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NCT04896658 · FLOW

Participant flow

Belantamab Mafodotin, Cyclophosphamide, and Dexamethasone in Relapsed/Refractory Multiple Myeloma · Source last updated 2025-04-03

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

groups
  1. description
    1. Dose level 1: The subject will take 1.9 mg/kg of Belantamab Mafodotin, 300 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 of each 3 weeks cycles. 2. Dose level 2: The subject will take 1.9 mg/kg of Belantamab Mafodotin, 500 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 each 3 weeks cycles. Belantamab Mafodotin, Cyclophosphamide and Dexamethasone: Study drug
    id
    FG000
    title
    Phase I: Arm A
  2. description
    1. Dose level 1: The subject will take 2.5 mg/kg of Belantamab Mafodotin, 300 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 of each 6 weeks cycles. 2. Dose level 2: The subject will take 2.5 mg/kg of Belantamab Mafodotin, 500 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 each 6 weeks cycles. Belantamab Mafodotin, Cyclophosphamide and Dexamethasone: Study drug
    id
    FG001
    title
    Phase 1: Arm B
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Dose Level 1
  2. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        4
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        4
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Dose Level 2
pre Assignment Details
Reasons for exclusion- history of GvHD; wears scleral lenses, Patient withdrew consent, No Measurable Disease, Inadequate organ system function, Current unstable liver disease
recruitment Details
Dates of the recruitment period: 12/03/2021- 01/08/2024 Types of location: UMGCCC outpatient clinic
Complete source fields
groups
  1. description
    1. Dose level 1: The subject will take 1.9 mg/kg of Belantamab Mafodotin, 300 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 of each 3 weeks cycles. 2. Dose level 2: The subject will take 1.9 mg/kg of Belantamab Mafodotin, 500 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 each 3 weeks cycles. Belantamab Mafodotin, Cyclophosphamide and Dexamethasone: Study drug
    id
    FG000
    title
    Phase I: Arm A
  2. description
    1. Dose level 1: The subject will take 2.5 mg/kg of Belantamab Mafodotin, 300 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 of each 6 weeks cycles. 2. Dose level 2: The subject will take 2.5 mg/kg of Belantamab Mafodotin, 500 mg of Cyclophosphamide, and 40 mg of Dexamethasone on day 1 each 6 weeks cycles. Belantamab Mafodotin, Cyclophosphamide and Dexamethasone: Study drug
    id
    FG001
    title
    Phase 1: Arm B
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Dose Level 1
  2. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        4
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        4
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Dose Level 2
pre Assignment Details
Reasons for exclusion- history of GvHD; wears scleral lenses, Patient withdrew consent, No Measurable Disease, Inadequate organ system function, Current unstable liver disease
recruitment Details
Dates of the recruitment period: 12/03/2021- 01/08/2024 Types of location: UMGCCC outpatient clinic

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Preserved source evidence · Not medical advice