NCT03710603 · BASELINE

Baseline characteristics

Daratumumab, VELCADE (Bortezomib), Lenalidomide and Dexamethasone Compared to VELCADE, Lenalidomide and Dexamethasone in Subjects With Previously Untreated Multiple Myeloma · Source last updated 2026-02-10

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

denoms

counts
group Id
BG000
value
354
group Id
BG001
value
355
group Id
BG002
value
709
units
Participants

groups

description
Arm A: Patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplantation were treated with h bortezomib, lenalidomide, and dexamethasone for induction and consolidation followed by lenalidomide maintenance in 28-day cycles. After 4 cycles of induction, patients received high dose therapy with autologous stem cell transplantation.
id
BG000
title
Velcade Lenalidomide Dexamethasone (VRd)
description
Arm B: Patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplantation were treated with subcutaneous daratumumab in combination with bortezomib, lenalidomide, and dexamethasone for induction and consolidation followed by subcutaneous daratumumab in combination with lenalidomide maintenance in 28-day cycles. After 4 cycles of induction, patients received high dose therapy with autologous stem cell transplantation.
id
BG001
title
Daratumumab + VRd (D-VRd)
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
8.12
value
58.1
group Id
BG001
spread
7.81
value
58.7
group Id
BG002
spread
7.96
value
58.4
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
149
group Id
BG001
value
144
group Id
BG002
value
293
title
Female
measurements
group Id
BG000
value
205
group Id
BG001
value
211
group Id
BG002
value
416
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
20
group Id
BG001
value
30
group Id
BG002
value
50
title
Hispanic or Latino
measurements
group Id
BG000
value
254
group Id
BG001
value
242
group Id
BG002
value
496
title
Not Hispanic or Latino
measurements
group Id
BG000
value
80
group Id
BG001
value
83
group Id
BG002
value
163
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
1
group Id
BG001
value
2
group Id
BG002
value
3
title
American Indian or Alaska Native
measurements
group Id
BG000
value
6
group Id
BG001
value
4
group Id
BG002
value
10
title
Asian
measurements
group Id
BG000
value
2
group Id
BG001
value
2
group Id
BG002
value
4
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
4
group Id
BG001
value
5
group Id
BG002
value
9
title
Black or African American
measurements
group Id
BG000
value
323
group Id
BG001
value
330
group Id
BG002
value
653
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
18
group Id
BG001
value
12
group Id
BG002
value
30
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
6
group Id
BG001
value
4
group Id
BG002
value
10
title
Asian
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
5
group Id
BG002
value
9
title
Black or African American
categories
measurements
group Id
BG000
value
19
group Id
BG001
value
28
group Id
BG002
value
47
title
Hispanic or Latino
categories
measurements
group Id
BG000
value
82
group Id
BG001
value
83
group Id
BG002
value
165
title
Other
categories
measurements
group Id
BG000
value
243
group Id
BG001
value
235
group Id
BG002
value
478
title
White Non-Hispanic
param Type
COUNT_OF_PARTICIPANTS
title
Race/Ethnicity, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
1
group Id
BG002
value
5
title
Czechia
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
7
group Id
BG002
value
12
title
Switzerland
categories
measurements
group Id
BG000
value
49
group Id
BG001
value
53
group Id
BG002
value
102
title
Spain
categories
measurements
group Id
BG000
value
27
group Id
BG001
value
32
group Id
BG002
value
59
title
Greece
categories
measurements
group Id
BG000
value
27
group Id
BG001
value
30
group Id
BG002
value
57
title
Netherlands
categories
measurements
group Id
BG000
value
14
group Id
BG001
value
19
group Id
BG002
value
33
title
Turkey
categories
measurements
group Id
BG000
value
10
group Id
BG001
value
7
group Id
BG002
value
17
title
Belgium
categories
measurements
group Id
BG000
value
7
group Id
BG001
value
2
group Id
BG002
value
9
title
Norway
categories
measurements
group Id
BG000
value
9
group Id
BG001
value
10
group Id
BG002
value
19
title
Denmark
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
8
group Id
BG002
value
14
title
Poland
categories
measurements
group Id
BG000
value
86
group Id
BG001
value
64
group Id
BG002
value
150
title
Italy
categories
measurements
group Id
BG000
value
38
group Id
BG001
value
34
group Id
BG002
value
72
title
Australia
param Type
NUMBER
title
Region of Enrollment
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
spread
11.41
value
3
group Id
BG001
spread
4.46
value
2.2
group Id
BG002
spread
8.66
value
2.6
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Time Since Initial Diagnosis (months)
unit Of Measure
months
classes
categories
measurements
group Id
BG000
value
178
group Id
BG001
value
186
group Id
BG002
value
364
title
I
measurements
group Id
BG000
value
125
group Id
BG001
value
114
group Id
BG002
value
239
title
II
measurements
group Id
BG000
value
50
group Id
BG001
value
55
group Id
BG002
value
105
title
III
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
unknown
description
The International Staging System (ISS) for myeloma was published by the International Myeloma Working Group (a lower stage indicates less progressed disease): Stage I: β2-microglobulin (β2M) \< 3.5 mg/L, albumin \>= 3.5 g/dL Stage II: β2M \< 3.5 mg/L and albumin \< 3.5 g/dL; or β2M 3.5 mg/L - 5.5 mg/L irrespective of the serum albumin Stage III: β2M ≥ 5.5 mg/L. Higher stages indicate more advanced disease and/or poorer prognosis. Data is the ISS result assessed at the time of randomization.
param Type
COUNT_OF_PARTICIPANTS
title
Stage of Disease (ISS)
unit Of Measure
Participants

Complete source fields

denoms

counts
group Id
BG000
value
354
group Id
BG001
value
355
group Id
BG002
value
709
units
Participants

groups

description
Arm A: Patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplantation were treated with h bortezomib, lenalidomide, and dexamethasone for induction and consolidation followed by lenalidomide maintenance in 28-day cycles. After 4 cycles of induction, patients received high dose therapy with autologous stem cell transplantation.
id
BG000
title
Velcade Lenalidomide Dexamethasone (VRd)
description
Arm B: Patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplantation were treated with subcutaneous daratumumab in combination with bortezomib, lenalidomide, and dexamethasone for induction and consolidation followed by subcutaneous daratumumab in combination with lenalidomide maintenance in 28-day cycles. After 4 cycles of induction, patients received high dose therapy with autologous stem cell transplantation.
id
BG001
title
Daratumumab + VRd (D-VRd)
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
8.12
value
58.1
group Id
BG001
spread
7.81
value
58.7
group Id
BG002
spread
7.96
value
58.4
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
149
group Id
BG001
value
144
group Id
BG002
value
293
title
Female
measurements
group Id
BG000
value
205
group Id
BG001
value
211
group Id
BG002
value
416
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
20
group Id
BG001
value
30
group Id
BG002
value
50
title
Hispanic or Latino
measurements
group Id
BG000
value
254
group Id
BG001
value
242
group Id
BG002
value
496
title
Not Hispanic or Latino
measurements
group Id
BG000
value
80
group Id
BG001
value
83
group Id
BG002
value
163
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
1
group Id
BG001
value
2
group Id
BG002
value
3
title
American Indian or Alaska Native
measurements
group Id
BG000
value
6
group Id
BG001
value
4
group Id
BG002
value
10
title
Asian
measurements
group Id
BG000
value
2
group Id
BG001
value
2
group Id
BG002
value
4
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
4
group Id
BG001
value
5
group Id
BG002
value
9
title
Black or African American
measurements
group Id
BG000
value
323
group Id
BG001
value
330
group Id
BG002
value
653
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
18
group Id
BG001
value
12
group Id
BG002
value
30
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
6
group Id
BG001
value
4
group Id
BG002
value
10
title
Asian
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
5
group Id
BG002
value
9
title
Black or African American
categories
measurements
group Id
BG000
value
19
group Id
BG001
value
28
group Id
BG002
value
47
title
Hispanic or Latino
categories
measurements
group Id
BG000
value
82
group Id
BG001
value
83
group Id
BG002
value
165
title
Other
categories
measurements
group Id
BG000
value
243
group Id
BG001
value
235
group Id
BG002
value
478
title
White Non-Hispanic
param Type
COUNT_OF_PARTICIPANTS
title
Race/Ethnicity, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
1
group Id
BG002
value
5
title
Czechia
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
7
group Id
BG002
value
12
title
Switzerland
categories
measurements
group Id
BG000
value
49
group Id
BG001
value
53
group Id
BG002
value
102
title
Spain
categories
measurements
group Id
BG000
value
27
group Id
BG001
value
32
group Id
BG002
value
59
title
Greece
categories
measurements
group Id
BG000
value
27
group Id
BG001
value
30
group Id
BG002
value
57
title
Netherlands
categories
measurements
group Id
BG000
value
14
group Id
BG001
value
19
group Id
BG002
value
33
title
Turkey
categories
measurements
group Id
BG000
value
10
group Id
BG001
value
7
group Id
BG002
value
17
title
Belgium
categories
measurements
group Id
BG000
value
7
group Id
BG001
value
2
group Id
BG002
value
9
title
Norway
categories
measurements
group Id
BG000
value
9
group Id
BG001
value
10
group Id
BG002
value
19
title
Denmark
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
8
group Id
BG002
value
14
title
Poland
categories
measurements
group Id
BG000
value
86
group Id
BG001
value
64
group Id
BG002
value
150
title
Italy
categories
measurements
group Id
BG000
value
38
group Id
BG001
value
34
group Id
BG002
value
72
title
Australia
param Type
NUMBER
title
Region of Enrollment
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
spread
11.41
value
3
group Id
BG001
spread
4.46
value
2.2
group Id
BG002
spread
8.66
value
2.6
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Time Since Initial Diagnosis (months)
unit Of Measure
months
classes
categories
measurements
group Id
BG000
value
178
group Id
BG001
value
186
group Id
BG002
value
364
title
I
measurements
group Id
BG000
value
125
group Id
BG001
value
114
group Id
BG002
value
239
title
II
measurements
group Id
BG000
value
50
group Id
BG001
value
55
group Id
BG002
value
105
title
III
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
unknown
description
The International Staging System (ISS) for myeloma was published by the International Myeloma Working Group (a lower stage indicates less progressed disease): Stage I: β2-microglobulin (β2M) \< 3.5 mg/L, albumin \>= 3.5 g/dL Stage II: β2M \< 3.5 mg/L and albumin \< 3.5 g/dL; or β2M 3.5 mg/L - 5.5 mg/L irrespective of the serum albumin Stage III: β2M ≥ 5.5 mg/L. Higher stages indicate more advanced disease and/or poorer prognosis. Data is the ISS result assessed at the time of randomization.
param Type
COUNT_OF_PARTICIPANTS
title
Stage of Disease (ISS)
unit Of Measure
Participants

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Preserved source evidence · Not medical advice