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NCT03194867 · FLOW

Participant flow

Isatuximab in Combination With Cemiplimab in Relapsed/Refractory Multiple Myeloma (RRMM) Patients · Source last updated 2024-06-14

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/ kilogram (mg/kg) intravenous (IV) infusion once weekly for 4 weeks (QWx4) followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q2W (on Days 1 and 15 every cycle of a 28-day cycle) until disease progression, unacceptable adverse events (AEs), consent withdrawal, or any other reason.
    id
    FG000
    title
    Phase 1: Isatuximab + Cemiplimab Once Every 2 Weeks (Q2W)
  2. description
    Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.
    id
    FG001
    title
    Phase 2: Isatuximab
  3. description
    Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q2W (on Days 1 and 15 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.
    id
    FG002
    title
    Phase 2: Isatuximab + CemiplimabQ2W
  4. description
    Participants isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q4W (on Day 1 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.
    id
    FG003
    title
    Phase 2: Isatuximab + Cemiplimab Once Every 4 Weeks (Q4W)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      type
      Incorrect completion of end of study form
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        34
      3. group Id
        FG002
        num Subjects
        36
      4. group Id
        FG003
        num Subjects
        36
      comment
      Enrolled for Phase 1; randomized for Phase 2
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        34
      3. group Id
        FG002
        num Subjects
        35
      4. group Id
        FG003
        num Subjects
        36
      comment
      Enrolled for Phase1; randomized for Phase 2. Phase 2 Isatuximab + CemiplimabQ2W, one participant was randomized but not treated.
      type
      Randomized and Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        34
      3. group Id
        FG002
        num Subjects
        35
      4. group Id
        FG003
        num Subjects
        36
      comment
      Participants with end of study or death from any cause forms completed.
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
The study consisted of 2 phases: Phase 1 confirmed the feasibility of isatuximab/cemiplimab combination and Phase 2 further evaluated safety, efficacy and pharmacokinetics (PK) of combination versus isatuximab monotherapy. Participants in Phase 2 were randomized in a 1:1:1 ratio to receive either isatuximab monotherapy or combination therapy. The duration of study for a participant included a screening period (up to 21 days) and 3-month post treatment follow-up. Each cycle duration was 28 days.
recruitment Details
Participants were screened at 30 sites. The study was conducted i.e. participants were randomized at 29 sites in 10 countries. A total of 3 participants in Phase 1 and 106 participants in Phase 2 were enrolled (Phase 1)/randomized (Phase 2) from 21 Feb 2018 to 20 Mar 2019.
Complete source fields
groups
  1. description
    Participants received isatuximab 10 milligram/ kilogram (mg/kg) intravenous (IV) infusion once weekly for 4 weeks (QWx4) followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q2W (on Days 1 and 15 every cycle of a 28-day cycle) until disease progression, unacceptable adverse events (AEs), consent withdrawal, or any other reason.
    id
    FG000
    title
    Phase 1: Isatuximab + Cemiplimab Once Every 2 Weeks (Q2W)
  2. description
    Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.
    id
    FG001
    title
    Phase 2: Isatuximab
  3. description
    Participants received isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q2W (on Days 1 and 15 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.
    id
    FG002
    title
    Phase 2: Isatuximab + CemiplimabQ2W
  4. description
    Participants isatuximab 10 mg/kg IV infusion QWx4 followed by Q2W (on Days 1, 8, 15 and 22 in Cycle 1, and on Days 1 and 15 in Cycle 2 and beyond of a 28-day cycle) and cemiplimab 250 mg IV infusion Q4W (on Day 1 every cycle of a 28-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or any other reason.
    id
    FG003
    title
    Phase 2: Isatuximab + Cemiplimab Once Every 4 Weeks (Q4W)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      type
      Incorrect completion of end of study form
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        34
      3. group Id
        FG002
        num Subjects
        36
      4. group Id
        FG003
        num Subjects
        36
      comment
      Enrolled for Phase 1; randomized for Phase 2
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        34
      3. group Id
        FG002
        num Subjects
        35
      4. group Id
        FG003
        num Subjects
        36
      comment
      Enrolled for Phase1; randomized for Phase 2. Phase 2 Isatuximab + CemiplimabQ2W, one participant was randomized but not treated.
      type
      Randomized and Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        34
      3. group Id
        FG002
        num Subjects
        35
      4. group Id
        FG003
        num Subjects
        36
      comment
      Participants with end of study or death from any cause forms completed.
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
The study consisted of 2 phases: Phase 1 confirmed the feasibility of isatuximab/cemiplimab combination and Phase 2 further evaluated safety, efficacy and pharmacokinetics (PK) of combination versus isatuximab monotherapy. Participants in Phase 2 were randomized in a 1:1:1 ratio to receive either isatuximab monotherapy or combination therapy. The duration of study for a participant included a screening period (up to 21 days) and 3-month post treatment follow-up. Each cycle duration was 28 days.
recruitment Details
Participants were screened at 30 sites. The study was conducted i.e. participants were randomized at 29 sites in 10 countries. A total of 3 participants in Phase 1 and 106 participants in Phase 2 were enrolled (Phase 1)/randomized (Phase 2) from 21 Feb 2018 to 20 Mar 2019.

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Preserved source evidence · Not medical advice