NCT03180736 · BASELINE

Baseline characteristics

Comparison of Pom and Dex in Subjects With RRMM Previously Treated With Len and a PI Dara/Pom/Dex vs Pom/Dex · Source last updated 2025-12-19

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

denoms

counts
group Id
BG000
value
151
group Id
BG001
value
153
group Id
BG002
value
304
units
Participants

groups

description
Patients received Daratumumab subcutaneously (fixed dose of 1800 mg) or intravenously (16 mg/kg) weekly for cycles 1-2, every 2 weeks for cycles 3-6, and every 4 weeks thereafter. Pomalidomide was administered at a dose of 4 mg orally every day on days 1 through 21, and dexamethasone at 40 mg (or 20 mg for patients ≥75 years of age) orally weekly, in 28-day cycles.. Pomalidomide: Pomalidomide will be administered at full dose of 4 mg orally (PO) on Days 1 through 21 of each 28-day cycle. Dexamethasone: Dexamethasone will be administered at a dose of 40 mg (20 mg for patients ≥75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
id
BG000
title
Daratumumab+Pomalidomide+Dexamethasone
description
Patients received Pomalidomide at a dose of 4 mg orally every day on days 1 through 21, and dexamethasone 40 mg (or 20 mg for patients ≥75 years of age) orally weekly, in 28-day cycles
id
BG001
title
Pomalidomide + Dexamethasone
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
9.57
value
65.4
group Id
BG001
spread
9.70
value
66.5
group Id
BG002
spread
9.63
value
66.0
denoms
counts
group Id
BG000
value
151
group Id
BG001
value
153
group Id
BG002
value
304
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
72
group Id
BG001
value
71
group Id
BG002
value
143
title
Female
measurements
group Id
BG000
value
79
group Id
BG001
value
82
group Id
BG002
value
161
title
Male
denoms
counts
group Id
BG000
value
151
group Id
BG001
value
153
group Id
BG002
value
304
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG002
value
0
denoms
counts
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
units
Participants
param Type
COUNT_OF_PARTICIPANTS
population Description
Race and Ethnicity were not collected from any participant.
title
Race and Ethnicity Not Collected
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
53
group Id
BG001
value
44
group Id
BG002
value
97
denoms
counts
group Id
BG000
value
151
group Id
BG001
value
153
group Id
BG002
value
304
units
Participants
title
Greece
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
4
group Id
BG002
value
9
denoms
counts
group Id
BG000
value
151
group Id
BG001
value
153
group Id
BG002
value
304
units
Participants
title
Netherlands
categories
measurements
group Id
BG000
value
16
group Id
BG001
value
24
group Id
BG002
value
40
denoms
counts
group Id
BG000
value
151
group Id
BG001
value
153
group Id
BG002
value
304
units
Participants
title
Turkey
categories
measurements
group Id
BG000
value
7
group Id
BG001
value
9
group Id
BG002
value
16
denoms
counts
group Id
BG000
value
151
group Id
BG001
value
153
group Id
BG002
value
304
units
Participants
title
Belgium
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
4
group Id
BG002
value
10
denoms
counts
group Id
BG000
value
151
group Id
BG001
value
153
group Id
BG002
value
304
units
Participants
title
Czechia
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
2
denoms
counts
group Id
BG000
value
151
group Id
BG001
value
153
group Id
BG002
value
304
units
Participants
title
Denmark
categories
measurements
group Id
BG000
value
19
group Id
BG001
value
20
group Id
BG002
value
39
denoms
counts
group Id
BG000
value
151
group Id
BG001
value
153
group Id
BG002
value
304
units
Participants
title
Italy
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
5
group Id
BG002
value
9
denoms
counts
group Id
BG000
value
151
group Id
BG001
value
153
group Id
BG002
value
304
units
Participants
title
Serbia
categories
measurements
group Id
BG000
value
8
group Id
BG001
value
7
group Id
BG002
value
15
denoms
counts
group Id
BG000
value
151
group Id
BG001
value
153
group Id
BG002
value
304
units
Participants
title
Germany
categories
measurements
group Id
BG000
value
15
group Id
BG001
value
22
group Id
BG002
value
37
denoms
counts
group Id
BG000
value
151
group Id
BG001
value
153
group Id
BG002
value
304
units
Participants
title
Spain
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
2
denoms
counts
group Id
BG000
value
151
group Id
BG001
value
153
group Id
BG002
value
304
units
Participants
title
Poland
categories
measurements
group Id
BG000
value
16
group Id
BG001
value
12
group Id
BG002
value
28
denoms
counts
group Id
BG000
value
151
group Id
BG001
value
153
group Id
BG002
value
304
units
Participants
title
France
param Type
NUMBER
title
Region of Enrollment
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
68
group Id
BG001
value
69
group Id
BG002
value
137
denoms
counts
group Id
BG000
value
151
group Id
BG001
value
153
group Id
BG002
value
304
units
Participants
title
I
categories
measurements
group Id
BG000
value
50
group Id
BG001
value
51
group Id
BG002
value
101
denoms
counts
group Id
BG000
value
151
group Id
BG001
value
153
group Id
BG002
value
304
units
Participants
title
II
categories
measurements
group Id
BG000
value
33
group Id
BG001
value
33
group Id
BG002
value
66
denoms
counts
group Id
BG000
value
151
group Id
BG001
value
153
group Id
BG002
value
304
units
Participants
title
III
description
The International Staging System (ISS) consists of the following 3 stages; Stage I: serum beta2-microglobulin less than (\<) 3.5 milligram per liter (mg/L) and albumin greater than or equal to (≥) 3.5 gram per 100 Milliliter (g/100 mL); Stage II: neither stage I nor stage III; and Stage III: serum beta2-microglobulin greater than or equal to (≥) 5.5 mg/L. Higher stages indicate more severe disease (i.e. worse outcomes).
param Type
COUNT_OF_PARTICIPANTS
title
Stage of Disease (ISS)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
16
group Id
BG001
value
18
group Id
BG002
value
34
denoms
counts
group Id
BG000
value
151
group Id
BG001
value
153
group Id
BG002
value
304
units
Participants
title
1
categories
measurements
group Id
BG000
value
114
group Id
BG001
value
113
group Id
BG002
value
227
denoms
counts
group Id
BG000
value
151
group Id
BG001
value
153
group Id
BG002
value
304
units
Participants
title
2-3
categories
measurements
group Id
BG000
value
21
group Id
BG001
value
22
group Id
BG002
value
43
denoms
counts
group Id
BG000
value
151
group Id
BG001
value
153
group Id
BG002
value
304
units
Participants
title
≥4
param Type
COUNT_OF_PARTICIPANTS
title
No. of Prior Lines of Therapy
unit Of Measure
Participants

Complete source fields

denoms

counts
group Id
BG000
value
151
group Id
BG001
value
153
group Id
BG002
value
304
units
Participants

groups

description
Patients received Daratumumab subcutaneously (fixed dose of 1800 mg) or intravenously (16 mg/kg) weekly for cycles 1-2, every 2 weeks for cycles 3-6, and every 4 weeks thereafter. Pomalidomide was administered at a dose of 4 mg orally every day on days 1 through 21, and dexamethasone at 40 mg (or 20 mg for patients ≥75 years of age) orally weekly, in 28-day cycles.. Pomalidomide: Pomalidomide will be administered at full dose of 4 mg orally (PO) on Days 1 through 21 of each 28-day cycle. Dexamethasone: Dexamethasone will be administered at a dose of 40 mg (20 mg for patients ≥75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
id
BG000
title
Daratumumab+Pomalidomide+Dexamethasone
description
Patients received Pomalidomide at a dose of 4 mg orally every day on days 1 through 21, and dexamethasone 40 mg (or 20 mg for patients ≥75 years of age) orally weekly, in 28-day cycles
id
BG001
title
Pomalidomide + Dexamethasone
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
9.57
value
65.4
group Id
BG001
spread
9.70
value
66.5
group Id
BG002
spread
9.63
value
66.0
denoms
counts
group Id
BG000
value
151
group Id
BG001
value
153
group Id
BG002
value
304
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
72
group Id
BG001
value
71
group Id
BG002
value
143
title
Female
measurements
group Id
BG000
value
79
group Id
BG001
value
82
group Id
BG002
value
161
title
Male
denoms
counts
group Id
BG000
value
151
group Id
BG001
value
153
group Id
BG002
value
304
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG002
value
0
denoms
counts
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
units
Participants
param Type
COUNT_OF_PARTICIPANTS
population Description
Race and Ethnicity were not collected from any participant.
title
Race and Ethnicity Not Collected
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
53
group Id
BG001
value
44
group Id
BG002
value
97
denoms
counts
group Id
BG000
value
151
group Id
BG001
value
153
group Id
BG002
value
304
units
Participants
title
Greece
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
4
group Id
BG002
value
9
denoms
counts
group Id
BG000
value
151
group Id
BG001
value
153
group Id
BG002
value
304
units
Participants
title
Netherlands
categories
measurements
group Id
BG000
value
16
group Id
BG001
value
24
group Id
BG002
value
40
denoms
counts
group Id
BG000
value
151
group Id
BG001
value
153
group Id
BG002
value
304
units
Participants
title
Turkey
categories
measurements
group Id
BG000
value
7
group Id
BG001
value
9
group Id
BG002
value
16
denoms
counts
group Id
BG000
value
151
group Id
BG001
value
153
group Id
BG002
value
304
units
Participants
title
Belgium
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
4
group Id
BG002
value
10
denoms
counts
group Id
BG000
value
151
group Id
BG001
value
153
group Id
BG002
value
304
units
Participants
title
Czechia
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
2
denoms
counts
group Id
BG000
value
151
group Id
BG001
value
153
group Id
BG002
value
304
units
Participants
title
Denmark
categories
measurements
group Id
BG000
value
19
group Id
BG001
value
20
group Id
BG002
value
39
denoms
counts
group Id
BG000
value
151
group Id
BG001
value
153
group Id
BG002
value
304
units
Participants
title
Italy
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
5
group Id
BG002
value
9
denoms
counts
group Id
BG000
value
151
group Id
BG001
value
153
group Id
BG002
value
304
units
Participants
title
Serbia
categories
measurements
group Id
BG000
value
8
group Id
BG001
value
7
group Id
BG002
value
15
denoms
counts
group Id
BG000
value
151
group Id
BG001
value
153
group Id
BG002
value
304
units
Participants
title
Germany
categories
measurements
group Id
BG000
value
15
group Id
BG001
value
22
group Id
BG002
value
37
denoms
counts
group Id
BG000
value
151
group Id
BG001
value
153
group Id
BG002
value
304
units
Participants
title
Spain
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
2
denoms
counts
group Id
BG000
value
151
group Id
BG001
value
153
group Id
BG002
value
304
units
Participants
title
Poland
categories
measurements
group Id
BG000
value
16
group Id
BG001
value
12
group Id
BG002
value
28
denoms
counts
group Id
BG000
value
151
group Id
BG001
value
153
group Id
BG002
value
304
units
Participants
title
France
param Type
NUMBER
title
Region of Enrollment
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
68
group Id
BG001
value
69
group Id
BG002
value
137
denoms
counts
group Id
BG000
value
151
group Id
BG001
value
153
group Id
BG002
value
304
units
Participants
title
I
categories
measurements
group Id
BG000
value
50
group Id
BG001
value
51
group Id
BG002
value
101
denoms
counts
group Id
BG000
value
151
group Id
BG001
value
153
group Id
BG002
value
304
units
Participants
title
II
categories
measurements
group Id
BG000
value
33
group Id
BG001
value
33
group Id
BG002
value
66
denoms
counts
group Id
BG000
value
151
group Id
BG001
value
153
group Id
BG002
value
304
units
Participants
title
III
description
The International Staging System (ISS) consists of the following 3 stages; Stage I: serum beta2-microglobulin less than (\<) 3.5 milligram per liter (mg/L) and albumin greater than or equal to (≥) 3.5 gram per 100 Milliliter (g/100 mL); Stage II: neither stage I nor stage III; and Stage III: serum beta2-microglobulin greater than or equal to (≥) 5.5 mg/L. Higher stages indicate more severe disease (i.e. worse outcomes).
param Type
COUNT_OF_PARTICIPANTS
title
Stage of Disease (ISS)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
16
group Id
BG001
value
18
group Id
BG002
value
34
denoms
counts
group Id
BG000
value
151
group Id
BG001
value
153
group Id
BG002
value
304
units
Participants
title
1
categories
measurements
group Id
BG000
value
114
group Id
BG001
value
113
group Id
BG002
value
227
denoms
counts
group Id
BG000
value
151
group Id
BG001
value
153
group Id
BG002
value
304
units
Participants
title
2-3
categories
measurements
group Id
BG000
value
21
group Id
BG001
value
22
group Id
BG002
value
43
denoms
counts
group Id
BG000
value
151
group Id
BG001
value
153
group Id
BG002
value
304
units
Participants
title
≥4
param Type
COUNT_OF_PARTICIPANTS
title
No. of Prior Lines of Therapy
unit Of Measure
Participants

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Preserved source evidence · Not medical advice