Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02004275 · OUTCOME

Overall Response Rate (ORR)

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 participants
Interval / dispersion
95% Confidence Interval
Time frame
3 years

What was measured

ORR is defined as partial response (PR), very good partial response (VGPR), complete response (CR), or stringent complete response (sCR) according to International Myeloma Working Group (IMWG) Uniform Response Criteria

Analysis population: All eligible and treated Phase II patients were included in analysis. Phase I patients were excluded from response analysis.

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.

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
Arm I (Pomalidomide, Dexamethasone)39
Arm II (Pomalidomide, Dexamethasone, Ixazomib)38

Reported measurements

Source class 1
Values in proportion of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm I (Pomalidomide, Dexamethasone).436Not reported.278.604Not reported
Arm II (Pomalidomide, Dexamethasone, Ixazomib).632Not reported.460.782Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        .278
        upper Limit
        .604
        value
        .436
      2. group Id
        OG001
        lower Limit
        .460
        upper Limit
        .782
        value
        .632
denoms
  1. counts
    1. group Id
      OG000
      value
      39
    2. group Id
      OG001
      value
      38
    units
    Participants
description
ORR is defined as partial response (PR), very good partial response (VGPR), complete response (CR), or stringent complete response (sCR) according to International Myeloma Working Group (IMWG) Uniform Response Criteria
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
    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
    Arm II (Pomalidomide, Dexamethasone, Ixazomib)
param Type
NUMBER
population Description
All eligible and treated Phase II patients were included in analysis. Phase I patients were excluded from response analysis.
reporting Status
POSTED
time Frame
3 years
title
Overall Response Rate (ORR)
type
SECONDARY
unit Of Measure
proportion of participants

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

Preserved source evidence · Not medical advice