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NCT01570387 · FLOW

Participant flow

A Phase I/II Trial of Pomalidomide and Dexamethasone in Subjects With Previously-Treated AL Amyloidosis · Source last updated 2020-09-22

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

groups
  1. description
    Drug: Pomalidomide Cohort 1 = 2 mg/day, Days 1-28 Drug: Dexamethasone 10-20 mg on days 1, 8, 15, and 22
    id
    FG000
    title
    Experimental: Phase I - Cohort 1 (Pomalidomide 2mg)
  2. description
    Drug: Pomalidomide Cohort 12= 3 mg/day, Days 1-28 Drug: Dexamethasone 10-20 mg on days 1, 8, 15, and 22
    id
    FG001
    title
    Experimental: Phase I - Cohort 2 (Pomalidomide 3mg)
  3. description
    Drug: Pomalidomide Cohort 3 = 4 mg/day, Days 1-28 Drug: Dexamethasone 10-20 mg on days 1, 8, 15, and 22
    id
    FG002
    title
    Experimental: Phase I - Cohort 3 (Pomalidomide 4mg)
  4. description
    Drug: Pomalidomide Expansion Phase - Maximum Tolerated Dose = 4 mg/day, Days 1-28 Drug: Dexamethasone 10-20 mg on days 1, 8, 15, and 22
    id
    FG003
    title
    Experimental: Phase II Expansion- Maximum Tolerated Dose
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
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        12
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        12
      type
      Dose Limiting Toxicity
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        6
      type
      Response to Maximal Tolerated Dose
    4. achievements
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        10
      type
      COMPLETED
    5. achievements
      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
        2
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
Protocol was open to accrual between January 2012 and August 2016. Participants were recruited from within the amyloidosis clinic within Boston Medical Center.
Complete source fields
groups
  1. description
    Drug: Pomalidomide Cohort 1 = 2 mg/day, Days 1-28 Drug: Dexamethasone 10-20 mg on days 1, 8, 15, and 22
    id
    FG000
    title
    Experimental: Phase I - Cohort 1 (Pomalidomide 2mg)
  2. description
    Drug: Pomalidomide Cohort 12= 3 mg/day, Days 1-28 Drug: Dexamethasone 10-20 mg on days 1, 8, 15, and 22
    id
    FG001
    title
    Experimental: Phase I - Cohort 2 (Pomalidomide 3mg)
  3. description
    Drug: Pomalidomide Cohort 3 = 4 mg/day, Days 1-28 Drug: Dexamethasone 10-20 mg on days 1, 8, 15, and 22
    id
    FG002
    title
    Experimental: Phase I - Cohort 3 (Pomalidomide 4mg)
  4. description
    Drug: Pomalidomide Expansion Phase - Maximum Tolerated Dose = 4 mg/day, Days 1-28 Drug: Dexamethasone 10-20 mg on days 1, 8, 15, and 22
    id
    FG003
    title
    Experimental: Phase II Expansion- Maximum Tolerated Dose
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
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        12
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        12
      type
      Dose Limiting Toxicity
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        6
      type
      Response to Maximal Tolerated Dose
    4. achievements
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        10
      type
      COMPLETED
    5. achievements
      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
        2
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
Protocol was open to accrual between January 2012 and August 2016. Participants were recruited from within the amyloidosis clinic within Boston Medical Center.

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Preserved source evidence · Not medical advice