NCT00511238 · OUTCOME

Clinical Benefit Response (CBR) (A1 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: 1. had measurable disease at Baseline 2. received at least 1 dose of carfilzomib 3. underwent baseline disease response assessments and at least 1 post-baseline disease assessment, or discontinued protocol treatment before Cycle 2 Day 1 due to an AE that was considered to be possibly or probably related to carfilzomib

Groups in this outcome

Carfilzomib (A1)

In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16. If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles. Assessed by Independent Review Committee

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 (A1)	257

Reported measurements

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

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Carfilzomib (A1)	95	Not reported	Not reported	Not reported	Not reported

Complete Response

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Carfilzomib (A1)	1	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 (A1)	13	Not reported	Not reported	Not reported	Not reported

Partial Response

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Carfilzomib (A1)	47	Not reported	Not reported	Not reported	Not reported

Minimal Response

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Carfilzomib (A1)	34	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
95
title
Clinical Benefit Response (sCR+CR+VGPR+PR+MR)
categories
measurements
group Id
OG000
value
1
title
Complete Response
categories
measurements
group Id
OG000
value
13
title
Very Good Partial Response
categories
measurements
group Id
OG000
value
47
title
Partial Response
categories
measurements
group Id
OG000
value
34
title
Minimal Response

denoms

counts
group Id
OG000
value
257
units
Participants

description

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

groups

description
In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16. If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles. Assessed by Independent Review Committee
id
OG000
title
Carfilzomib (A1)

param Type

NUMBER

population Description

Response-Evaluable Population: 1. had measurable disease at Baseline 2. received at least 1 dose of carfilzomib 3. underwent baseline disease response assessments and at least 1 post-baseline disease assessment, or discontinued protocol treatment before Cycle 2 Day 1 due to an AE that was considered to be possibly or probably related to carfilzomib

reporting Status

POSTED

time Frame

Response assessments same as described in primary outcome measure

title

Clinical Benefit Response (CBR) (A1 Only)

type

SECONDARY

unit Of Measure

participants

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

Preserved source evidence · Not medical advice