Participant flow

A Phase 3 Study Comparing Oral Ixazomib Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma · Source last updated 2023-03-10

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

groups

1. description

   Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to end of treatment (EOT) (up to approximately 42.9 months).

   id

   FG000

   title

   Ixazomib+ Lenalidomide + Dexamethasone

2. description

   Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until PD or unacceptable toxicity, whichever occurred first (up to approximately 41 months).

   id

   FG001

   title

   Placebo + Lenalidomide + Dexamethasone

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Site Terminated by Sponsor

   2. reasons

      1. group Id

         FG000

         num Subjects

         12

      2. group Id

         FG001

         num Subjects

         14

      type

      Withdrawal by Subject

   3. reasons

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         3

      type

      Lost to Follow-up

   4. reasons

      1. group Id

         FG000

         num Subjects

         81

      2. group Id

         FG001

         num Subjects

         82

      type

      Reason not specified

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         360

      2. group Id

         FG001

         num Subjects

         362

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         360

      2. group Id

         FG001

         num Subjects

         362

      comment

      ITT population was defined as all randomized participants.

      type

      Intent-to-Treat (ITT) Population

   3. achievements

      1. group Id

         FG000

         num Subjects

         361

      2. group Id

         FG001

         num Subjects

         359

      comment

      Safety population included all randomized participants who received at least 1 dose of any study drug, regardless of their randomized treatment.

      type

      Safety Population

   4. achievements

      1. group Id

         FG000

         num Subjects

         345

      2. group Id

         FG001

         num Subjects

         348

      comment

      Response-Evaluable population included all participants who received at least 1 dose of study drug, had measurable disease at baseline, and at least 1 post-baseline response assessment.

      type

      Response Evaluable Population

   5. achievements

      1. group Id

         FG000

         num Subjects

         259

      2. group Id

         FG001

         num Subjects

         263

      type

      COMPLETED

   6. achievements

      1. group Id

         FG000

         num Subjects

         101

      2. group Id

         FG001

         num Subjects

         99

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Participants with a diagnosis of relapsed and/or refractory multiple myeloma were enrolled in 1 of 2 treatment groups: Ixazomib 4 mg or Ixazomib placebo-matching tablets in combination with lenalidomide, and dexamethasone.

recruitment Details

Participants were enrolled at 187 sites in Australia, Austria, Belgium, Canada, China, Czech Republic, Denmark, France, Germany, Hungary, Israel, Italy, Japan, Republic of Korea, Netherlands, New Zealand, Poland, Portugal, Romania, Russian Federation, Singapore, Spain, Sweden, Turkey, United Kingdom and US from 01 August 2012 to 08 February 2022.

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

Preserved source evidence · Not medical advice