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NCT03481556 · FLOW

Participant flow

Study of Melphalan Flufenamide (Melflufen) + Dex With Bortezomib or Daratumumab in Patients With RRMM · Source last updated 2022-12-19

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

groups
  1. description
    Participants were administered intravenous (IV) melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with subcutaneous (SQ) bortezomib at a dose of 1.3mg/m\^2 on Days 1, 4, 8, and 11 and dexamethasone orally (PO) at a dose of 20 mg (12 mg if the participants is ≥ 75 years of age) on Days 1, 4, 8, and 11 and 40 mg (20 mg if the participants is ≥ 75 years of age) on Day 15 and 22 of each 28-day cycle.
    id
    FG000
    title
    Regimen A - Melflufen 30mg + Bortezomib + Dexamethasone
  2. description
    Participants were administered intravenous (IV) melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with subcutaneous (SQ) bortezomib at a dose of 1.3mg/m\^2 on Days 1, 4, 8, and 11 and dexamethasone orally (PO) at a dose of 20 mg (12 mg if the participants is ≥ 75 years of age) on Days 1, 4, 8, and 11 and 40 mg (20 mg if the participants is ≥ 75 years of age) on Day 15 and 22 of each 28-day cycle.
    id
    FG001
    title
    Regimen A - Melflufen 40mg + Bortezomib + Dexamethasone
  3. description
    Participants were administered intravenous (IV) melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age).
    id
    FG002
    title
    Regimen B - Melflufen 30mg + Daratumumab + Dexamethasone
  4. description
    Participants were administered intravenous (IV) melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age).
    id
    FG003
    title
    Regimen B - Melflufen 40mg + Daratumumab + Dexamethasone
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        16
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        9
      type
      Study Terminated by Sponsor
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        15
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        27
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        2
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        15
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        25
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
A total of 56 participants were enrolled in the study, all of whom received study treatment.
recruitment Details
56 participants were enrolled across 13 sites in the Czech Republic, France, Spain and the United States.
Complete source fields
groups
  1. description
    Participants were administered intravenous (IV) melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with subcutaneous (SQ) bortezomib at a dose of 1.3mg/m\^2 on Days 1, 4, 8, and 11 and dexamethasone orally (PO) at a dose of 20 mg (12 mg if the participants is ≥ 75 years of age) on Days 1, 4, 8, and 11 and 40 mg (20 mg if the participants is ≥ 75 years of age) on Day 15 and 22 of each 28-day cycle.
    id
    FG000
    title
    Regimen A - Melflufen 30mg + Bortezomib + Dexamethasone
  2. description
    Participants were administered intravenous (IV) melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with subcutaneous (SQ) bortezomib at a dose of 1.3mg/m\^2 on Days 1, 4, 8, and 11 and dexamethasone orally (PO) at a dose of 20 mg (12 mg if the participants is ≥ 75 years of age) on Days 1, 4, 8, and 11 and 40 mg (20 mg if the participants is ≥ 75 years of age) on Day 15 and 22 of each 28-day cycle.
    id
    FG001
    title
    Regimen A - Melflufen 40mg + Bortezomib + Dexamethasone
  3. description
    Participants were administered intravenous (IV) melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age).
    id
    FG002
    title
    Regimen B - Melflufen 30mg + Daratumumab + Dexamethasone
  4. description
    Participants were administered intravenous (IV) melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age).
    id
    FG003
    title
    Regimen B - Melflufen 40mg + Daratumumab + Dexamethasone
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        16
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        9
      type
      Study Terminated by Sponsor
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        15
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        27
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        2
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        15
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        25
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
A total of 56 participants were enrolled in the study, all of whom received study treatment.
recruitment Details
56 participants were enrolled across 13 sites in the Czech Republic, France, Spain and the United States.

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

Preserved source evidence · Not medical advice