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NCT00558896 · FLOW

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CC-4047 and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma or Amyloidosis · Source last updated 2018-04-18

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

groups
  1. description
    Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
    id
    FG000
    title
    Relapsed Myeloma (<4 Prior Regimens): Low Dose
  2. description
    Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
    id
    FG001
    title
    Lenalidomide Refractory Myeloma: Low Dose
  3. description
    Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
    id
    FG002
    title
    Bortezomib/Lenalidomide Refractory/Relapsed Myeloma: Low Dose
  4. description
    Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
    id
    FG003
    title
    Bortezomib/Lenalidomide Relapsed/Refractory Myeloma: High Dose
  5. description
    Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
    id
    FG004
    title
    Relapsed Myeloma (< 4 Prior Regimens): High Dose
  6. description
    Pomalidomide: 4 mg orally once daily, days 1-21 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
    id
    FG005
    title
    Relapsed/Refractory Myeloma: High Dose
  7. description
    Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
    id
    FG006
    title
    Relapsed Amyloidosis: Low Dose
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        4
      6. group Id
        FG005
        num Subjects
        10
      7. group Id
        FG006
        num Subjects
        3
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        6
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        5
      7. group Id
        FG006
        num Subjects
        5
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        6
      6. group Id
        FG005
        num Subjects
        7
      7. group Id
        FG006
        num Subjects
        1
      type
      Alternative Treatment
    5. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        3
      type
      Physician discretion
    6. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        9
      6. group Id
        FG005
        num Subjects
        25
      7. group Id
        FG006
        num Subjects
        6
      type
      Continues on treatment
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        60
      2. group Id
        FG001
        num Subjects
        34
      3. group Id
        FG002
        num Subjects
        35
      4. group Id
        FG003
        num Subjects
        35
      5. group Id
        FG004
        num Subjects
        60
      6. group Id
        FG005
        num Subjects
        120
      7. group Id
        FG006
        num Subjects
        33
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        39
      2. group Id
        FG001
        num Subjects
        27
      3. group Id
        FG002
        num Subjects
        30
      4. group Id
        FG003
        num Subjects
        23
      5. group Id
        FG004
        num Subjects
        37
      6. group Id
        FG005
        num Subjects
        68
      7. group Id
        FG006
        num Subjects
        9
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        21
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        12
      5. group Id
        FG004
        num Subjects
        23
      6. group Id
        FG005
        num Subjects
        52
      7. group Id
        FG006
        num Subjects
        24
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
One patient was deemed ineligible and excluded from all analyses.
recruitment Details
Between November 2007 and March 2012, 7 sequential phase 2 trials (reported as separate arms) were conducted. A total of 378 participants were recruited at Mayo Clinic (Arizona, Florida or Arizona).
Complete source fields
groups
  1. description
    Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
    id
    FG000
    title
    Relapsed Myeloma (<4 Prior Regimens): Low Dose
  2. description
    Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
    id
    FG001
    title
    Lenalidomide Refractory Myeloma: Low Dose
  3. description
    Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
    id
    FG002
    title
    Bortezomib/Lenalidomide Refractory/Relapsed Myeloma: Low Dose
  4. description
    Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
    id
    FG003
    title
    Bortezomib/Lenalidomide Relapsed/Refractory Myeloma: High Dose
  5. description
    Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
    id
    FG004
    title
    Relapsed Myeloma (< 4 Prior Regimens): High Dose
  6. description
    Pomalidomide: 4 mg orally once daily, days 1-21 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
    id
    FG005
    title
    Relapsed/Refractory Myeloma: High Dose
  7. description
    Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
    id
    FG006
    title
    Relapsed Amyloidosis: Low Dose
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        4
      6. group Id
        FG005
        num Subjects
        10
      7. group Id
        FG006
        num Subjects
        3
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        6
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        5
      7. group Id
        FG006
        num Subjects
        5
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        6
      6. group Id
        FG005
        num Subjects
        7
      7. group Id
        FG006
        num Subjects
        1
      type
      Alternative Treatment
    5. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        3
      type
      Physician discretion
    6. reasons
      1. group Id
        FG000
        num Subjects
        10
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        9
      6. group Id
        FG005
        num Subjects
        25
      7. group Id
        FG006
        num Subjects
        6
      type
      Continues on treatment
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        60
      2. group Id
        FG001
        num Subjects
        34
      3. group Id
        FG002
        num Subjects
        35
      4. group Id
        FG003
        num Subjects
        35
      5. group Id
        FG004
        num Subjects
        60
      6. group Id
        FG005
        num Subjects
        120
      7. group Id
        FG006
        num Subjects
        33
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        39
      2. group Id
        FG001
        num Subjects
        27
      3. group Id
        FG002
        num Subjects
        30
      4. group Id
        FG003
        num Subjects
        23
      5. group Id
        FG004
        num Subjects
        37
      6. group Id
        FG005
        num Subjects
        68
      7. group Id
        FG006
        num Subjects
        9
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        21
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        12
      5. group Id
        FG004
        num Subjects
        23
      6. group Id
        FG005
        num Subjects
        52
      7. group Id
        FG006
        num Subjects
        24
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
One patient was deemed ineligible and excluded from all analyses.
recruitment Details
Between November 2007 and March 2012, 7 sequential phase 2 trials (reported as separate arms) were conducted. A total of 378 participants were recruited at Mayo Clinic (Arizona, Florida or Arizona).

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Preserved source evidence · Not medical advice