Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose
Study of Carfilzomib, Daratumumab and Dexamethasone for Patients With Relapsed and/or Refractory Multiple Myeloma. · Source last updated 2025-05-09
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 pre-dose) up to 236.3 weeks (longest treatment duration as of the FA DCO)
What was measured
Health-related quality of life was assessed with the use of the European Organization for Research and Treatment of Cancer Quality of Life Core Module (QLQ-C30) questionnaire, a validated instrument in multiple myeloma patients. Scores range from 0 to 100, with higher scores indicating better health related quality of life.
QLQ-C30 questionnaire was administered prior to dosing every 28 ± 7 days starting from cycle 1 day 1 through first follow-up visit (30 days \[+3\] after last dose of all study drugs).
Analysis population: Intent to Treat Population
Groups in this outcome
Kd - Carfilzomib and Dexamethasone
Carfilzomib was administered intravenously (IV) at 20 mg/m\^2 in Cycle 1: days 1 and 2; at 56 mg/m\^2 in Cycle 1: days 8, 9, 15 and 16. The 56 mg/m\^2 dosage was continued in Cycles 2+ on days 1, 2, 8, 9, 15 and 16.
Dexamethasone was taken by IV infusion at 20 mg on Cycle 1, days 1 and 2 (in Cycles 2+, days 1 and 2 could be either oral or IV) and either orally or by IV infusion on days 8, 9, 15 and 16 and at 40 mg on day 22 of all 28-day cycles.
KdD - Carfilzomib, Dexamethasone and Daratumumab
Carfilzomib was administered intravenously (IV) at 20 mg/m\^2 in Cycle 1: days 1 and 2; at 56 mg/m\^2 in Cycle 1: days 8, 9, 15 and 16. The 56 mg/m\^2 dosage was continued in Cycles 2+ on days 1, 2, 8, 9, 15 and 16.
Dexamethasone was taken by IV infusion at 20 mg on Cycle 1, days 1 and 2 (in Cycles 2+, days 1 and 2 could be either oral or IV) and either orally or by IV infusion on days 8, 9, 15 and 16 and at 40 mg on day 22 of all 28-day cycles. The administration of dexamethasone was given on carfilzomib and/or daratumumab IV infusion days.
Daratumumab was administered by IV at 8 mg/kg on Cycle 1: days 1 and 2; at 16 mg/kg on Cycle 1: days 8, 15 and 22, and Cycle 2: days 1, 8, 15, and 22. The 16 mg/kg dosage was continued on Cycles 3-6: days 1 and 15. The 16 mg/kg dosage was continued on Cycles 7+: day 1 only.
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
Kd - Carfilzomib and Dexamethasone
154
KdD - Carfilzomib, Dexamethasone and Daratumumab
312
Reported measurements
Baseline
Analysis denominator · Participants
Group
Source count
Kd - Carfilzomib and Dexamethasone
139
KdD - Carfilzomib, Dexamethasone and Daratumumab
289
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Kd - Carfilzomib and Dexamethasone
66.19
19.19
Not reported
Not reported
Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab
61.79
20.37
Not reported
Not reported
Not reported
Cycle 2
Analysis denominator · Participants
Group
Source count
Kd - Carfilzomib and Dexamethasone
126
KdD - Carfilzomib, Dexamethasone and Daratumumab
281
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Kd - Carfilzomib and Dexamethasone
64.35
16.25
Not reported
Not reported
Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab
61.00
19.65
Not reported
Not reported
Not reported
Cycle 3
Analysis denominator · Participants
Group
Source count
Kd - Carfilzomib and Dexamethasone
124
KdD - Carfilzomib, Dexamethasone and Daratumumab
264
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Kd - Carfilzomib and Dexamethasone
66.13
18.12
Not reported
Not reported
Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab
63.10
18.24
Not reported
Not reported
Not reported
Cycle 4
Analysis denominator · Participants
Group
Source count
Kd - Carfilzomib and Dexamethasone
112
KdD - Carfilzomib, Dexamethasone and Daratumumab
258
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Kd - Carfilzomib and Dexamethasone
66.67
15.01
Not reported
Not reported
Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab
63.47
18.66
Not reported
Not reported
Not reported
Cycle 5
Analysis denominator · Participants
Group
Source count
Kd - Carfilzomib and Dexamethasone
105
KdD - Carfilzomib, Dexamethasone and Daratumumab
252
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Kd - Carfilzomib and Dexamethasone
67.62
17.19
Not reported
Not reported
Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab
64.45
16.76
Not reported
Not reported
Not reported
Cycle 6
Analysis denominator · Participants
Group
Source count
Kd - Carfilzomib and Dexamethasone
96
KdD - Carfilzomib, Dexamethasone and Daratumumab
244
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Kd - Carfilzomib and Dexamethasone
68.06
15.80
Not reported
Not reported
Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab
65.92
16.85
Not reported
Not reported
Not reported
Cycle 7
Analysis denominator · Participants
Group
Source count
Kd - Carfilzomib and Dexamethasone
94
KdD - Carfilzomib, Dexamethasone and Daratumumab
223
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Kd - Carfilzomib and Dexamethasone
69.33
14.68
Not reported
Not reported
Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab
65.73
16.59
Not reported
Not reported
Not reported
Cycle 8
Analysis denominator · Participants
Group
Source count
Kd - Carfilzomib and Dexamethasone
87
KdD - Carfilzomib, Dexamethasone and Daratumumab
206
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Kd - Carfilzomib and Dexamethasone
69.44
17.82
Not reported
Not reported
Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab
66.34
16.64
Not reported
Not reported
Not reported
Cycle 9
Analysis denominator · Participants
Group
Source count
Kd - Carfilzomib and Dexamethasone
79
KdD - Carfilzomib, Dexamethasone and Daratumumab
202
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Kd - Carfilzomib and Dexamethasone
65.72
15.90
Not reported
Not reported
Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab
67.82
15.53
Not reported
Not reported
Not reported
Cycle 10
Analysis denominator · Participants
Group
Source count
Kd - Carfilzomib and Dexamethasone
73
KdD - Carfilzomib, Dexamethasone and Daratumumab
197
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Kd - Carfilzomib and Dexamethasone
68.38
14.56
Not reported
Not reported
Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab
67.98
16.26
Not reported
Not reported
Not reported
Cycle 11
Analysis denominator · Participants
Group
Source count
Kd - Carfilzomib and Dexamethasone
66
KdD - Carfilzomib, Dexamethasone and Daratumumab
189
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Kd - Carfilzomib and Dexamethasone
67.42
15.24
Not reported
Not reported
Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab
68.52
17.37
Not reported
Not reported
Not reported
Cycle 12
Analysis denominator · Participants
Group
Source count
Kd - Carfilzomib and Dexamethasone
65
KdD - Carfilzomib, Dexamethasone and Daratumumab
187
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Kd - Carfilzomib and Dexamethasone
65.13
14.94
Not reported
Not reported
Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab
67.47
17.16
Not reported
Not reported
Not reported
Cycle 13
Analysis denominator · Participants
Group
Source count
Kd - Carfilzomib and Dexamethasone
61
KdD - Carfilzomib, Dexamethasone and Daratumumab
175
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Kd - Carfilzomib and Dexamethasone
67.49
16.51
Not reported
Not reported
Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab
67.00
18.21
Not reported
Not reported
Not reported
Cycle 14
Analysis denominator · Participants
Group
Source count
Kd - Carfilzomib and Dexamethasone
59
KdD - Carfilzomib, Dexamethasone and Daratumumab
169
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Kd - Carfilzomib and Dexamethasone
67.66
17.03
Not reported
Not reported
Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab
66.12
16.60
Not reported
Not reported
Not reported
Cycle 15
Analysis denominator · Participants
Group
Source count
Kd - Carfilzomib and Dexamethasone
53
KdD - Carfilzomib, Dexamethasone and Daratumumab
167
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Kd - Carfilzomib and Dexamethasone
69.34
15.31
Not reported
Not reported
Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab
67.61
17.68
Not reported
Not reported
Not reported
Cycle 16
Analysis denominator · Participants
Group
Source count
Kd - Carfilzomib and Dexamethasone
54
KdD - Carfilzomib, Dexamethasone and Daratumumab
165
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Kd - Carfilzomib and Dexamethasone
68.21
16.44
Not reported
Not reported
Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab
66.41
18.69
Not reported
Not reported
Not reported
Cycle 17
Analysis denominator · Participants
Group
Source count
Kd - Carfilzomib and Dexamethasone
54
KdD - Carfilzomib, Dexamethasone and Daratumumab
159
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Kd - Carfilzomib and Dexamethasone
69.44
14.92
Not reported
Not reported
Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab
69.81
15.28
Not reported
Not reported
Not reported
Cycle 18
Analysis denominator · Participants
Group
Source count
Kd - Carfilzomib and Dexamethasone
52
KdD - Carfilzomib, Dexamethasone and Daratumumab
155
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Kd - Carfilzomib and Dexamethasone
66.67
16.50
Not reported
Not reported
Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab
66.29
16.38
Not reported
Not reported
Not reported
Cycle 19
Analysis denominator · Participants
Group
Source count
Kd - Carfilzomib and Dexamethasone
47
KdD - Carfilzomib, Dexamethasone and Daratumumab
150
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Kd - Carfilzomib and Dexamethasone
69.68
17.50
Not reported
Not reported
Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab
68.00
17.33
Not reported
Not reported
Not reported
Cycle 20
Analysis denominator · Participants
Group
Source count
Kd - Carfilzomib and Dexamethasone
40
KdD - Carfilzomib, Dexamethasone and Daratumumab
141
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Kd - Carfilzomib and Dexamethasone
71.04
14.49
Not reported
Not reported
Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab
66.43
19.52
Not reported
Not reported
Not reported
Cycle 21
Analysis denominator · Participants
Group
Source count
Kd - Carfilzomib and Dexamethasone
39
KdD - Carfilzomib, Dexamethasone and Daratumumab
143
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Kd - Carfilzomib and Dexamethasone
70.94
15.87
Not reported
Not reported
Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab
67.42
16.25
Not reported
Not reported
Not reported
Cycle 22
Analysis denominator · Participants
Group
Source count
Kd - Carfilzomib and Dexamethasone
36
KdD - Carfilzomib, Dexamethasone and Daratumumab
139
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Kd - Carfilzomib and Dexamethasone
68.52
12.30
Not reported
Not reported
Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab
67.51
17.90
Not reported
Not reported
Not reported
Cycle 23
Analysis denominator · Participants
Group
Source count
Kd - Carfilzomib and Dexamethasone
35
KdD - Carfilzomib, Dexamethasone and Daratumumab
131
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Kd - Carfilzomib and Dexamethasone
69.52
16.41
Not reported
Not reported
Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab
66.67
17.63
Not reported
Not reported
Not reported
Cycle 24
Analysis denominator · Participants
Group
Source count
Kd - Carfilzomib and Dexamethasone
35
KdD - Carfilzomib, Dexamethasone and Daratumumab
125
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Kd - Carfilzomib and Dexamethasone
68.10
18.24
Not reported
Not reported
Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab
68.00
16.51
Not reported
Not reported
Not reported
Cycle 25
Analysis denominator · Participants
Group
Source count
Kd - Carfilzomib and Dexamethasone
33
KdD - Carfilzomib, Dexamethasone and Daratumumab
127
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Kd - Carfilzomib and Dexamethasone
67.93
16.15
Not reported
Not reported
Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab
66.21
16.78
Not reported
Not reported
Not reported
Cycle 26
Analysis denominator · Participants
Group
Source count
Kd - Carfilzomib and Dexamethasone
33
KdD - Carfilzomib, Dexamethasone and Daratumumab
121
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Kd - Carfilzomib and Dexamethasone
70.71
18.65
Not reported
Not reported
Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab
66.12
17.54
Not reported
Not reported
Not reported
Cycle 27
Analysis denominator · Participants
Group
Source count
Kd - Carfilzomib and Dexamethasone
29
KdD - Carfilzomib, Dexamethasone and Daratumumab
112
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Kd - Carfilzomib and Dexamethasone
65.23
14.78
Not reported
Not reported
Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab
66.52
18.35
Not reported
Not reported
Not reported
Cycle 28
Analysis denominator · Participants
Group
Source count
Kd - Carfilzomib and Dexamethasone
29
KdD - Carfilzomib, Dexamethasone and Daratumumab
109
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Kd - Carfilzomib and Dexamethasone
63.22
19.61
Not reported
Not reported
Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab
67.28
18.66
Not reported
Not reported
Not reported
Cycle 29
Analysis denominator · Participants
Group
Source count
Kd - Carfilzomib and Dexamethasone
25
KdD - Carfilzomib, Dexamethasone and Daratumumab
105
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Kd - Carfilzomib and Dexamethasone
66.67
19.25
Not reported
Not reported
Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab
67.22
18.10
Not reported
Not reported
Not reported
Cycle 30
Analysis denominator · Participants
Group
Source count
Kd - Carfilzomib and Dexamethasone
24
KdD - Carfilzomib, Dexamethasone and Daratumumab
104
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Kd - Carfilzomib and Dexamethasone
67.01
17.63
Not reported
Not reported
Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab
67.23
18.52
Not reported
Not reported
Not reported
Cycle 31
Analysis denominator · Participants
Group
Source count
Kd - Carfilzomib and Dexamethasone
24
KdD - Carfilzomib, Dexamethasone and Daratumumab
101
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Kd - Carfilzomib and Dexamethasone
68.06
16.24
Not reported
Not reported
Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab
67.33
18.81
Not reported
Not reported
Not reported
Cycle 32
Analysis denominator · Participants
Group
Source count
Kd - Carfilzomib and Dexamethasone
23
KdD - Carfilzomib, Dexamethasone and Daratumumab
94
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Kd - Carfilzomib and Dexamethasone
66.67
19.62
Not reported
Not reported
Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab
67.91
18.45
Not reported
Not reported
Not reported
Cycle 33
Analysis denominator · Participants
Group
Source count
Kd - Carfilzomib and Dexamethasone
23
KdD - Carfilzomib, Dexamethasone and Daratumumab
91
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Kd - Carfilzomib and Dexamethasone
67.75
15.35
Not reported
Not reported
Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab
67.95
18.92
Not reported
Not reported
Not reported
Cycle 34
Analysis denominator · Participants
Group
Source count
Kd - Carfilzomib and Dexamethasone
22
KdD - Carfilzomib, Dexamethasone and Daratumumab
86
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Kd - Carfilzomib and Dexamethasone
68.18
15.78
Not reported
Not reported
Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab
69.86
17.77
Not reported
Not reported
Not reported
Cycle 35
Analysis denominator · Participants
Group
Source count
Kd - Carfilzomib and Dexamethasone
22
KdD - Carfilzomib, Dexamethasone and Daratumumab
88
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Kd - Carfilzomib and Dexamethasone
65.91
15.62
Not reported
Not reported
Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab
69.51
18.00
Not reported
Not reported
Not reported
Cycle 36
Analysis denominator · Participants
Group
Source count
Kd - Carfilzomib and Dexamethasone
23
KdD - Carfilzomib, Dexamethasone and Daratumumab
86
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Kd - Carfilzomib and Dexamethasone
63.77
18.22
Not reported
Not reported
Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab
68.22
16.93
Not reported
Not reported
Not reported
Cycle 37
Analysis denominator · Participants
Group
Source count
Kd - Carfilzomib and Dexamethasone
20
KdD - Carfilzomib, Dexamethasone and Daratumumab
89
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Kd - Carfilzomib and Dexamethasone
67.50
18.91
Not reported
Not reported
Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab
68.63
19.01
Not reported
Not reported
Not reported
Cycle 38
Analysis denominator · Participants
Group
Source count
Kd - Carfilzomib and Dexamethasone
17
KdD - Carfilzomib, Dexamethasone and Daratumumab
84
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Kd - Carfilzomib and Dexamethasone
65.20
18.69
Not reported
Not reported
Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab
69.25
18.47
Not reported
Not reported
Not reported
Cycle 39
Analysis denominator · Participants
Group
Source count
Kd - Carfilzomib and Dexamethasone
17
KdD - Carfilzomib, Dexamethasone and Daratumumab
78
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Kd - Carfilzomib and Dexamethasone
64.71
15.46
Not reported
Not reported
Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab
68.38
19.15
Not reported
Not reported
Not reported
Cycle 40
Analysis denominator · Participants
Group
Source count
Kd - Carfilzomib and Dexamethasone
14
KdD - Carfilzomib, Dexamethasone and Daratumumab
78
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Kd - Carfilzomib and Dexamethasone
58.33
14.25
Not reported
Not reported
Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab
67.74
19.34
Not reported
Not reported
Not reported
Cycle 41
Analysis denominator · Participants
Group
Source count
Kd - Carfilzomib and Dexamethasone
14
KdD - Carfilzomib, Dexamethasone and Daratumumab
79
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Kd - Carfilzomib and Dexamethasone
66.07
13.26
Not reported
Not reported
Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab
68.46
19.37
Not reported
Not reported
Not reported
Cycle 42
Analysis denominator · Participants
Group
Source count
Kd - Carfilzomib and Dexamethasone
14
KdD - Carfilzomib, Dexamethasone and Daratumumab
68
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Kd - Carfilzomib and Dexamethasone
63.69
15.19
Not reported
Not reported
Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab
67.16
18.77
Not reported
Not reported
Not reported
Cycle 43
Analysis denominator · Participants
Group
Source count
Kd - Carfilzomib and Dexamethasone
15
KdD - Carfilzomib, Dexamethasone and Daratumumab
57
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Kd - Carfilzomib and Dexamethasone
67.22
15.89
Not reported
Not reported
Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab
63.30
19.91
Not reported
Not reported
Not reported
Cycle 44
Analysis denominator · Participants
Group
Source count
Kd - Carfilzomib and Dexamethasone
12
KdD - Carfilzomib, Dexamethasone and Daratumumab
50
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Kd - Carfilzomib and Dexamethasone
61.81
15.27
Not reported
Not reported
Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab
65.50
18.21
Not reported
Not reported
Not reported
Cycle 45
Analysis denominator · Participants
Group
Source count
Kd - Carfilzomib and Dexamethasone
9
KdD - Carfilzomib, Dexamethasone and Daratumumab
41
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Kd - Carfilzomib and Dexamethasone
67.59
12.11
Not reported
Not reported
Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab
66.87
15.53
Not reported
Not reported
Not reported
Cycle 46
Analysis denominator · Participants
Group
Source count
Kd - Carfilzomib and Dexamethasone
8
KdD - Carfilzomib, Dexamethasone and Daratumumab
34
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Kd - Carfilzomib and Dexamethasone
64.58
13.91
Not reported
Not reported
Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab
67.89
17.66
Not reported
Not reported
Not reported
Cycle 47
Analysis denominator · Participants
Group
Source count
Kd - Carfilzomib and Dexamethasone
4
KdD - Carfilzomib, Dexamethasone and Daratumumab
27
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Kd - Carfilzomib and Dexamethasone
66.67
0.00
Not reported
Not reported
Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab
68.52
13.74
Not reported
Not reported
Not reported
Cycle 48
Analysis denominator · Participants
Group
Source count
Kd - Carfilzomib and Dexamethasone
3
KdD - Carfilzomib, Dexamethasone and Daratumumab
22
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Kd - Carfilzomib and Dexamethasone
61.11
9.62
Not reported
Not reported
Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab
68.56
13.35
Not reported
Not reported
Not reported
Cycle 49
Analysis denominator · Participants
Group
Source count
Kd - Carfilzomib and Dexamethasone
3
KdD - Carfilzomib, Dexamethasone and Daratumumab
19
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Kd - Carfilzomib and Dexamethasone
61.11
9.62
Not reported
Not reported
Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab
68.42
13.49
Not reported
Not reported
Not reported
Cycle 50
Analysis denominator · Participants
Group
Source count
Kd - Carfilzomib and Dexamethasone
3
KdD - Carfilzomib, Dexamethasone and Daratumumab
16
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Kd - Carfilzomib and Dexamethasone
61.11
9.62
Not reported
Not reported
Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab
68.75
13.09
Not reported
Not reported
Not reported
Cycle 51
Analysis denominator · Participants
Group
Source count
Kd - Carfilzomib and Dexamethasone
3
KdD - Carfilzomib, Dexamethasone and Daratumumab
12
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Kd - Carfilzomib and Dexamethasone
63.89
4.81
Not reported
Not reported
Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab
67.36
11.49
Not reported
Not reported
Not reported
Cycle 52
Analysis denominator · Participants
Group
Source count
Kd - Carfilzomib and Dexamethasone
2
KdD - Carfilzomib, Dexamethasone and Daratumumab
9
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Kd - Carfilzomib and Dexamethasone
54.17
17.68
Not reported
Not reported
Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab
62.04
17.24
Not reported
Not reported
Not reported
Cycle 53
Analysis denominator · Participants
Group
Source count
Kd - Carfilzomib and Dexamethasone
0
KdD - Carfilzomib, Dexamethasone and Daratumumab
3
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
KdD - Carfilzomib, Dexamethasone and Daratumumab
61.11
9.62
Not reported
Not reported
Not reported
Follow-up
Analysis denominator · Participants
Group
Source count
Kd - Carfilzomib and Dexamethasone
25
KdD - Carfilzomib, Dexamethasone and Daratumumab
32
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Kd - Carfilzomib and Dexamethasone
61.00
23.04
Not reported
Not reported
Not reported
KdD - Carfilzomib, Dexamethasone and Daratumumab
59.90
18.02
Not reported
Not reported
Not reported
Source statistical analyses
Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.
ci Lower Limit
-2.52
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
2.35
dispersion Type
STANDARD_ERROR_OF_MEAN
dispersion Value
1.24
estimate Comment
The overall treatment difference (KdD - Kd)
group Description
Analysis was performed based on a linear mixed effects model. The model included fixed effects of treatment (all baseline responses were modeled with a dummy treatment), baseline QLQ-C30 GHS/QoL score, randomization stratification factors (ISS stage at screening (Stage 1 or 2 vs Stage 3), prior proteasome inhibitor exposure (yes vs no), number of prior lines of therapy (1 vs ≥ 2)), interaction between treatment and time, and random effects of participant intercept and random slope of time.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.9480
param Type
Mean Difference (Final Values)
param Value
-0.08
statistical Method
linear mixed effects model
Complete source fields
analyses
ci Lower Limit
-2.52
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
2.35
dispersion Type
STANDARD_ERROR_OF_MEAN
dispersion Value
1.24
estimate Comment
The overall treatment difference (KdD - Kd)
group Description
Analysis was performed based on a linear mixed effects model. The model included fixed effects of treatment (all baseline responses were modeled with a dummy treatment), baseline QLQ-C30 GHS/QoL score, randomization stratification factors (ISS stage at screening (Stage 1 or 2 vs Stage 3), prior proteasome inhibitor exposure (yes vs no), number of prior lines of therapy (1 vs ≥ 2)), interaction between treatment and time, and random effects of participant intercept and random slope of time.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.9480
param Type
Mean Difference (Final Values)
param Value
-0.08
statistical Method
linear mixed effects model
classes
categories
measurements
group Id
OG000
spread
19.19
value
66.19
group Id
OG001
spread
20.37
value
61.79
denoms
counts
group Id
OG000
value
139
group Id
OG001
value
289
units
Participants
title
Baseline
categories
measurements
group Id
OG000
spread
16.25
value
64.35
group Id
OG001
spread
19.65
value
61.00
denoms
counts
group Id
OG000
value
126
group Id
OG001
value
281
units
Participants
title
Cycle 2
categories
measurements
group Id
OG000
spread
18.12
value
66.13
group Id
OG001
spread
18.24
value
63.10
denoms
counts
group Id
OG000
value
124
group Id
OG001
value
264
units
Participants
title
Cycle 3
categories
measurements
group Id
OG000
spread
15.01
value
66.67
group Id
OG001
spread
18.66
value
63.47
denoms
counts
group Id
OG000
value
112
group Id
OG001
value
258
units
Participants
title
Cycle 4
categories
measurements
group Id
OG000
spread
17.19
value
67.62
group Id
OG001
spread
16.76
value
64.45
denoms
counts
group Id
OG000
value
105
group Id
OG001
value
252
units
Participants
title
Cycle 5
categories
measurements
group Id
OG000
spread
15.80
value
68.06
group Id
OG001
spread
16.85
value
65.92
denoms
counts
group Id
OG000
value
96
group Id
OG001
value
244
units
Participants
title
Cycle 6
categories
measurements
group Id
OG000
spread
14.68
value
69.33
group Id
OG001
spread
16.59
value
65.73
denoms
counts
group Id
OG000
value
94
group Id
OG001
value
223
units
Participants
title
Cycle 7
categories
measurements
group Id
OG000
spread
17.82
value
69.44
group Id
OG001
spread
16.64
value
66.34
denoms
counts
group Id
OG000
value
87
group Id
OG001
value
206
units
Participants
title
Cycle 8
categories
measurements
group Id
OG000
spread
15.90
value
65.72
group Id
OG001
spread
15.53
value
67.82
denoms
counts
group Id
OG000
value
79
group Id
OG001
value
202
units
Participants
title
Cycle 9
categories
measurements
group Id
OG000
spread
14.56
value
68.38
group Id
OG001
spread
16.26
value
67.98
denoms
counts
group Id
OG000
value
73
group Id
OG001
value
197
units
Participants
title
Cycle 10
categories
measurements
group Id
OG000
spread
15.24
value
67.42
group Id
OG001
spread
17.37
value
68.52
denoms
counts
group Id
OG000
value
66
group Id
OG001
value
189
units
Participants
title
Cycle 11
categories
measurements
group Id
OG000
spread
14.94
value
65.13
group Id
OG001
spread
17.16
value
67.47
denoms
counts
group Id
OG000
value
65
group Id
OG001
value
187
units
Participants
title
Cycle 12
denoms
counts
group Id
OG000
value
154
group Id
OG001
value
312
units
Participants
description
Health-related quality of life was assessed with the use of the European Organization for Research and Treatment of Cancer Quality of Life Core Module (QLQ-C30) questionnaire, a validated instrument in multiple myeloma patients. Scores range from 0 to 100, with higher scores indicating better health related quality of life.
QLQ-C30 questionnaire was administered prior to dosing every 28 ± 7 days starting from cycle 1 day 1 through first follow-up visit (30 days \[+3\] after last dose of all study drugs).
dispersion Type
Standard Deviation
groups
description
Carfilzomib was administered intravenously (IV) at 20 mg/m\^2 in Cycle 1: days 1 and 2; at 56 mg/m\^2 in Cycle 1: days 8, 9, 15 and 16. The 56 mg/m\^2 dosage was continued in Cycles 2+ on days 1, 2, 8, 9, 15 and 16.
Dexamethasone was taken by IV infusion at 20 mg on Cycle 1, days 1 and 2 (in Cycles 2+, days 1 and 2 could be either oral or IV) and either orally or by IV infusion on days 8, 9, 15 and 16 and at 40 mg on day 22 of all 28-day cycles.
id
OG000
title
Kd - Carfilzomib and Dexamethasone
description
Carfilzomib was administered intravenously (IV) at 20 mg/m\^2 in Cycle 1: days 1 and 2; at 56 mg/m\^2 in Cycle 1: days 8, 9, 15 and 16. The 56 mg/m\^2 dosage was continued in Cycles 2+ on days 1, 2, 8, 9, 15 and 16.
Dexamethasone was taken by IV infusion at 20 mg on Cycle 1, days 1 and 2 (in Cycles 2+, days 1 and 2 could be either oral or IV) and either orally or by IV infusion on days 8, 9, 15 and 16 and at 40 mg on day 22 of all 28-day cycles. The administration of dexamethasone was given on carfilzomib and/or daratumumab IV infusion days.
Daratumumab was administered by IV at 8 mg/kg on Cycle 1: days 1 and 2; at 16 mg/kg on Cycle 1: days 8, 15 and 22, and Cycle 2: days 1, 8, 15, and 22. The 16 mg/kg dosage was continued on Cycles 3-6: days 1 and 15. The 16 mg/kg dosage was continued on Cycles 7+: day 1 only.
id
OG001
title
KdD - Carfilzomib, Dexamethasone and Daratumumab
param Type
MEAN
population Description
Intent to Treat Population
reporting Status
POSTED
time Frame
Baseline (Day 1 pre-dose) up to 236.3 weeks (longest treatment duration as of the FA DCO)
title
Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores For Baseline Up to the First Follow-Up Visit After the Last Dose
Triangle