NCT01212952 · OUTCOME

Number of Participants With Adverse Events

Pomalidomide, Bortezomib, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma · Source last updated 2020-04-17

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: 2.5 years

What was measured

Reported in Adverse Events section of the results

Analysis population: All participants combined in this analysis due to small numbers in Phase I portion.

Groups in this outcome

Phase I - Dose Level 1

Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8, 15, 22; and oral dexamethasone on days 1, 8, 15, 22. Treatment repeats every 28 days for 8 courses. Patients then receive maintenance therapy comprising oral pomalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 1.0 mg/m2 Bortezomib, 4 mg Pomalidomide, 40 mg Dexamethasone

Phase I - Dose Level 2

Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8, 15, 22; and oral dexamethasone on days 1, 8, 15, 22. Treatment repeats every 28 days for 8 courses. Patients then receive maintenance therapy comprising oral pomalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 1.3 mg/m2 Bortezomib, 4 mg Pomalidomide, 40 mg Dexamethasone

Phase II

Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8, 15, 22; and oral dexamethasone on days 1, 8, 15, 22. Treatment repeats every 28 days for 8 courses. Patients then receive maintenance therapy comprising oral pomalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 1.3 mg/m2 Bortezomib, 4 mg Pomalidomide, 40 mg Dexamethasone

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
Phase I - Dose Level 1	3
Phase I - Dose Level 2	6
Phase II	41

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase I - Dose Level 1	3	Not reported	Not reported	Not reported	Not reported
Phase I - Dose Level 2	6	Not reported	Not reported	Not reported	Not reported
Phase II	41	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
3
group Id
OG001
value
6
group Id
OG002
value
41

denoms

counts
group Id
OG000
value
3
group Id
OG001
value
6
group Id
OG002
value
41
units
Participants

description

Reported in Adverse Events section of the results

groups

description
Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8, 15, 22; and oral dexamethasone on days 1, 8, 15, 22. Treatment repeats every 28 days for 8 courses. Patients then receive maintenance therapy comprising oral pomalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 1.0 mg/m2 Bortezomib, 4 mg Pomalidomide, 40 mg Dexamethasone
id
OG000
title
Phase I - Dose Level 1
description
Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8, 15, 22; and oral dexamethasone on days 1, 8, 15, 22. Treatment repeats every 28 days for 8 courses. Patients then receive maintenance therapy comprising oral pomalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 1.3 mg/m2 Bortezomib, 4 mg Pomalidomide, 40 mg Dexamethasone
id
OG001
title
Phase I - Dose Level 2
description
Patients receive oral pomalidomide on days 1-21; bortezomib IV on days 1, 8, 15, 22; and oral dexamethasone on days 1, 8, 15, 22. Treatment repeats every 28 days for 8 courses. Patients then receive maintenance therapy comprising oral pomalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. 1.3 mg/m2 Bortezomib, 4 mg Pomalidomide, 40 mg Dexamethasone
id
OG002
title
Phase II

param Type

COUNT_OF_PARTICIPANTS

population Description

All participants combined in this analysis due to small numbers in Phase I portion.

reporting Status

POSTED

time Frame

2.5 years

title

Number of Participants With Adverse Events

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice