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NCT00150462 · FLOW

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Safety Study of the Proteasome Inhibitor PR-171 (Carfilzomib for Injection) in Patients With Hematological Malignancies · Source last updated 2017-05-02

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

groups
  1. description
    Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
    id
    FG000
    title
    CFZ 1.2 mg/m²
  2. description
    Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
    id
    FG001
    title
    CFZ 2.4 mg/m²
  3. description
    Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
    id
    FG002
    title
    CFZ 4.0 mg/m²
  4. description
    Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
    id
    FG003
    title
    CFZ 6.0 mg/m²
  5. description
    Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
    id
    FG004
    title
    CFZ 8.4 mg/m²
  6. description
    Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
    id
    FG005
    title
    CFZ 11.0 mg/m²
  7. description
    Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
    id
    FG006
    title
    CFZ 15.0 mg/m²
  8. description
    Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
    id
    FG007
    title
    CFZ 20.0 mg/m²
  9. description
    Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
    id
    FG008
    title
    CFZ 27.0 mg/m²
  10. description
    Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
    id
    FG009
    title
    CFZ 20/27 mg/m²
  11. description
    Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles. Participants also received 20 mg dexamethasone (DEX) administered before each dose of carfilzomib (i.e. 40 mg weekly).
    id
    FG010
    title
    CFZ 20/27 mg/m² + DEX
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        3
      8. group Id
        FG007
        num Subjects
        5
      9. group Id
        FG008
        num Subjects
        5
      10. group Id
        FG009
        num Subjects
        3
      11. group Id
        FG010
        num Subjects
        2
      type
      Disease Progression or Relapse
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        1
      11. group Id
        FG010
        num Subjects
        0
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        1
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      type
      Death
    4. 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
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        2
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        1
      11. group Id
        FG010
        num Subjects
        0
      type
      Adverse Event
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      type
      Physician Decision
    6. 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
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        1
      11. group Id
        FG010
        num Subjects
        1
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        4
      7. group Id
        FG006
        num Subjects
        3
      8. group Id
        FG007
        num Subjects
        8
      9. group Id
        FG008
        num Subjects
        6
      10. group Id
        FG009
        num Subjects
        7
      11. group Id
        FG010
        num Subjects
        4
      type
      STARTED
    2. achievements
      1. comment
        Indicates participants remaining on study treatment
        group Id
        FG000
        num Subjects
        0
      2. comment
        Indicates participants remaining on study treatment
        group Id
        FG001
        num Subjects
        0
      3. comment
        Indicates participants remaining on study treatment
        group Id
        FG002
        num Subjects
        0
      4. comment
        Indicates participants remaining on study treatment
        group Id
        FG003
        num Subjects
        0
      5. comment
        Indicates participants remaining on study treatment
        group Id
        FG004
        num Subjects
        0
      6. comment
        Indicates participants remaining on study treatment
        group Id
        FG005
        num Subjects
        0
      7. comment
        Indicates participants remaining on study treatment
        group Id
        FG006
        num Subjects
        0
      8. comment
        Indicates participants remaining on study treatment
        group Id
        FG007
        num Subjects
        0
      9. comment
        Indicates participants remaining on study treatment
        group Id
        FG008
        num Subjects
        0
      10. comment
        Indicates participants who completed 12 cycles of treatment.
        group Id
        FG009
        num Subjects
        1
      11. comment
        Indicates participants who completed 12 cycles of treatment.
        group Id
        FG010
        num Subjects
        1
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        4
      7. group Id
        FG006
        num Subjects
        3
      8. group Id
        FG007
        num Subjects
        8
      9. group Id
        FG008
        num Subjects
        6
      10. group Id
        FG009
        num Subjects
        6
      11. group Id
        FG010
        num Subjects
        3
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
The study was divided into a sequential Dose Escalation phase (Part 1; Arms 1-9), followed by a Dose Expansion phase (Part 2; Arms 10-11) consisting of a carfilzomib-only cohort and a carfilzomib-plus dexamethasone cohort.
recruitment Details
Adults with with multiple myeloma (MM)-both secretory and nonsecretory, non-Hodgkin's lymphoma (NHL), Hodgkin's disease (HD), or Waldenström's macroglobulinemia (WM) were eligible for enrollment in this study.
Complete source fields
groups
  1. description
    Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
    id
    FG000
    title
    CFZ 1.2 mg/m²
  2. description
    Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
    id
    FG001
    title
    CFZ 2.4 mg/m²
  3. description
    Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
    id
    FG002
    title
    CFZ 4.0 mg/m²
  4. description
    Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
    id
    FG003
    title
    CFZ 6.0 mg/m²
  5. description
    Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
    id
    FG004
    title
    CFZ 8.4 mg/m²
  6. description
    Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
    id
    FG005
    title
    CFZ 11.0 mg/m²
  7. description
    Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
    id
    FG006
    title
    CFZ 15.0 mg/m²
  8. description
    Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
    id
    FG007
    title
    CFZ 20.0 mg/m²
  9. description
    Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
    id
    FG008
    title
    CFZ 27.0 mg/m²
  10. description
    Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
    id
    FG009
    title
    CFZ 20/27 mg/m²
  11. description
    Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles. Participants also received 20 mg dexamethasone (DEX) administered before each dose of carfilzomib (i.e. 40 mg weekly).
    id
    FG010
    title
    CFZ 20/27 mg/m² + DEX
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        3
      8. group Id
        FG007
        num Subjects
        5
      9. group Id
        FG008
        num Subjects
        5
      10. group Id
        FG009
        num Subjects
        3
      11. group Id
        FG010
        num Subjects
        2
      type
      Disease Progression or Relapse
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        1
      11. group Id
        FG010
        num Subjects
        0
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        1
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      type
      Death
    4. 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
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        2
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        1
      11. group Id
        FG010
        num Subjects
        0
      type
      Adverse Event
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      type
      Physician Decision
    6. 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
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        1
      11. group Id
        FG010
        num Subjects
        1
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        4
      7. group Id
        FG006
        num Subjects
        3
      8. group Id
        FG007
        num Subjects
        8
      9. group Id
        FG008
        num Subjects
        6
      10. group Id
        FG009
        num Subjects
        7
      11. group Id
        FG010
        num Subjects
        4
      type
      STARTED
    2. achievements
      1. comment
        Indicates participants remaining on study treatment
        group Id
        FG000
        num Subjects
        0
      2. comment
        Indicates participants remaining on study treatment
        group Id
        FG001
        num Subjects
        0
      3. comment
        Indicates participants remaining on study treatment
        group Id
        FG002
        num Subjects
        0
      4. comment
        Indicates participants remaining on study treatment
        group Id
        FG003
        num Subjects
        0
      5. comment
        Indicates participants remaining on study treatment
        group Id
        FG004
        num Subjects
        0
      6. comment
        Indicates participants remaining on study treatment
        group Id
        FG005
        num Subjects
        0
      7. comment
        Indicates participants remaining on study treatment
        group Id
        FG006
        num Subjects
        0
      8. comment
        Indicates participants remaining on study treatment
        group Id
        FG007
        num Subjects
        0
      9. comment
        Indicates participants remaining on study treatment
        group Id
        FG008
        num Subjects
        0
      10. comment
        Indicates participants who completed 12 cycles of treatment.
        group Id
        FG009
        num Subjects
        1
      11. comment
        Indicates participants who completed 12 cycles of treatment.
        group Id
        FG010
        num Subjects
        1
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        4
      7. group Id
        FG006
        num Subjects
        3
      8. group Id
        FG007
        num Subjects
        8
      9. group Id
        FG008
        num Subjects
        6
      10. group Id
        FG009
        num Subjects
        6
      11. group Id
        FG010
        num Subjects
        3
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
The study was divided into a sequential Dose Escalation phase (Part 1; Arms 1-9), followed by a Dose Expansion phase (Part 2; Arms 10-11) consisting of a carfilzomib-only cohort and a carfilzomib-plus dexamethasone cohort.
recruitment Details
Adults with with multiple myeloma (MM)-both secretory and nonsecretory, non-Hodgkin's lymphoma (NHL), Hodgkin's disease (HD), or Waldenström's macroglobulinemia (WM) were eligible for enrollment in this study.

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