NCT01335685 · BASELINE

Baseline characteristics

Study of Oral Ixazomib in Combination With Melphalan and Prednisone in Participants With Newly Diagnosed Multiple Myeloma · Source last updated 2018-01-23

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

denoms

counts
group Id
BG000
value
11
group Id
BG001
value
34
group Id
BG002
value
10
group Id
BG003
value
6
group Id
BG004
value
61
units
Participants

groups

description
Ixazomib 3.0 - 3.7 mg, capsules, orally, on Days 1, 4, 8, 11, 22, 25, 29, 32 plus melphalan 9 mg/m\^2, tablets, orally, on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 23 maintenance cycles; overall up to 32 cycles).
id
BG000
title
Arm A: Ixazomib 3.0 - 3.7 mg
description
Ixazomib 3.0 - 5.5 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m\^2, tablets, orally, on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally, on Days 1-4 for in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 49 maintenance cycles; overall up to 61 cycles).
id
BG001
title
Arm B: Ixazomib 3.0 - 5.5 mg
description
Ixazomib 3.0 - 4.0 mg, capsules, orally, on Days 1, 8, 15, 22, and 29 plus melphalan 9 mg/m\^2, tablets, orally, on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally, on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 30 maintenance cycles; overall up to 39 cycles).
id
BG002
title
Arm C: Ixazomib 3.0 - 4.0 mg
description
Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 22, and 29 plus melphalan 9 mg/m\^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles in maintenance phase (up to 28 maintenance cycles; overall up to 37 cycles).
id
BG003
title
Arm D: Ixazomib 4.0 mg
description
Total of all reporting groups
id
BG004
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
6.68
value
74.2
group Id
BG001
spread
4.79
value
74.3
group Id
BG002
spread
4.27
value
76.3
group Id
BG003
spread
9.66
value
73.2
group Id
BG004
spread
5.60
value
74.5
denoms
counts
group Id
BG000
value
11
group Id
BG001
value
34
group Id
BG002
value
10
group Id
BG003
value
6
group Id
BG004
value
61
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
19
group Id
BG002
value
2
group Id
BG003
value
4
group Id
BG004
value
31
denoms
counts
group Id
BG000
value
11
group Id
BG001
value
34
group Id
BG002
value
10
group Id
BG003
value
6
group Id
BG004
value
61
units
Participants
title
<75
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
15
group Id
BG002
value
8
group Id
BG003
value
2
group Id
BG004
value
30
denoms
counts
group Id
BG000
value
11
group Id
BG001
value
34
group Id
BG002
value
10
group Id
BG003
value
6
group Id
BG004
value
61
units
Participants
title
>=75
param Type
COUNT_OF_PARTICIPANTS
title
Age, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
12
group Id
BG002
value
5
group Id
BG003
value
3
group Id
BG004
value
23
title
Female
measurements
group Id
BG000
value
8
group Id
BG001
value
22
group Id
BG002
value
5
group Id
BG003
value
3
group Id
BG004
value
38
title
Male
denoms
counts
group Id
BG000
value
11
group Id
BG001
value
34
group Id
BG002
value
10
group Id
BG003
value
6
group Id
BG004
value
61
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
3
group Id
BG002
value
0
group Id
BG003
value
0
group Id
BG004
value
5
denoms
counts
group Id
BG000
value
11
group Id
BG001
value
34
group Id
BG002
value
10
group Id
BG003
value
6
group Id
BG004
value
61
units
Participants
title
Missing
categories
measurements
group Id
BG000
value
9
group Id
BG001
value
31
group Id
BG002
value
10
group Id
BG003
value
6
group Id
BG004
value
56
denoms
counts
group Id
BG000
value
11
group Id
BG001
value
34
group Id
BG002
value
10
group Id
BG003
value
6
group Id
BG004
value
61
units
Participants
title
Not Hispanic or Latino
param Type
COUNT_OF_PARTICIPANTS
title
Race/Ethnicity, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
1
group Id
BG003
value
0
group Id
BG004
value
1
denoms
counts
group Id
BG000
value
11
group Id
BG001
value
34
group Id
BG002
value
10
group Id
BG003
value
6
group Id
BG004
value
61
units
Participants
title
Asian
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
0
group Id
BG003
value
0
group Id
BG004
value
1
denoms
counts
group Id
BG000
value
11
group Id
BG001
value
34
group Id
BG002
value
10
group Id
BG003
value
6
group Id
BG004
value
61
units
Participants
title
Black or African American
categories
measurements
group Id
BG000
value
10
group Id
BG001
value
32
group Id
BG002
value
9
group Id
BG003
value
6
group Id
BG004
value
57
denoms
counts
group Id
BG000
value
11
group Id
BG001
value
34
group Id
BG002
value
10
group Id
BG003
value
6
group Id
BG004
value
61
units
Participants
title
White
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
0
group Id
BG003
value
0
group Id
BG004
value
2
denoms
counts
group Id
BG000
value
11
group Id
BG001
value
34
group Id
BG002
value
10
group Id
BG003
value
6
group Id
BG004
value
61
units
Participants
title
Other
param Type
COUNT_OF_PARTICIPANTS
title
Race/Ethnicity, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
6
group Id
BG002
value
2
group Id
BG003
value
0
group Id
BG004
value
8
denoms
counts
group Id
BG000
value
11
group Id
BG001
value
34
group Id
BG002
value
10
group Id
BG003
value
6
group Id
BG004
value
61
units
Participants
title
Canada
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
8
group Id
BG002
value
0
group Id
BG003
value
1
group Id
BG004
value
15
denoms
counts
group Id
BG000
value
11
group Id
BG001
value
34
group Id
BG002
value
10
group Id
BG003
value
6
group Id
BG004
value
61
units
Participants
title
Czech Republic
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
15
group Id
BG002
value
7
group Id
BG003
value
5
group Id
BG004
value
30
denoms
counts
group Id
BG000
value
11
group Id
BG001
value
34
group Id
BG002
value
10
group Id
BG003
value
6
group Id
BG004
value
61
units
Participants
title
Spain
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
2
group Id
BG002
value
1
group Id
BG003
value
0
group Id
BG004
value
4
denoms
counts
group Id
BG000
value
11
group Id
BG001
value
34
group Id
BG002
value
10
group Id
BG003
value
6
group Id
BG004
value
61
units
Participants
title
United Kingdom
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
3
group Id
BG002
value
0
group Id
BG003
value
0
group Id
BG004
value
4
denoms
counts
group Id
BG000
value
11
group Id
BG001
value
34
group Id
BG002
value
10
group Id
BG003
value
6
group Id
BG004
value
61
units
Participants
title
United States
param Type
COUNT_OF_PARTICIPANTS
title
Region of Enrollment
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
spread
7.872
value
162.24
group Id
BG001
spread
12.087
value
162.68
group Id
BG002
spread
11.413
value
164.50
group Id
BG003
spread
16.897
value
160.50
group Id
BG004
spread
11.615
value
162.65
denoms
counts
group Id
BG000
value
11
group Id
BG001
value
33
group Id
BG002
value
9
group Id
BG003
value
6
group Id
BG004
value
59
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
population Description
Height data was only available for 11, 33, 9 and 6 participants in the Arms A, B, C and D respectively.
title
Height
unit Of Measure
cm
classes
categories
measurements
group Id
BG000
spread
9.389
value
70.58
group Id
BG001
spread
16.642
value
73.43
group Id
BG002
spread
20.532
value
72.77
group Id
BG003
spread
21.404
value
66.97
group Id
BG004
spread
16.509
value
72.17
denoms
counts
group Id
BG000
value
11
group Id
BG001
value
34
group Id
BG002
value
10
group Id
BG003
value
6
group Id
BG004
value
61
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Weight at Baseline
unit Of Measure
kg
classes
categories
measurements
group Id
BG000
spread
0.1426
value
1.782
group Id
BG001
spread
0.2638
value
1.813
group Id
BG002
spread
0.3337
value
1.799
group Id
BG003
spread
0.3650
value
1.718
group Id
BG004
spread
0.2638
value
1.795
denoms
counts
group Id
BG000
value
11
group Id
BG001
value
33
group Id
BG002
value
9
group Id
BG003
value
6
group Id
BG004
value
59
units
Participants
description
Body Surface Area (m\^2) = square root \[height (cm) x weight (kg) / 3600\].
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
population Description
Body Surface Area data was only available for 11, 33, 9 and 6 participants in the Arms A, B, C and D respectively.
title
Body Surface Area at Baseline
unit Of Measure
m^2

population Description

The safety population consisted of participants who received at least 1 dose of any study drug.

Complete source fields

denoms

counts
group Id
BG000
value
11
group Id
BG001
value
34
group Id
BG002
value
10
group Id
BG003
value
6
group Id
BG004
value
61
units
Participants

groups

description
Ixazomib 3.0 - 3.7 mg, capsules, orally, on Days 1, 4, 8, 11, 22, 25, 29, 32 plus melphalan 9 mg/m\^2, tablets, orally, on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 23 maintenance cycles; overall up to 32 cycles).
id
BG000
title
Arm A: Ixazomib 3.0 - 3.7 mg
description
Ixazomib 3.0 - 5.5 mg, capsules, orally, on Days 1, 8, 15 plus melphalan 6 mg/m\^2, tablets, orally, on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally, on Days 1-4 for in 28-day cycle for up to 13 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 49 maintenance cycles; overall up to 61 cycles).
id
BG001
title
Arm B: Ixazomib 3.0 - 5.5 mg
description
Ixazomib 3.0 - 4.0 mg, capsules, orally, on Days 1, 8, 15, 22, and 29 plus melphalan 9 mg/m\^2, tablets, orally, on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally, on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles or until disease progression or unacceptable toxicity if deriving benefit in maintenance phase (up to 30 maintenance cycles; overall up to 39 cycles).
id
BG002
title
Arm C: Ixazomib 3.0 - 4.0 mg
description
Ixazomib 4.0 mg, capsules, orally, on Days 1, 8, 22, and 29 plus melphalan 9 mg/m\^2, tablets, orally on Days 1 to 4 and prednisone 60 mg/m\^2, tablets, orally on Days 1 to 4 in 42-day cycle for up to 9 cycles in induction phase followed by ixazomib at dose last tolerated in induction, orally, on Days 1, 8, 15 in 28-day cycle up to 12 cycles in maintenance phase (up to 28 maintenance cycles; overall up to 37 cycles).
id
BG003
title
Arm D: Ixazomib 4.0 mg
description
Total of all reporting groups
id
BG004
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
6.68
value
74.2
group Id
BG001
spread
4.79
value
74.3
group Id
BG002
spread
4.27
value
76.3
group Id
BG003
spread
9.66
value
73.2
group Id
BG004
spread
5.60
value
74.5
denoms
counts
group Id
BG000
value
11
group Id
BG001
value
34
group Id
BG002
value
10
group Id
BG003
value
6
group Id
BG004
value
61
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
19
group Id
BG002
value
2
group Id
BG003
value
4
group Id
BG004
value
31
denoms
counts
group Id
BG000
value
11
group Id
BG001
value
34
group Id
BG002
value
10
group Id
BG003
value
6
group Id
BG004
value
61
units
Participants
title
<75
categories
measurements
group Id
BG000
value
5
group Id
BG001
value
15
group Id
BG002
value
8
group Id
BG003
value
2
group Id
BG004
value
30
denoms
counts
group Id
BG000
value
11
group Id
BG001
value
34
group Id
BG002
value
10
group Id
BG003
value
6
group Id
BG004
value
61
units
Participants
title
>=75
param Type
COUNT_OF_PARTICIPANTS
title
Age, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
12
group Id
BG002
value
5
group Id
BG003
value
3
group Id
BG004
value
23
title
Female
measurements
group Id
BG000
value
8
group Id
BG001
value
22
group Id
BG002
value
5
group Id
BG003
value
3
group Id
BG004
value
38
title
Male
denoms
counts
group Id
BG000
value
11
group Id
BG001
value
34
group Id
BG002
value
10
group Id
BG003
value
6
group Id
BG004
value
61
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
3
group Id
BG002
value
0
group Id
BG003
value
0
group Id
BG004
value
5
denoms
counts
group Id
BG000
value
11
group Id
BG001
value
34
group Id
BG002
value
10
group Id
BG003
value
6
group Id
BG004
value
61
units
Participants
title
Missing
categories
measurements
group Id
BG000
value
9
group Id
BG001
value
31
group Id
BG002
value
10
group Id
BG003
value
6
group Id
BG004
value
56
denoms
counts
group Id
BG000
value
11
group Id
BG001
value
34
group Id
BG002
value
10
group Id
BG003
value
6
group Id
BG004
value
61
units
Participants
title
Not Hispanic or Latino
param Type
COUNT_OF_PARTICIPANTS
title
Race/Ethnicity, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
1
group Id
BG003
value
0
group Id
BG004
value
1
denoms
counts
group Id
BG000
value
11
group Id
BG001
value
34
group Id
BG002
value
10
group Id
BG003
value
6
group Id
BG004
value
61
units
Participants
title
Asian
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
0
group Id
BG003
value
0
group Id
BG004
value
1
denoms
counts
group Id
BG000
value
11
group Id
BG001
value
34
group Id
BG002
value
10
group Id
BG003
value
6
group Id
BG004
value
61
units
Participants
title
Black or African American
categories
measurements
group Id
BG000
value
10
group Id
BG001
value
32
group Id
BG002
value
9
group Id
BG003
value
6
group Id
BG004
value
57
denoms
counts
group Id
BG000
value
11
group Id
BG001
value
34
group Id
BG002
value
10
group Id
BG003
value
6
group Id
BG004
value
61
units
Participants
title
White
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
0
group Id
BG003
value
0
group Id
BG004
value
2
denoms
counts
group Id
BG000
value
11
group Id
BG001
value
34
group Id
BG002
value
10
group Id
BG003
value
6
group Id
BG004
value
61
units
Participants
title
Other
param Type
COUNT_OF_PARTICIPANTS
title
Race/Ethnicity, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
6
group Id
BG002
value
2
group Id
BG003
value
0
group Id
BG004
value
8
denoms
counts
group Id
BG000
value
11
group Id
BG001
value
34
group Id
BG002
value
10
group Id
BG003
value
6
group Id
BG004
value
61
units
Participants
title
Canada
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
8
group Id
BG002
value
0
group Id
BG003
value
1
group Id
BG004
value
15
denoms
counts
group Id
BG000
value
11
group Id
BG001
value
34
group Id
BG002
value
10
group Id
BG003
value
6
group Id
BG004
value
61
units
Participants
title
Czech Republic
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
15
group Id
BG002
value
7
group Id
BG003
value
5
group Id
BG004
value
30
denoms
counts
group Id
BG000
value
11
group Id
BG001
value
34
group Id
BG002
value
10
group Id
BG003
value
6
group Id
BG004
value
61
units
Participants
title
Spain
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
2
group Id
BG002
value
1
group Id
BG003
value
0
group Id
BG004
value
4
denoms
counts
group Id
BG000
value
11
group Id
BG001
value
34
group Id
BG002
value
10
group Id
BG003
value
6
group Id
BG004
value
61
units
Participants
title
United Kingdom
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
3
group Id
BG002
value
0
group Id
BG003
value
0
group Id
BG004
value
4
denoms
counts
group Id
BG000
value
11
group Id
BG001
value
34
group Id
BG002
value
10
group Id
BG003
value
6
group Id
BG004
value
61
units
Participants
title
United States
param Type
COUNT_OF_PARTICIPANTS
title
Region of Enrollment
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
spread
7.872
value
162.24
group Id
BG001
spread
12.087
value
162.68
group Id
BG002
spread
11.413
value
164.50
group Id
BG003
spread
16.897
value
160.50
group Id
BG004
spread
11.615
value
162.65
denoms
counts
group Id
BG000
value
11
group Id
BG001
value
33
group Id
BG002
value
9
group Id
BG003
value
6
group Id
BG004
value
59
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
population Description
Height data was only available for 11, 33, 9 and 6 participants in the Arms A, B, C and D respectively.
title
Height
unit Of Measure
cm
classes
categories
measurements
group Id
BG000
spread
9.389
value
70.58
group Id
BG001
spread
16.642
value
73.43
group Id
BG002
spread
20.532
value
72.77
group Id
BG003
spread
21.404
value
66.97
group Id
BG004
spread
16.509
value
72.17
denoms
counts
group Id
BG000
value
11
group Id
BG001
value
34
group Id
BG002
value
10
group Id
BG003
value
6
group Id
BG004
value
61
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Weight at Baseline
unit Of Measure
kg
classes
categories
measurements
group Id
BG000
spread
0.1426
value
1.782
group Id
BG001
spread
0.2638
value
1.813
group Id
BG002
spread
0.3337
value
1.799
group Id
BG003
spread
0.3650
value
1.718
group Id
BG004
spread
0.2638
value
1.795
denoms
counts
group Id
BG000
value
11
group Id
BG001
value
33
group Id
BG002
value
9
group Id
BG003
value
6
group Id
BG004
value
59
units
Participants
description
Body Surface Area (m\^2) = square root \[height (cm) x weight (kg) / 3600\].
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
population Description
Body Surface Area data was only available for 11, 33, 9 and 6 participants in the Arms A, B, C and D respectively.
title
Body Surface Area at Baseline
unit Of Measure
m^2

population Description

The safety population consisted of participants who received at least 1 dose of any study drug.

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Preserved source evidence · Not medical advice