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NCT00721734 · FLOW

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Study of the Safety and Pharmacokinetics of Carfilzomib in Patients With Relapsed and Refractory Multiple Myeloma and Varying Degrees of Renal Function · 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 with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) \> 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
    id
    FG000
    title
    Carfilzomib - Normal RF
  2. description
    Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
    id
    FG001
    title
    Carfilzomib - Mild RI
  3. description
    Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
    id
    FG002
    title
    Carfilzomib - Moderate RI
  4. description
    Participants with severe renal impairment (CrCL \< 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
    id
    FG003
    title
    Carfilzomib - Severe RI
  5. description
    Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
    id
    FG004
    title
    Carfilzomib - Dialysis
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        10
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        5
      5. group Id
        FG004
        num Subjects
        2
      type
      Progressive Disease
    2. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        3
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      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
        1
      type
      Withdrawal by Subject
    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
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        12
      3. group Id
        FG002
        num Subjects
        10
      4. group Id
        FG003
        num Subjects
        8
      5. group Id
        FG004
        num Subjects
        8
      type
      STARTED
    2. achievements
      1. comment
        Completed 12 cycles of carfilzomib treatment
        group Id
        FG000
        num Subjects
        4
      2. comment
        Completed 12 cycles of carfilzomib treatment
        group Id
        FG001
        num Subjects
        0
      3. comment
        Completed 12 cycles of carfilzomib treatment
        group Id
        FG002
        num Subjects
        2
      4. comment
        Completed 12 cycles of carfilzomib treatment
        group Id
        FG003
        num Subjects
        2
      5. comment
        Completed 12 cycles of carfilzomib treatment
        group Id
        FG004
        num Subjects
        2
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        12
      3. group Id
        FG002
        num Subjects
        8
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        6
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
This study enrolled patients with multiple myeloma (MM) who had relapsed or progressive disease (PD) after at least 1 (original protocol) or 2 (following protocol Amendment 1) prior therapeutic treatments or regimens. Five groups of MM patients, representing different levels of renal function, were evaluated.
Complete source fields
groups
  1. description
    Participants with normal renal function (RF; defined as 24-hour urine creatinine clearance (CrCL) \> 80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously (IV) on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
    id
    FG000
    title
    Carfilzomib - Normal RF
  2. description
    Participants with mild renal impairment (RI; CrCL between 50-80 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
    id
    FG001
    title
    Carfilzomib - Mild RI
  3. description
    Participants with moderate renal impairment (CrCL between 30-49 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
    id
    FG002
    title
    Carfilzomib - Moderate RI
  4. description
    Participants with severe renal impairment (CrCL \< 30 mL/minute) received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
    id
    FG003
    title
    Carfilzomib - Severe RI
  5. description
    Participants undergoing chronic hemodialysis received carfilzomib, 15 mg/m², administered intravenously on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles for a maximum of 12 cycles. If the 15 mg/m² dose was tolerated the dose could be increased to 20 mg/m² starting at Cycle 2. If 20 mg/m² was tolerated, an additional dose escalation to 27 mg/m² was allowed at Cycle 3 or at subsequent cycles.
    id
    FG004
    title
    Carfilzomib - Dialysis
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        10
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        5
      5. group Id
        FG004
        num Subjects
        2
      type
      Progressive Disease
    2. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        3
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      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
        1
      type
      Withdrawal by Subject
    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
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        12
      3. group Id
        FG002
        num Subjects
        10
      4. group Id
        FG003
        num Subjects
        8
      5. group Id
        FG004
        num Subjects
        8
      type
      STARTED
    2. achievements
      1. comment
        Completed 12 cycles of carfilzomib treatment
        group Id
        FG000
        num Subjects
        4
      2. comment
        Completed 12 cycles of carfilzomib treatment
        group Id
        FG001
        num Subjects
        0
      3. comment
        Completed 12 cycles of carfilzomib treatment
        group Id
        FG002
        num Subjects
        2
      4. comment
        Completed 12 cycles of carfilzomib treatment
        group Id
        FG003
        num Subjects
        2
      5. comment
        Completed 12 cycles of carfilzomib treatment
        group Id
        FG004
        num Subjects
        2
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        12
      3. group Id
        FG002
        num Subjects
        8
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        6
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
This study enrolled patients with multiple myeloma (MM) who had relapsed or progressive disease (PD) after at least 1 (original protocol) or 2 (following protocol Amendment 1) prior therapeutic treatments or regimens. Five groups of MM patients, representing different levels of renal function, were evaluated.

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Preserved source evidence · Not medical advice