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NCT02254551 · BASELINE

Baseline characteristics

Safety/Efficacy Study of LDE225 (Sonidegib) Plus Bortezomib in Patients With Relapsed or Relapsed/Refractory Multiple Myeloma · Source last updated 2017-02-16

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
      7
    units
    Participants
groups
  1. description
    Safety Lead-In: To determine the maximum tolerated dose (MTD), LDE225 will be administered orally at three dose levels: 400mg, 600mg, and 800mg. Bortezomib will be administered by subcutaneous injection (SQ) at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle. Expansion: Patients will receive LDE225 orally once daily for 21 days at the MTD. Bortezomib will be administered SQ at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle. Maintenance Therapy: Patients who complete 16 cycles of therapy with stable disease or better will be eligible for single agent maintenance therapy of LDE225 at the MTD orally for up to 2 years or until progressive disease or unacceptable toxicity.
    id
    BG000
    title
    LDE225 Plus Bortezomib
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          52
          upper Limit
          84
          value
          79
    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
          6
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          1
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Gender
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      Caucasian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Black or African AMerican
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Unknown
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      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
      7
    units
    Participants
groups
  1. description
    Safety Lead-In: To determine the maximum tolerated dose (MTD), LDE225 will be administered orally at three dose levels: 400mg, 600mg, and 800mg. Bortezomib will be administered by subcutaneous injection (SQ) at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle. Expansion: Patients will receive LDE225 orally once daily for 21 days at the MTD. Bortezomib will be administered SQ at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle. Maintenance Therapy: Patients who complete 16 cycles of therapy with stable disease or better will be eligible for single agent maintenance therapy of LDE225 at the MTD orally for up to 2 years or until progressive disease or unacceptable toxicity.
    id
    BG000
    title
    LDE225 Plus Bortezomib
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          52
          upper Limit
          84
          value
          79
    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
          6
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          1
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Gender
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      Caucasian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Black or African AMerican
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Unknown
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants

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Preserved source evidence · Not medical advice