Participant flow

Isatuximab Single Agent Study in Japanese Relapsed AND Refractory Multiple Myeloma Patients · Source last updated 2024-04-01

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 milligram per kilogram (mg/kg) intravenous (IV) infusion once every week (QW) for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then every 2 weeks (Q2W) (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable adverse events (AEs), disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 112 weeks).

   id

   FG000

   title

   Phase 1, Cohort 1: Isatuximab 10 mg/kg

2. description

   Participants received Isatuximab 20 mg/kg IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 137 weeks).

   id

   FG001

   title

   Phase 1, Cohort 2: Isatuximab 20 mg/kg

3. description

   Participants received Isatuximab 20 mg/kg IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 248 weeks).

   id

   FG002

   title

   Phase 2: Isatuximab 20 mg/kg

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         0

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         0

      type

      Progressive disease

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         5

      3. comment

         Phase 1 and Phase 2 were separate populations.

         group Id

         FG002

         num Subjects

         0

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         5

      3. group Id

         FG002

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Phase 1

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         2

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         22

      type

      Progressive disease

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         4

      type

      Other-Unspecified

   milestones

   1. achievements

      1. comment

         Phase 1 and Phase 2 were separate populations

         group Id

         FG000

         num Subjects

         0

      2. comment

         Phase 1 and Phase 2 were separate populations.

         group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         28

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         28

      type

      NOT COMPLETED

   title

   Phase 2

pre Assignment Details

Study consisted of 2 phases: Phase 1 and Phase 2. Phase I (Cohorts 1 and 2) was a dose escalation part to evaluate the safety, pharmacokinetics (PK), and efficacy of isatuximab. Phase 2 was commenced after completion of the DLT observation period in Phase 1 and determination of the recommended dose to be used in Phase 2.

recruitment Details

The study was conducted at 13 centers in Japan. A total of 36 participants were enrolled between 05 September 2016 and 6 April 2018, and received isatuximab monotherapy.

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Preserved source evidence · Not medical advice