NCT03871829 · BASELINE

Baseline characteristics

Daratumumab Retreatment in Participants With Multiple Myeloma Who Have Been Previously Treated With Daratumumab · Source last updated 2025-03-30

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

denoms

counts
group Id
BG000
value
44
group Id
BG001
value
44
group Id
BG002
value
88
units
Participants

groups

description
Participants received carfilzomib 20 milligram per meter square (mg/m\^2) intravenously (IV) on Cycle 1 Day 1 and then 70 mg/m\^2 on Cycle 1 Days 8 and 15, and thereafter on Days 1, 8, 15 from Cycle 2 onwards. Participants received dexamethasone 20 milligrams (mg) on Cycle 1 Days 1 and 2, and 40 mg IV or orally on Days 8, 15, 22 of Cycle 1. Participants then received dexamethasone 40 mg IV or orally on Days 1, 8, 15 and 22 of Cycles 2-9, then on Days 1, 8, 15 from Cycle 10 onwards, until confirmed progressive disease (PD), death, intolerable toxicity, start of a new treatment for multiple myeloma, withdrawal of consent, or end of the study, whichever occurs first. Each cycle of 28 days.
id
BG000
title
Arm A: Carfilzomib+Dexamethasone (Kd)
description
Participants received daratumumab 1800 mg by SC injection (Dara-SC) on Days 1, 8, 15, 22 of Cycle 1 and 2, Days 1 and 15 of Cycle 3-6, and on Day 1 from Cycle 7 onwards. Participants received carfilzomib 20 mg/m\^2 IV on Cycle 1 Day 1 and then 70 mg/m\^2 on Cycle 1 Days 8 and 15, and Days 1, 8 and 15 from Cycle 2 onwards. Participants received dexamethasone 20 mg on Cycle 1 Days 1 and 2 and 40 mg IV or orally on Days 8, 15, 22 of Cycle 1. Participants then received dexamethasone 40 mg IV or orally on Days 1, 8, 15 and 22 of Cycles 2-9, then on Days 1, 8, 15 from Cycle 10 onwards, until confirmed PD, death, intolerable toxicity, start of a new treatment for multiple myeloma, withdrawal of consent, or end of the study, whichever occurs first. Each cycle of 28 days.
id
BG001
title
Arm B: Dara-SC in Combination With Kd (DKd)
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
8.56
value
67.4
group Id
BG001
spread
9.72
value
66.7
group Id
BG002
spread
9.12
value
67
denoms
counts
group Id
BG000
value
44
group Id
BG001
value
44
group Id
BG002
value
88
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Children (2-11 years)
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Adolescents (12-17 years)
measurements
group Id
BG000
value
15
group Id
BG001
value
16
group Id
BG002
value
31
title
Adults (18-64 years)
measurements
group Id
BG000
value
26
group Id
BG001
value
28
group Id
BG002
value
54
title
From 65 to 84 years
measurements
group Id
BG000
value
3
group Id
BG001
value
0
group Id
BG002
value
3
title
85 years and over
denoms
counts
group Id
BG000
value
44
group Id
BG001
value
44
group Id
BG002
value
88
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Age, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
21
group Id
BG001
value
18
group Id
BG002
value
39
title
Female
measurements
group Id
BG000
value
23
group Id
BG001
value
26
group Id
BG002
value
49
title
Male
denoms
counts
group Id
BG000
value
44
group Id
BG001
value
44
group Id
BG002
value
88
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
12
group Id
BG001
value
8
group Id
BG002
value
20
title
Hispanic or Latino
measurements
group Id
BG000
value
27
group Id
BG001
value
28
group Id
BG002
value
55
title
Not Hispanic or Latino
measurements
group Id
BG000
value
5
group Id
BG001
value
8
group Id
BG002
value
13
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
44
group Id
BG001
value
44
group Id
BG002
value
88
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Ethnicity (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
American Indian or Alaska Native
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Asian
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
2
group Id
BG001
value
3
group Id
BG002
value
5
title
Black or African American
measurements
group Id
BG000
value
39
group Id
BG001
value
36
group Id
BG002
value
75
title
White
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
More than one race
measurements
group Id
BG000
value
2
group Id
BG001
value
5
group Id
BG002
value
7
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
44
group Id
BG001
value
44
group Id
BG002
value
88
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Race (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
2
group Id
BG002
value
3
denoms
counts
group Id
BG000
value
44
group Id
BG001
value
44
group Id
BG002
value
88
units
Participants
title
BELGIUM
categories
measurements
group Id
BG000
value
8
group Id
BG001
value
7
group Id
BG002
value
15
denoms
counts
group Id
BG000
value
44
group Id
BG001
value
44
group Id
BG002
value
88
units
Participants
title
BRAZIL
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
2
group Id
BG002
value
2
denoms
counts
group Id
BG000
value
44
group Id
BG001
value
44
group Id
BG002
value
88
units
Participants
title
CANADA
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
3
group Id
BG002
value
3
denoms
counts
group Id
BG000
value
44
group Id
BG001
value
44
group Id
BG002
value
88
units
Participants
title
DENMARK
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
5
group Id
BG002
value
7
denoms
counts
group Id
BG000
value
44
group Id
BG001
value
44
group Id
BG002
value
88
units
Participants
title
FRANCE
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
2
group Id
BG002
value
2
denoms
counts
group Id
BG000
value
44
group Id
BG001
value
44
group Id
BG002
value
88
units
Participants
title
GERMANY
categories
measurements
group Id
BG000
value
7
group Id
BG001
value
5
group Id
BG002
value
12
denoms
counts
group Id
BG000
value
44
group Id
BG001
value
44
group Id
BG002
value
88
units
Participants
title
GREECE
categories
measurements
group Id
BG000
value
10
group Id
BG001
value
5
group Id
BG002
value
15
denoms
counts
group Id
BG000
value
44
group Id
BG001
value
44
group Id
BG002
value
88
units
Participants
title
ITALY
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
2
denoms
counts
group Id
BG000
value
44
group Id
BG001
value
44
group Id
BG002
value
88
units
Participants
title
NETHERLANDS
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
1
group Id
BG002
value
3
denoms
counts
group Id
BG000
value
44
group Id
BG001
value
44
group Id
BG002
value
88
units
Participants
title
POLAND
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
6
group Id
BG002
value
10
denoms
counts
group Id
BG000
value
44
group Id
BG001
value
44
group Id
BG002
value
88
units
Participants
title
RUSSIAN FEDERATION
categories
measurements
group Id
BG000
value
7
group Id
BG001
value
4
group Id
BG002
value
11
denoms
counts
group Id
BG000
value
44
group Id
BG001
value
44
group Id
BG002
value
88
units
Participants
title
SPAIN
param Type
COUNT_OF_PARTICIPANTS
title
Region of Enrollment
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
8
group Id
BG001
value
7
group Id
BG002
value
15
denoms
counts
group Id
BG000
value
43
group Id
BG001
value
43
group Id
BG002
value
86
units
Participants
title
Anti-CD38 antibody only
categories
measurements
group Id
BG000
value
10
group Id
BG001
value
5
group Id
BG002
value
15
denoms
counts
group Id
BG000
value
43
group Id
BG001
value
43
group Id
BG002
value
86
units
Participants
title
Both PI and IMiD
categories
measurements
group Id
BG000
value
11
group Id
BG001
value
14
group Id
BG002
value
25
denoms
counts
group Id
BG000
value
43
group Id
BG001
value
43
group Id
BG002
value
86
units
Participants
title
IMiD + anti-CD38
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
1
group Id
BG002
value
5
denoms
counts
group Id
BG000
value
43
group Id
BG001
value
43
group Id
BG002
value
86
units
Participants
title
IMiD only
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
4
group Id
BG002
value
9
denoms
counts
group Id
BG000
value
43
group Id
BG001
value
43
group Id
BG002
value
86
units
Participants
title
PI + IMiD + anti-CD38
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
denoms
counts
group Id
BG000
value
43
group Id
BG001
value
43
group Id
BG002
value
86
units
Participants
title
PI only
param Type
COUNT_OF_PARTICIPANTS
population Description
Here, 'N' (number of subjects analyzed) signifies participants who were evaluable for this baseline characteristics.
title
Refractory status
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
12
group Id
BG001
value
24
group Id
BG002
value
36
denoms
counts
group Id
BG000
value
43
group Id
BG001
value
44
group Id
BG002
value
87
units
Participants
title
STAGE I
categories
measurements
group Id
BG000
value
19
group Id
BG001
value
11
group Id
BG002
value
30
denoms
counts
group Id
BG000
value
43
group Id
BG001
value
44
group Id
BG002
value
87
units
Participants
title
STAGE II
categories
measurements
group Id
BG000
value
12
group Id
BG001
value
9
group Id
BG002
value
21
denoms
counts
group Id
BG000
value
43
group Id
BG001
value
44
group Id
BG002
value
87
units
Participants
title
STAGE III
description
The International Staging System (ISS) system consists of stage I: beta2-microglobulin less than (\<)3.5 milligram per liter (mg/l) and albumin greater than or equal to (\>=) 3.5 gram (g) per 100 milliliter (mL) (g/100 mL); stage II: neither stage I nor stage III and stage III: beta2-microglobulin \>= 5.5 mg/l.
param Type
COUNT_OF_PARTICIPANTS
population Description
Here, 'N' (number of subjects analyzed) signifies participants who were evaluable for this baseline characteristics.
title
Stage of Disease (ISS)
unit Of Measure
Participants

Complete source fields

denoms

counts
group Id
BG000
value
44
group Id
BG001
value
44
group Id
BG002
value
88
units
Participants

groups

description
Participants received carfilzomib 20 milligram per meter square (mg/m\^2) intravenously (IV) on Cycle 1 Day 1 and then 70 mg/m\^2 on Cycle 1 Days 8 and 15, and thereafter on Days 1, 8, 15 from Cycle 2 onwards. Participants received dexamethasone 20 milligrams (mg) on Cycle 1 Days 1 and 2, and 40 mg IV or orally on Days 8, 15, 22 of Cycle 1. Participants then received dexamethasone 40 mg IV or orally on Days 1, 8, 15 and 22 of Cycles 2-9, then on Days 1, 8, 15 from Cycle 10 onwards, until confirmed progressive disease (PD), death, intolerable toxicity, start of a new treatment for multiple myeloma, withdrawal of consent, or end of the study, whichever occurs first. Each cycle of 28 days.
id
BG000
title
Arm A: Carfilzomib+Dexamethasone (Kd)
description
Participants received daratumumab 1800 mg by SC injection (Dara-SC) on Days 1, 8, 15, 22 of Cycle 1 and 2, Days 1 and 15 of Cycle 3-6, and on Day 1 from Cycle 7 onwards. Participants received carfilzomib 20 mg/m\^2 IV on Cycle 1 Day 1 and then 70 mg/m\^2 on Cycle 1 Days 8 and 15, and Days 1, 8 and 15 from Cycle 2 onwards. Participants received dexamethasone 20 mg on Cycle 1 Days 1 and 2 and 40 mg IV or orally on Days 8, 15, 22 of Cycle 1. Participants then received dexamethasone 40 mg IV or orally on Days 1, 8, 15 and 22 of Cycles 2-9, then on Days 1, 8, 15 from Cycle 10 onwards, until confirmed PD, death, intolerable toxicity, start of a new treatment for multiple myeloma, withdrawal of consent, or end of the study, whichever occurs first. Each cycle of 28 days.
id
BG001
title
Arm B: Dara-SC in Combination With Kd (DKd)
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
8.56
value
67.4
group Id
BG001
spread
9.72
value
66.7
group Id
BG002
spread
9.12
value
67
denoms
counts
group Id
BG000
value
44
group Id
BG001
value
44
group Id
BG002
value
88
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Children (2-11 years)
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Adolescents (12-17 years)
measurements
group Id
BG000
value
15
group Id
BG001
value
16
group Id
BG002
value
31
title
Adults (18-64 years)
measurements
group Id
BG000
value
26
group Id
BG001
value
28
group Id
BG002
value
54
title
From 65 to 84 years
measurements
group Id
BG000
value
3
group Id
BG001
value
0
group Id
BG002
value
3
title
85 years and over
denoms
counts
group Id
BG000
value
44
group Id
BG001
value
44
group Id
BG002
value
88
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Age, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
21
group Id
BG001
value
18
group Id
BG002
value
39
title
Female
measurements
group Id
BG000
value
23
group Id
BG001
value
26
group Id
BG002
value
49
title
Male
denoms
counts
group Id
BG000
value
44
group Id
BG001
value
44
group Id
BG002
value
88
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
12
group Id
BG001
value
8
group Id
BG002
value
20
title
Hispanic or Latino
measurements
group Id
BG000
value
27
group Id
BG001
value
28
group Id
BG002
value
55
title
Not Hispanic or Latino
measurements
group Id
BG000
value
5
group Id
BG001
value
8
group Id
BG002
value
13
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
44
group Id
BG001
value
44
group Id
BG002
value
88
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Ethnicity (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
American Indian or Alaska Native
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Asian
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
2
group Id
BG001
value
3
group Id
BG002
value
5
title
Black or African American
measurements
group Id
BG000
value
39
group Id
BG001
value
36
group Id
BG002
value
75
title
White
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
More than one race
measurements
group Id
BG000
value
2
group Id
BG001
value
5
group Id
BG002
value
7
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
44
group Id
BG001
value
44
group Id
BG002
value
88
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Race (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
2
group Id
BG002
value
3
denoms
counts
group Id
BG000
value
44
group Id
BG001
value
44
group Id
BG002
value
88
units
Participants
title
BELGIUM
categories
measurements
group Id
BG000
value
8
group Id
BG001
value
7
group Id
BG002
value
15
denoms
counts
group Id
BG000
value
44
group Id
BG001
value
44
group Id
BG002
value
88
units
Participants
title
BRAZIL
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
2
group Id
BG002
value
2
denoms
counts
group Id
BG000
value
44
group Id
BG001
value
44
group Id
BG002
value
88
units
Participants
title
CANADA
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
3
group Id
BG002
value
3
denoms
counts
group Id
BG000
value
44
group Id
BG001
value
44
group Id
BG002
value
88
units
Participants
title
DENMARK
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
5
group Id
BG002
value
7
denoms
counts
group Id
BG000
value
44
group Id
BG001
value
44
group Id
BG002
value
88
units
Participants
title
FRANCE
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
2
group Id
BG002
value
2
denoms
counts
group Id
BG000
value
44
group Id
BG001
value
44
group Id
BG002
value
88
units
Participants
title
GERMANY
categories
measurements
group Id
BG000
value
7
group Id
BG001
value
5
group Id
BG002
value
12
denoms
counts
group Id
BG000
value
44
group Id
BG001
value
44
group Id
BG002
value
88
units
Participants
title
GREECE
categories
measurements
group Id
BG000
value
10
group Id
BG001
value
5
group Id
BG002
value
15
denoms
counts
group Id
BG000
value
44
group Id
BG001
value
44
group Id
BG002
value
88
units
Participants
title
ITALY
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
2
denoms
counts
group Id
BG000
value
44
group Id
BG001
value
44
group Id
BG002
value
88
units
Participants
title
NETHERLANDS
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
1
group Id
BG002
value
3
denoms
counts
group Id
BG000
value
44
group Id
BG001
value
44
group Id
BG002
value
88
units
Participants
title
POLAND
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
6
group Id
BG002
value
10
denoms
counts
group Id
BG000
value
44
group Id
BG001
value
44
group Id
BG002
value
88
units
Participants
title
RUSSIAN FEDERATION
categories
measurements
group Id
BG000
value
7
group Id
BG001
value
4
group Id
BG002
value
11
denoms
counts
group Id
BG000
value
44
group Id
BG001
value
44
group Id
BG002
value
88
units
Participants
title
SPAIN
param Type
COUNT_OF_PARTICIPANTS
title
Region of Enrollment
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
8
group Id
BG001
value
7
group Id
BG002
value
15
denoms
counts
group Id
BG000
value
43
group Id
BG001
value
43
group Id
BG002
value
86
units
Participants
title
Anti-CD38 antibody only
categories
measurements
group Id
BG000
value
10
group Id
BG001
value
5
group Id
BG002
value
15
denoms
counts
group Id
BG000
value
43
group Id
BG001
value
43
group Id
BG002
value
86
units
Participants
title
Both PI and IMiD
categories
measurements
group Id
BG000
value
11
group Id
BG001
value
14
group Id
BG002
value
25
denoms
counts
group Id
BG000
value
43
group Id
BG001
value
43
group Id
BG002
value
86
units
Participants
title
IMiD + anti-CD38
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
1
group Id
BG002
value
5
denoms
counts
group Id
BG000
value
43
group Id
BG001
value
43
group Id
BG002
value
86
units
Participants
title
IMiD only
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
4
group Id
BG002
value
9
denoms
counts
group Id
BG000
value
43
group Id
BG001
value
43
group Id
BG002
value
86
units
Participants
title
PI + IMiD + anti-CD38
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
denoms
counts
group Id
BG000
value
43
group Id
BG001
value
43
group Id
BG002
value
86
units
Participants
title
PI only
param Type
COUNT_OF_PARTICIPANTS
population Description
Here, 'N' (number of subjects analyzed) signifies participants who were evaluable for this baseline characteristics.
title
Refractory status
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
12
group Id
BG001
value
24
group Id
BG002
value
36
denoms
counts
group Id
BG000
value
43
group Id
BG001
value
44
group Id
BG002
value
87
units
Participants
title
STAGE I
categories
measurements
group Id
BG000
value
19
group Id
BG001
value
11
group Id
BG002
value
30
denoms
counts
group Id
BG000
value
43
group Id
BG001
value
44
group Id
BG002
value
87
units
Participants
title
STAGE II
categories
measurements
group Id
BG000
value
12
group Id
BG001
value
9
group Id
BG002
value
21
denoms
counts
group Id
BG000
value
43
group Id
BG001
value
44
group Id
BG002
value
87
units
Participants
title
STAGE III
description
The International Staging System (ISS) system consists of stage I: beta2-microglobulin less than (\<)3.5 milligram per liter (mg/l) and albumin greater than or equal to (\>=) 3.5 gram (g) per 100 milliliter (mL) (g/100 mL); stage II: neither stage I nor stage III and stage III: beta2-microglobulin \>= 5.5 mg/l.
param Type
COUNT_OF_PARTICIPANTS
population Description
Here, 'N' (number of subjects analyzed) signifies participants who were evaluable for this baseline characteristics.
title
Stage of Disease (ISS)
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice