NCT03158688 · BASELINE

Baseline characteristics

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.

denoms

counts
group Id
BG000
value
154
group Id
BG001
value
312
group Id
BG002
value
466
units
Participants

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
BG000
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
BG001
title
KdD - Carfilzomib, Dexamethasone and Daratumumab
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
9.6
value
64.3
group Id
BG001
spread
10.0
value
62.9
group Id
BG002
spread
9.9
value
63.4
denoms
counts
group Id
BG000
value
154
group Id
BG001
value
312
group Id
BG002
value
466
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
77
group Id
BG001
value
163
group Id
BG002
value
240
title
18 - 64 years
measurements
group Id
BG000
value
55
group Id
BG001
value
121
group Id
BG002
value
176
title
65 - 74 years
measurements
group Id
BG000
value
22
group Id
BG001
value
28
group Id
BG002
value
50
title
75 - 84 years
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
>=85 years
denoms
counts
group Id
BG000
value
154
group Id
BG001
value
312
group Id
BG002
value
466
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Age, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
63
group Id
BG001
value
135
group Id
BG002
value
198
title
Female
measurements
group Id
BG000
value
91
group Id
BG001
value
177
group Id
BG002
value
268
title
Male
denoms
counts
group Id
BG000
value
154
group Id
BG001
value
312
group Id
BG002
value
466
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
7
group Id
BG002
value
8
title
Hispanic or Latino
measurements
group Id
BG000
value
146
group Id
BG001
value
291
group Id
BG002
value
437
title
Not Hispanic or Latino
measurements
group Id
BG000
value
7
group Id
BG001
value
14
group Id
BG002
value
21
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
154
group Id
BG001
value
312
group Id
BG002
value
466
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Ethnicity (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
20
group Id
BG001
value
46
group Id
BG002
value
66
title
Asian
measurements
group Id
BG000
value
2
group Id
BG001
value
7
group Id
BG002
value
9
title
Black or African American
measurements
group Id
BG000
value
123
group Id
BG001
value
243
group Id
BG002
value
366
title
White
measurements
group Id
BG000
value
9
group Id
BG001
value
16
group Id
BG002
value
25
title
Other
denoms
counts
group Id
BG000
value
154
group Id
BG001
value
312
group Id
BG002
value
466
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Race/Ethnicity, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
68
group Id
BG001
value
176
group Id
BG002
value
244
title
Fit
measurements
group Id
BG000
value
36
group Id
BG001
value
54
group Id
BG002
value
90
title
Intermediate fitness
measurements
group Id
BG000
value
9
group Id
BG001
value
10
group Id
BG002
value
19
title
Frail
measurements
group Id
BG000
value
37
group Id
BG001
value
66
group Id
BG002
value
103
title
Not available
measurements
group Id
BG000
value
4
group Id
BG001
value
6
group Id
BG002
value
10
title
Missing
denoms
counts
group Id
BG000
value
154
group Id
BG001
value
312
group Id
BG002
value
466
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Frailty Status as Assessed by Investigator
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
147
group Id
BG001
value
295
group Id
BG002
value
442
title
Disease status 0 or 1
measurements
group Id
BG000
value
7
group Id
BG001
value
15
group Id
BG002
value
22
title
Disease status 2
measurements
group Id
BG000
value
0
group Id
BG001
value
2
group Id
BG002
value
2
title
Missing
denoms
counts
group Id
BG000
value
154
group Id
BG001
value
312
group Id
BG002
value
466
units
Participants
description
A scale to assess a patient's disease status. 0 = Fully active, able to carry out all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity, ambulatory and able to carry out work of a light nature; 2 = Ambulatory and capable of all self care, unable to carry out any work activities. Up and about \> 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair \> 50% of waking hours; 4 = Completely disabled, confined to bed or chair; 5 = Dead.
param Type
COUNT_OF_PARTICIPANTS
title
Eastern Cooperative Oncology Group (ECOG) Performance Status
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
spread
36.57
value
44.03
group Id
BG001
spread
34.69
value
47.86
group Id
BG002
spread
35.34
value
46.58
denoms
counts
group Id
BG000
value
149
group Id
BG001
value
297
group Id
BG002
value
446
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
population Description
Data was not available for some participants.
title
Time from Initial Diagnosis to Randomization
unit Of Measure
months
classes
categories
measurements
group Id
BG000
value
26
group Id
BG001
value
48
group Id
BG002
value
74
title
High risk
measurements
group Id
BG000
value
56
group Id
BG001
value
108
group Id
BG002
value
164
title
Standard risk
measurements
group Id
BG000
value
72
group Id
BG001
value
156
group Id
BG002
value
228
title
Unknown
denoms
counts
group Id
BG000
value
154
group Id
BG001
value
312
group Id
BG002
value
466
units
Participants
description
The high-risk group consists of the genetic subtypes t(4; 14), t(14; 16), or deletion17p. The standard-risk group consists of participants without t(4; 14), t(14; 16), and deletion 17p. The unknown risk group is participants with FISH result not done, failed or quantity was not sufficient.
param Type
COUNT_OF_PARTICIPANTS
title
Risk Group as Determined by Fluorescent in situ Hybridization (FISH)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
127
group Id
BG001
value
252
group Id
BG002
value
379
title
Stage I or II
measurements
group Id
BG000
value
27
group Id
BG001
value
60
group Id
BG002
value
87
title
Stage III
denoms
counts
group Id
BG000
value
154
group Id
BG001
value
312
group Id
BG002
value
466
units
Participants
description
The International Staging System (ISS) for myeloma was published by the International Myeloma Working Group (a lower stage indicates less progressed disease): Stage I: β2-microglobulin (β2M) \< 3.5 mg/L, albumin \>= 3.5 g/dL Stage II: β2M \< 3.5 mg/L and albumin \< 3.5 g/dL; or β2M 3.5 mg/L - 5.5 mg/L irrespective of the serum albumin Stage III: β2M ≥ 5.5 mg/L. Higher stages indicate more advanced disease and/or poorer prognosis. Data is the ISS result assessed at the time of randomization using an interactive voice/web response system (IxRS).
param Type
COUNT_OF_PARTICIPANTS
title
Stratification Factor: International Staging System (ISS) Stage per IxRS
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
67
group Id
BG001
value
133
group Id
BG002
value
200
title
1 prior treatment
measurements
group Id
BG000
value
87
group Id
BG001
value
179
group Id
BG002
value
266
title
> = 2 prior treatments
denoms
counts
group Id
BG000
value
154
group Id
BG001
value
312
group Id
BG002
value
466
units
Participants
description
Number of participants grouped by total number of prior regimens. Data reported are randomization stratification values.
param Type
COUNT_OF_PARTICIPANTS
title
Stratification Factor: Lines of Prior Treatment per IxRS
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
139
group Id
BG001
value
279
group Id
BG002
value
418
title
Yes
measurements
group Id
BG000
value
15
group Id
BG001
value
33
group Id
BG002
value
48
title
No
denoms
counts
group Id
BG000
value
154
group Id
BG001
value
312
group Id
BG002
value
466
units
Participants
description
The number of participants with prior proteasome inhibitor treatment assessed at the time of randomization per the IxRS. Data reported are randomization stratification values.
param Type
COUNT_OF_PARTICIPANTS
title
Stratification Factor: Prior Proteasome Inhibitor Treatment per IxRS
unit Of Measure
Participants

population Description

Intent to Treat population

Complete source fields

denoms

counts
group Id
BG000
value
154
group Id
BG001
value
312
group Id
BG002
value
466
units
Participants

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
BG000
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
BG001
title
KdD - Carfilzomib, Dexamethasone and Daratumumab
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
9.6
value
64.3
group Id
BG001
spread
10.0
value
62.9
group Id
BG002
spread
9.9
value
63.4
denoms
counts
group Id
BG000
value
154
group Id
BG001
value
312
group Id
BG002
value
466
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
77
group Id
BG001
value
163
group Id
BG002
value
240
title
18 - 64 years
measurements
group Id
BG000
value
55
group Id
BG001
value
121
group Id
BG002
value
176
title
65 - 74 years
measurements
group Id
BG000
value
22
group Id
BG001
value
28
group Id
BG002
value
50
title
75 - 84 years
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
>=85 years
denoms
counts
group Id
BG000
value
154
group Id
BG001
value
312
group Id
BG002
value
466
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Age, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
63
group Id
BG001
value
135
group Id
BG002
value
198
title
Female
measurements
group Id
BG000
value
91
group Id
BG001
value
177
group Id
BG002
value
268
title
Male
denoms
counts
group Id
BG000
value
154
group Id
BG001
value
312
group Id
BG002
value
466
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
7
group Id
BG002
value
8
title
Hispanic or Latino
measurements
group Id
BG000
value
146
group Id
BG001
value
291
group Id
BG002
value
437
title
Not Hispanic or Latino
measurements
group Id
BG000
value
7
group Id
BG001
value
14
group Id
BG002
value
21
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
154
group Id
BG001
value
312
group Id
BG002
value
466
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Ethnicity (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
20
group Id
BG001
value
46
group Id
BG002
value
66
title
Asian
measurements
group Id
BG000
value
2
group Id
BG001
value
7
group Id
BG002
value
9
title
Black or African American
measurements
group Id
BG000
value
123
group Id
BG001
value
243
group Id
BG002
value
366
title
White
measurements
group Id
BG000
value
9
group Id
BG001
value
16
group Id
BG002
value
25
title
Other
denoms
counts
group Id
BG000
value
154
group Id
BG001
value
312
group Id
BG002
value
466
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Race/Ethnicity, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
68
group Id
BG001
value
176
group Id
BG002
value
244
title
Fit
measurements
group Id
BG000
value
36
group Id
BG001
value
54
group Id
BG002
value
90
title
Intermediate fitness
measurements
group Id
BG000
value
9
group Id
BG001
value
10
group Id
BG002
value
19
title
Frail
measurements
group Id
BG000
value
37
group Id
BG001
value
66
group Id
BG002
value
103
title
Not available
measurements
group Id
BG000
value
4
group Id
BG001
value
6
group Id
BG002
value
10
title
Missing
denoms
counts
group Id
BG000
value
154
group Id
BG001
value
312
group Id
BG002
value
466
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Frailty Status as Assessed by Investigator
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
147
group Id
BG001
value
295
group Id
BG002
value
442
title
Disease status 0 or 1
measurements
group Id
BG000
value
7
group Id
BG001
value
15
group Id
BG002
value
22
title
Disease status 2
measurements
group Id
BG000
value
0
group Id
BG001
value
2
group Id
BG002
value
2
title
Missing
denoms
counts
group Id
BG000
value
154
group Id
BG001
value
312
group Id
BG002
value
466
units
Participants
description
A scale to assess a patient's disease status. 0 = Fully active, able to carry out all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity, ambulatory and able to carry out work of a light nature; 2 = Ambulatory and capable of all self care, unable to carry out any work activities. Up and about \> 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair \> 50% of waking hours; 4 = Completely disabled, confined to bed or chair; 5 = Dead.
param Type
COUNT_OF_PARTICIPANTS
title
Eastern Cooperative Oncology Group (ECOG) Performance Status
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
spread
36.57
value
44.03
group Id
BG001
spread
34.69
value
47.86
group Id
BG002
spread
35.34
value
46.58
denoms
counts
group Id
BG000
value
149
group Id
BG001
value
297
group Id
BG002
value
446
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
population Description
Data was not available for some participants.
title
Time from Initial Diagnosis to Randomization
unit Of Measure
months
classes
categories
measurements
group Id
BG000
value
26
group Id
BG001
value
48
group Id
BG002
value
74
title
High risk
measurements
group Id
BG000
value
56
group Id
BG001
value
108
group Id
BG002
value
164
title
Standard risk
measurements
group Id
BG000
value
72
group Id
BG001
value
156
group Id
BG002
value
228
title
Unknown
denoms
counts
group Id
BG000
value
154
group Id
BG001
value
312
group Id
BG002
value
466
units
Participants
description
The high-risk group consists of the genetic subtypes t(4; 14), t(14; 16), or deletion17p. The standard-risk group consists of participants without t(4; 14), t(14; 16), and deletion 17p. The unknown risk group is participants with FISH result not done, failed or quantity was not sufficient.
param Type
COUNT_OF_PARTICIPANTS
title
Risk Group as Determined by Fluorescent in situ Hybridization (FISH)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
127
group Id
BG001
value
252
group Id
BG002
value
379
title
Stage I or II
measurements
group Id
BG000
value
27
group Id
BG001
value
60
group Id
BG002
value
87
title
Stage III
denoms
counts
group Id
BG000
value
154
group Id
BG001
value
312
group Id
BG002
value
466
units
Participants
description
The International Staging System (ISS) for myeloma was published by the International Myeloma Working Group (a lower stage indicates less progressed disease): Stage I: β2-microglobulin (β2M) \< 3.5 mg/L, albumin \>= 3.5 g/dL Stage II: β2M \< 3.5 mg/L and albumin \< 3.5 g/dL; or β2M 3.5 mg/L - 5.5 mg/L irrespective of the serum albumin Stage III: β2M ≥ 5.5 mg/L. Higher stages indicate more advanced disease and/or poorer prognosis. Data is the ISS result assessed at the time of randomization using an interactive voice/web response system (IxRS).
param Type
COUNT_OF_PARTICIPANTS
title
Stratification Factor: International Staging System (ISS) Stage per IxRS
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
67
group Id
BG001
value
133
group Id
BG002
value
200
title
1 prior treatment
measurements
group Id
BG000
value
87
group Id
BG001
value
179
group Id
BG002
value
266
title
> = 2 prior treatments
denoms
counts
group Id
BG000
value
154
group Id
BG001
value
312
group Id
BG002
value
466
units
Participants
description
Number of participants grouped by total number of prior regimens. Data reported are randomization stratification values.
param Type
COUNT_OF_PARTICIPANTS
title
Stratification Factor: Lines of Prior Treatment per IxRS
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
139
group Id
BG001
value
279
group Id
BG002
value
418
title
Yes
measurements
group Id
BG000
value
15
group Id
BG001
value
33
group Id
BG002
value
48
title
No
denoms
counts
group Id
BG000
value
154
group Id
BG001
value
312
group Id
BG002
value
466
units
Participants
description
The number of participants with prior proteasome inhibitor treatment assessed at the time of randomization per the IxRS. Data reported are randomization stratification values.
param Type
COUNT_OF_PARTICIPANTS
title
Stratification Factor: Prior Proteasome Inhibitor Treatment per IxRS
unit Of Measure
Participants

population Description

Intent to Treat population

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Preserved source evidence · Not medical advice