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NCT00098475 · BASELINE

Baseline characteristics

Lenalidomide and Dexamethasone With or Without Thalidomide in Treating Patients With Multiple Myeloma · Source last updated 2026-08-28

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
      223
    2. group Id
      BG001
      value
      222
    3. group Id
      BG002
      value
      445
    units
    Participants
groups
  1. description
    Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and high-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1-4, 9-12, and 17-20 for 4 cycles. As the expansion phase was a substudy terminated early with only 7 patients enrolled, the clinical results presented are mainly for the first phase only. Toxicity data are available for both the first phase and the expansion phase.
    id
    BG000
    title
    Arm I (Lenalidomide, Dexamethasone)
  2. description
    Patients receive oral lenalidomide and acetylsalicylic acid as in arm I and low-dose oral dexamethasone once daily on days 1, 8, 15, and 22. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and low-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1, 8, 15, and 22 for 4 cycles. As the expansion phase was a substudy terminated early with only 7 patients enrolled, the clinical results presented are mainly for the first phase only. Toxicity data are available for both the first phase and the expansion phase.
    id
    BG001
    title
    Arm II (Lenalidomide, Low-dose Dexamethasone)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          36
          upper Limit
          87
          value
          66
        2. group Id
          BG001
          lower Limit
          35
          upper Limit
          85
          value
          65
        3. group Id
          BG002
          lower Limit
          35
          upper Limit
          87
          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
          91
        2. group Id
          BG001
          value
          101
        3. group Id
          BG002
          value
          192
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          132
        2. group Id
          BG001
          value
          121
        3. group Id
          BG002
          value
          253
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      223
    2. group Id
      BG001
      value
      222
    3. group Id
      BG002
      value
      445
    units
    Participants
groups
  1. description
    Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and high-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1-4, 9-12, and 17-20 for 4 cycles. As the expansion phase was a substudy terminated early with only 7 patients enrolled, the clinical results presented are mainly for the first phase only. Toxicity data are available for both the first phase and the expansion phase.
    id
    BG000
    title
    Arm I (Lenalidomide, Dexamethasone)
  2. description
    Patients receive oral lenalidomide and acetylsalicylic acid as in arm I and low-dose oral dexamethasone once daily on days 1, 8, 15, and 22. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and low-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1, 8, 15, and 22 for 4 cycles. As the expansion phase was a substudy terminated early with only 7 patients enrolled, the clinical results presented are mainly for the first phase only. Toxicity data are available for both the first phase and the expansion phase.
    id
    BG001
    title
    Arm II (Lenalidomide, Low-dose Dexamethasone)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          36
          upper Limit
          87
          value
          66
        2. group Id
          BG001
          lower Limit
          35
          upper Limit
          85
          value
          65
        3. group Id
          BG002
          lower Limit
          35
          upper Limit
          87
          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
          91
        2. group Id
          BG001
          value
          101
        3. group Id
          BG002
          value
          192
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          132
        2. group Id
          BG001
          value
          121
        3. group Id
          BG002
          value
          253
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice