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A Study of Weekly Carfilzomib in Combination With Dexamethasone for Progressive Multiple Myeloma · Source last updated 2022-09-23

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

groups
  1. description
    Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
    id
    FG000
    title
    Phase 1: Carfilzomib 45 mg/m²
  2. description
    Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 56 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
    id
    FG001
    title
    Phase 1: Carfilzomib 56 mg/m²
  3. description
    Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
    id
    FG002
    title
    Phase 1: Carfilzomib 70 mg/m²
  4. description
    Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 88 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
    id
    FG003
    title
    Phase 1: Carfilzomib 88 mg/m²
  5. description
    Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
    id
    FG004
    title
    Phase 2: Carfilzomib 70 mg/m²
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      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
        13
      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
        0
      5. group Id
        FG004
        num Subjects
        1
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        12
      type
      Physician Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        9
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        43
      type
      Progressive Disease
    5. 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
        15
      type
      Withdrawal by Subject
    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
        1
      type
      Lost to Follow-up
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        15
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        89
      type
      STARTED
    2. achievements
      1. comment
        Completed indicates participants ongoing in study
        group Id
        FG000
        num Subjects
        0
      2. comment
        Completed indicates participants ongoing in study
        group Id
        FG001
        num Subjects
        1
      3. comment
        Completed indicates participants ongoing in study
        group Id
        FG002
        num Subjects
        1
      4. comment
        Completed indicates participants ongoing in study
        group Id
        FG003
        num Subjects
        0
      5. comment
        Completed indicates participants ongoing in study
        group Id
        FG004
        num Subjects
        4
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        14
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        85
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
In phase 1 participants were enrolled into 1 of 4 sequential dose-escalating cohorts to establish the maximum tolerated dose (MTD) of carfilzomib plus dexamethasone. In phase 2 participants were enrolled to evaluate the efficacy and safety of carfilzomib plus dexamethasone at the MTD established in phase 1.
recruitment Details
This study was conducted at 32 centers in the United States. Participants were enrolled from September 2012 to September 2014.
Complete source fields
groups
  1. description
    Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
    id
    FG000
    title
    Phase 1: Carfilzomib 45 mg/m²
  2. description
    Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 56 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
    id
    FG001
    title
    Phase 1: Carfilzomib 56 mg/m²
  3. description
    Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
    id
    FG002
    title
    Phase 1: Carfilzomib 70 mg/m²
  4. description
    Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 88 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
    id
    FG003
    title
    Phase 1: Carfilzomib 88 mg/m²
  5. description
    Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
    id
    FG004
    title
    Phase 2: Carfilzomib 70 mg/m²
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      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
        13
      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
        0
      5. group Id
        FG004
        num Subjects
        1
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        12
      type
      Physician Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        9
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        43
      type
      Progressive Disease
    5. 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
        15
      type
      Withdrawal by Subject
    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
        1
      type
      Lost to Follow-up
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        15
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        89
      type
      STARTED
    2. achievements
      1. comment
        Completed indicates participants ongoing in study
        group Id
        FG000
        num Subjects
        0
      2. comment
        Completed indicates participants ongoing in study
        group Id
        FG001
        num Subjects
        1
      3. comment
        Completed indicates participants ongoing in study
        group Id
        FG002
        num Subjects
        1
      4. comment
        Completed indicates participants ongoing in study
        group Id
        FG003
        num Subjects
        0
      5. comment
        Completed indicates participants ongoing in study
        group Id
        FG004
        num Subjects
        4
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        14
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        85
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
In phase 1 participants were enrolled into 1 of 4 sequential dose-escalating cohorts to establish the maximum tolerated dose (MTD) of carfilzomib plus dexamethasone. In phase 2 participants were enrolled to evaluate the efficacy and safety of carfilzomib plus dexamethasone at the MTD established in phase 1.
recruitment Details
This study was conducted at 32 centers in the United States. Participants were enrolled from September 2012 to September 2014.

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