Participant flow

A Study Comparing Once-weekly vs Twice-weekly Carfilzomib in Combination With Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma · Source last updated 2024-08-13

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

groups

1. description

   Carfilzomib was administered twice-weekly intravenously as a 10 ± 5 minute infusion using an infusion pump on Days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. The dose was 20 mg/m\^2 on Days 1 and 2 of Cycle 1 and 27 mg/m\^2 beginning on Day 8 of Cycle 1 and thereafter. Participants also received lenalidomide 25 mg daily orally on Days 1 to 21 of each cycle and dexamethasone 40 mg weekly orally or intravenously. Participants were treated for up to 12 28-day cycles.

   id

   FG000

   title

   Twice-weekly Kyprolis (Carfilzomib) + Lenalidomide + Dexamethsone (KRd) 20/27 mg/m^2

2. description

   Carfilzomib was administered once-weekly intravenously as a 30 ± 5 minute infusion using an infusion pump on Days 1, 8, and 15 of each 28-day cycle. The dose was 20 mg/m\^2 on Day 1 of Cycle 1 and 56 mg/m\^2 beginning on Day 8 of Cycle 1 and thereafter. Participants also received lenalidomide 25 mg daily orally on Days 1 to 21 of each cycle and dexamethasone 40 mg weekly orally or intravenously. Participants were treated for up to 12 28-day cycles.

   id

   FG001

   title

   Once-weekly KRd 20/56 mg/m^2

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         7

      type

      Withdrawal by Subject

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         3

      type

      Decision by sponsor

   3. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         2

      type

      Lost to Follow-up

   4. reasons

      1. group Id

         FG000

         num Subjects

         22

      2. group Id

         FG001

         num Subjects

         25

      type

      Death

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         226

      2. group Id

         FG001

         num Subjects

         228

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         226

      2. group Id

         FG001

         num Subjects

         228

      type

      Received Carfilzomib

   3. achievements

      1. group Id

         FG000

         num Subjects

         152

      2. group Id

         FG001

         num Subjects

         150

      type

      Completed 12 Cycles Carfilzomib

   4. achievements

      1. group Id

         FG000

         num Subjects

         226

      2. group Id

         FG001

         num Subjects

         228

      type

      Received Lenalidomide

   5. achievements

      1. group Id

         FG000

         num Subjects

         226

      2. group Id

         FG001

         num Subjects

         228

      type

      Received Dexamethasone

   6. achievements

      1. group Id

         FG000

         num Subjects

         231

      2. group Id

         FG001

         num Subjects

         223

      comment

      Participants were analyzed according to the treatment arm corresponding to the actual treatment received.

      type

      Safety Population

   7. achievements

      1. group Id

         FG000

         num Subjects

         197

      2. group Id

         FG001

         num Subjects

         191

      type

      COMPLETED

   8. achievements

      1. group Id

         FG000

         num Subjects

         29

      2. group Id

         FG001

         num Subjects

         37

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Participants with relapsed or refractory multiple myeloma were randomized in a 1:1 ratio to receive once-weekly or twice-weekly carfilzomib. Randomization was stratified by original International Staging System (ISS) stage at the time of study entry (stage 1 or 2 versus stage 3), prior lenalidomide treatment (yes versus no), prior proteasome inhibitor treatment (yes versus no), and prior anti-CD38 exposure (yes versus no).

recruitment Details

Participants were enrolled at 80 study centers in Europe, Japan, and the United States, and participated from 08 May 2019 to 31 March 2023.

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Preserved source evidence · Not medical advice