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NCT02004275 · OUTCOME

Overall Survival (OS) (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 patients alive
Interval / dispersion
95% Confidence Interval
Time frame
2 years

What was measured

Overall survival was analyzed from the time of registration to the date of death or last known date living. Due to median OS time not being reached due to lack of deaths at the time of this report by either arm, the 2 year OS rate has been reported. This analysis censors living patients at 2 years.

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 patients alive · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase II Arm I (Pomalidomide, Dexamethasone).795Not reported.662.928Not reported
Phase II Arm II (Pomalidomide, Dexamethasone, Ixazomib).784Not reported.662.928Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        .662
        upper Limit
        .928
        value
        .795
      2. group Id
        OG001
        lower Limit
        .662
        upper Limit
        .928
        value
        .784
denoms
  1. counts
    1. group Id
      OG000
      value
      39
    2. group Id
      OG001
      value
      38
    units
    Participants
description
Overall survival was analyzed from the time of registration to the date of death or last known date living. Due to median OS time not being reached due to lack of deaths at the time of this report by either arm, the 2 year OS rate has been reported. This analysis censors living patients at 2 years.
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
2 years
title
Overall Survival (OS) (Phase II)
type
SECONDARY
unit Of Measure
proportion of patients alive

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

Preserved source evidence · Not medical advice