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NCT04246047 · BASELINE

Baseline characteristics

Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma · Source last updated 2026-04-23

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

denoms
  1. counts
    1. group Id
      BG000
      value
      243
    2. group Id
      BG001
      value
      251
    3. group Id
      BG002
      value
      494
    units
    Participants
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 each 21-day Cycle until disease progression, intolerable toxicity, death, informed consent withdrawal, or study end, whichever comes first in combination with 1.3 mg/meter\^2 (m\^2) Bor administered subcutaneously (SC) once daily on Days 1, 4, 8 and 11 of each 21-day cycle along with 20 mg Dex via oral tablet or IV infusion once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle for a total of 8 cycles.
    id
    BG000
    title
    Belantamab Mafodotin + Bortezomib (Bor) + Dexamethasone (Dex)
  2. description
    Participants with RRMM received 16 mg/kg Daratumumab IV infusion once weekly of each 21-day cycle in Cycle 1 to Cycle 3; once every 3 weeks on Day 1 of each 21-day cycle in Cycle 4 to Cycle 8; and once every 4 weeks on day 1 of each 28-day cycle from cycle 9 onwards until disease progression, intolerable toxicity, death, informed consent withdrawal, or study end, whichever comes first in combination with 1.3 mg/m\^2 Bor administered SC once daily on Days 1, 4, 8 and 11 of each 21-day cycle along with 20 mg Dex oral tablet or IV infusion once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle for a total of 8 cycles.
    id
    BG001
    title
    Daratumumab + Bor + Dex
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.47
          value
          64.5
        2. group Id
          BG001
          spread
          10.11
          value
          63.6
        3. group Id
          BG002
          spread
          9.80
          value
          64.0
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    YEARS
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          115
        2. group Id
          BG001
          value
          107
        3. group Id
          BG002
          value
          222
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          128
        2. group Id
          BG001
          value
          144
        3. group Id
          BG002
          value
          272
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          71
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          213
        2. group Id
          BG001
          value
          208
        3. group Id
          BG002
          value
          421
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      243
    2. group Id
      BG001
      value
      251
    3. group Id
      BG002
      value
      494
    units
    Participants
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 each 21-day Cycle until disease progression, intolerable toxicity, death, informed consent withdrawal, or study end, whichever comes first in combination with 1.3 mg/meter\^2 (m\^2) Bor administered subcutaneously (SC) once daily on Days 1, 4, 8 and 11 of each 21-day cycle along with 20 mg Dex via oral tablet or IV infusion once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle for a total of 8 cycles.
    id
    BG000
    title
    Belantamab Mafodotin + Bortezomib (Bor) + Dexamethasone (Dex)
  2. description
    Participants with RRMM received 16 mg/kg Daratumumab IV infusion once weekly of each 21-day cycle in Cycle 1 to Cycle 3; once every 3 weeks on Day 1 of each 21-day cycle in Cycle 4 to Cycle 8; and once every 4 weeks on day 1 of each 28-day cycle from cycle 9 onwards until disease progression, intolerable toxicity, death, informed consent withdrawal, or study end, whichever comes first in combination with 1.3 mg/m\^2 Bor administered SC once daily on Days 1, 4, 8 and 11 of each 21-day cycle along with 20 mg Dex oral tablet or IV infusion once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle for a total of 8 cycles.
    id
    BG001
    title
    Daratumumab + Bor + Dex
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.47
          value
          64.5
        2. group Id
          BG001
          spread
          10.11
          value
          63.6
        3. group Id
          BG002
          spread
          9.80
          value
          64.0
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    YEARS
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          115
        2. group Id
          BG001
          value
          107
        3. group Id
          BG002
          value
          222
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          128
        2. group Id
          BG001
          value
          144
        3. group Id
          BG002
          value
          272
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          71
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          213
        2. group Id
          BG001
          value
          208
        3. group Id
          BG002
          value
          421
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice