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NCT03433001 · OUTCOME

Percentage of Participants Who Achieve VGPR or Better (CR+VGPR)

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

The percentage of participants of CR + VGPR is defined as the rate of participants who achieve a best response of VGPR or better (sCR, CR, or VGPR) according to the IMWG Criteria after the start of the IRd therapy.

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 + Dexamethasone31.5Not reported26.337.2Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        26.3
        upper Limit
        37.2
        value
        31.5
denoms
  1. counts
    1. group Id
      OG000
      value
      295
    units
    Participants
description
The percentage of participants of CR + VGPR is defined as the rate of participants who achieve a best response of VGPR or better (sCR, CR, or VGPR) according to the IMWG Criteria after the start of the IRd therapy.
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
Percentage of Participants Who Achieve VGPR or Better (CR+VGPR)
type
SECONDARY
unit Of Measure
Percentage of Participants

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

Preserved source evidence · Not medical advice