Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00743288 · BASELINE

Baseline characteristics

Melphalan and Panobinostat (LBH589) for the Treatment of Patients With Recurrent Multiple Myeloma · Source last updated 2014-05-08

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
      40
    units
    Participants
groups
  1. description
    Schedule A: 10mg/daily of LBH589 per orem (PO) on days 1, 3 and 5 of weeks 1-4 of a 28-day cycle and melphalan PO at 0.05 mg/kg on days 1-5 of week 1. Toxicity led to the following changes in dose and schedule Schedule B1: 10mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1. Schedule B2: 20mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 and 0.05 mg/kg melphalan POon days 1, 3 and 5 of week 1. Schedule C: 20mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1 and 2 and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1 Schedule D1: 15 mg/daily LBH589 PO and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1. Schedule D2: 15 mg/daily LBH589 PO and 0.10 mg/kg melphalan PO on days 1, 3 and 5 of week 1. Schedule D3: 20 mg/daily LBH589 PO and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1.
    id
    BG000
    title
    Melphalan and Panobinostat (LBH589)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          34.2
          upper Limit
          88.2
          value
          65.4
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          25
        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
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          2
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          4
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          32
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          2
        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
          40
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          1
          upper Limit
          16
          value
          4
      title
      Number of prior regimens
    2. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0
          upper Limit
          9
          value
          2
      title
      Number of Bortezomib-containing prior regimens
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Prior regimens
    unit Of Measure
    number of prior regimens
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      40
    units
    Participants
groups
  1. description
    Schedule A: 10mg/daily of LBH589 per orem (PO) on days 1, 3 and 5 of weeks 1-4 of a 28-day cycle and melphalan PO at 0.05 mg/kg on days 1-5 of week 1. Toxicity led to the following changes in dose and schedule Schedule B1: 10mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1. Schedule B2: 20mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1-4 and 0.05 mg/kg melphalan POon days 1, 3 and 5 of week 1. Schedule C: 20mg/daily of LBH589 PO on days 1, 3 and 5 of weeks 1 and 2 and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1 Schedule D1: 15 mg/daily LBH589 PO and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1. Schedule D2: 15 mg/daily LBH589 PO and 0.10 mg/kg melphalan PO on days 1, 3 and 5 of week 1. Schedule D3: 20 mg/daily LBH589 PO and 0.05 mg/kg melphalan PO on days 1, 3 and 5 of week 1.
    id
    BG000
    title
    Melphalan and Panobinostat (LBH589)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          34.2
          upper Limit
          88.2
          value
          65.4
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          25
        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
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          2
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          4
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          32
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          2
        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
          40
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          1
          upper Limit
          16
          value
          4
      title
      Number of prior regimens
    2. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0
          upper Limit
          9
          value
          2
      title
      Number of Bortezomib-containing prior regimens
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Prior regimens
    unit Of Measure
    number of prior regimens

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

Preserved source evidence · Not medical advice