NCT02004275 · OUTCOME

Response Rates (Overall Response Rate (ORR), Clinical Benefit Rate (CBR), Disease Control Rate (DCR) for All Patients on the Pomalidomide/Dexamethasone Arm at the Time of Cross-over to Pomalidomide/Dexamethasone/Ixazomib (Phase II)

Pomalidomide and Dexamethasone With or Without Ixazomib in Treating Patients With Relapsed Multiple Myeloma · Source last updated 2023-12-01

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

Measure: NUMBER
Unit: proportion of partcipants
Interval / dispersion: 95% Confidence Interval
Time frame: Up to 3 years

Groups in this outcome

Arm I(Pomalidomide, Dexamethasone)

Patients receive pomalidomide PO QD on days 1-21 and dexamethasone PO QD on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving disease progression may cross over to Arm II.

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(Pomalidomide, Dexamethasone)	26

Reported measurements

Overall Response Rate

Values in proportion of partcipants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Arm I(Pomalidomide, Dexamethasone)	.231	Not reported	.090	.437	Not reported

Clinical Benefit Rate

Values in proportion of partcipants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Arm I(Pomalidomide, Dexamethasone)	.269	Not reported	.116	.478	Not reported

Disease Control Rate

Values in proportion of partcipants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Arm I(Pomalidomide, Dexamethasone)	.962	Not reported	.804	.999	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
.090
upper Limit
.437
value
.231
title
Overall Response Rate
categories
measurements
group Id
OG000
lower Limit
.116
upper Limit
.478
value
.269
title
Clinical Benefit Rate
categories
measurements
group Id
OG000
lower Limit
.804
upper Limit
.999
value
.962
title
Disease Control Rate

denoms

counts
group Id
OG000
value
26
units
Participants

dispersion Type

95% Confidence Interval

groups

description
Patients receive pomalidomide PO QD on days 1-21 and dexamethasone PO QD on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving disease progression may cross over to Arm II.
id
OG000
title
Arm I(Pomalidomide, Dexamethasone)

param Type

NUMBER

reporting Status

POSTED

time Frame

Up to 3 years

title

Response Rates (Overall Response Rate (ORR), Clinical Benefit Rate (CBR), Disease Control Rate (DCR) for All Patients on the Pomalidomide/Dexamethasone Arm at the Time of Cross-over to Pomalidomide/Dexamethasone/Ixazomib (Phase II)

type

SECONDARY

unit Of Measure

proportion of partcipants

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

Preserved source evidence · Not medical advice