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NCT00602641 · BASELINE

Baseline characteristics

Melphalan, Prednisone, and Thalidomide or Lenalidomide in Treating Patients With Newly Diagnosed 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
      154
    2. group Id
      BG001
      value
      152
    3. group Id
      BG002
      value
      306
    units
    Participants
groups
  1. description
    Patients receive melphalan, prednisone and thalidomide induction plus thalidomide maintenance (MPT-T). INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and thalidomide PO daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive thalidomide PO daily and continue in the absence of disease progression. melphalan: Given PO prednisone: Given PO thalidomide: Given PO
    id
    BG000
    title
    Arm I (MPT-T)
  2. description
    Patients receive lower-dose melphalan, prednisone and lenalidomide (Revlimid®) induction plus lenalidomide maintenance (mPR-R). INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive lenalidomide PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression. melphalan: Given PO prednisone: Given PO lenalidomide: Given PO
    id
    BG001
    title
    Arm II (mPR-R)
  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
          9
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          15
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          145
        2. group Id
          BG001
          value
          146
        3. group Id
          BG002
          value
          291
        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
          68
        2. group Id
          BG001
          value
          71
        3. group Id
          BG002
          value
          139
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          86
        2. group Id
          BG001
          value
          81
        3. group Id
          BG002
          value
          167
        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
          45
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          81
      title
      Stage I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          58
        2. group Id
          BG001
          value
          70
        3. group Id
          BG002
          value
          128
      title
      Stage II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          95
      title
      Stage III
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
      title
      Unknown/Missing
    description
    The staging criteria for International Staging System: Stage I: Serum β2 microglobulin \<3.5 mg/L, Serum albumin ≥ 3.5 g/dL Stage II: Not I or III Stage III: Serum β2 microglobulin \>5.5 mg/L
    param Type
    NUMBER
    title
    International Staging System (ISS)
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      154
    2. group Id
      BG001
      value
      152
    3. group Id
      BG002
      value
      306
    units
    Participants
groups
  1. description
    Patients receive melphalan, prednisone and thalidomide induction plus thalidomide maintenance (MPT-T). INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and thalidomide PO daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive thalidomide PO daily and continue in the absence of disease progression. melphalan: Given PO prednisone: Given PO thalidomide: Given PO
    id
    BG000
    title
    Arm I (MPT-T)
  2. description
    Patients receive lower-dose melphalan, prednisone and lenalidomide (Revlimid®) induction plus lenalidomide maintenance (mPR-R). INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive lenalidomide PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression. melphalan: Given PO prednisone: Given PO lenalidomide: Given PO
    id
    BG001
    title
    Arm II (mPR-R)
  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
          9
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          15
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          145
        2. group Id
          BG001
          value
          146
        3. group Id
          BG002
          value
          291
        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
          68
        2. group Id
          BG001
          value
          71
        3. group Id
          BG002
          value
          139
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          86
        2. group Id
          BG001
          value
          81
        3. group Id
          BG002
          value
          167
        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
          45
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          81
      title
      Stage I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          58
        2. group Id
          BG001
          value
          70
        3. group Id
          BG002
          value
          128
      title
      Stage II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          95
      title
      Stage III
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
      title
      Unknown/Missing
    description
    The staging criteria for International Staging System: Stage I: Serum β2 microglobulin \<3.5 mg/L, Serum albumin ≥ 3.5 g/dL Stage II: Not I or III Stage III: Serum β2 microglobulin \>5.5 mg/L
    param Type
    NUMBER
    title
    International Staging System (ISS)
    unit Of Measure
    participants

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

Preserved source evidence · Not medical advice