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NCT00644228 · BASELINE

Baseline characteristics

Lenalidomide and Dexamethasone With or Without Bortezomib in Treating Patients With Previously Untreated Multiple Myeloma · Source last updated 2026-07-29

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
      229
    2. group Id
      BG001
      value
      242
    3. group Id
      BG002
      value
      471
    units
    Participants
groups
  1. description
    Patients receive dexamethasone PO QD on days 1, 8, 15, and 22 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Dexamethasone: Given PO Laboratory Biomarker Analysis: Optional correlative studies Lenalidomide: Given PO
    id
    BG000
    title
    Arm I (Dexamethasone and Lenalidomide)
  2. description
    Patients receive dexamethasone PO QD on days 1, 2, 4, 5, 8, 9, 11, and 12; lenalidomide PO QD on days 1-14; and bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. Bortezomib: Given IV Dexamethasone: Given PO Laboratory Biomarker Analysis: Optional correlative studies Lenalidomide: Given PO
    id
    BG001
    title
    Arm II (Dexamethasone, Lenalidomide, Bortezomib)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          120
        2. group Id
          BG001
          value
          149
        3. group Id
          BG002
          value
          269
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          109
        2. group Id
          BG001
          value
          93
        3. group Id
          BG002
          value
          202
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          107
        2. group Id
          BG001
          value
          89
        3. group Id
          BG002
          value
          196
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          122
        2. group Id
          BG001
          value
          153
        3. group Id
          BG002
          value
          275
        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
          150
        2. group Id
          BG001
          value
          164
        3. group Id
          BG002
          value
          314
        title
        ISS Stage I or II
      2. measurements
        1. group Id
          BG000
          value
          79
        2. group Id
          BG001
          value
          78
        3. group Id
          BG002
          value
          157
        title
        ISS Stage III
    description
    International Staging System (ISS) Criteria: Stage I: Serum β2-microglobulin \< 3.5mg/L and Serum Albumin ≥ 3.5 g/dL; expected median survival is 62 months. Stage II\*: Not Stage I or III; expected median survival is 44 months. Stage III: Serum β2-microglobulin \> 5.5 mg/L; expected median survival is 29 months. \*There are two categories for stage II: serum β2-microglobulin \< 3.5 mg/L but serum albumin \< 3.5 g/dL; or serum β2-microglobulin 3.5 to \< 5.5 mg/L irrespective of the serum albumin level.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ISS Stage
    unit Of Measure
    Participants
population Description
Includes all eligible and analyzable patients.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      229
    2. group Id
      BG001
      value
      242
    3. group Id
      BG002
      value
      471
    units
    Participants
groups
  1. description
    Patients receive dexamethasone PO QD on days 1, 8, 15, and 22 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Dexamethasone: Given PO Laboratory Biomarker Analysis: Optional correlative studies Lenalidomide: Given PO
    id
    BG000
    title
    Arm I (Dexamethasone and Lenalidomide)
  2. description
    Patients receive dexamethasone PO QD on days 1, 2, 4, 5, 8, 9, 11, and 12; lenalidomide PO QD on days 1-14; and bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. Bortezomib: Given IV Dexamethasone: Given PO Laboratory Biomarker Analysis: Optional correlative studies Lenalidomide: Given PO
    id
    BG001
    title
    Arm II (Dexamethasone, Lenalidomide, Bortezomib)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          120
        2. group Id
          BG001
          value
          149
        3. group Id
          BG002
          value
          269
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          109
        2. group Id
          BG001
          value
          93
        3. group Id
          BG002
          value
          202
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          107
        2. group Id
          BG001
          value
          89
        3. group Id
          BG002
          value
          196
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          122
        2. group Id
          BG001
          value
          153
        3. group Id
          BG002
          value
          275
        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
          150
        2. group Id
          BG001
          value
          164
        3. group Id
          BG002
          value
          314
        title
        ISS Stage I or II
      2. measurements
        1. group Id
          BG000
          value
          79
        2. group Id
          BG001
          value
          78
        3. group Id
          BG002
          value
          157
        title
        ISS Stage III
    description
    International Staging System (ISS) Criteria: Stage I: Serum β2-microglobulin \< 3.5mg/L and Serum Albumin ≥ 3.5 g/dL; expected median survival is 62 months. Stage II\*: Not Stage I or III; expected median survival is 44 months. Stage III: Serum β2-microglobulin \> 5.5 mg/L; expected median survival is 29 months. \*There are two categories for stage II: serum β2-microglobulin \< 3.5 mg/L but serum albumin \< 3.5 g/dL; or serum β2-microglobulin 3.5 to \< 5.5 mg/L irrespective of the serum albumin level.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ISS Stage
    unit Of Measure
    Participants
population Description
Includes all eligible and analyzable patients.

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

Preserved source evidence · Not medical advice