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NCT03201250 · BASELINE

Baseline characteristics

Cabozantinib as a Targeted Strategy to Reverse Carfilzomib Resistance in Refractory Multiple Myeloma · Source last updated 2023-09-08

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

denoms
  1. counts
    1. group Id
      BG000
      value
      5
    2. group Id
      BG001
      value
      3
    3. group Id
      BG002
      value
      0
    4. group Id
      BG003
      value
      8
    units
    Participants
groups
  1. description
    Combination of cabozantinib, carfilzomib and dexamethasone Cabozantinib: patients will receive cabozantinib orally once daily continuously during the four weeks of a 28-day cycle. Cabozantinib: Phase I: Level -1 = 20 mg Carfilzomib: 27 mg/m2 IV over 10 min on days 1, 2, 8, 9, 15, 16 Dexamethasone: 40 mg PO/IV on days 1, 8,15 and 22 (for patient age ≥ 75, acceptable to be given as 20 mg PO/IV on days 1, 2, 8, 9, 15, 16, 22, 23)
    id
    BG000
    title
    Level -1 = 20 mg
  2. description
    Combination of cabozantinib, carfilzomib and dexamethasone Cabozantinib: patients will receive cabozantinib orally once daily continuously during the four weeks of a 28-day cycle. Cabozantinib: Phase I: Level 0 = 40 mg Carfilzomib: 27 mg/m2 IV over 10 min on days 1, 2, 8, 9, 15, 16 Dexamethasone: 40 mg PO/IV on days 1, 8,15 and 22 (for patient age ≥ 75, acceptable to be given as 20 mg PO/IV on days 1, 2, 8, 9, 15, 16, 22, 23)
    id
    BG001
    title
    Level 0 = 40 mg
  3. description
    Combination of cabozantinib, carfilzomib and dexamethasone Cabozantinib: patients will receive cabozantinib orally once daily continuously during the four weeks of a 28-day cycle. Cabozantinib: Phase I: Level +1 = 60 mg Carfilzomib: 27 mg/m2 IV over 10 min on days 1, 2, 8, 9, 15, 16 Dexamethasone: 40 mg PO/IV on days 1, 8,15 and 22 (for patient age ≥ 75, acceptable to be given as 20 mg PO/IV on days 1, 2, 8, 9, 15, 16, 22, 23)
    id
    BG002
    title
    Level +1 = 60 mg
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG003
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG003
          value
          3
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          1
        3. group Id
          BG003
          value
          5
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG003
          value
          3
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG003
          value
          5
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG003
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG003
          value
          1
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG003
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG003
          value
          2
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          1
        3. group Id
          BG003
          value
          5
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG003
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG003
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          3
        3. group Id
          BG003
          value
          8
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
We only included the 8 subjects that passed eligibility and were dosed.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      5
    2. group Id
      BG001
      value
      3
    3. group Id
      BG002
      value
      0
    4. group Id
      BG003
      value
      8
    units
    Participants
groups
  1. description
    Combination of cabozantinib, carfilzomib and dexamethasone Cabozantinib: patients will receive cabozantinib orally once daily continuously during the four weeks of a 28-day cycle. Cabozantinib: Phase I: Level -1 = 20 mg Carfilzomib: 27 mg/m2 IV over 10 min on days 1, 2, 8, 9, 15, 16 Dexamethasone: 40 mg PO/IV on days 1, 8,15 and 22 (for patient age ≥ 75, acceptable to be given as 20 mg PO/IV on days 1, 2, 8, 9, 15, 16, 22, 23)
    id
    BG000
    title
    Level -1 = 20 mg
  2. description
    Combination of cabozantinib, carfilzomib and dexamethasone Cabozantinib: patients will receive cabozantinib orally once daily continuously during the four weeks of a 28-day cycle. Cabozantinib: Phase I: Level 0 = 40 mg Carfilzomib: 27 mg/m2 IV over 10 min on days 1, 2, 8, 9, 15, 16 Dexamethasone: 40 mg PO/IV on days 1, 8,15 and 22 (for patient age ≥ 75, acceptable to be given as 20 mg PO/IV on days 1, 2, 8, 9, 15, 16, 22, 23)
    id
    BG001
    title
    Level 0 = 40 mg
  3. description
    Combination of cabozantinib, carfilzomib and dexamethasone Cabozantinib: patients will receive cabozantinib orally once daily continuously during the four weeks of a 28-day cycle. Cabozantinib: Phase I: Level +1 = 60 mg Carfilzomib: 27 mg/m2 IV over 10 min on days 1, 2, 8, 9, 15, 16 Dexamethasone: 40 mg PO/IV on days 1, 8,15 and 22 (for patient age ≥ 75, acceptable to be given as 20 mg PO/IV on days 1, 2, 8, 9, 15, 16, 22, 23)
    id
    BG002
    title
    Level +1 = 60 mg
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG003
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG003
          value
          3
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          1
        3. group Id
          BG003
          value
          5
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG003
          value
          3
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG003
          value
          5
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG003
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG003
          value
          1
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG003
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG003
          value
          2
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          1
        3. group Id
          BG003
          value
          5
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG003
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG003
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          3
        3. group Id
          BG003
          value
          8
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
We only included the 8 subjects that passed eligibility and were dosed.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice