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NCT02004275 · OUTCOME

Clinical Benefit Rate (CBR)

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

Disease response status is based on the IMWG criteria being held for two consecutive evaluations at least 4 weeks apart. Clinical benefit rate (CBR) is defined as proportion of patients with minimal response (MR) and better according to International Myeloma Working Group (IMWG) Uniform Response Criteria (Phase II)

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 participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase II Arm I (Pomalidomide, Dexamethasone).564Not reported.396.722Not reported
Phase II Arm II (Pomalidomide, Dexamethasone, Ixazomib).737Not reported.569.866Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        .396
        upper Limit
        .722
        value
        .564
      2. group Id
        OG001
        lower Limit
        .569
        upper Limit
        .866
        value
        .737
denoms
  1. counts
    1. group Id
      OG000
      value
      39
    2. group Id
      OG001
      value
      38
    units
    Participants
description
Disease response status is based on the IMWG criteria being held for two consecutive evaluations at least 4 weeks apart. Clinical benefit rate (CBR) is defined as proportion of patients with minimal response (MR) and better according to International Myeloma Working Group (IMWG) Uniform Response Criteria (Phase II)
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
3 years
title
Clinical Benefit Rate (CBR)
type
SECONDARY
unit Of Measure
proportion of participants

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

Preserved source evidence · Not medical advice