Participant flow

A Study of MLN9708 in Japanese Participants With Relapsed and/or Refractory Multiple Myeloma (RRMM) · Source last updated 2020-03-17

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

groups

1. description

   Ixazomib 4.0 mg, capsules, orally, once, on Days 1, 8, and 15 in 28-day treatment cycle for up to Cycle 87.

   id

   FG000

   title

   Cohort 1: Ixazomib 4.0 mg

2. description

   Ixazomib 4.0 mg, capsules, orally, once, on Days 1, 8, and 15 in 28-day treatment cycle along with lenalidomide 25 mg/day, capsules, orally, once, from Days 1 to 21 and dexamethasone 40 mg/day, tablets, orally, once, on Days 1, 8, 15, and 22 in a 28-day treatment cycle for up to Cycle 62.

   id

   FG001

   title

   Cohort 2: Ixazomib 4.0 mg + Lenalidomide and Dexamethasone

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Study Terminated by Sponsor

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Protocol Violation

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Symptomatic Deterioration

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         2

      type

      Withdrawal by Subject

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         2

      type

      Adverse Event

   6. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         1

      type

      Progressive Disease

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         7

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         7

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Relapsed and/or refractory multiple myeloma (RRMM) participants were enrolled to receive ixazomib 4.0 milligram (mg) in: Cohort 1 and along with lenalidomide 25 milligram per day (mg/day) and dexamethasone 40 mg/day (Rd) in Cohort 2. Study was terminated after completion of Cohorts 1 and 2 due to business decision; no safety or efficacy concerns.

recruitment Details

Participants took part in the study at 5 investigative sites in Japan from 05 June 2012 to 15 February 2019.

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Preserved source evidence · Not medical advice