Participant flow

IXAZOMIB Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Newly Diagnosed Multiple Myeloma · Source last updated 2023-07-21

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

groups

1. description

   Participants who were randomly assigned to receive placebo matching capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib matching placebo capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).

   id

   FG000

   title

   Placebo + LenDex

2. description

   Participants who were randomly assigned to receive Ixazomib 4.0 mg capsule single oral dose on Days 1, 8 and 15 along with standard regimen of LenDex (lenalidomide 25 mg capsules orally on Days 1-21 and dexamethasone 40 mg tablets orally on Days 1, 8, 15 and 22) for the first 18 cycles (each cycle was of 28 days). Following Cycle 18, participants received 3.0 mg ixazomib capsule as single oral dose on Days 1, 8 and 15 along with lenalidomide 10 mg capsules orally on Days 1-21 in each 28-day cycle until progressive disease or unacceptable toxicity, whichever comes first up to end of study (up to approximately 109 months).

   id

   FG001

   title

   Ixazomib + LenDex

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         10

      type

      Lost to Follow-up

   2. reasons

      1. group Id

         FG000

         num Subjects

         24

      2. group Id

         FG001

         num Subjects

         22

      type

      Withdrawal by Subject

   3. reasons

      1. group Id

         FG000

         num Subjects

         142

      2. group Id

         FG001

         num Subjects

         141

      type

      Reason not Specified

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         354

      2. group Id

         FG001

         num Subjects

         351

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         354

      2. group Id

         FG001

         num Subjects

         351

      type

      Intent-to-Treat (ITT) Population

   3. achievements

      1. comment

         1 participant in this arm who withdrew from the study was not included in the safety population.

         group Id

         FG000

         num Subjects

         349

      2. comment

         Included 4 participants from placebo who received ixazomib; 1 participant who withdrew was excluded.

         group Id

         FG001

         num Subjects

         354

      comment

      Includes all treated participants. Participants were analyzed as treated.

      type

      Safety Population

   4. achievements

      1. group Id

         FG000

         num Subjects

         283

      2. group Id

         FG001

         num Subjects

         284

      comment

      Includes participants who completed treatment per protocol until disease progression or until discontinuation for unacceptable toxicity, withdrawal of consent, or death.

      type

      Participants Completed Study Treatment Per Protocol

   5. achievements

      1. group Id

         FG000

         num Subjects

         293

      2. group Id

         FG001

         num Subjects

         296

      type

      Per Protocol (PP) Population

   6. achievements

      1. group Id

         FG000

         num Subjects

         189

      2. group Id

         FG001

         num Subjects

         191

      type

      Participants With Exposure of ≥ 19 Cycles

   7. achievements

      1. group Id

         FG000

         num Subjects

         347

      2. group Id

         FG001

         num Subjects

         335

      comment

      Includes all participants in the ITT population who receive at least 1 dose of any study drug, have measurable disease at baseline, and at least 1 post baseline response assessment assessed by an Independent Review Committee (IRC).

      type

      Response-evaluable Population

   8. achievements

      1. group Id

         FG000

         num Subjects

         183

      2. group Id

         FG001

         num Subjects

         178

      comment

      Completed=who completed the study.

      type

      COMPLETED

   9. achievements

      1. group Id

         FG000

         num Subjects

         171

      2. group Id

         FG001

         num Subjects

         173

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Participants with newly diagnosed multiple myeloma were enrolled in 1:1 ratio to receive ixazomib or placebo in addition to the background therapy of Lenalidomide and Dexamethasone (LenDex) in this study.

recruitment Details

Participants took part in the study at 238 investigative sites in multiple countries from 29 April 2013 to 24 June 2022.

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Preserved source evidence · Not medical advice