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NCT01078454 · FLOW

Participant flow

Melphalan and Dexamethasone With or Without Bortezomib in Treating Patients With Previously Untreated Systemic Light-Chain Amyloidosis · Source last updated 2022-02-01

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

groups
  1. description
    Patients receive melphalan 0.22 mg/kg orally (PO) and dexamethasone 40 mg PO on days 1-4 every 4 weeks. Treatment repeats every 4 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity.
    id
    FG000
    title
    Arm A (Mel-Dex)
  2. description
    Patients receive melphalan 0.22 mg/kg PO and dexamethasone 40 mg PO on days 1-4 and bortezomib 1.3 mg/m\^2 intravenously (IV) on days 1, 4, 8, and 11 every 4 weeks. Treatment repeats every 4 weeks for 2 cycles. Patients then receive melphalan PO and dexamethasone PO on days 1-4 and bortezomib IV on days 1, 8, 15, and 22 every 5 weeks. Treatment repeats every 5 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
    id
    FG001
    title
    Arm B (B-Mel-Dex)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        5
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        3
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
Participants were recruited from ECOG member institutions between November 1, 2010 and September 7, 2012.
Complete source fields
groups
  1. description
    Patients receive melphalan 0.22 mg/kg orally (PO) and dexamethasone 40 mg PO on days 1-4 every 4 weeks. Treatment repeats every 4 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity.
    id
    FG000
    title
    Arm A (Mel-Dex)
  2. description
    Patients receive melphalan 0.22 mg/kg PO and dexamethasone 40 mg PO on days 1-4 and bortezomib 1.3 mg/m\^2 intravenously (IV) on days 1, 4, 8, and 11 every 4 weeks. Treatment repeats every 4 weeks for 2 cycles. Patients then receive melphalan PO and dexamethasone PO on days 1-4 and bortezomib IV on days 1, 8, 15, and 22 every 5 weeks. Treatment repeats every 5 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
    id
    FG001
    title
    Arm B (B-Mel-Dex)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        5
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        3
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
Participants were recruited from ECOG member institutions between November 1, 2010 and September 7, 2012.

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

Preserved source evidence · Not medical advice