NCT01903811 · OUTCOME

Best Overall Response - Partial Response (PR), Very Good Partial Response (VGPR), Unconfirmed PR (uPR), Stable Disease (SD) Progression (PROG)

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.

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: From date of registration to date of best response while on study treatment

What was measured

Per International Uniform Response Criteria for Multiple Myeloma PR- ≥ 50% reduction in size of soft tissue plasmacytomas \& plasma cells; ≥ 50% decrease in serum \& reduction in urine M protein ≥ 90% or to \< 200 mg/24hr or ≥ 50% decrease in difference in uninvolved \& involved serum free light chain levels; VGPR- PR + Serum and urine M proteins detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M protein \& urine M protein \< 100 mg/24 hrs; uPR- 1 objective status of PR, but confirmation studies are not done, or do not meet the requirements necessary to confirm response; SD- does not meet criteria for sCR, CR, VGPR, PR or PROG; PROG- new or increase in size of existing bone lesions or soft tissue plasmacytomas/ development of hypercalcemia attributable solely to MM/ ≥ 25% increase from baseline/ lowest response level of either serum or Urine M protein, difference in involved \& uninvolved serum free light chain level or bone marrow plasma cell percentage.

Analysis population: This population includes eligible and analyzable patients who had a follow-up response assessment.

Groups in this outcome

Arm I (Dexamethasone, Low-dose Carfilzomib)

Patients receive 20 mg dexamethasone IV and low-dose (27 mg/m\^2) 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 of 20 mg/m\^2.) 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

Arm II (Dexamethasone, High-dose Carfilzomib)

Patients receive 20 mg dexamethasone IV and high-dose (56 mg/m\^2) carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. (Note that course 1 is given at a reduced dose of 20 mg/m\^2 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

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
Arm I (Dexamethasone, Low-dose Carfilzomib)	59
Arm II (Dexamethasone, High-dose Carfilzomib)	53

Reported measurements

Very Good Partial Response (VGPR)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I (Dexamethasone, Low-dose Carfilzomib)	5	Not reported	Not reported	Not reported	Not reported
Arm II (Dexamethasone, High-dose Carfilzomib)	14	Not reported	Not reported	Not reported	Not reported

Partial Response (PR)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I (Dexamethasone, Low-dose Carfilzomib)	18	Not reported	Not reported	Not reported	Not reported
Arm II (Dexamethasone, High-dose Carfilzomib)	11	Not reported	Not reported	Not reported	Not reported

Unconfirmed Partial Response (uPR)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I (Dexamethasone, Low-dose Carfilzomib)	0	Not reported	Not reported	Not reported	Not reported
Arm II (Dexamethasone, High-dose Carfilzomib)	2	Not reported	Not reported	Not reported	Not reported

Stable Disease (SD)

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I (Dexamethasone, Low-dose Carfilzomib)	24	Not reported	Not reported	Not reported	Not reported
Arm II (Dexamethasone, High-dose Carfilzomib)	19	Not reported	Not reported	Not reported	Not reported

Progressive Disease

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm I (Dexamethasone, Low-dose Carfilzomib)	12	Not reported	Not reported	Not reported	Not reported
Arm II (Dexamethasone, High-dose Carfilzomib)	7	Not reported	Not reported	Not reported	Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

group Description
Compare the rate of confirmed PR or better between treatment arms.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.1130
statistical Method
Cochran-Mantel-Haenszel

Complete source fields

analyses

group Description
Compare the rate of confirmed PR or better between treatment arms.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.1130
statistical Method
Cochran-Mantel-Haenszel

classes

categories
measurements
group Id
OG000
value
5
group Id
OG001
value
14
title
Very Good Partial Response (VGPR)
categories
measurements
group Id
OG000
value
18
group Id
OG001
value
11
title
Partial Response (PR)
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
2
title
Unconfirmed Partial Response (uPR)
categories
measurements
group Id
OG000
value
24
group Id
OG001
value
19
title
Stable Disease (SD)
categories
measurements
group Id
OG000
value
12
group Id
OG001
value
7
title
Progressive Disease

denoms

counts
group Id
OG000
value
59
group Id
OG001
value
53
units
Participants

description

groups

description
Patients receive 20 mg dexamethasone IV and low-dose (27 mg/m\^2) 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 of 20 mg/m\^2.) 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
OG000
title
Arm I (Dexamethasone, Low-dose Carfilzomib)
description
Patients receive 20 mg dexamethasone IV and high-dose (56 mg/m\^2) carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. (Note that course 1 is given at a reduced dose of 20 mg/m\^2 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
OG001
title
Arm II (Dexamethasone, High-dose Carfilzomib)

param Type

COUNT_OF_PARTICIPANTS

population Description

This population includes eligible and analyzable patients who had a follow-up response assessment.

reporting Status

POSTED

time Frame

From date of registration to date of best response while on study treatment

title

Best Overall Response - Partial Response (PR), Very Good Partial Response (VGPR), Unconfirmed PR (uPR), Stable Disease (SD) Progression (PROG)

type

SECONDARY

unit Of Measure

Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice