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NCT03416374 · OUTCOME

Duration of Therapy (DOT)

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
Months
Interval / dispersion
95% Confidence Interval
Time frame
Up to 39 months as a maximum

What was measured

DOT is defined as the treatment duration of study drug at study treatment Period I.

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

[VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy

Bortezomib + 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)

[KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy

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)

[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
[VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy6
[KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy39
[Overall]; Combination Therapy + Ixazomib Therapy45

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
[VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy14.69Not reported4.86NANA: Upper limit for 95% CI was not available due to below the level of detection and insufficient number of participants with events.
[KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy12.43Not reported7.7424.79Not reported
[Overall]; Combination Therapy + Ixazomib Therapy12.43Not reported8.8624.79Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        NA: Upper limit for 95% CI was not available due to below the level of detection and insufficient number of participants with events.
        group Id
        OG000
        lower Limit
        4.86
        upper Limit
        NA
        value
        14.69
      2. group Id
        OG001
        lower Limit
        7.74
        upper Limit
        24.79
        value
        12.43
      3. group Id
        OG002
        lower Limit
        8.86
        upper Limit
        24.79
        value
        12.43
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      39
    3. group Id
      OG002
      value
      45
    units
    Participants
description
DOT is defined as the treatment duration of study drug at study treatment Period I.
dispersion Type
95% Confidence Interval
groups
  1. description
    Bortezomib + 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
    [VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy
  2. description
    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
    OG001
    title
    [KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy
  3. 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
    OG002
    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
Duration of Therapy (DOT)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice