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NCT01658904 · BASELINE

Baseline characteristics

Carfilzomib and Stem Cell Transplant for Plasma Cell Myeloma · Source last updated 2016-06-01

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
      3
    2. group Id
      BG001
      value
      0
    3. group Id
      BG002
      value
      0
    4. group Id
      BG003
      value
      3
    units
    Participants
groups
  1. description
    Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT) •Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects: Cohort 1: add CFZ 20 mg/m\^2 intravenous (IV) on days +1, +2 Cohort 2 : add CFZ 20 mg/m\^2 IV on days: +1, +2, +8, +9 Cohort 3: add CFZ 20 mg/m\^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m\^2 IV given on days 42-43 then CFZ 56 mg/m\^2 IV given on days 49-50, 56-57, then on days 70.
    id
    BG000
    title
    Cohort 1- CFZ 20 mg/m^2 (Day 1,2)
  2. description
    Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT) •Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects: Cohort 1: add CFZ 20 mg/m\^2 intravenous (IV) on days +1, +2 Cohort 2 : add CFZ 20 mg/m\^2 IV on days: +1, +2, +8, +9 Cohort 3: add CFZ 20 mg/m\^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m\^2 IV given on days 42-43 then CFZ 56 mg/m\^2 IV given on days 49-50, 56-57, then on days 70.
    id
    BG001
    title
    Cohort 2- CFZ 20 mg/m^2 (Day 1,2,8,9)
  3. description
    Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT) •Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects: Cohort 1: add CFZ 20 mg/m\^2 intravenous (IV) on days +1, +2 Cohort 2 : add CFZ 20 mg/m\^2 IV on days: +1, +2, +8, +9 Cohort 3: add CFZ 20 mg/m\^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m\^2 IV given on days 42-43 then CFZ 56 mg/m\^2 IV given on days 49-50, 56-57, then on days 70.
    id
    BG002
    title
    Cohort 3-CFZ 20 mg/m^2 (Day1,2,8,9/AHCT)
  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
          BG003
          value
          0
      title
      <=18 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG003
          value
          3
      title
      Between 18 and 65 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG003
          value
          0
      title
      >=65 years
    param Type
    NUMBER
    title
    Age, Categorical
    unit Of Measure
    participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.39
          value
          49.6
        2. group Id
          BG003
          spread
          10.39
          value
          49.6
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG003
          value
          1
      title
      Female
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG003
          value
          2
      title
      Male
    param Type
    NUMBER
    title
    Gender
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG003
          value
          0
      title
      Hispanic or Latino
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG003
          value
          3
      title
      Not Hispanic or Latino
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG003
          value
          0
      title
      Unknown or Not Reported
    param Type
    NUMBER
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG003
          value
          0
      title
      American Indian or Alaska Native
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG003
          value
          0
      title
      Asian
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG003
          value
          0
      title
      Native Hawaiian or Other Pacific Islander
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG003
          value
          1
      title
      Black or African American
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG003
          value
          2
      title
      White
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG003
          value
          0
      title
      More than one race
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG003
          value
          0
      title
      Unknown or Not Reported
    param Type
    NUMBER
    title
    Race (NIH/OMB)
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG003
          value
          3
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      3
    2. group Id
      BG001
      value
      0
    3. group Id
      BG002
      value
      0
    4. group Id
      BG003
      value
      3
    units
    Participants
groups
  1. description
    Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT) •Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects: Cohort 1: add CFZ 20 mg/m\^2 intravenous (IV) on days +1, +2 Cohort 2 : add CFZ 20 mg/m\^2 IV on days: +1, +2, +8, +9 Cohort 3: add CFZ 20 mg/m\^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m\^2 IV given on days 42-43 then CFZ 56 mg/m\^2 IV given on days 49-50, 56-57, then on days 70.
    id
    BG000
    title
    Cohort 1- CFZ 20 mg/m^2 (Day 1,2)
  2. description
    Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT) •Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects: Cohort 1: add CFZ 20 mg/m\^2 intravenous (IV) on days +1, +2 Cohort 2 : add CFZ 20 mg/m\^2 IV on days: +1, +2, +8, +9 Cohort 3: add CFZ 20 mg/m\^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m\^2 IV given on days 42-43 then CFZ 56 mg/m\^2 IV given on days 49-50, 56-57, then on days 70.
    id
    BG001
    title
    Cohort 2- CFZ 20 mg/m^2 (Day 1,2,8,9)
  3. description
    Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT) •Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects: Cohort 1: add CFZ 20 mg/m\^2 intravenous (IV) on days +1, +2 Cohort 2 : add CFZ 20 mg/m\^2 IV on days: +1, +2, +8, +9 Cohort 3: add CFZ 20 mg/m\^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m\^2 IV given on days 42-43 then CFZ 56 mg/m\^2 IV given on days 49-50, 56-57, then on days 70.
    id
    BG002
    title
    Cohort 3-CFZ 20 mg/m^2 (Day1,2,8,9/AHCT)
  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
          BG003
          value
          0
      title
      <=18 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG003
          value
          3
      title
      Between 18 and 65 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG003
          value
          0
      title
      >=65 years
    param Type
    NUMBER
    title
    Age, Categorical
    unit Of Measure
    participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.39
          value
          49.6
        2. group Id
          BG003
          spread
          10.39
          value
          49.6
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG003
          value
          1
      title
      Female
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG003
          value
          2
      title
      Male
    param Type
    NUMBER
    title
    Gender
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG003
          value
          0
      title
      Hispanic or Latino
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG003
          value
          3
      title
      Not Hispanic or Latino
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG003
          value
          0
      title
      Unknown or Not Reported
    param Type
    NUMBER
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG003
          value
          0
      title
      American Indian or Alaska Native
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG003
          value
          0
      title
      Asian
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG003
          value
          0
      title
      Native Hawaiian or Other Pacific Islander
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG003
          value
          1
      title
      Black or African American
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG003
          value
          2
      title
      White
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG003
          value
          0
      title
      More than one race
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG003
          value
          0
      title
      Unknown or Not Reported
    param Type
    NUMBER
    title
    Race (NIH/OMB)
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG003
          value
          3
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants

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

Preserved source evidence · Not medical advice