NCT02252172 · BASELINE

Baseline characteristics

Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Participants With Previously Untreated Multiple Myeloma · Source last updated 2025-10-20

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

denoms

counts
group Id
BG000
value
369
group Id
BG001
value
368
group Id
BG002
value
737
units
Participants

groups

description
Participants received Lenalidomide 25 milligrams (mg) capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously (IV) once a week (QW) until disease progression or unacceptable toxicity up to 77.5 months. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by the International Myeloma Working Group \[IMWG\] criteria).
id
BG000
title
Lenalidomide + Dexamethasone (Rd)
description
Participants received Daratumumab 16 milligrams per kilograms (mg/kg) IV QW for the first 8 weeks (cycles 1-2) and then every 2 weeks (Q2W) for 16 weeks (Cycle 3-6), then every 4 weeks (Q4W) (from Cycle 7 and beyond) (each cycle of 28 days), Lenalidomide 25 mg capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or IV QW until disease progression or unacceptable toxicity up to 77.3 months. After implementation of Amendment 8, participants who were ongoing with daratumumab IV treatment were given an option to switch to daratumumab subcutaneous (SC) injection on Day 1 of any cycle, as per investigator's discretion. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by IMWG criteria).
id
BG001
title
Daratumumab + Lenalidomide + Dexamethasone (DRd)
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
5.66
value
74.2
group Id
BG001
spread
5.44
value
74.0
group Id
BG002
spread
5.55
value
74.1
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
Years
classes
categories
measurements
group Id
BG000
value
174
group Id
BG001
value
179
group Id
BG002
value
353
title
Female
measurements
group Id
BG000
value
195
group Id
BG001
value
189
group Id
BG002
value
384
title
Male
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
11
group Id
BG002
value
23
title
Hispanic or Latino
measurements
group Id
BG000
value
352
group Id
BG001
value
347
group Id
BG002
value
699
title
Not Hispanic or Latino
measurements
group Id
BG000
value
5
group Id
BG001
value
10
group Id
BG002
value
15
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
339
group Id
BG001
value
336
group Id
BG002
value
675
title
White
measurements
group Id
BG000
value
16
group Id
BG001
value
12
group Id
BG002
value
28
title
Black or African American
measurements
group Id
BG000
value
2
group Id
BG001
value
3
group Id
BG002
value
5
title
Asian
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
1
group Id
BG001
value
0
group Id
BG002
value
1
title
Native Hawaiian or other Pacific Islander
measurements
group Id
BG000
value
6
group Id
BG001
value
6
group Id
BG002
value
12
title
Other
measurements
group Id
BG000
value
1
group Id
BG001
value
2
group Id
BG002
value
3
title
Unknown
measurements
group Id
BG000
value
4
group Id
BG001
value
9
group Id
BG002
value
13
title
Not Reported
param Type
COUNT_OF_PARTICIPANTS
title
Race/Ethnicity, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
18
group Id
BG001
value
17
group Id
BG002
value
35
title
Australia
categories
measurements
group Id
BG000
value
11
group Id
BG001
value
3
group Id
BG002
value
14
title
Austria
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
2
group Id
BG002
value
7
title
Belgium
categories
measurements
group Id
BG000
value
28
group Id
BG001
value
24
group Id
BG002
value
52
title
Canada
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
10
group Id
BG002
value
16
title
Denmark
categories
measurements
group Id
BG000
value
155
group Id
BG001
value
157
group Id
BG002
value
312
title
France
categories
measurements
group Id
BG000
value
16
group Id
BG001
value
19
group Id
BG002
value
35
title
Germany
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
4
group Id
BG002
value
7
title
Ireland
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
5
group Id
BG002
value
8
title
Israel
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
3
group Id
BG002
value
6
title
Italy
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
4
group Id
BG002
value
5
title
Netherlands
categories
measurements
group Id
BG000
value
12
group Id
BG001
value
10
group Id
BG002
value
22
title
Sweden
param Type
COUNT_OF_PARTICIPANTS
title
Region of Enrollment
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
103
group Id
BG001
value
98
group Id
BG002
value
201
title
Stage I
categories
measurements
group Id
BG000
value
156
group Id
BG001
value
163
group Id
BG002
value
319
title
Stage II
categories
measurements
group Id
BG000
value
110
group Id
BG001
value
107
group Id
BG002
value
217
title
Stage III
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 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
spread
1.4
value
1.3
group Id
BG001
spread
1.5
value
1.4
group Id
BG002
spread
1.5
value
1.3
description
Time from MM diagnosis is the time from diagnosis of multiple myeloma to randomization in each treatment group.
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Time from Multiple Myeloma (MM) diagnosis
unit Of Measure
Months

Complete source fields

denoms

counts
group Id
BG000
value
369
group Id
BG001
value
368
group Id
BG002
value
737
units
Participants

groups

description
Participants received Lenalidomide 25 milligrams (mg) capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously (IV) once a week (QW) until disease progression or unacceptable toxicity up to 77.5 months. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by the International Myeloma Working Group \[IMWG\] criteria).
id
BG000
title
Lenalidomide + Dexamethasone (Rd)
description
Participants received Daratumumab 16 milligrams per kilograms (mg/kg) IV QW for the first 8 weeks (cycles 1-2) and then every 2 weeks (Q2W) for 16 weeks (Cycle 3-6), then every 4 weeks (Q4W) (from Cycle 7 and beyond) (each cycle of 28 days), Lenalidomide 25 mg capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or IV QW until disease progression or unacceptable toxicity up to 77.3 months. After implementation of Amendment 8, participants who were ongoing with daratumumab IV treatment were given an option to switch to daratumumab subcutaneous (SC) injection on Day 1 of any cycle, as per investigator's discretion. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by IMWG criteria).
id
BG001
title
Daratumumab + Lenalidomide + Dexamethasone (DRd)
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
5.66
value
74.2
group Id
BG001
spread
5.44
value
74.0
group Id
BG002
spread
5.55
value
74.1
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
Years
classes
categories
measurements
group Id
BG000
value
174
group Id
BG001
value
179
group Id
BG002
value
353
title
Female
measurements
group Id
BG000
value
195
group Id
BG001
value
189
group Id
BG002
value
384
title
Male
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
11
group Id
BG002
value
23
title
Hispanic or Latino
measurements
group Id
BG000
value
352
group Id
BG001
value
347
group Id
BG002
value
699
title
Not Hispanic or Latino
measurements
group Id
BG000
value
5
group Id
BG001
value
10
group Id
BG002
value
15
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
339
group Id
BG001
value
336
group Id
BG002
value
675
title
White
measurements
group Id
BG000
value
16
group Id
BG001
value
12
group Id
BG002
value
28
title
Black or African American
measurements
group Id
BG000
value
2
group Id
BG001
value
3
group Id
BG002
value
5
title
Asian
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
1
group Id
BG001
value
0
group Id
BG002
value
1
title
Native Hawaiian or other Pacific Islander
measurements
group Id
BG000
value
6
group Id
BG001
value
6
group Id
BG002
value
12
title
Other
measurements
group Id
BG000
value
1
group Id
BG001
value
2
group Id
BG002
value
3
title
Unknown
measurements
group Id
BG000
value
4
group Id
BG001
value
9
group Id
BG002
value
13
title
Not Reported
param Type
COUNT_OF_PARTICIPANTS
title
Race/Ethnicity, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
18
group Id
BG001
value
17
group Id
BG002
value
35
title
Australia
categories
measurements
group Id
BG000
value
11
group Id
BG001
value
3
group Id
BG002
value
14
title
Austria
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
2
group Id
BG002
value
7
title
Belgium
categories
measurements
group Id
BG000
value
28
group Id
BG001
value
24
group Id
BG002
value
52
title
Canada
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
10
group Id
BG002
value
16
title
Denmark
categories
measurements
group Id
BG000
value
155
group Id
BG001
value
157
group Id
BG002
value
312
title
France
categories
measurements
group Id
BG000
value
16
group Id
BG001
value
19
group Id
BG002
value
35
title
Germany
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
4
group Id
BG002
value
7
title
Ireland
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
5
group Id
BG002
value
8
title
Israel
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
3
group Id
BG002
value
6
title
Italy
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
4
group Id
BG002
value
5
title
Netherlands
categories
measurements
group Id
BG000
value
12
group Id
BG001
value
10
group Id
BG002
value
22
title
Sweden
param Type
COUNT_OF_PARTICIPANTS
title
Region of Enrollment
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
103
group Id
BG001
value
98
group Id
BG002
value
201
title
Stage I
categories
measurements
group Id
BG000
value
156
group Id
BG001
value
163
group Id
BG002
value
319
title
Stage II
categories
measurements
group Id
BG000
value
110
group Id
BG001
value
107
group Id
BG002
value
217
title
Stage III
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 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
spread
1.4
value
1.3
group Id
BG001
spread
1.5
value
1.4
group Id
BG002
spread
1.5
value
1.3
description
Time from MM diagnosis is the time from diagnosis of multiple myeloma to randomization in each treatment group.
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Time from Multiple Myeloma (MM) diagnosis
unit Of Measure
Months

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Preserved source evidence · Not medical advice