NCT01850524 · BASELINE

Baseline characteristics

IXAZOMIB Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Newly Diagnosed Multiple Myeloma · Source last updated 2023-07-21

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
351
group Id
BG002
value
705
units
Participants

groups

description
Participants who were randomly assigned to receive placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib matching placebo capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).
id
BG000
title
Placebo + LenDex
description
Participants who were randomly assigned to receive Ixazomib 4.0 mg capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).
id
BG001
title
Ixazomib + LenDex
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
5.91
value
73.7
group Id
BG001
spread
6.53
value
73.5
group Id
BG002
spread
6.22
value
73.6
denoms
counts
group Id
BG000
value
354
group Id
BG001
value
351
group Id
BG002
value
705
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
172
group Id
BG001
value
179
group Id
BG002
value
351
title
Female
measurements
group Id
BG000
value
182
group Id
BG001
value
172
group Id
BG002
value
354
title
Male
denoms
counts
group Id
BG000
value
354
group Id
BG001
value
351
group Id
BG002
value
705
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
14
group Id
BG001
value
12
group Id
BG002
value
26
title
Hispanic or Latino
measurements
group Id
BG000
value
340
group Id
BG001
value
337
group Id
BG002
value
677
title
Not Hispanic or Latino
measurements
group Id
BG000
value
0
group Id
BG001
value
2
group Id
BG002
value
2
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
354
group Id
BG001
value
351
group Id
BG002
value
705
units
Participants
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
52
group Id
BG001
value
44
group Id
BG002
value
96
title
Asian
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
13
group Id
BG001
value
11
group Id
BG002
value
24
title
Black or African American
measurements
group Id
BG000
value
285
group Id
BG001
value
291
group Id
BG002
value
576
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
3
group Id
BG001
value
2
group Id
BG002
value
5
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
354
group Id
BG001
value
351
group Id
BG002
value
705
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Race (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
136
group Id
BG001
value
126
group Id
BG002
value
262
denoms
counts
group Id
BG000
value
354
group Id
BG001
value
351
group Id
BG002
value
705
units
Participants
title
France
categories
measurements
group Id
BG000
value
37
group Id
BG001
value
36
group Id
BG002
value
73
denoms
counts
group Id
BG000
value
354
group Id
BG001
value
351
group Id
BG002
value
705
units
Participants
title
Belgium
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
2
group Id
BG002
value
5
denoms
counts
group Id
BG000
value
354
group Id
BG001
value
351
group Id
BG002
value
705
units
Participants
title
Russia
categories
measurements
group Id
BG000
value
28
group Id
BG001
value
31
group Id
BG002
value
59
denoms
counts
group Id
BG000
value
354
group Id
BG001
value
351
group Id
BG002
value
705
units
Participants
title
Japan
categories
measurements
group Id
BG000
value
20
group Id
BG001
value
11
group Id
BG002
value
31
denoms
counts
group Id
BG000
value
354
group Id
BG001
value
351
group Id
BG002
value
705
units
Participants
title
South Korea
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
3
group Id
BG002
value
6
denoms
counts
group Id
BG000
value
354
group Id
BG001
value
351
group Id
BG002
value
705
units
Participants
title
New Zealand
categories
measurements
group Id
BG000
value
68
group Id
BG001
value
79
group Id
BG002
value
147
denoms
counts
group Id
BG000
value
354
group Id
BG001
value
351
group Id
BG002
value
705
units
Participants
title
United States
categories
measurements
group Id
BG000
value
59
group Id
BG001
value
63
group Id
BG002
value
122
denoms
counts
group Id
BG000
value
354
group Id
BG001
value
351
group Id
BG002
value
705
units
Participants
title
Canada
param Type
COUNT_OF_PARTICIPANTS
title
Region of Enrollment
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
spread
10.04
value
164.7
group Id
BG001
spread
10.13
value
164.3
group Id
BG002
spread
10.08
value
164.5
denoms
counts
group Id
BG000
value
341
group Id
BG001
value
339
group Id
BG002
value
680
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
population Description
Number analyzed indicates number of participants available for analysis at baseline.
title
Height
unit Of Measure
cm
classes
categories
measurements
group Id
BG000
spread
15.353
value
70.53
group Id
BG001
spread
16.995
value
72.67
group Id
BG002
spread
16.215
value
71.59
denoms
counts
group Id
BG000
value
354
group Id
BG001
value
351
group Id
BG002
value
705
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Weight
unit Of Measure
kg
classes
categories
measurements
group Id
BG000
spread
0.2306
value
1.789
group Id
BG001
spread
0.2456
value
1.810
group Id
BG002
spread
0.2383
value
1.800
denoms
counts
group Id
BG000
value
341
group Id
BG001
value
339
group Id
BG002
value
680
units
Participants
description
BSA = square root of (height x weight/3600)
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
population Description
Number analyzed indicates number of participants available for analysis at baseline.
title
Body Surface Area (BSA)
unit Of Measure
m^2

population Description

ITT population included all participants who are randomized.

Complete source fields

denoms

counts
group Id
BG000
value
354
group Id
BG001
value
351
group Id
BG002
value
705
units
Participants

groups

description
Participants who were randomly assigned to receive placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib matching placebo capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).
id
BG000
title
Placebo + LenDex
description
Participants who were randomly assigned to receive Ixazomib 4.0 mg capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).
id
BG001
title
Ixazomib + LenDex
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
5.91
value
73.7
group Id
BG001
spread
6.53
value
73.5
group Id
BG002
spread
6.22
value
73.6
denoms
counts
group Id
BG000
value
354
group Id
BG001
value
351
group Id
BG002
value
705
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
172
group Id
BG001
value
179
group Id
BG002
value
351
title
Female
measurements
group Id
BG000
value
182
group Id
BG001
value
172
group Id
BG002
value
354
title
Male
denoms
counts
group Id
BG000
value
354
group Id
BG001
value
351
group Id
BG002
value
705
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
14
group Id
BG001
value
12
group Id
BG002
value
26
title
Hispanic or Latino
measurements
group Id
BG000
value
340
group Id
BG001
value
337
group Id
BG002
value
677
title
Not Hispanic or Latino
measurements
group Id
BG000
value
0
group Id
BG001
value
2
group Id
BG002
value
2
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
354
group Id
BG001
value
351
group Id
BG002
value
705
units
Participants
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
52
group Id
BG001
value
44
group Id
BG002
value
96
title
Asian
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
13
group Id
BG001
value
11
group Id
BG002
value
24
title
Black or African American
measurements
group Id
BG000
value
285
group Id
BG001
value
291
group Id
BG002
value
576
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
3
group Id
BG001
value
2
group Id
BG002
value
5
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
354
group Id
BG001
value
351
group Id
BG002
value
705
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Race (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
136
group Id
BG001
value
126
group Id
BG002
value
262
denoms
counts
group Id
BG000
value
354
group Id
BG001
value
351
group Id
BG002
value
705
units
Participants
title
France
categories
measurements
group Id
BG000
value
37
group Id
BG001
value
36
group Id
BG002
value
73
denoms
counts
group Id
BG000
value
354
group Id
BG001
value
351
group Id
BG002
value
705
units
Participants
title
Belgium
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
2
group Id
BG002
value
5
denoms
counts
group Id
BG000
value
354
group Id
BG001
value
351
group Id
BG002
value
705
units
Participants
title
Russia
categories
measurements
group Id
BG000
value
28
group Id
BG001
value
31
group Id
BG002
value
59
denoms
counts
group Id
BG000
value
354
group Id
BG001
value
351
group Id
BG002
value
705
units
Participants
title
Japan
categories
measurements
group Id
BG000
value
20
group Id
BG001
value
11
group Id
BG002
value
31
denoms
counts
group Id
BG000
value
354
group Id
BG001
value
351
group Id
BG002
value
705
units
Participants
title
South Korea
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
3
group Id
BG002
value
6
denoms
counts
group Id
BG000
value
354
group Id
BG001
value
351
group Id
BG002
value
705
units
Participants
title
New Zealand
categories
measurements
group Id
BG000
value
68
group Id
BG001
value
79
group Id
BG002
value
147
denoms
counts
group Id
BG000
value
354
group Id
BG001
value
351
group Id
BG002
value
705
units
Participants
title
United States
categories
measurements
group Id
BG000
value
59
group Id
BG001
value
63
group Id
BG002
value
122
denoms
counts
group Id
BG000
value
354
group Id
BG001
value
351
group Id
BG002
value
705
units
Participants
title
Canada
param Type
COUNT_OF_PARTICIPANTS
title
Region of Enrollment
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
spread
10.04
value
164.7
group Id
BG001
spread
10.13
value
164.3
group Id
BG002
spread
10.08
value
164.5
denoms
counts
group Id
BG000
value
341
group Id
BG001
value
339
group Id
BG002
value
680
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
population Description
Number analyzed indicates number of participants available for analysis at baseline.
title
Height
unit Of Measure
cm
classes
categories
measurements
group Id
BG000
spread
15.353
value
70.53
group Id
BG001
spread
16.995
value
72.67
group Id
BG002
spread
16.215
value
71.59
denoms
counts
group Id
BG000
value
354
group Id
BG001
value
351
group Id
BG002
value
705
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Weight
unit Of Measure
kg
classes
categories
measurements
group Id
BG000
spread
0.2306
value
1.789
group Id
BG001
spread
0.2456
value
1.810
group Id
BG002
spread
0.2383
value
1.800
denoms
counts
group Id
BG000
value
341
group Id
BG001
value
339
group Id
BG002
value
680
units
Participants
description
BSA = square root of (height x weight/3600)
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
population Description
Number analyzed indicates number of participants available for analysis at baseline.
title
Body Surface Area (BSA)
unit Of Measure
m^2

population Description

ITT population included all participants who are randomized.

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

Preserved source evidence · Not medical advice