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NCT03433001 · OUTCOME

Overall Response Rate (ORR)

A Study in Relapsed and/or Refractory Multiple Myeloma Patients Treated With Ixazomib Plus Lenalidomide and Dexamethasone · Source last updated 2023-12-07

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
Percentage of Participants
Interval / dispersion
95% Confidence Interval
Time frame
Up to 36 months as a maximum

What was measured

ORR is defined as the percentage of participants who achieve a best response of PR or better including stringent complete response (sCR), VGPR and PR assessed with IMWG Criteria, after the start of the study treatment.

Analysis population: Full Analysis Set, defined as all participants who were enrolled into the study and who receive at least one dose of ixazomib.

Groups in this outcome

Ixazomib + Lenalidomide + Dexamethasone

Participants took ixazomib, lenalidomide, and dexamethasone under conditions of standard medical care in this study. The dosage and administration of ixazomib, lenalidomide, and dexamethasone were not defined by the protocol but according to the package insert of each drug.

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

Analysis denominator · Participants

GroupSource count
Ixazomib + Lenalidomide + Dexamethasone295

Reported measurements

Source class 1
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ixazomib + Lenalidomide + Dexamethasone53.9Not reported48.059.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        48.0
        upper Limit
        59.7
        value
        53.9
denoms
  1. counts
    1. group Id
      OG000
      value
      295
    units
    Participants
description
ORR is defined as the percentage of participants who achieve a best response of PR or better including stringent complete response (sCR), VGPR and PR assessed with IMWG Criteria, after the start of the study treatment.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants took ixazomib, lenalidomide, and dexamethasone under conditions of standard medical care in this study. The dosage and administration of ixazomib, lenalidomide, and dexamethasone were not defined by the protocol but according to the package insert of each drug.
    id
    OG000
    title
    Ixazomib + Lenalidomide + Dexamethasone
param Type
NUMBER
population Description
Full Analysis Set, defined as all participants who were enrolled into the study and who receive at least one dose of ixazomib.
reporting Status
POSTED
time Frame
Up to 36 months as a maximum
title
Overall Response Rate (ORR)
type
SECONDARY
unit Of Measure
Percentage of Participants

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

Preserved source evidence · Not medical advice