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NCT04484623 · FLOW

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Belantamab Mafodotin Plus Pomalidomide and Dexamethasone (Pd) Versus Bortezomib Plus Pd in Relapsed/Refractory Multiple Myeloma · Source last updated 2026-06-12

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 intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin on Day 1 of Cycle 1 and 1.9 mg/kg on Day 1 of Cycle 2 onwards in each 28-day cycle, in combination with oral 4 mg per day Pomalidomide capsule on Days 1 to 21 of each 28-day cycle; and oral 40 mg per day Dexamethasone tablet on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, initiation of another anti-myeloma therapy or end of study, whichever occurs first.
    id
    FG000
    title
    Belantamab Mafodotin+Pomalidomide+Dexamethasone
  2. description
    Participants with RRMM received oral 4 mg per day Pomalidomide capsule on Days 1 to 14 of each 21-day cycle, in combination with subcutaneous (SC) injection of 1.3 mg/meter\^2(m\^2) Bortezomib on Days 1, 4, 8, 11, of each 21-day cycle for Cycles 1 through 8, and on Days 1, 8, of each 21-day cycle for Cycles 9+, and oral 20 mg Dexamethasone tablet on Days 1, 2, 4, 5, 8, 9, 11, 12, of each 21-day cycle for Cycles 1 through 8 and then on Days 1, 2, 8, 9, every 3 Weeks (Q3W) from Cycles 9 onwards until disease progression, death, unacceptable toxicity, withdrawal of consent, initiation of another anti-myeloma therapy or end of study, whichever occurs first.
    id
    FG001
    title
    Pomalidomide+Bortezomib+Dexamethasone
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Lost to Follow-up
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Protocol Deviation
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Physician Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        8
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        94
      2. group Id
        FG001
        num Subjects
        84
      type
      Ongoing
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        155
      2. group Id
        FG001
        num Subjects
        147
      comment
      Intent-to-Treat (ITT) Population included of all randomized participants whether or not randomized treatment was administered.
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        150
      2. group Id
        FG001
        num Subjects
        145
      comment
      All randomized participants who received at least 1 dose of study intervention (any component).
      type
      Safety Population
    3. achievements
      1. comment
        Note: Participants who died following randomization whilst on study, including 1 participant who died prior to dosing.
        group Id
        FG000
        num Subjects
        48
      2. comment
        Note: Participants who died following randomization whilst on study, including 1 participant who died prior to dosing.
        group Id
        FG001
        num Subjects
        54
      comment
      Note: Participants who died following randomization whilst on study, were considered to have completed the study.
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        107
      2. group Id
        FG001
        num Subjects
        93
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Complete source fields
groups
  1. description
    Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin on Day 1 of Cycle 1 and 1.9 mg/kg on Day 1 of Cycle 2 onwards in each 28-day cycle, in combination with oral 4 mg per day Pomalidomide capsule on Days 1 to 21 of each 28-day cycle; and oral 40 mg per day Dexamethasone tablet on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, initiation of another anti-myeloma therapy or end of study, whichever occurs first.
    id
    FG000
    title
    Belantamab Mafodotin+Pomalidomide+Dexamethasone
  2. description
    Participants with RRMM received oral 4 mg per day Pomalidomide capsule on Days 1 to 14 of each 21-day cycle, in combination with subcutaneous (SC) injection of 1.3 mg/meter\^2(m\^2) Bortezomib on Days 1, 4, 8, 11, of each 21-day cycle for Cycles 1 through 8, and on Days 1, 8, of each 21-day cycle for Cycles 9+, and oral 20 mg Dexamethasone tablet on Days 1, 2, 4, 5, 8, 9, 11, 12, of each 21-day cycle for Cycles 1 through 8 and then on Days 1, 2, 8, 9, every 3 Weeks (Q3W) from Cycles 9 onwards until disease progression, death, unacceptable toxicity, withdrawal of consent, initiation of another anti-myeloma therapy or end of study, whichever occurs first.
    id
    FG001
    title
    Pomalidomide+Bortezomib+Dexamethasone
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Lost to Follow-up
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Protocol Deviation
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Physician Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        8
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        94
      2. group Id
        FG001
        num Subjects
        84
      type
      Ongoing
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        155
      2. group Id
        FG001
        num Subjects
        147
      comment
      Intent-to-Treat (ITT) Population included of all randomized participants whether or not randomized treatment was administered.
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        150
      2. group Id
        FG001
        num Subjects
        145
      comment
      All randomized participants who received at least 1 dose of study intervention (any component).
      type
      Safety Population
    3. achievements
      1. comment
        Note: Participants who died following randomization whilst on study, including 1 participant who died prior to dosing.
        group Id
        FG000
        num Subjects
        48
      2. comment
        Note: Participants who died following randomization whilst on study, including 1 participant who died prior to dosing.
        group Id
        FG001
        num Subjects
        54
      comment
      Note: Participants who died following randomization whilst on study, were considered to have completed the study.
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        107
      2. group Id
        FG001
        num Subjects
        93
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
The results presented are until the primary completion date. Additional results will be provided within a year of study completion.

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Preserved source evidence · Not medical advice