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NCT07217184 · FLOW

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Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With Isatuximab in Participants With RRMM · Source last updated 2026-06-25

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

groups
  1. description
    Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 10 mg/kg isatuximab, given 1 hour after belantamab mafodotin end of infusion (EOI), administered as an IV infusion once weekly (Q1W) for 5 doses, then every 2 weeks (Q2W), and thereafter on day 1, 8, 15 and 22 of each 28-day cycle.
    id
    FG000
    title
    1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab
  2. description
    Participants with RRMM received 1.4 mg/kg of belantamab mafodotin IV infusion, once every 8 weeks (Q8W) infused over 30- 60 minutes on day 1 of each 56 day cycle in combination with 10 mg/kg isatuximab, given 1 hour after belantamab mafodotin EOI administered as an IV infusion once weekly (Q1W) for 5 doses, then every 2 weeks (Q2W) and thereafter on days 1, 8, 15, and 22 of each 28-day cycle.
    id
    FG001
    title
    1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab
  3. description
    Participants with RRMM received 1.9 mg/kg of belantamab mafodotin IV infusion, Q8W infused over 30- 60 minutes on day 1 of each 56 day cycle in combination with 10 mg/kg isatuximab, given 1 hour after belantamab mafodotin EOI administered as an IV infusion once weekly (Q1W) for 5 doses, then every 2 weeks (Q2W) and thereafter on days 1, 8, 15, and 22 of each 28-day cycle.
    id
    FG002
    title
    1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Physician Decision
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        2
      type
      Ongoing at the time of analysis
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        10
      3. group Id
        FG002
        num Subjects
        10
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        8
      comment
      DLT Evaluable Population included participants in DE Phase who have received at least 80% of all components of the intended dose of treatment in cycle 1 and were followed up for a period of one cycle length or withdrawn within the first cycle due to an AE meeting the definition of a DLT.
      type
      Dose Limiting Toxicity (DLT) Evaluable Population
    3. achievements
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        8
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        2
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
The results presented are based on the data cut-off date of 17 Apr 2025. Those participants still benefiting from study drug in the opinion of their treating physician continued to receive study drug in Post Analysis Continuation of Treatment (PACT) phase and their safety data will be provided within a year of study completion.
recruitment Details
This is a sub-study of the master study NCT04126200. The study was planned to include two phases - Dose Escalation (DE) and Cohort Expansion (CE) and no participants from this sub study were enrolled in CE phase as CE Phase was not initiated due to business strategic reason.
Complete source fields
groups
  1. description
    Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 10 mg/kg isatuximab, given 1 hour after belantamab mafodotin end of infusion (EOI), administered as an IV infusion once weekly (Q1W) for 5 doses, then every 2 weeks (Q2W), and thereafter on day 1, 8, 15 and 22 of each 28-day cycle.
    id
    FG000
    title
    1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab
  2. description
    Participants with RRMM received 1.4 mg/kg of belantamab mafodotin IV infusion, once every 8 weeks (Q8W) infused over 30- 60 minutes on day 1 of each 56 day cycle in combination with 10 mg/kg isatuximab, given 1 hour after belantamab mafodotin EOI administered as an IV infusion once weekly (Q1W) for 5 doses, then every 2 weeks (Q2W) and thereafter on days 1, 8, 15, and 22 of each 28-day cycle.
    id
    FG001
    title
    1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab
  3. description
    Participants with RRMM received 1.9 mg/kg of belantamab mafodotin IV infusion, Q8W infused over 30- 60 minutes on day 1 of each 56 day cycle in combination with 10 mg/kg isatuximab, given 1 hour after belantamab mafodotin EOI administered as an IV infusion once weekly (Q1W) for 5 doses, then every 2 weeks (Q2W) and thereafter on days 1, 8, 15, and 22 of each 28-day cycle.
    id
    FG002
    title
    1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Physician Decision
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        2
      type
      Ongoing at the time of analysis
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        10
      3. group Id
        FG002
        num Subjects
        10
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        8
      comment
      DLT Evaluable Population included participants in DE Phase who have received at least 80% of all components of the intended dose of treatment in cycle 1 and were followed up for a period of one cycle length or withdrawn within the first cycle due to an AE meeting the definition of a DLT.
      type
      Dose Limiting Toxicity (DLT) Evaluable Population
    3. achievements
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        8
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        2
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
The results presented are based on the data cut-off date of 17 Apr 2025. Those participants still benefiting from study drug in the opinion of their treating physician continued to receive study drug in Post Analysis Continuation of Treatment (PACT) phase and their safety data will be provided within a year of study completion.
recruitment Details
This is a sub-study of the master study NCT04126200. The study was planned to include two phases - Dose Escalation (DE) and Cohort Expansion (CE) and no participants from this sub study were enrolled in CE phase as CE Phase was not initiated due to business strategic reason.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice