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NCT00603447 · FLOW

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Phase 1b Multicenter Study of Carfilzomib With Lenalidomide and Dexamethasone in Relapsed Multiple Myeloma · Source last updated 2017-05-30

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

groups
  1. description
    Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 10 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
    id
    FG000
    title
    1: CFZ 15 mg/m² + LEN 10 mg
  2. description
    Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 15 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
    id
    FG001
    title
    2: CFZ 15 mg/m² + LEN 15 mg
  3. description
    Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
    id
    FG002
    title
    3: CFZ 15 mg/m² + LEN 20 mg
  4. description
    Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
    id
    FG003
    title
    4: CFZ 20 mg/m² + LEN 20 mg
  5. description
    Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
    id
    FG004
    title
    5: CFZ 20 mg/m² + LEN 25 mg
  6. description
    Treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
    id
    FG005
    title
    6: CFZ 20/27 mg/m² + LEN 25 mg
  7. description
    In the Expansion portion, treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
    id
    FG006
    title
    7: CFZ 20/27 mg/m² + LEN 25 mg
periods
  1. drop Withdraws
    1. 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
        2
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        10
      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
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        13
      type
      Other
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        1
      type
      Withdrew Consent
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        8
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        6
      6. group Id
        FG005
        num Subjects
        8
      7. group Id
        FG006
        num Subjects
        44
      type
      STARTED
    2. achievements
      1. comment
        Participants on-going as of 08 May 2013, discontinued due to PD or completed treatment per protocol.
        group Id
        FG000
        num Subjects
        6
      2. comment
        Participants on-going as of 08 May 2013, discontinued due to PD or completed treatment per protocol.
        group Id
        FG001
        num Subjects
        3
      3. comment
        Participants on-going as of 08 May 2013, discontinued due to PD or completed treatment per protocol.
        group Id
        FG002
        num Subjects
        6
      4. comment
        Participants on-going as of 08 May 2013, discontinued due to PD or completed treatment per protocol.
        group Id
        FG003
        num Subjects
        4
      5. comment
        Participants on-going as of 08 May 2013, discontinued due to PD or completed treatment per protocol.
        group Id
        FG004
        num Subjects
        1
      6. comment
        Participants on-going as of 08 May 2013, discontinued due to PD or completed treatment per protocol.
        group Id
        FG005
        num Subjects
        6
      7. comment
        Participants on-going as of 08 May 2013, discontinued due to PD or completed treatment per protocol.
        group Id
        FG006
        num Subjects
        20
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        5
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        24
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
In the dose-escalation portion, participants were enrolled in sequential cohorts to determine the maximum tolerated doses (MTD) of carfilzomib and lenalidomide. In the expansion portion either the MTD or the maximum planned dose (MPD) from Cohort 6 (if no MTD was determined) was administered to gain additional safety and efficacy information.
recruitment Details
This was an open-label study of carfilzomib (CFZ) given in combination with lenalidomide (LEN) and low-dose dexamethasone (DEX) in patients with relapsed multiple myeloma. The study consisted of a dose-escalation portion and an expansion portion. Participants were treated until disease progression (PD) or unacceptable toxicity.
Complete source fields
groups
  1. description
    Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 10 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
    id
    FG000
    title
    1: CFZ 15 mg/m² + LEN 10 mg
  2. description
    Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 15 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
    id
    FG001
    title
    2: CFZ 15 mg/m² + LEN 15 mg
  3. description
    Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
    id
    FG002
    title
    3: CFZ 15 mg/m² + LEN 20 mg
  4. description
    Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
    id
    FG003
    title
    4: CFZ 20 mg/m² + LEN 20 mg
  5. description
    Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
    id
    FG004
    title
    5: CFZ 20 mg/m² + LEN 25 mg
  6. description
    Treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
    id
    FG005
    title
    6: CFZ 20/27 mg/m² + LEN 25 mg
  7. description
    In the Expansion portion, treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
    id
    FG006
    title
    7: CFZ 20/27 mg/m² + LEN 25 mg
periods
  1. drop Withdraws
    1. 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
        2
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        10
      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
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        13
      type
      Other
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        1
      type
      Withdrew Consent
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        8
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        6
      6. group Id
        FG005
        num Subjects
        8
      7. group Id
        FG006
        num Subjects
        44
      type
      STARTED
    2. achievements
      1. comment
        Participants on-going as of 08 May 2013, discontinued due to PD or completed treatment per protocol.
        group Id
        FG000
        num Subjects
        6
      2. comment
        Participants on-going as of 08 May 2013, discontinued due to PD or completed treatment per protocol.
        group Id
        FG001
        num Subjects
        3
      3. comment
        Participants on-going as of 08 May 2013, discontinued due to PD or completed treatment per protocol.
        group Id
        FG002
        num Subjects
        6
      4. comment
        Participants on-going as of 08 May 2013, discontinued due to PD or completed treatment per protocol.
        group Id
        FG003
        num Subjects
        4
      5. comment
        Participants on-going as of 08 May 2013, discontinued due to PD or completed treatment per protocol.
        group Id
        FG004
        num Subjects
        1
      6. comment
        Participants on-going as of 08 May 2013, discontinued due to PD or completed treatment per protocol.
        group Id
        FG005
        num Subjects
        6
      7. comment
        Participants on-going as of 08 May 2013, discontinued due to PD or completed treatment per protocol.
        group Id
        FG006
        num Subjects
        20
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        5
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        24
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
In the dose-escalation portion, participants were enrolled in sequential cohorts to determine the maximum tolerated doses (MTD) of carfilzomib and lenalidomide. In the expansion portion either the MTD or the maximum planned dose (MPD) from Cohort 6 (if no MTD was determined) was administered to gain additional safety and efficacy information.
recruitment Details
This was an open-label study of carfilzomib (CFZ) given in combination with lenalidomide (LEN) and low-dose dexamethasone (DEX) in patients with relapsed multiple myeloma. The study consisted of a dose-escalation portion and an expansion portion. Participants were treated until disease progression (PD) or unacceptable toxicity.

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Preserved source evidence · Not medical advice