Participant flow

Multinational Clinical Study Comparing Isatuximab, Carfilzomib And Dexamethasone To Carfilzomib And Dexamethasone In Relapse And/Or Refractory Multiple Myeloma Patients · Source last updated 2026-02-09

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

groups

1. description

   Participants received carfilzomib 20 milligrams per meter square (mg/m\^2), intravenous (IV) infusion on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle along with dexamethasone 20 milligrams (mg), orally (PO) or IV on Days 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 349 weeks).

   id

   FG000

   title

   Carfilzomib + Dexamethasone (Kd)

2. description

   Participants received isatuximab 10 milligrams per kilogram (mg/kg), IV infusion on Days 1, 8, 15 and 22 in Cycle 1, and then on Days 1 and 15 of each 28-day treatment cycle plus carfilzomib 20 mg/m\^2, IV on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle and dexamethasone 20 mg, PO or IV on Day 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 356 weeks).

   id

   FG001

   title

   Isatuximab + Carfilzomib + Dexamethasone (IKd)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         24

      2. group Id

         FG001

         num Subjects

         29

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         68

      2. group Id

         FG001

         num Subjects

         86

      type

      Progressive disease

   3. reasons

      1. group Id

         FG000

         num Subjects

         18

      2. group Id

         FG001

         num Subjects

         21

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         24

      type

      Treatment extension study

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         2

      type

      Randomized and not treated

   6. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         5

      type

      Study discontinuation

   7. reasons

      1. group Id

         FG000

         num Subjects

         10

      2. group Id

         FG001

         num Subjects

         12

      type

      Others

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         123

      2. group Id

         FG001

         num Subjects

         179

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         122

      2. group Id

         FG001

         num Subjects

         177

      type

      Treated

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         123

      2. group Id

         FG001

         num Subjects

         179

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

First result analysis (A) reported was for a data cut-off date of 7 Feb 2020 for efficacy outcomes, 14 Jan 2022 for CR, MRD and PFS2. PFS data was reported at both cut-off dates: 7 Feb 2020 \& 14 Jan 2022. Primary A of PFS refers to planned interim A conducted at 103 events (death/PD) with cut-off date 7 Feb 2020 \& Final A of PFS conducted at 159 events with cut-off date 14 Jan 2022. Data cut-off for overall survival and LPLV was 7 Feb 2023 and 3 Jan 2025, respectively.

recruitment Details

Study was conducted at 69 active centers in 16 countries. A total of 341 participants were screened between 25 October 2017 and 21 March 2019, of which 39 participants were screen failure due to not meeting eligibility criteria. Randomization was stratified by number of prior lines (1 versus \>1) \& revised international staging system (R-ISS) I or II versus III versus not classified. Reason for not completed = Reason for definitive treatment discontinuation.

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Preserved source evidence · Not medical advice