Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03416374 · OUTCOME

Relative Dose Intensity (RDI)

A Study to Evaluate the Efficacy and Safety of Ixazomib in Combination With Lenalidomide and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma Initially Treated With an Injection of Proteasome Inhibitor-Based Therapy · Source last updated 2022-09-27

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

Measure
MEDIAN
Unit
Percent
Interval / dispersion
Full Range
Time frame
Up to 39 months as a maximum

What was measured

RDI for each study drug is defined as 100\*(Total amount of dose taken)/(Total prescribed dose of treated cycles), where total prescribed dose equals \[dose prescribed at enrollment\* number of prescribed doses per cycle\* the number of treated cycles\].

Analysis population: Full Analysis Set (FAS): all participants who were enrolled in Treatment Period I and who receive at least one dose of any therapy during the Treatment Period.

Groups in this outcome

[Overall]; Combination Therapy + Ixazomib Therapy

Bortezomib + Lenalidomide + Dexamethasone, or Carfilzomib + Lenalidomide + Dexamethasone, standard recommended dose according to the package insert of each drug (Treatment Period I), followed by Ixazomib (4.0 mg) on Days 1, 8 and 15, plus Lenalidomide (25 mg) on Days 1 to 21, and Dexamethasone (40 mg) on Days 1, 8, 15 and 22, of a 28-day cycle (Treatment Period II)

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

Analysis denominator · Participants

GroupSource count
[Overall]; Combination Therapy + Ixazomib Therapy45

Reported measurements

Bortezomib, Ixazomib

Analysis denominator · Participants

GroupSource count
[Overall]; Combination Therapy + Ixazomib Therapy6
Values in Percent · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
[Overall]; Combination Therapy + Ixazomib Therapy71.93Not reported58.297.2Not reported
Carfilzomib, Ixazomib

Analysis denominator · Participants

GroupSource count
[Overall]; Combination Therapy + Ixazomib Therapy39
Values in Percent · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
[Overall]; Combination Therapy + Ixazomib Therapy87.70Not reported27.0108.4Not reported
Bortezomib/Carfilzomib, Ixazomib

Analysis denominator · Participants

GroupSource count
[Overall]; Combination Therapy + Ixazomib Therapy45
Values in Percent · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
[Overall]; Combination Therapy + Ixazomib Therapy83.24Not reported27.0108.4Not reported
Lenalidomide

Analysis denominator · Participants

GroupSource count
[Overall]; Combination Therapy + Ixazomib Therapy45
Values in Percent · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
[Overall]; Combination Therapy + Ixazomib Therapy47.18Not reported9.0100.4Not reported
Dexamethasone

Analysis denominator · Participants

GroupSource count
[Overall]; Combination Therapy + Ixazomib Therapy45
Values in Percent · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
[Overall]; Combination Therapy + Ixazomib Therapy48.61Not reported6.6105.3Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        58.2
        upper Limit
        97.2
        value
        71.93
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      units
      Participants
    title
    Bortezomib, Ixazomib
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        27.0
        upper Limit
        108.4
        value
        87.70
    denoms
    1. counts
      1. group Id
        OG000
        value
        39
      units
      Participants
    title
    Carfilzomib, Ixazomib
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        27.0
        upper Limit
        108.4
        value
        83.24
    denoms
    1. counts
      1. group Id
        OG000
        value
        45
      units
      Participants
    title
    Bortezomib/Carfilzomib, Ixazomib
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        9.0
        upper Limit
        100.4
        value
        47.18
    denoms
    1. counts
      1. group Id
        OG000
        value
        45
      units
      Participants
    title
    Lenalidomide
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.6
        upper Limit
        105.3
        value
        48.61
    denoms
    1. counts
      1. group Id
        OG000
        value
        45
      units
      Participants
    title
    Dexamethasone
denoms
  1. counts
    1. group Id
      OG000
      value
      45
    units
    Participants
description
RDI for each study drug is defined as 100\*(Total amount of dose taken)/(Total prescribed dose of treated cycles), where total prescribed dose equals \[dose prescribed at enrollment\* number of prescribed doses per cycle\* the number of treated cycles\].
dispersion Type
Full Range
groups
  1. description
    Bortezomib + Lenalidomide + Dexamethasone, or Carfilzomib + Lenalidomide + Dexamethasone, standard recommended dose according to the package insert of each drug (Treatment Period I), followed by Ixazomib (4.0 mg) on Days 1, 8 and 15, plus Lenalidomide (25 mg) on Days 1 to 21, and Dexamethasone (40 mg) on Days 1, 8, 15 and 22, of a 28-day cycle (Treatment Period II)
    id
    OG000
    title
    [Overall]; Combination Therapy + Ixazomib Therapy
param Type
MEDIAN
population Description
Full Analysis Set (FAS): all participants who were enrolled in Treatment Period I and who receive at least one dose of any therapy during the Treatment Period.
reporting Status
POSTED
time Frame
Up to 39 months as a maximum
title
Relative Dose Intensity (RDI)
type
SECONDARY
unit Of Measure
Percent

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

Preserved source evidence · Not medical advice