Participant flow

A Study of Oral Ixazomib Citrate (MLN9708) Maintenance Therapy in Participants With Multiple Myeloma Following Autologous Stem Cell Transplant · Source last updated 2024-11-19

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

groups

1. description

   Ixazomib citrate placebo-matching capsules, orally, once on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 26 until progressive disease (PD), unacceptable toxicity, or discontinuation for alternate reasons.

   id

   FG000

   title

   Placebo

2. description

   Ixazomib citrate 3 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 4. Ixazomib citrate 4 mg, capsules, orally, once, on Days 1, 8 and 15 in a 28-day cycle for Cycles 5 through 26 until PD, unacceptable toxicity, or discontinuation for alternate reasons. Participants who had any dose reductions due to adverse events (AEs) were not dose escalated.

   id

   FG001

   title

   Ixazomib Citrate

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         45

      2. group Id

         FG001

         num Subjects

         61

      type

      Withdrawal by Subject

   2. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         5

      type

      Reason Not Specified

   3. reasons

      1. group Id

         FG000

         num Subjects

         8

      2. group Id

         FG001

         num Subjects

         7

      type

      Lost to Follow-up

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         261

      2. group Id

         FG001

         num Subjects

         395

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         261

      2. group Id

         FG001

         num Subjects

         395

      type

      Intent-to-Treat (ITT) Population

   3. achievements

      1. group Id

         FG000

         num Subjects

         259

      2. group Id

         FG001

         num Subjects

         394

      type

      Safety Population

   4. achievements

      1. group Id

         FG000

         num Subjects

         256

      2. group Id

         FG001

         num Subjects

         387

      type

      Per Protocol (PP) Population

   5. achievements

      1. group Id

         FG000

         num Subjects

         206

      2. group Id

         FG001

         num Subjects

         322

      type

      COMPLETED

   6. achievements

      1. group Id

         FG000

         num Subjects

         55

      2. group Id

         FG001

         num Subjects

         73

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Participants with newly diagnosed multiple myeloma (NDMM) who underwent induction therapy according to regional standard of care (SoC), followed by high-dose melphalan (200 milligrams per meter square \[mg/m\^2\]) and Autologous Stem Cell Transplant (ASCT) were enrolled in a 3:2 ratio to receive ixazomib citrate or placebo.

recruitment Details

Participants enrolled at 167 sites globally to take part in this study from 16 July 2014 to 8 September 2023.

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Preserved source evidence · Not medical advice