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Study to Investigate Alternative Dosing Regimens of Belantamab Mafodotin in Participants With Relapsed or Refractory Multiple Myeloma · Source last updated 2026-05-05

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

groups
  1. description
    Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.
    id
    FG000
    title
    Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)
  2. description
    Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
    id
    FG001
    title
    Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W
  3. description
    Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
    id
    FG002
    title
    Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)
  4. description
    Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
    id
    FG003
    title
    Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W
  5. description
    Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.
    id
    FG004
    title
    Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        23
      2. group Id
        FG001
        num Subjects
        23
      3. group Id
        FG002
        num Subjects
        25
      4. group Id
        FG003
        num Subjects
        21
      5. group Id
        FG004
        num Subjects
        5
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        0
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Physician Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        3
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        2
      type
      Ongoing at the time of analysis
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        40
      2. group Id
        FG001
        num Subjects
        40
      3. group Id
        FG002
        num Subjects
        40
      4. group Id
        FG003
        num Subjects
        40
      5. group Id
        FG004
        num Subjects
        17
      comment
      Intent-to-Treat Population included all randomized participants, whether or not randomized treatment was administered.
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        39
      2. group Id
        FG001
        num Subjects
        40
      3. group Id
        FG002
        num Subjects
        39
      4. group Id
        FG003
        num Subjects
        40
      5. group Id
        FG004
        num Subjects
        17
      comment
      All randomized participants who received at least 1 dose of study treatment.
      type
      Safety
    3. achievements
      1. group Id
        FG000
        num Subjects
        38
      2. comment
        1 participant was randomized in Arm A but inadvertently given Arm B treatment at Cycle 1.
        group Id
        FG001
        num Subjects
        41
      3. group Id
        FG002
        num Subjects
        39
      4. group Id
        FG003
        num Subjects
        40
      5. group Id
        FG004
        num Subjects
        17
      comment
      All participants in the Safety Population from whom at least 1 post-treatment pharmacokinetic (PK) sample was obtained and analyzed.
      type
      Pharmacokinetic
    4. achievements
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        8
      4. group Id
        FG003
        num Subjects
        9
      5. group Id
        FG004
        num Subjects
        7
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        30
      2. group Id
        FG001
        num Subjects
        33
      3. group Id
        FG002
        num Subjects
        32
      4. group Id
        FG003
        num Subjects
        31
      5. group Id
        FG004
        num Subjects
        10
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
The results presented are based on the data cut-off date of 30 Jan 2025. Those participants still benefiting from study drug in the opinion of their treating physician continued to receive study drug in the Post Analysis Continuation of Treatment (PACT) phase. Additional safety results will be provided within one year of study completion.
Complete source fields
groups
  1. description
    Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.
    id
    FG000
    title
    Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)
  2. description
    Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
    id
    FG001
    title
    Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W
  3. description
    Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
    id
    FG002
    title
    Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)
  4. description
    Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
    id
    FG003
    title
    Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W
  5. description
    Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.
    id
    FG004
    title
    Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        23
      2. group Id
        FG001
        num Subjects
        23
      3. group Id
        FG002
        num Subjects
        25
      4. group Id
        FG003
        num Subjects
        21
      5. group Id
        FG004
        num Subjects
        5
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        0
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      type
      Physician Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        3
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        2
      type
      Ongoing at the time of analysis
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        40
      2. group Id
        FG001
        num Subjects
        40
      3. group Id
        FG002
        num Subjects
        40
      4. group Id
        FG003
        num Subjects
        40
      5. group Id
        FG004
        num Subjects
        17
      comment
      Intent-to-Treat Population included all randomized participants, whether or not randomized treatment was administered.
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        39
      2. group Id
        FG001
        num Subjects
        40
      3. group Id
        FG002
        num Subjects
        39
      4. group Id
        FG003
        num Subjects
        40
      5. group Id
        FG004
        num Subjects
        17
      comment
      All randomized participants who received at least 1 dose of study treatment.
      type
      Safety
    3. achievements
      1. group Id
        FG000
        num Subjects
        38
      2. comment
        1 participant was randomized in Arm A but inadvertently given Arm B treatment at Cycle 1.
        group Id
        FG001
        num Subjects
        41
      3. group Id
        FG002
        num Subjects
        39
      4. group Id
        FG003
        num Subjects
        40
      5. group Id
        FG004
        num Subjects
        17
      comment
      All participants in the Safety Population from whom at least 1 post-treatment pharmacokinetic (PK) sample was obtained and analyzed.
      type
      Pharmacokinetic
    4. achievements
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        8
      4. group Id
        FG003
        num Subjects
        9
      5. group Id
        FG004
        num Subjects
        7
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        30
      2. group Id
        FG001
        num Subjects
        33
      3. group Id
        FG002
        num Subjects
        32
      4. group Id
        FG003
        num Subjects
        31
      5. group Id
        FG004
        num Subjects
        10
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
The results presented are based on the data cut-off date of 30 Jan 2025. Those participants still benefiting from study drug in the opinion of their treating physician continued to receive study drug in the Post Analysis Continuation of Treatment (PACT) phase. Additional safety results will be provided within one year of study completion.

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

Preserved source evidence · Not medical advice