Participant flow

SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM · Source last updated 2026-09-02

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

groups

1. description

   Participants received isatuximab 10 milligrams/kilogram (mg/kg) IV infusion once weekly (QW) (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg every 2 weeks (Q2W) (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable adverse events (AEs), participant request to discontinue treatment, or any other reason, whichever came first.

   id

   FG000

   title

   Isa-IV + Pd

2. description

   Participants received isatuximab 1400 mg SC injection administered via an on-body delivery system (OBDS) which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.

   id

   FG001

   title

   Isa-SC + Pd

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         73

      2. group Id

         FG001

         num Subjects

         77

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         13

      2. group Id

         FG001

         num Subjects

         4

      type

      Withdrawal by Subject

   3. reasons

      1. group Id

         FG000

         num Subjects

         182

      2. group Id

         FG001

         num Subjects

         182

      type

      Ongoing at the time of DCO

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         268

      2. group Id

         FG001

         num Subjects

         263

      comment

      Randomized

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         264

      2. group Id

         FG001

         num Subjects

         263

      type

      Randomized and 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

         268

      2. group Id

         FG001

         num Subjects

         263

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

A total of 531 participants were randomized in a 1:1 ratio to receive isatuximab (Isa) either via intravenous (IV) or subcutaneous (SC) route in combination with pomalidomide and dexamethasone (Pd). Current results are updated to report the participant flow, safety and efficacy data based on data cut-off (DCO) date of 29-Aug-2025. A few participants still on treatment are being monitored for safety. Each cycle=28 days.

recruitment Details

This study was conducted at 120 sites in 21 countries. A total of 637 participants were screened from 23-Jun-2022 to 13-May-2024, of which 106 were screen failures. Screen failures were mainly due to not meeting eligibility criteria.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice