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NCT00477971 · FLOW

Participant flow

Low-Dose Melphalan and Dexamethasone Compared With High-Dose Melphalan Followed By Autologous Stem Cell Transplant in Treating Patients With Primary Systemic Amyloidosis · Source last updated 2016-05-17

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

groups
  1. description
    Patients receive low-dose melphalan 20 mg/m\^2 IV over 15-30 minutes on day 1 or 0.12 mg/kg tablet orally once daily on days 1-7 and dexamethasone 40 mg orally on days 1-4 and 22-25. Treatment repeats every 6 weeks for 10 courses. (Study treatment beyond one year is not allowed.)
    id
    FG000
    title
    Low-Dose Melphalan
  2. description
    Patients receive filgrastim (G-CSF) 10 mg/kg/day on days -7 to -3 and undergo autologous hematopoietic stem cell (HSC) collection. Patients receive high-dose melphalan 140 mg/m\^2 IV for low risk or 200 mg/m\^2 IV for high risk patients over 1 hour on days -2 and -1 and undergo autologous HSC transplantation on day 0.
    id
    FG001
    title
    High-Dose Melphalan + Autologous HSC
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        0
      type
      Disease progression
    2. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        1
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        0
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        4
      type
      Death
    5. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        1
      type
      Alternative treatment
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        34
      2. group Id
        FG001
        num Subjects
        55
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        17
      2. group Id
        FG001
        num Subjects
        49
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        17
      2. group Id
        FG001
        num Subjects
        6
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
This study was originally designed as a randomized Phase III clinical trial; however the unwillingness of participants to be randomized to treatment led to changes. The protocol was amended to allow participants to choose between the two regimens.
recruitment Details
From October 2005 to August 2012, 89 participants were recruited.
Complete source fields
groups
  1. description
    Patients receive low-dose melphalan 20 mg/m\^2 IV over 15-30 minutes on day 1 or 0.12 mg/kg tablet orally once daily on days 1-7 and dexamethasone 40 mg orally on days 1-4 and 22-25. Treatment repeats every 6 weeks for 10 courses. (Study treatment beyond one year is not allowed.)
    id
    FG000
    title
    Low-Dose Melphalan
  2. description
    Patients receive filgrastim (G-CSF) 10 mg/kg/day on days -7 to -3 and undergo autologous hematopoietic stem cell (HSC) collection. Patients receive high-dose melphalan 140 mg/m\^2 IV for low risk or 200 mg/m\^2 IV for high risk patients over 1 hour on days -2 and -1 and undergo autologous HSC transplantation on day 0.
    id
    FG001
    title
    High-Dose Melphalan + Autologous HSC
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        0
      type
      Disease progression
    2. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        1
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        0
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        4
      type
      Death
    5. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        1
      type
      Alternative treatment
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        34
      2. group Id
        FG001
        num Subjects
        55
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        17
      2. group Id
        FG001
        num Subjects
        49
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        17
      2. group Id
        FG001
        num Subjects
        6
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
This study was originally designed as a randomized Phase III clinical trial; however the unwillingness of participants to be randomized to treatment led to changes. The protocol was amended to allow participants to choose between the two regimens.
recruitment Details
From October 2005 to August 2012, 89 participants were recruited.

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Preserved source evidence · Not medical advice