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NCT02043847 · FLOW

Participant flow

TMI With HD Mel in ASCT for R/R Multiple Myeloma (BMT-03) · Source last updated 2024-11-13

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

groups
  1. description
    3Gy with standard high dose melphalan prior to autologous stem cell rescue Total Marrow Irradiation: Subjects in this trial will receive total marrow irradiation 3Gy per day for up to four days and as little as one day Melphalan: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning therapy prior to transplant Filgrastim (G-CSF): Subjects to begin GCSF 5 μg/kg/d SC or IV on Day 5 and continue until ANC \> 1000/mm\^3 over period of 3 days. Autologous transplant: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning with autologous stem cell rescue
    id
    FG000
    title
    Cohort 1Total Marrow Irradiation (TMI) 3Gy
  2. description
    6Gy with standard high dose melphalan prior to autologous stem cell rescue Total Marrow Irradiation: Subjects in this trial will receive total marrow irradiation 6Gy per day for up to four days and as little as one day Melphalan: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning therapy prior to transplant Filgrastim (G-CSF): Subjects to begin GCSF 5 μg/kg/d SC or IV on Day 5 and continue until ANC \> 1000/mm\^3 over period of 3 days Autologous transplant: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning with autologous stem cell rescue
    id
    FG001
    title
    Cohort 2 Total Marrow Irradiation (TMI) 6Gy
  3. description
    9Gy with standard high dose melphalan prior to autologous stem cell rescue Total Marrow Irradiation: Subjects in this trial will receive total marrow irradiation 9Gy per day for up to four days and as little as one day Melphalan: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning therapy prior to transplant Filgrastim (G-CSF): Subjects to begin GCSF 5 μg/kg/d SC or IV on Day 5 and continue until ANC \> 1000/mm\^3 over period of 3 days Autologous transplant: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning with autologous stem cell rescue
    id
    FG002
    title
    Cohort 3 Total Marrow Irradiation (TMI) 9Gy
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        6
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        6
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    3Gy with standard high dose melphalan prior to autologous stem cell rescue Total Marrow Irradiation: Subjects in this trial will receive total marrow irradiation 3Gy per day for up to four days and as little as one day Melphalan: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning therapy prior to transplant Filgrastim (G-CSF): Subjects to begin GCSF 5 μg/kg/d SC or IV on Day 5 and continue until ANC \> 1000/mm\^3 over period of 3 days. Autologous transplant: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning with autologous stem cell rescue
    id
    FG000
    title
    Cohort 1Total Marrow Irradiation (TMI) 3Gy
  2. description
    6Gy with standard high dose melphalan prior to autologous stem cell rescue Total Marrow Irradiation: Subjects in this trial will receive total marrow irradiation 6Gy per day for up to four days and as little as one day Melphalan: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning therapy prior to transplant Filgrastim (G-CSF): Subjects to begin GCSF 5 μg/kg/d SC or IV on Day 5 and continue until ANC \> 1000/mm\^3 over period of 3 days Autologous transplant: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning with autologous stem cell rescue
    id
    FG001
    title
    Cohort 2 Total Marrow Irradiation (TMI) 6Gy
  3. description
    9Gy with standard high dose melphalan prior to autologous stem cell rescue Total Marrow Irradiation: Subjects in this trial will receive total marrow irradiation 9Gy per day for up to four days and as little as one day Melphalan: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning therapy prior to transplant Filgrastim (G-CSF): Subjects to begin GCSF 5 μg/kg/d SC or IV on Day 5 and continue until ANC \> 1000/mm\^3 over period of 3 days Autologous transplant: Subjects will receive standard melphalan 200mg/m\^2 (100mg/m\^2 day-2 and day-1) conditioning with autologous stem cell rescue
    id
    FG002
    title
    Cohort 3 Total Marrow Irradiation (TMI) 9Gy
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        6
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        6
      type
      NOT COMPLETED
    title
    Overall Study

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

Preserved source evidence · Not medical advice