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NCT02004275 · OUTCOME

Disease Control Rate (DCR), Defined as Stable Disease (SD) and Better According to International Myeloma Working Group (IMWG) Uniform Response Criteria (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
42 days

What was measured

Proportion of patients that went two of more cycles of treatment without discontinuing treatment for progression or intolerability.

Groups in this outcome

Phase II 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.

Phase II Arm II (Pomalidomide, Dexamethasone, Ixazomib)

Patients receive pomalidomide, dexamethasone, and ixazomib as in Phase I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

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

Analysis denominator · Participants

GroupSource count
Phase II Arm I (Pomalidomide, Dexamethasone)39
Phase II Arm II (Pomalidomide, Dexamethasone, Ixazomib)38

Reported measurements

Source class 1
Values in proportion of partcipants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase II Arm I (Pomalidomide, Dexamethasone).949Not reported.827.994Not reported
Phase II Arm II (Pomalidomide, Dexamethasone, Ixazomib).921Not reported.786.983Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        .827
        upper Limit
        .994
        value
        .949
      2. group Id
        OG001
        lower Limit
        .786
        upper Limit
        .983
        value
        .921
denoms
  1. counts
    1. group Id
      OG000
      value
      39
    2. group Id
      OG001
      value
      38
    units
    Participants
description
Proportion of patients that went two of more cycles of treatment without discontinuing treatment for progression or intolerability.
dispersion Type
95% Confidence Interval
groups
  1. 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
    Phase II Arm I (Pomalidomide, Dexamethasone)
  2. description
    Patients receive pomalidomide, dexamethasone, and ixazomib as in Phase I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    OG001
    title
    Phase II Arm II (Pomalidomide, Dexamethasone, Ixazomib)
param Type
NUMBER
reporting Status
POSTED
time Frame
42 days
title
Disease Control Rate (DCR), Defined as Stable Disease (SD) and Better According to International Myeloma Working Group (IMWG) Uniform Response Criteria (Phase II)
type
SECONDARY
unit Of Measure
proportion of partcipants

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

Preserved source evidence · Not medical advice