NCT01564537 · BASELINE

Baseline characteristics

A Phase 3 Study Comparing Oral Ixazomib Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma · Source last updated 2023-03-10

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

denoms

counts
group Id
BG000
value
360
group Id
BG001
value
362
group Id
BG002
value
722
units
Participants

groups

description
Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until PD or unacceptable toxicity, whichever occurred first up to EOT (up to approximately 42.9 months).
id
BG000
title
Ixazomib+ Lenalidomide + Dexamethasone
description
Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until PD or unacceptable toxicity, whichever occurred first (up to approximately 41 months).
id
BG001
title
Placebo + Lenalidomide + Dexamethasone
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
9.13
value
65.5
group Id
BG001
spread
9.70
value
65.8
group Id
BG002
spread
9.41
value
65.7
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
168
group Id
BG001
value
176
group Id
BG002
value
344
title
≤65 years
categories
measurements
group Id
BG000
value
145
group Id
BG001
value
125
group Id
BG002
value
270
title
>65-≤75 years
categories
measurements
group Id
BG000
value
47
group Id
BG001
value
61
group Id
BG002
value
108
title
>75 years
param Type
NUMBER
title
Age, Customized
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
153
group Id
BG001
value
160
group Id
BG002
value
313
title
Female
measurements
group Id
BG000
value
207
group Id
BG001
value
202
group Id
BG002
value
409
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
312
group Id
BG001
value
303
group Id
BG002
value
615
title
White
categories
measurements
group Id
BG000
value
7
group Id
BG001
value
6
group Id
BG002
value
13
title
Black or African American
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
2
group Id
BG002
value
4
title
Native Hawaiian/Other Pacific Islander
categories
measurements
group Id
BG000
value
30
group Id
BG001
value
34
group Id
BG002
value
64
title
Asian
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
title
American Indian/Alaska native
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
3
group Id
BG002
value
7
title
Other
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
13
group Id
BG002
value
18
title
Not reported
param Type
NUMBER
title
Race/Ethnicity, Customized
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
9
group Id
BG001
value
12
group Id
BG002
value
21
title
Hispanic or Latino
categories
measurements
group Id
BG000
value
341
group Id
BG001
value
333
group Id
BG002
value
674
title
Not Hispanic or Latino
categories
measurements
group Id
BG000
value
8
group Id
BG001
value
15
group Id
BG002
value
23
title
Not Reported
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
2
group Id
BG002
value
4
title
Missing
param Type
NUMBER
title
Race/Ethnicity, Customized
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
21
group Id
BG001
value
18
group Id
BG002
value
39
title
Russian Federation
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
4
group Id
BG002
value
6
title
Singapore
categories
measurements
group Id
BG000
value
28
group Id
BG001
value
23
group Id
BG002
value
51
title
United States
categories
measurements
group Id
BG000
value
7
group Id
BG001
value
8
group Id
BG002
value
15
title
Portugal
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
4
group Id
BG002
value
9
title
Austria
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
6
group Id
BG002
value
9
title
Netherlands
categories
measurements
group Id
BG000
value
15
group Id
BG001
value
12
group Id
BG002
value
27
title
Sweden
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
3
group Id
BG002
value
6
title
China
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
2
group Id
BG002
value
6
title
Korea, Republic of
categories
measurements
group Id
BG000
value
21
group Id
BG001
value
20
group Id
BG002
value
41
title
Poland
categories
measurements
group Id
BG000
value
36
group Id
BG001
value
45
group Id
BG002
value
81
title
France
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
6
group Id
BG002
value
12
title
Romania
param Type
NUMBER
title
Region of Enrollment
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
212
group Id
BG001
value
213
group Id
BG002
value
425
title
1 Line
categories
measurements
group Id
BG000
value
148
group Id
BG001
value
149
group Id
BG002
value
297
title
2 or 3 Lines
param Type
NUMBER
title
Stratification Factor: Lines of Prior Therapy
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
250
group Id
BG001
value
253
group Id
BG002
value
503
title
Exposed
categories
measurements
group Id
BG000
value
110
group Id
BG001
value
109
group Id
BG002
value
219
title
Naïve
param Type
NUMBER
title
Stratification Factor: Proteasome Inhibitor
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
314
group Id
BG001
value
318
group Id
BG002
value
632
title
Stage I or Stage II
categories
measurements
group Id
BG000
value
46
group Id
BG001
value
44
group Id
BG002
value
90
title
Stage III
description
Stage I: Serum beta2-microglobulin \<3.5 mg/L and albumin ≥3.5 g/dL; Stage II: Neither Stage I or III, meaning that either: beta2-microglobulin level ≥3.5 and \<5.5 mg/L (with any albumin level), OR albumin \<3.5 g/dL with beta2-microglobulin \<3.5 mg/L; Stage III: Serum beta2-microglobulin ≥5.5 mg/L. Normal serum beta2-microglobulin: \<3.0 mg/L; normal albumin: 3.5-5.0 g/dL.
param Type
NUMBER
title
Stratification Factor: International Staging System (ISS) Stag at Screening
unit Of Measure
participants

population Description

Intent-to-Treat (ITT) population was defined as all randomized participants.

Complete source fields

denoms

counts
group Id
BG000
value
360
group Id
BG001
value
362
group Id
BG002
value
722
units
Participants

groups

description
Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until PD or unacceptable toxicity, whichever occurred first up to EOT (up to approximately 42.9 months).
id
BG000
title
Ixazomib+ Lenalidomide + Dexamethasone
description
Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until PD or unacceptable toxicity, whichever occurred first (up to approximately 41 months).
id
BG001
title
Placebo + Lenalidomide + Dexamethasone
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
9.13
value
65.5
group Id
BG001
spread
9.70
value
65.8
group Id
BG002
spread
9.41
value
65.7
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
168
group Id
BG001
value
176
group Id
BG002
value
344
title
≤65 years
categories
measurements
group Id
BG000
value
145
group Id
BG001
value
125
group Id
BG002
value
270
title
>65-≤75 years
categories
measurements
group Id
BG000
value
47
group Id
BG001
value
61
group Id
BG002
value
108
title
>75 years
param Type
NUMBER
title
Age, Customized
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
153
group Id
BG001
value
160
group Id
BG002
value
313
title
Female
measurements
group Id
BG000
value
207
group Id
BG001
value
202
group Id
BG002
value
409
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
312
group Id
BG001
value
303
group Id
BG002
value
615
title
White
categories
measurements
group Id
BG000
value
7
group Id
BG001
value
6
group Id
BG002
value
13
title
Black or African American
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
2
group Id
BG002
value
4
title
Native Hawaiian/Other Pacific Islander
categories
measurements
group Id
BG000
value
30
group Id
BG001
value
34
group Id
BG002
value
64
title
Asian
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
title
American Indian/Alaska native
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
3
group Id
BG002
value
7
title
Other
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
13
group Id
BG002
value
18
title
Not reported
param Type
NUMBER
title
Race/Ethnicity, Customized
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
9
group Id
BG001
value
12
group Id
BG002
value
21
title
Hispanic or Latino
categories
measurements
group Id
BG000
value
341
group Id
BG001
value
333
group Id
BG002
value
674
title
Not Hispanic or Latino
categories
measurements
group Id
BG000
value
8
group Id
BG001
value
15
group Id
BG002
value
23
title
Not Reported
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
2
group Id
BG002
value
4
title
Missing
param Type
NUMBER
title
Race/Ethnicity, Customized
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
21
group Id
BG001
value
18
group Id
BG002
value
39
title
Russian Federation
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
4
group Id
BG002
value
6
title
Singapore
categories
measurements
group Id
BG000
value
28
group Id
BG001
value
23
group Id
BG002
value
51
title
United States
categories
measurements
group Id
BG000
value
7
group Id
BG001
value
8
group Id
BG002
value
15
title
Portugal
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
4
group Id
BG002
value
9
title
Austria
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
6
group Id
BG002
value
9
title
Netherlands
categories
measurements
group Id
BG000
value
15
group Id
BG001
value
12
group Id
BG002
value
27
title
Sweden
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
3
group Id
BG002
value
6
title
China
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
2
group Id
BG002
value
6
title
Korea, Republic of
categories
measurements
group Id
BG000
value
21
group Id
BG001
value
20
group Id
BG002
value
41
title
Poland
categories
measurements
group Id
BG000
value
36
group Id
BG001
value
45
group Id
BG002
value
81
title
France
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
6
group Id
BG002
value
12
title
Romania
param Type
NUMBER
title
Region of Enrollment
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
212
group Id
BG001
value
213
group Id
BG002
value
425
title
1 Line
categories
measurements
group Id
BG000
value
148
group Id
BG001
value
149
group Id
BG002
value
297
title
2 or 3 Lines
param Type
NUMBER
title
Stratification Factor: Lines of Prior Therapy
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
250
group Id
BG001
value
253
group Id
BG002
value
503
title
Exposed
categories
measurements
group Id
BG000
value
110
group Id
BG001
value
109
group Id
BG002
value
219
title
Naïve
param Type
NUMBER
title
Stratification Factor: Proteasome Inhibitor
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
314
group Id
BG001
value
318
group Id
BG002
value
632
title
Stage I or Stage II
categories
measurements
group Id
BG000
value
46
group Id
BG001
value
44
group Id
BG002
value
90
title
Stage III
description
Stage I: Serum beta2-microglobulin \<3.5 mg/L and albumin ≥3.5 g/dL; Stage II: Neither Stage I or III, meaning that either: beta2-microglobulin level ≥3.5 and \<5.5 mg/L (with any albumin level), OR albumin \<3.5 g/dL with beta2-microglobulin \<3.5 mg/L; Stage III: Serum beta2-microglobulin ≥5.5 mg/L. Normal serum beta2-microglobulin: \<3.0 mg/L; normal albumin: 3.5-5.0 g/dL.
param Type
NUMBER
title
Stratification Factor: International Staging System (ISS) Stag at Screening
unit Of Measure
participants

population Description

Intent-to-Treat (ITT) population was defined as all randomized participants.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice