NCT00511238 · OUTCOME

Clinical Benefit Response (CBR) (A0 Only)

Phase 2 Study of Carfilzomib in Relapsed and Refractory Multiple Myeloma · Source last updated 2017-08-31

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

Measure: NUMBER
Unit: participants
Interval / dispersion: Not reported
Time frame: Response assessments same as described in primary outcome measure

What was measured

sCR, CR, VGPR, PR, and minimal response (MR)

Analysis population: Response-evaluable Population: Enrolled patients who completed at least 1 cycle of carfilzomib and who underwent disease assessments at Screening, Cycle 1 Day 15, and Cycle 2 Day 24. This analysis set also included patients who discontinued treatment during this time due to an AE that was considered probably related to carfilzomib.

Groups in this outcome

Carfilzomib (A0)

Subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 of 28 day cycle. Assessed by principal investigator.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Carfilzomib (A0)	42

Reported measurements

Clinical Benefit Response (sCR+CR+VGPR+PR+MR)

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Carfilzomib (A0)	10	Not reported	Not reported	Not reported	Not reported

Complete Response

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Carfilzomib (A0)	0	Not reported	Not reported	Not reported	Not reported

Very Good Partial Response

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Carfilzomib (A0)	0	Not reported	Not reported	Not reported	Not reported

Partial Response

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Carfilzomib (A0)	7	Not reported	Not reported	Not reported	Not reported

Minimal Response

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Carfilzomib (A0)	3	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
10
title
Clinical Benefit Response (sCR+CR+VGPR+PR+MR)
categories
measurements
group Id
OG000
value
0
title
Complete Response
categories
measurements
group Id
OG000
value
0
title
Very Good Partial Response
categories
measurements
group Id
OG000
value
7
title
Partial Response
categories
measurements
group Id
OG000
value
3
title
Minimal Response

denoms

counts
group Id
OG000
value
42
units
Participants

description

sCR, CR, VGPR, PR, and minimal response (MR)

groups

description
Subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 of 28 day cycle. Assessed by principal investigator.
id
OG000
title
Carfilzomib (A0)

param Type

NUMBER

population Description

Response-evaluable Population: Enrolled patients who completed at least 1 cycle of carfilzomib and who underwent disease assessments at Screening, Cycle 1 Day 15, and Cycle 2 Day 24. This analysis set also included patients who discontinued treatment during this time due to an AE that was considered probably related to carfilzomib.

reporting Status

POSTED

time Frame

Response assessments same as described in primary outcome measure

title

Clinical Benefit Response (CBR) (A0 Only)

type

SECONDARY

unit Of Measure

participants

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

Preserved source evidence · Not medical advice