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NCT04162210 · FLOW

Participant flow

Study of Single Agent Belantamab Mafodotin Versus Pomalidomide Plus Low-dose Dexamethasone (Pom/Dex) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) · Source last updated 2026-07-01

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 30 minutes intravenous infusion of 2.5 milligram/kilogram (mg/kg) belantamab mafodotin on day 1 of each 21-day cycle
    id
    FG000
    title
    Belantamab Mafodotin
  2. description
    Participants with RRMM received 4 mg pomalidomide capsule daily on Days 1 to 21 of each 28-day cycle, along with 40 mg or at lower 20 mg (for participants \>75 years of age) dose of dexamethasone tablet once weekly (Days 1, 8, 15 and 22)
    id
    FG001
    title
    Pomalidomide Plus Dexamethasone
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        1
      type
      Lost to Follow-up
    2. reasons
      1. group Id
        FG000
        num Subjects
        51
      2. group Id
        FG001
        num Subjects
        26
      type
      Physician Decision
    3. reasons
      1. group Id
        FG000
        num Subjects
        22
      2. group Id
        FG001
        num Subjects
        9
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        15
      2. group Id
        FG001
        num Subjects
        3
      type
      Ongoing at the time of analysis
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        218
      2. group Id
        FG001
        num Subjects
        107
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        217
      2. group Id
        FG001
        num Subjects
        102
      comment
      All randomized participants who took at least 1 dose of study intervention
      type
      Safety Population
    3. achievements
      1. group Id
        FG000
        num Subjects
        126
      2. group Id
        FG001
        num Subjects
        68
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        92
      2. group Id
        FG001
        num Subjects
        39
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
The results presented are based on the data cut-off date of 22 April 2025. Those participants still benefiting from study drug in the opinion of their treating physician continue to receive study drug in Post Analysis Continued Treatment (PACT) phase and their safety data will be reported after they stop receiving treatment as per protocol
Complete source fields
groups
  1. description
    Participants with relapsed/refractory multiple myeloma (RRMM) received 30 minutes intravenous infusion of 2.5 milligram/kilogram (mg/kg) belantamab mafodotin on day 1 of each 21-day cycle
    id
    FG000
    title
    Belantamab Mafodotin
  2. description
    Participants with RRMM received 4 mg pomalidomide capsule daily on Days 1 to 21 of each 28-day cycle, along with 40 mg or at lower 20 mg (for participants \>75 years of age) dose of dexamethasone tablet once weekly (Days 1, 8, 15 and 22)
    id
    FG001
    title
    Pomalidomide Plus Dexamethasone
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        1
      type
      Lost to Follow-up
    2. reasons
      1. group Id
        FG000
        num Subjects
        51
      2. group Id
        FG001
        num Subjects
        26
      type
      Physician Decision
    3. reasons
      1. group Id
        FG000
        num Subjects
        22
      2. group Id
        FG001
        num Subjects
        9
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        15
      2. group Id
        FG001
        num Subjects
        3
      type
      Ongoing at the time of analysis
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        218
      2. group Id
        FG001
        num Subjects
        107
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        217
      2. group Id
        FG001
        num Subjects
        102
      comment
      All randomized participants who took at least 1 dose of study intervention
      type
      Safety Population
    3. achievements
      1. group Id
        FG000
        num Subjects
        126
      2. group Id
        FG001
        num Subjects
        68
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        92
      2. group Id
        FG001
        num Subjects
        39
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
The results presented are based on the data cut-off date of 22 April 2025. Those participants still benefiting from study drug in the opinion of their treating physician continue to receive study drug in Post Analysis Continued Treatment (PACT) phase and their safety data will be reported after they stop receiving treatment as per protocol

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Preserved source evidence · Not medical advice