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NCT01979276 · OUTCOME

Efficacy of Study Regimen Combination

Study of Pomalidomide, Dexamethasone, and Romidepsin for Rel/Ref Myeloma · Source last updated 2018-06-06

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 baseline to cycle of maximum response, which occurred on average after 2 cycles; 1 cycle = 28 days

What was measured

The efficacy (as assessed by clinical response) of the combination of pomalidomide (CC-4047®) and romidepsin as therapy for patients with relapsed or refractory multiple myeloma (MM) (phase II portion) was evaluated using the IMWG Response Criteria for disease assessment. The best response was reported. (Criteria can be found at the following link, due to length and complexity of the response criteria: http://imwg.myeloma.org/international-myeloma-working-group-imwg-uniform-response-criteria-for-multiple-myeloma/)

Groups in this outcome

ALL Patients

Pomalidomide, 4 mg by mouth daily on days 1-21 of 28 day cycle Dexamethasone, 40 mg by mouth on days 1, 8, 15, and 22 of 28 day cycle Romidepsin, IV on days 1 and 15 of 28 day cycle, dose level to be determined

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

Analysis denominator · Participants

GroupSource count
ALL Patients2

Reported measurements

Source class 1

Progression of Disease

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
ALL Patients1Not reportedNot reportedNot reportedNot reported

Very Good Partial Response

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
ALL Patients1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      title
      Progression of Disease
    2. measurements
      1. group Id
        OG000
        value
        1
      title
      Very Good Partial Response
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    units
    Participants
description
The efficacy (as assessed by clinical response) of the combination of pomalidomide (CC-4047®) and romidepsin as therapy for patients with relapsed or refractory multiple myeloma (MM) (phase II portion) was evaluated using the IMWG Response Criteria for disease assessment. The best response was reported. (Criteria can be found at the following link, due to length and complexity of the response criteria: http://imwg.myeloma.org/international-myeloma-working-group-imwg-uniform-response-criteria-for-multiple-myeloma/)
groups
  1. description
    Pomalidomide, 4 mg by mouth daily on days 1-21 of 28 day cycle Dexamethasone, 40 mg by mouth on days 1, 8, 15, and 22 of 28 day cycle Romidepsin, IV on days 1 and 15 of 28 day cycle, dose level to be determined
    id
    OG000
    title
    ALL Patients
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
From baseline to cycle of maximum response, which occurred on average after 2 cycles; 1 cycle = 28 days
title
Efficacy of Study Regimen Combination
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice