NCT01903811 · BASELINE

Baseline characteristics

S1304, Carfilzomib and Dexamethasone for Treating Patients With Relapsed or Refractory Myeloma · Source last updated 2024-12-20

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

denoms

counts
group Id
BG000
value
64
group Id
BG001
value
57
group Id
BG002
value
121
units
Participants

groups

description
Patients receive dexamethasone IV and low-dose carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16. (Note that course 1 is given at a reduced dose.) Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients with progression cross-over to Arm II. Carfilzomib: Given IV Dexamethasone: Given IV Laboratory Biomarker Analysis: Correlative studies
id
BG000
title
Arm I (Dexamethasone, Low-dose Carfilzomib)
description
Patients receive dexamethasone IV and high-dose carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. (Note that course 1 is given at a reduced dose over 2-10 minutes.) Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Carfilzomib: Given IV Dexamethasone: Given IV Laboratory Biomarker Analysis: Correlative studies
id
BG001
title
Arm II (Dexamethasone, High-dose Carfilzomib)
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
value
31
group Id
BG001
value
32
group Id
BG002
value
63
denoms
counts
group Id
BG000
value
64
group Id
BG001
value
57
group Id
BG002
value
121
units
Participants
title
Age >= 65
categories
measurements
group Id
BG000
value
33
group Id
BG001
value
25
group Id
BG002
value
58
denoms
counts
group Id
BG000
value
64
group Id
BG001
value
57
group Id
BG002
value
121
units
Participants
title
Age < 65
param Type
COUNT_OF_PARTICIPANTS
title
Age, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
31
group Id
BG001
value
24
group Id
BG002
value
55
title
Female
measurements
group Id
BG000
value
33
group Id
BG001
value
33
group Id
BG002
value
66
title
Male
denoms
counts
group Id
BG000
value
64
group Id
BG001
value
57
group Id
BG002
value
121
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
American Indian or Alaska Native
measurements
group Id
BG000
value
1
group Id
BG001
value
4
group Id
BG002
value
5
title
Asian
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
11
group Id
BG001
value
8
group Id
BG002
value
19
title
Black or African American
measurements
group Id
BG000
value
51
group Id
BG001
value
41
group Id
BG002
value
92
title
White
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
title
More than one race
measurements
group Id
BG000
value
0
group Id
BG001
value
3
group Id
BG002
value
3
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
64
group Id
BG001
value
57
group Id
BG002
value
121
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Race (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
3
group Id
BG002
value
5
denoms
counts
group Id
BG000
value
64
group Id
BG001
value
57
group Id
BG002
value
121
units
Participants
description
POINT DESCRIPTION 0: Fully active, able to carry on all pre-disease performance without restriction. 1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work. 2. Ambulatory and capable of self-care but unable to carry out any work activities; up and about more than 50% of waking hours. 3. Capable of limited self-care, confined to bed or chair more than 50% of waking hours. 4. Completely disabled; cannot carry on any self-care; totally confined to bed or chair.
param Type
COUNT_OF_PARTICIPANTS
title
Zubrod performance status > 1
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
36
group Id
BG001
value
31
group Id
BG002
value
67
denoms
counts
group Id
BG000
value
64
group Id
BG001
value
57
group Id
BG002
value
121
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Beta-2-microglobulin >=3.5 mg/L
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
6
group Id
BG002
value
12
denoms
counts
group Id
BG000
value
33
group Id
BG001
value
23
group Id
BG002
value
56
units
Participants
param Type
COUNT_OF_PARTICIPANTS
population Description
Due to missing/not done labs, number analyzed in row differs from overall.
title
CRP >= 8 mg/L
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
denoms
counts
group Id
BG000
value
64
group Id
BG001
value
57
group Id
BG002
value
121
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Creatinine >= 2 mg/dl
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
23
group Id
BG001
value
18
group Id
BG002
value
41
denoms
counts
group Id
BG000
value
64
group Id
BG001
value
57
group Id
BG002
value
121
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Creatinine clearance < 60 ml/min
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
31
group Id
BG001
value
26
group Id
BG002
value
57
denoms
counts
group Id
BG000
value
63
group Id
BG001
value
56
group Id
BG002
value
119
units
Participants
param Type
COUNT_OF_PARTICIPANTS
population Description
Due to missing/not done labs, number analyzed in row differs from overall.
title
LDH >= 190 U/L
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
16
group Id
BG001
value
14
group Id
BG002
value
30
denoms
counts
group Id
BG000
value
64
group Id
BG001
value
57
group Id
BG002
value
121
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Albumin < 3.5 g/dl
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
20
group Id
BG001
value
22
group Id
BG002
value
42
denoms
counts
group Id
BG000
value
64
group Id
BG001
value
57
group Id
BG002
value
121
units
Participants
description
Stage Criteria: I: Serum β2-microglobulin \< 3.5 mg/L Serum albumin ≥ 3.5 g/dL II: Not Stage I or III III: Serum β2-microglobulin \> 5.5 mg/L Note: Expected survival outcomes worsen with increasing stage.
param Type
COUNT_OF_PARTICIPANTS
title
ISS disease stage: Stage 1
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
30
group Id
BG001
value
19
group Id
BG002
value
49
denoms
counts
group Id
BG000
value
64
group Id
BG001
value
57
group Id
BG002
value
121
units
Participants
description
Stage Criteria: I: Serum β2-microglobulin \< 3.5 mg/L Serum albumin ≥ 3.5 g/dL II: Not Stage I or III III: Serum β2-microglobulin \> 5.5 mg/L Note: Expected survival outcomes worsen with increasing stage.
param Type
COUNT_OF_PARTICIPANTS
title
ISS disease stage: Stage 2
unit Of Measure
Participants

population Description

Includes patients who were eligible and analyzable for study endpoints (indicated as "Completed" in participant flow).

Complete source fields

denoms

counts
group Id
BG000
value
64
group Id
BG001
value
57
group Id
BG002
value
121
units
Participants

groups

description
Patients receive dexamethasone IV and low-dose carfilzomib IV over 2-10 minutes on days 1, 2, 8, 9, 15, and 16. (Note that course 1 is given at a reduced dose.) Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients with progression cross-over to Arm II. Carfilzomib: Given IV Dexamethasone: Given IV Laboratory Biomarker Analysis: Correlative studies
id
BG000
title
Arm I (Dexamethasone, Low-dose Carfilzomib)
description
Patients receive dexamethasone IV and high-dose carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. (Note that course 1 is given at a reduced dose over 2-10 minutes.) Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Carfilzomib: Given IV Dexamethasone: Given IV Laboratory Biomarker Analysis: Correlative studies
id
BG001
title
Arm II (Dexamethasone, High-dose Carfilzomib)
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
value
31
group Id
BG001
value
32
group Id
BG002
value
63
denoms
counts
group Id
BG000
value
64
group Id
BG001
value
57
group Id
BG002
value
121
units
Participants
title
Age >= 65
categories
measurements
group Id
BG000
value
33
group Id
BG001
value
25
group Id
BG002
value
58
denoms
counts
group Id
BG000
value
64
group Id
BG001
value
57
group Id
BG002
value
121
units
Participants
title
Age < 65
param Type
COUNT_OF_PARTICIPANTS
title
Age, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
31
group Id
BG001
value
24
group Id
BG002
value
55
title
Female
measurements
group Id
BG000
value
33
group Id
BG001
value
33
group Id
BG002
value
66
title
Male
denoms
counts
group Id
BG000
value
64
group Id
BG001
value
57
group Id
BG002
value
121
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
American Indian or Alaska Native
measurements
group Id
BG000
value
1
group Id
BG001
value
4
group Id
BG002
value
5
title
Asian
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
11
group Id
BG001
value
8
group Id
BG002
value
19
title
Black or African American
measurements
group Id
BG000
value
51
group Id
BG001
value
41
group Id
BG002
value
92
title
White
measurements
group Id
BG000
value
0
group Id
BG001
value
1
group Id
BG002
value
1
title
More than one race
measurements
group Id
BG000
value
0
group Id
BG001
value
3
group Id
BG002
value
3
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
64
group Id
BG001
value
57
group Id
BG002
value
121
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Race (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
2
group Id
BG001
value
3
group Id
BG002
value
5
denoms
counts
group Id
BG000
value
64
group Id
BG001
value
57
group Id
BG002
value
121
units
Participants
description
POINT DESCRIPTION 0: Fully active, able to carry on all pre-disease performance without restriction. 1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work. 2. Ambulatory and capable of self-care but unable to carry out any work activities; up and about more than 50% of waking hours. 3. Capable of limited self-care, confined to bed or chair more than 50% of waking hours. 4. Completely disabled; cannot carry on any self-care; totally confined to bed or chair.
param Type
COUNT_OF_PARTICIPANTS
title
Zubrod performance status > 1
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
36
group Id
BG001
value
31
group Id
BG002
value
67
denoms
counts
group Id
BG000
value
64
group Id
BG001
value
57
group Id
BG002
value
121
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Beta-2-microglobulin >=3.5 mg/L
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
6
group Id
BG001
value
6
group Id
BG002
value
12
denoms
counts
group Id
BG000
value
33
group Id
BG001
value
23
group Id
BG002
value
56
units
Participants
param Type
COUNT_OF_PARTICIPANTS
population Description
Due to missing/not done labs, number analyzed in row differs from overall.
title
CRP >= 8 mg/L
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
denoms
counts
group Id
BG000
value
64
group Id
BG001
value
57
group Id
BG002
value
121
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Creatinine >= 2 mg/dl
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
23
group Id
BG001
value
18
group Id
BG002
value
41
denoms
counts
group Id
BG000
value
64
group Id
BG001
value
57
group Id
BG002
value
121
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Creatinine clearance < 60 ml/min
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
31
group Id
BG001
value
26
group Id
BG002
value
57
denoms
counts
group Id
BG000
value
63
group Id
BG001
value
56
group Id
BG002
value
119
units
Participants
param Type
COUNT_OF_PARTICIPANTS
population Description
Due to missing/not done labs, number analyzed in row differs from overall.
title
LDH >= 190 U/L
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
16
group Id
BG001
value
14
group Id
BG002
value
30
denoms
counts
group Id
BG000
value
64
group Id
BG001
value
57
group Id
BG002
value
121
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Albumin < 3.5 g/dl
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
20
group Id
BG001
value
22
group Id
BG002
value
42
denoms
counts
group Id
BG000
value
64
group Id
BG001
value
57
group Id
BG002
value
121
units
Participants
description
Stage Criteria: I: Serum β2-microglobulin \< 3.5 mg/L Serum albumin ≥ 3.5 g/dL II: Not Stage I or III III: Serum β2-microglobulin \> 5.5 mg/L Note: Expected survival outcomes worsen with increasing stage.
param Type
COUNT_OF_PARTICIPANTS
title
ISS disease stage: Stage 1
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
30
group Id
BG001
value
19
group Id
BG002
value
49
denoms
counts
group Id
BG000
value
64
group Id
BG001
value
57
group Id
BG002
value
121
units
Participants
description
Stage Criteria: I: Serum β2-microglobulin \< 3.5 mg/L Serum albumin ≥ 3.5 g/dL II: Not Stage I or III III: Serum β2-microglobulin \> 5.5 mg/L Note: Expected survival outcomes worsen with increasing stage.
param Type
COUNT_OF_PARTICIPANTS
title
ISS disease stage: Stage 2
unit Of Measure
Participants

population Description

Includes patients who were eligible and analyzable for study endpoints (indicated as "Completed" in participant flow).

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Preserved source evidence · Not medical advice