NCT02076009 · BASELINE

Baseline characteristics

A Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma · Source last updated 2025-05-01

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

denoms

counts
group Id
BG000
value
283
group Id
BG001
value
286
group Id
BG002
value
569
units
Participants

groups

description
Participants received lenalidomide at a dose of 25 milligrams (mg) orally on Day 1 through Day 21 of each 28-day treatment cycle and low-dose dexamethasone at a total dose of 40 mg weekly (or 20 mg weekly for participants greater than \[\>\] 75 years old or with a body mass index less than \[\<\] 18.5 kilograms per meter square \[kg/m\^2\]).
id
BG000
title
Lenalidomide, Low-dose Dexamethasone (Rd)
description
Participants received daratumumab 16 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks, each 28-day cycle); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks, each 28-day cycle); once only on Day 1 during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Day 1 through Day 21 of each 28-day treatment cycle and low-dose dexamethasone was administered at a total dose of 40 mg weekly (or 20 mg weekly for participants \>75 years old or with a body mass index \< 18.5 kg/m\^2).
id
BG001
title
Daratumumab, Lenalidomide, Low-dose Dexamethasone (DRd)
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
8.84
value
64.3
group Id
BG001
spread
9.03
value
64.4
group Id
BG002
spread
8.93
value
64.4
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
119
group Id
BG001
value
113
group Id
BG002
value
232
title
Female
measurements
group Id
BG000
value
164
group Id
BG001
value
173
group Id
BG002
value
337
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
9
group Id
BG002
value
18
title
Australia
categories
measurements
group Id
BG000
value
10
group Id
BG001
value
12
group Id
BG002
value
22
title
Belgium
categories
measurements
group Id
BG000
value
17
group Id
BG001
value
17
group Id
BG002
value
34
title
Canada
categories
measurements
group Id
BG000
value
7
group Id
BG001
value
10
group Id
BG002
value
17
title
Denmark
categories
measurements
group Id
BG000
value
36
group Id
BG001
value
21
group Id
BG002
value
57
title
France
categories
measurements
group Id
BG000
value
7
group Id
BG001
value
11
group Id
BG002
value
18
title
Germany
categories
measurements
group Id
BG000
value
8
group Id
BG001
value
11
group Id
BG002
value
19
title
Greece
categories
measurements
group Id
BG000
value
20
group Id
BG001
value
19
group Id
BG002
value
39
title
Israel
categories
measurements
group Id
BG000
value
15
group Id
BG001
value
21
group Id
BG002
value
36
title
Japan
categories
measurements
group Id
BG000
value
20
group Id
BG001
value
20
group Id
BG002
value
40
title
Korea, Republic of
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
1
group Id
BG002
value
4
title
Netherlands
categories
measurements
group Id
BG000
value
13
group Id
BG001
value
15
group Id
BG002
value
28
title
Poland
param Type
COUNT_OF_PARTICIPANTS
title
Region of Enrollment
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
140
group Id
BG001
value
137
group Id
BG002
value
277
title
I
measurements
group Id
BG000
value
86
group Id
BG001
value
93
group Id
BG002
value
179
title
II
measurements
group Id
BG000
value
57
group Id
BG001
value
56
group Id
BG002
value
113
title
III
description
The International Staging System (ISS) consists of 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 \>= 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
146
group Id
BG001
value
149
group Id
BG002
value
295
title
1
measurements
group Id
BG000
value
80
group Id
BG001
value
85
group Id
BG002
value
165
title
2
measurements
group Id
BG000
value
38
group Id
BG001
value
38
group Id
BG002
value
76
title
3
measurements
group Id
BG000
value
19
group Id
BG001
value
14
group Id
BG002
value
33
title
>3
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
283
group Id
BG001
value
286
group Id
BG002
value
569
units
Participants

groups

description
Participants received lenalidomide at a dose of 25 milligrams (mg) orally on Day 1 through Day 21 of each 28-day treatment cycle and low-dose dexamethasone at a total dose of 40 mg weekly (or 20 mg weekly for participants greater than \[\>\] 75 years old or with a body mass index less than \[\<\] 18.5 kilograms per meter square \[kg/m\^2\]).
id
BG000
title
Lenalidomide, Low-dose Dexamethasone (Rd)
description
Participants received daratumumab 16 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks, each 28-day cycle); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks, each 28-day cycle); once only on Day 1 during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Day 1 through Day 21 of each 28-day treatment cycle and low-dose dexamethasone was administered at a total dose of 40 mg weekly (or 20 mg weekly for participants \>75 years old or with a body mass index \< 18.5 kg/m\^2).
id
BG001
title
Daratumumab, Lenalidomide, Low-dose Dexamethasone (DRd)
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
8.84
value
64.3
group Id
BG001
spread
9.03
value
64.4
group Id
BG002
spread
8.93
value
64.4
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
119
group Id
BG001
value
113
group Id
BG002
value
232
title
Female
measurements
group Id
BG000
value
164
group Id
BG001
value
173
group Id
BG002
value
337
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
9
group Id
BG002
value
18
title
Australia
categories
measurements
group Id
BG000
value
10
group Id
BG001
value
12
group Id
BG002
value
22
title
Belgium
categories
measurements
group Id
BG000
value
17
group Id
BG001
value
17
group Id
BG002
value
34
title
Canada
categories
measurements
group Id
BG000
value
7
group Id
BG001
value
10
group Id
BG002
value
17
title
Denmark
categories
measurements
group Id
BG000
value
36
group Id
BG001
value
21
group Id
BG002
value
57
title
France
categories
measurements
group Id
BG000
value
7
group Id
BG001
value
11
group Id
BG002
value
18
title
Germany
categories
measurements
group Id
BG000
value
8
group Id
BG001
value
11
group Id
BG002
value
19
title
Greece
categories
measurements
group Id
BG000
value
20
group Id
BG001
value
19
group Id
BG002
value
39
title
Israel
categories
measurements
group Id
BG000
value
15
group Id
BG001
value
21
group Id
BG002
value
36
title
Japan
categories
measurements
group Id
BG000
value
20
group Id
BG001
value
20
group Id
BG002
value
40
title
Korea, Republic of
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
1
group Id
BG002
value
4
title
Netherlands
categories
measurements
group Id
BG000
value
13
group Id
BG001
value
15
group Id
BG002
value
28
title
Poland
param Type
COUNT_OF_PARTICIPANTS
title
Region of Enrollment
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
140
group Id
BG001
value
137
group Id
BG002
value
277
title
I
measurements
group Id
BG000
value
86
group Id
BG001
value
93
group Id
BG002
value
179
title
II
measurements
group Id
BG000
value
57
group Id
BG001
value
56
group Id
BG002
value
113
title
III
description
The International Staging System (ISS) consists of 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 \>= 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
146
group Id
BG001
value
149
group Id
BG002
value
295
title
1
measurements
group Id
BG000
value
80
group Id
BG001
value
85
group Id
BG002
value
165
title
2
measurements
group Id
BG000
value
38
group Id
BG001
value
38
group Id
BG002
value
76
title
3
measurements
group Id
BG000
value
19
group Id
BG001
value
14
group Id
BG002
value
33
title
>3
param Type
COUNT_OF_PARTICIPANTS
title
No. of Prior Lines of Therapy
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice