NCT03277105 · BASELINE

Baseline characteristics

A Study of Subcutaneous Versus (vs.) Intravenous Administration of Daratumumab in Participants With Relapsed or Refractory Multiple Myeloma · Source last updated 2025-04-29

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

denoms

counts
group Id
BG000
value
259
group Id
BG001
value
263
group Id
BG002
value
522
units
Participants

groups

description
Participants received daratumumab intravenous infusion (Dara IV) 16 milligrams per kilogram (mg/kg) once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days.
id
BG000
title
Daratumumab IV
description
Participants received daratumumab 1800 mg subcutaneous injection (Dara SC) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 Units per milliliter (U/mL), once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days.
id
BG001
title
Daratumumab SC
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
10.16
value
66.8
group Id
BG001
spread
9.11
value
65.3
group Id
BG002
spread
9.66
value
66.1
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
110
group Id
BG001
value
127
group Id
BG002
value
237
title
Female
measurements
group Id
BG000
value
149
group Id
BG001
value
136
group Id
BG002
value
285
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
9
group Id
BG001
value
14
group Id
BG002
value
23
title
Hispanic or Latino
measurements
group Id
BG000
value
227
group Id
BG001
value
225
group Id
BG002
value
452
title
Not Hispanic or Latino
measurements
group Id
BG000
value
23
group Id
BG001
value
24
group Id
BG002
value
47
title
Unknown or Not Reported
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
1
group Id
BG002
value
1
title
American Indian or Alaska Native
measurements
group Id
BG000
value
40
group Id
BG001
value
32
group Id
BG002
value
72
title
Asian
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
5
group Id
BG001
value
9
group Id
BG002
value
14
title
Black or African American
measurements
group Id
BG000
value
201
group Id
BG001
value
207
group Id
BG002
value
408
title
White
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
More than one race
measurements
group Id
BG000
value
12
group Id
BG001
value
14
group Id
BG002
value
26
title
Unknown or Not Reported
param Type
COUNT_OF_PARTICIPANTS
title
Race (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
15
group Id
BG001
value
13
group Id
BG002
value
28
title
AUSTRALIA
categories
measurements
group Id
BG000
value
10
group Id
BG001
value
15
group Id
BG002
value
25
title
BRAZIL
categories
measurements
group Id
BG000
value
16
group Id
BG001
value
20
group Id
BG002
value
36
title
CANADA
categories
measurements
group Id
BG000
value
20
group Id
BG001
value
16
group Id
BG002
value
36
title
CZECH REPUBLIC
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
10
group Id
BG002
value
16
title
FRANCE
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
6
group Id
BG002
value
7
title
GREECE
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
8
group Id
BG002
value
13
title
ISRAEL
categories
measurements
group Id
BG000
value
10
group Id
BG001
value
16
group Id
BG002
value
26
title
ITALY
categories
measurements
group Id
BG000
value
24
group Id
BG001
value
18
group Id
BG002
value
42
title
JAPAN
categories
measurements
group Id
BG000
value
39
group Id
BG001
value
26
group Id
BG002
value
65
title
POLAND
categories
measurements
group Id
BG000
value
28
group Id
BG001
value
27
group Id
BG002
value
55
title
RUSSIAN FEDERATION
categories
measurements
group Id
BG000
value
7
group Id
BG001
value
4
group Id
BG002
value
11
title
SOUTH KOREA
param Type
COUNT_OF_PARTICIPANTS
title
Region of Enrollment
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
94
group Id
BG001
value
82
group Id
BG002
value
176
title
Stage I
categories
measurements
group Id
BG000
value
89
group Id
BG001
value
101
group Id
BG002
value
190
title
Stage II
categories
measurements
group Id
BG000
value
76
group Id
BG001
value
79
group Id
BG002
value
155
title
Stage III
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
title
Data missing or Unknown
description
Measure Description: The International Staging System (ISS) consists of following 3 stages - Stage I: serum beta2-microglobulin less than (\<) 3.5 milligrams per liter (mg/L) and albumin greater than or equal to (\>=) 3.5 grams (g) per 100 milliliter; Stage II: neither stage I nor stage III and Stage III: serum beta2-microglobulin \>= 5.5 mg/L.
param Type
COUNT_OF_PARTICIPANTS
title
Stage of Disease (ISS)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
175
group Id
BG001
value
174
group Id
BG002
value
349
title
Less than or equal to (<=) 4 Lines
categories
measurements
group Id
BG000
value
84
group Id
BG001
value
89
group Id
BG002
value
173
title
Greater than (>) 4 Lines
param Type
COUNT_OF_PARTICIPANTS
title
Number of prior lines
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
133
group Id
BG001
value
125
group Id
BG002
value
258
title
Both protease inhibitor (PI) and immunomodulatory drug (IMiD)
categories
measurements
group Id
BG000
value
81
group Id
BG001
value
67
group Id
BG002
value
148
title
IMiD only
categories
measurements
group Id
BG000
value
26
group Id
BG001
value
41
group Id
BG002
value
67
title
None
categories
measurements
group Id
BG000
value
19
group Id
BG001
value
30
group Id
BG002
value
49
title
PI only
param Type
COUNT_OF_PARTICIPANTS
title
Refractory status
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
92
group Id
BG001
value
94
group Id
BG002
value
186
title
<=65
categories
measurements
group Id
BG000
value
105
group Id
BG001
value
102
group Id
BG002
value
207
title
>65 - 85
categories
measurements
group Id
BG000
value
61
group Id
BG001
value
66
group Id
BG002
value
127
title
>85
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
2
title
Not Reported
param Type
COUNT_OF_PARTICIPANTS
title
Weight group
unit Of Measure
Participants

Complete source fields

denoms

counts
group Id
BG000
value
259
group Id
BG001
value
263
group Id
BG002
value
522
units
Participants

groups

description
Participants received daratumumab intravenous infusion (Dara IV) 16 milligrams per kilogram (mg/kg) once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days.
id
BG000
title
Daratumumab IV
description
Participants received daratumumab 1800 mg subcutaneous injection (Dara SC) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 Units per milliliter (U/mL), once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days.
id
BG001
title
Daratumumab SC
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
10.16
value
66.8
group Id
BG001
spread
9.11
value
65.3
group Id
BG002
spread
9.66
value
66.1
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
110
group Id
BG001
value
127
group Id
BG002
value
237
title
Female
measurements
group Id
BG000
value
149
group Id
BG001
value
136
group Id
BG002
value
285
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
9
group Id
BG001
value
14
group Id
BG002
value
23
title
Hispanic or Latino
measurements
group Id
BG000
value
227
group Id
BG001
value
225
group Id
BG002
value
452
title
Not Hispanic or Latino
measurements
group Id
BG000
value
23
group Id
BG001
value
24
group Id
BG002
value
47
title
Unknown or Not Reported
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
1
group Id
BG002
value
1
title
American Indian or Alaska Native
measurements
group Id
BG000
value
40
group Id
BG001
value
32
group Id
BG002
value
72
title
Asian
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
5
group Id
BG001
value
9
group Id
BG002
value
14
title
Black or African American
measurements
group Id
BG000
value
201
group Id
BG001
value
207
group Id
BG002
value
408
title
White
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
More than one race
measurements
group Id
BG000
value
12
group Id
BG001
value
14
group Id
BG002
value
26
title
Unknown or Not Reported
param Type
COUNT_OF_PARTICIPANTS
title
Race (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
15
group Id
BG001
value
13
group Id
BG002
value
28
title
AUSTRALIA
categories
measurements
group Id
BG000
value
10
group Id
BG001
value
15
group Id
BG002
value
25
title
BRAZIL
categories
measurements
group Id
BG000
value
16
group Id
BG001
value
20
group Id
BG002
value
36
title
CANADA
categories
measurements
group Id
BG000
value
20
group Id
BG001
value
16
group Id
BG002
value
36
title
CZECH REPUBLIC
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
10
group Id
BG002
value
16
title
FRANCE
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
6
group Id
BG002
value
7
title
GREECE
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
8
group Id
BG002
value
13
title
ISRAEL
categories
measurements
group Id
BG000
value
10
group Id
BG001
value
16
group Id
BG002
value
26
title
ITALY
categories
measurements
group Id
BG000
value
24
group Id
BG001
value
18
group Id
BG002
value
42
title
JAPAN
categories
measurements
group Id
BG000
value
39
group Id
BG001
value
26
group Id
BG002
value
65
title
POLAND
categories
measurements
group Id
BG000
value
28
group Id
BG001
value
27
group Id
BG002
value
55
title
RUSSIAN FEDERATION
categories
measurements
group Id
BG000
value
7
group Id
BG001
value
4
group Id
BG002
value
11
title
SOUTH KOREA
param Type
COUNT_OF_PARTICIPANTS
title
Region of Enrollment
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
94
group Id
BG001
value
82
group Id
BG002
value
176
title
Stage I
categories
measurements
group Id
BG000
value
89
group Id
BG001
value
101
group Id
BG002
value
190
title
Stage II
categories
measurements
group Id
BG000
value
76
group Id
BG001
value
79
group Id
BG002
value
155
title
Stage III
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
title
Data missing or Unknown
description
Measure Description: The International Staging System (ISS) consists of following 3 stages - Stage I: serum beta2-microglobulin less than (\<) 3.5 milligrams per liter (mg/L) and albumin greater than or equal to (\>=) 3.5 grams (g) per 100 milliliter; Stage II: neither stage I nor stage III and Stage III: serum beta2-microglobulin \>= 5.5 mg/L.
param Type
COUNT_OF_PARTICIPANTS
title
Stage of Disease (ISS)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
175
group Id
BG001
value
174
group Id
BG002
value
349
title
Less than or equal to (<=) 4 Lines
categories
measurements
group Id
BG000
value
84
group Id
BG001
value
89
group Id
BG002
value
173
title
Greater than (>) 4 Lines
param Type
COUNT_OF_PARTICIPANTS
title
Number of prior lines
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
133
group Id
BG001
value
125
group Id
BG002
value
258
title
Both protease inhibitor (PI) and immunomodulatory drug (IMiD)
categories
measurements
group Id
BG000
value
81
group Id
BG001
value
67
group Id
BG002
value
148
title
IMiD only
categories
measurements
group Id
BG000
value
26
group Id
BG001
value
41
group Id
BG002
value
67
title
None
categories
measurements
group Id
BG000
value
19
group Id
BG001
value
30
group Id
BG002
value
49
title
PI only
param Type
COUNT_OF_PARTICIPANTS
title
Refractory status
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
92
group Id
BG001
value
94
group Id
BG002
value
186
title
<=65
categories
measurements
group Id
BG000
value
105
group Id
BG001
value
102
group Id
BG002
value
207
title
>65 - 85
categories
measurements
group Id
BG000
value
61
group Id
BG001
value
66
group Id
BG002
value
127
title
>85
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
2
title
Not Reported
param Type
COUNT_OF_PARTICIPANTS
title
Weight group
unit Of Measure
Participants

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Preserved source evidence · Not medical advice