported
Cycle 8 Day 1
Analysis denominator · Participants
Group
Source count
Carfilzomib + Dexamethasone (Kd)
84
Isatuximab + Carfilzomib + Dexamethasone (IKd)
136
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Carfilzomib + Dexamethasone (Kd)
1.53
12.07
Not reported
Not reported
Not reported
Isatuximab + Carfilzomib + Dexamethasone (IKd)
2.86
12.77
Not reported
Not reported
Not reported
Cycle 9 Day 1
Analysis denominator · Participants
Group
Source count
Carfilzomib + Dexamethasone (Kd)
79
Isatuximab + Carfilzomib + Dexamethasone (IKd)
131
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Carfilzomib + Dexamethasone (Kd)
1.68
11.57
Not reported
Not reported
Not reported
Isatuximab + Carfilzomib + Dexamethasone (IKd)
1.49
11.96
Not reported
Not reported
Not reported
Cycle 10 Day 1
Analysis denominator · Participants
Group
Source count
Carfilzomib + Dexamethasone (Kd)
74
Isatuximab + Carfilzomib + Dexamethasone (IKd)
125
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Carfilzomib + Dexamethasone (Kd)
2.07
11.62
Not reported
Not reported
Not reported
Isatuximab + Carfilzomib + Dexamethasone (IKd)
2.68
12.51
Not reported
Not reported
Not reported
Cycle 11 Day 1
Analysis denominator · Participants
Group
Source count
Carfilzomib + Dexamethasone (Kd)
72
Isatuximab + Carfilzomib + Dexamethasone (IKd)
122
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Carfilzomib + Dexamethasone (Kd)
3.38
12.00
Not reported
Not reported
Not reported
Isatuximab + Carfilzomib + Dexamethasone (IKd)
2.03
12.16
Not reported
Not reported
Not reported
Cycle 12 Day 1
Analysis denominator · Participants
Group
Source count
Carfilzomib + Dexamethasone (Kd)
65
Isatuximab + Carfilzomib + Dexamethasone (IKd)
121
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Carfilzomib + Dexamethasone (Kd)
1.20
10.52
Not reported
Not reported
Not reported
Isatuximab + Carfilzomib + Dexamethasone (IKd)
3.04
12.72
Not reported
Not reported
Not reported
Cycle 13 Day 1
Analysis denominator · Participants
Group
Source count
Carfilzomib + Dexamethasone (Kd)
60
Isatuximab + Carfilzomib + Dexamethasone (IKd)
114
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Carfilzomib + Dexamethasone (Kd)
0.82
10.22
Not reported
Not reported
Not reported
Isatuximab + Carfilzomib + Dexamethasone (IKd)
2.12
12.33
Not reported
Not reported
Not reported
Cycle 14 Day 1
Analysis denominator · Participants
Group
Source count
Carfilzomib + Dexamethasone (Kd)
59
Isatuximab + Carfilzomib + Dexamethasone (IKd)
113
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Carfilzomib + Dexamethasone (Kd)
1.08
10.56
Not reported
Not reported
Not reported
Isatuximab + Carfilzomib + Dexamethasone (IKd)
1.71
12.58
Not reported
Not reported
Not reported
Cycle 15 Day 1
Analysis denominator · Participants
Group
Source count
Carfilzomib + Dexamethasone (Kd)
57
Isatuximab + Carfilzomib + Dexamethasone (IKd)
105
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Carfilzomib + Dexamethasone (Kd)
1.85
11.45
Not reported
Not reported
Not reported
Isatuximab + Carfilzomib + Dexamethasone (IKd)
1.87
11.80
Not reported
Not reported
Not reported
Cycle 16 Day 1
Analysis denominator · Participants
Group
Source count
Carfilzomib + Dexamethasone (Kd)
51
Isatuximab + Carfilzomib + Dexamethasone (IKd)
102
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Carfilzomib + Dexamethasone (Kd)
0.99
10.54
Not reported
Not reported
Not reported
Isatuximab + Carfilzomib + Dexamethasone (IKd)
2.58
11.88
Not reported
Not reported
Not reported
Cycle 17 Day 1
Analysis denominator · Participants
Group
Source count
Carfilzomib + Dexamethasone (Kd)
47
Isatuximab + Carfilzomib + Dexamethasone (IKd)
101
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Carfilzomib + Dexamethasone (Kd)
2.74
10.03
Not reported
Not reported
Not reported
Isatuximab + Carfilzomib + Dexamethasone (IKd)
4.10
12.77
Not reported
Not reported
Not reported
Cycle 18 Day 1
Analysis denominator · Participants
Group
Source count
Carfilzomib + Dexamethasone (Kd)
45
Isatuximab + Carfilzomib + Dexamethasone (IKd)
94
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Carfilzomib + Dexamethasone (Kd)
2.37
10.51
Not reported
Not reported
Not reported
Isatuximab + Carfilzomib + Dexamethasone (IKd)
2.95
13.38
Not reported
Not reported
Not reported
Cycle 19 Day 1
Analysis denominator · Participants
Group
Source count
Carfilzomib + Dexamethasone (Kd)
41
Isatuximab + Carfilzomib + Dexamethasone (IKd)
90
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Carfilzomib + Dexamethasone (Kd)
2.76
11.41
Not reported
Not reported
Not reported
Isatuximab + Carfilzomib + Dexamethasone (IKd)
2.16
11.56
Not reported
Not reported
Not reported
Cycle 20 Day 1
Analysis denominator · Participants
Group
Source count
Carfilzomib + Dexamethasone (Kd)
34
Isatuximab + Carfilzomib + Dexamethasone (IKd)
88
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Carfilzomib + Dexamethasone (Kd)
-0.17
10.62
Not reported
Not reported
Not reported
Isatuximab + Carfilzomib + Dexamethasone (IKd)
2.05
13.03
Not reported
Not reported
Not reported
Cycle 21 Day 1
Analysis denominator · Participants
Group
Source count
Carfilzomib + Dexamethasone (Kd)
28
Isatuximab + Carfilzomib + Dexamethasone (IKd)
73
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Carfilzomib + Dexamethasone (Kd)
3.17
10.61
Not reported
Not reported
Not reported
Isatuximab + Carfilzomib + Dexamethasone (IKd)
2.74
12.87
Not reported
Not reported
Not reported
Cycle 22 Day 1
Analysis denominator · Participants
Group
Source count
Carfilzomib + Dexamethasone (Kd)
19
Isatuximab + Carfilzomib + Dexamethasone (IKd)
54
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Carfilzomib + Dexamethasone (Kd)
3.55
6.46
Not reported
Not reported
Not reported
Isatuximab + Carfilzomib + Dexamethasone (IKd)
1.51
12.51
Not reported
Not reported
Not reported
Cycle 23 Day 1
Analysis denominator · Participants
Group
Source count
Carfilzomib + Dexamethasone (Kd)
15
Isatuximab + Carfilzomib + Dexamethasone (IKd)
37
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Carfilzomib + Dexamethasone (Kd)
7.85
9.93
Not reported
Not reported
Not reported
Isatuximab + Carfilzomib + Dexamethasone (IKd)
-1.39
12.02
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)
12.35
7.17
Not reported
Not reported
Not reported
Isatuximab + Carfilzomib + Dexamethasone (IKd)
-2.54
11.33
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)
11.85
4.06
Not reported
Not reported
Not reported
Isatuximab + Carfilzomib + Dexamethasone (IKd)
-3.50
12.83
Not reported
Not reported
Not reported
End of Treatment
Analysis denominator · Participants
Group
Source count
Carfilzomib + Dexamethasone (Kd)
59
Isatuximab + Carfilzomib + Dexamethasone (IKd)
57
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Carfilzomib + Dexamethasone (Kd)
4.63
13.01
Not reported
Not reported
Not reported
Isatuximab + Carfilzomib + Dexamethasone (IKd)
5.56
16.22
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
spread
11.56
value
1.23
group Id
OG001
spread
11.71
value
1.41
denoms
counts
group Id
OG000
value
103
group Id
OG001
value
157
units
Participants
title
Cycle 2 Day 1
categories
measurements
group Id
OG000
spread
10.11
value
0.44
group Id
OG001
spread
12.00
value
0.84
denoms
counts
group Id
OG000
value
102
group Id
OG001
value
158
units
Participants
title
Cycle 3 Day 1
categories
measurements
group Id
OG000
spread
11.38
value
0.83
group Id
OG001
spread
11.89
value
0.99
denoms
counts
group Id
OG000
value
102
group Id
OG001
value
152
units
Participants
title
Cycle 4 Day 1
categories
measurements
group Id
OG000
spread
11.36
value
1.91
group Id
OG001
spread
11.94
value
2.36
denoms
counts
group Id
OG000
value
97
group Id
OG001
value
150
units
Participants
title
Cycle 5 Day 1
categories
measurements
group Id
OG000
spread
11.81
value
2.08
group Id
OG001
spread
12.32
value
1.61
denoms
counts
group Id
OG000
value
91
group Id
OG001
value
146
units
Participants
title
Cycle 6 Day 1
categories
measurements
group Id
OG000
spread
12.14
value
1.47
group Id
OG001
spread
10.76
value
2.14
denoms
counts
group Id
OG000
value
87
group Id
OG001
value
143
units
Participants
title
Cycle 7 Day 1
categories
measurements
group Id
OG000
spread
12.07
value
1.53
group Id
OG001
spread
12.77
value
2.86
denoms
counts
group Id
OG000
value
84
group Id
OG001
value
136
units
Participants
title
Cycle 8 Day 1
categories
measurements
group Id
OG000
spread
11.57
value
1.68
group Id
OG001
spread
11.96
value
1.49
denoms
counts
group Id
OG000
value
79
group Id
OG001
value
131
units
Participants
title
Cycle 9 Day 1
categories
measurements
group Id
OG000
spread
11.62
value
2.07
group Id
OG001
spread
12.51
value
2.68
denoms
counts
group Id
OG000
value
74
group Id
OG001
value
125
units
Participants
title
Cycle 10 Day 1
categories
measurements
group Id
OG000
spread
12.00
value
3.38
group Id
OG001
spread
12.16
value
2.03
denoms
counts
group Id
OG000
value
72
group Id
OG001
value
122
units
Participants
title
Cycle 11 Day 1
categories
measurements
group Id
OG000
spread
10.52
value
1.20
group Id
OG001
spread
12.72
value
3.04
denoms
counts
group Id
OG000
value
65
group Id
OG001
value
121
units
Participants
title
Cycle 12 Day 1
categories
measurements
group Id
OG000
spread
10.22
value
0.82
group Id
OG001
spread
12.33
value
2.12
denoms
counts
group Id
OG000
value
60
group Id
OG001
value
114
units
Participants
title
Cycle 13 Day 1
denoms
counts
group Id
OG000
value
123
group Id
OG001
value
179
units
Participants
description
EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in participants with multiple myeloma. Side effects of treatment domain is one of the four domain scores. Side effects of treatment domain consists of 10 questions and the score uses a 4-point scale (1 'Not at All' to 4 'Very Much'). Side Effects of Treatment Score (MYSE) is calculated as (\[{Q37+Q38+Q39+Q40+Q41+Q42+Q43+Q44+Q45+Q46}/10\]-1)/3\*100. Scores are averaged, and transformed to 0-100 scale, where higher scores = more side effects and lower HRQL and lower scores = less side effects and better HRQL.
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 Organization for Research and Treatment of Cancer Quality of Life Cancer Specific Questionnaire With 20 Items (EORTC QLQ-MY20): Side Effects of Treatment at Specified Timepoints: Primary Analysis
Triangle