NCT02136134 · BASELINE

Baseline characteristics

Addition of Daratumumab to Combination of Bortezomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma · Source last updated 2025-08-29

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

denoms

counts
group Id
BG000
value
247
group Id
BG001
value
251
group Id
BG002
value
498
units
Participants

groups

description
Participants received bortezomib 1.3 milligrams per square meter (mg/m\^2) subcutaneous (SC) injection on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone 20 milligrams (mg) orally (PO) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles. Participants who met sponsor confirmed disease progression eligibility criteria received daratumumab monotherapy as a subsequent antimyeloma therapy as follow: daratumumab 16 milligrams per kilogram (mg/kg) intravenous (IV) infusion or daratumumab SC injection (1800 mg fixed dose) weekly for the first 2 cycles, every 2 weeks from Cycle 3 to 6, and then every 4 weeks thereafter.
id
BG000
title
Bortezomib + Dexamethasone (Vd)
description
Participants received daratumumab 16 mg/kg IV infusion weekly or daratumumab SC injection (1800 mg fixed dose) for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib 1.3 mg/m\^2 SC injection administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
id
BG001
title
Daratumumab + Bortezomib and Dexamethasone (DVd)
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
9.81
value
63.9
group Id
BG001
spread
9.66
value
62.8
group Id
BG002
spread
9.74
value
63.4
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
99
group Id
BG001
value
114
group Id
BG002
value
213
title
Female
measurements
group Id
BG000
value
148
group Id
BG001
value
137
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
20
group Id
BG001
value
23
group Id
BG002
value
43
title
Australia
categories
measurements
group Id
BG000
value
9
group Id
BG001
value
13
group Id
BG002
value
22
title
Brazil
categories
measurements
group Id
BG000
value
19
group Id
BG001
value
16
group Id
BG002
value
35
title
Czech Republic
categories
measurements
group Id
BG000
value
21
group Id
BG001
value
21
group Id
BG002
value
42
title
Germany
categories
measurements
group Id
BG000
value
14
group Id
BG001
value
16
group Id
BG002
value
30
title
Hungary
categories
measurements
group Id
BG000
value
25
group Id
BG001
value
24
group Id
BG002
value
49
title
Italy
categories
measurements
group Id
BG000
value
8
group Id
BG001
value
10
group Id
BG002
value
18
title
Korea, Republic of
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
2
group Id
BG002
value
3
title
Mexico
categories
measurements
group Id
BG000
value
14
group Id
BG001
value
11
group Id
BG002
value
25
title
Netherlands
categories
measurements
group Id
BG000
value
18
group Id
BG001
value
16
group Id
BG002
value
34
title
Poland
categories
measurements
group Id
BG000
value
13
group Id
BG001
value
21
group Id
BG002
value
34
title
Russian Federation
categories
measurements
group Id
BG000
value
19
group Id
BG001
value
10
group Id
BG002
value
29
title
Spain
param Type
NUMBER
title
Region of Enrollment
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
96
group Id
BG001
value
98
group Id
BG002
value
194
title
I
categories
measurements
group Id
BG000
value
100
group Id
BG001
value
94
group Id
BG002
value
194
title
II
categories
measurements
group Id
BG000
value
51
group Id
BG001
value
59
group Id
BG002
value
110
title
III
description
The International Staging System (ISS) system consists of stage I: beta2-microglobulin less than (\<) 3.5 milligrams per liter(mg/L) and albumin greater than or equal to (\>=) 3.5 grams (g) per 100 mL; stage II: neither stage I nor stage III and stage III:beta2-microglobulin \>= 5.5 mg/L. The higher of staging, the worst of outcome.
param Type
NUMBER
title
Stage of Disease (ISS)
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
113
group Id
BG001
value
122
group Id
BG002
value
235
title
1
categories
measurements
group Id
BG000
value
74
group Id
BG001
value
70
group Id
BG002
value
144
title
2
categories
measurements
group Id
BG000
value
32
group Id
BG001
value
37
group Id
BG002
value
69
title
3
categories
measurements
group Id
BG000
value
28
group Id
BG001
value
22
group Id
BG002
value
50
title
>3
param Type
NUMBER
title
No. of Prior Lines of Therapy
unit Of Measure
participants

Complete source fields

denoms

counts
group Id
BG000
value
247
group Id
BG001
value
251
group Id
BG002
value
498
units
Participants

groups

description
Participants received bortezomib 1.3 milligrams per square meter (mg/m\^2) subcutaneous (SC) injection on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone 20 milligrams (mg) orally (PO) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles. Participants who met sponsor confirmed disease progression eligibility criteria received daratumumab monotherapy as a subsequent antimyeloma therapy as follow: daratumumab 16 milligrams per kilogram (mg/kg) intravenous (IV) infusion or daratumumab SC injection (1800 mg fixed dose) weekly for the first 2 cycles, every 2 weeks from Cycle 3 to 6, and then every 4 weeks thereafter.
id
BG000
title
Bortezomib + Dexamethasone (Vd)
description
Participants received daratumumab 16 mg/kg IV infusion weekly or daratumumab SC injection (1800 mg fixed dose) for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib 1.3 mg/m\^2 SC injection administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
id
BG001
title
Daratumumab + Bortezomib and Dexamethasone (DVd)
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
9.81
value
63.9
group Id
BG001
spread
9.66
value
62.8
group Id
BG002
spread
9.74
value
63.4
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
99
group Id
BG001
value
114
group Id
BG002
value
213
title
Female
measurements
group Id
BG000
value
148
group Id
BG001
value
137
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
20
group Id
BG001
value
23
group Id
BG002
value
43
title
Australia
categories
measurements
group Id
BG000
value
9
group Id
BG001
value
13
group Id
BG002
value
22
title
Brazil
categories
measurements
group Id
BG000
value
19
group Id
BG001
value
16
group Id
BG002
value
35
title
Czech Republic
categories
measurements
group Id
BG000
value
21
group Id
BG001
value
21
group Id
BG002
value
42
title
Germany
categories
measurements
group Id
BG000
value
14
group Id
BG001
value
16
group Id
BG002
value
30
title
Hungary
categories
measurements
group Id
BG000
value
25
group Id
BG001
value
24
group Id
BG002
value
49
title
Italy
categories
measurements
group Id
BG000
value
8
group Id
BG001
value
10
group Id
BG002
value
18
title
Korea, Republic of
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
2
group Id
BG002
value
3
title
Mexico
categories
measurements
group Id
BG000
value
14
group Id
BG001
value
11
group Id
BG002
value
25
title
Netherlands
categories
measurements
group Id
BG000
value
18
group Id
BG001
value
16
group Id
BG002
value
34
title
Poland
categories
measurements
group Id
BG000
value
13
group Id
BG001
value
21
group Id
BG002
value
34
title
Russian Federation
categories
measurements
group Id
BG000
value
19
group Id
BG001
value
10
group Id
BG002
value
29
title
Spain
param Type
NUMBER
title
Region of Enrollment
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
96
group Id
BG001
value
98
group Id
BG002
value
194
title
I
categories
measurements
group Id
BG000
value
100
group Id
BG001
value
94
group Id
BG002
value
194
title
II
categories
measurements
group Id
BG000
value
51
group Id
BG001
value
59
group Id
BG002
value
110
title
III
description
The International Staging System (ISS) system consists of stage I: beta2-microglobulin less than (\<) 3.5 milligrams per liter(mg/L) and albumin greater than or equal to (\>=) 3.5 grams (g) per 100 mL; stage II: neither stage I nor stage III and stage III:beta2-microglobulin \>= 5.5 mg/L. The higher of staging, the worst of outcome.
param Type
NUMBER
title
Stage of Disease (ISS)
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
113
group Id
BG001
value
122
group Id
BG002
value
235
title
1
categories
measurements
group Id
BG000
value
74
group Id
BG001
value
70
group Id
BG002
value
144
title
2
categories
measurements
group Id
BG000
value
32
group Id
BG001
value
37
group Id
BG002
value
69
title
3
categories
measurements
group Id
BG000
value
28
group Id
BG001
value
22
group Id
BG002
value
50
title
>3
param Type
NUMBER
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