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NCT00378209 · BASELINE

Baseline characteristics

Bortezomib, Lenalidomide, and Dexamethasone Combination Therapy for Patients With Relapsed or Relapsed and Refractory Multiple Myeloma · Source last updated 2016-11-17

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
      64
    units
    Participants
groups
  1. description
    Patients were treated for up to 8 21-day cycles with the combination of bortezomib 1.0 mg/m2 IV, days 1, 4, 8, and 11, and oral lenalidomide 15 mg/day, days 1 through 14, with oral dexamethasone 40 mg/day (cycles 1-4) and 20 mg/day (cycles 5-8) on the days of and days after bortezomib dosing (days 1, 2, 4, 5, 8, 9, 11, and 12).Following a protocol amendment , dexamethasone dosing was reduced to 20 mg/day in cycles 1 through 4 and 10 mg/day in cycles 5 through 8. Beyond cycle 8, responding patients and those with stable disease (SD) could receive maintenance therapy until disease progression or unacceptable toxicity. Maintenance therapy comprised bortezomib and lenalidomide at the doses tolerated on completion of cycle 8, with lenalidomide on days 1 through 14 and using an amended schedule of weekly bortezomib (days 1 and 8) and dexamethasone 10 mg on days 1, 2, 8, and 9.
    id
    BG000
    title
    Lenalidomide, Dexamethasone, Bortezomib Combination
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          32
          upper Limit
          83
          value
          65
    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
          22
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          42
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
population Description
65 patients were enrolled and 64 were treated. One patient who was never treated was excluded from the analysis.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      64
    units
    Participants
groups
  1. description
    Patients were treated for up to 8 21-day cycles with the combination of bortezomib 1.0 mg/m2 IV, days 1, 4, 8, and 11, and oral lenalidomide 15 mg/day, days 1 through 14, with oral dexamethasone 40 mg/day (cycles 1-4) and 20 mg/day (cycles 5-8) on the days of and days after bortezomib dosing (days 1, 2, 4, 5, 8, 9, 11, and 12).Following a protocol amendment , dexamethasone dosing was reduced to 20 mg/day in cycles 1 through 4 and 10 mg/day in cycles 5 through 8. Beyond cycle 8, responding patients and those with stable disease (SD) could receive maintenance therapy until disease progression or unacceptable toxicity. Maintenance therapy comprised bortezomib and lenalidomide at the doses tolerated on completion of cycle 8, with lenalidomide on days 1 through 14 and using an amended schedule of weekly bortezomib (days 1 and 8) and dexamethasone 10 mg on days 1, 2, 8, and 9.
    id
    BG000
    title
    Lenalidomide, Dexamethasone, Bortezomib Combination
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          32
          upper Limit
          83
          value
          65
    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
          22
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          42
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
population Description
65 patients were enrolled and 64 were treated. One patient who was never treated was excluded from the analysis.

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Preserved source evidence · Not medical advice