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NCT00538824 · BASELINE

Baseline characteristics

Phase II Study of Dexamethasone, Thalidomide and Lenalidomide for Subjects With Relapsed or Refractory Multiple Myeloma · Source last updated 2018-06-06

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
      5
    units
    Participants
groups
  1. description
    All patients were treated with the DexTR (dexamethasone / thalidomide, lenalidomide (Revlimid®)), which consisted of lenalidomide 25mg/day during days 1-21, dexamethasone 40mg/day on days 1-4, 9-12, and 17-20, and thalidomide 50mg/day for the first 7 days, followed by 100mg/day for all subsequent days, for a total of 4 cycles of 28 days each. dexamethasone: Cycles 1-4 • Dexamethasone (40mg ) will be given on days 1-4, 9-12, 17-20 of a 28-day cycle. After completing 4 cycles: * Patients who demonstrate disease progression at any time will be taken off study. * Patients who achieve a resolution of monoclonal gammopathy as detected on serum immunofixation or achieve a plateau of disease (no change in M-spike as detected on serum protein electrophoresis) for \> 2 cycles will be transitioned to maintenance therapy. * Patients who continue to respond without achieving either a plateau or a CR will continue on induction therapy until plateau for \>2 cycles or CR in the absence of unt
    id
    BG000
    title
    DexTR (All Patients)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          50
          upper Limit
          80
          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
          1
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          4
        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
          0
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          5
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          4
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          3.1
          upper Limit
          4.2
          value
          3.8
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    serum creatinine at baseline (in mg/dL)
    unit Of Measure
    mg/dL
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          1.5
          upper Limit
          5.6
          value
          4.1
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Beta-2 microglobulin at baseline (in mg/L)
    unit Of Measure
    mg/dL
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          150
          upper Limit
          225
          value
          177
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    lactage dehydrogenase at baseline (U/L)
    unit Of Measure
    U/L
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      1 (a or b)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      2a
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      2b
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      3a
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      3b
    description
    Subjects were staged according to the Durie salmon Staging Classification System. Criteria for the staging system can be found here: https://www.themmrf.org/multiple-myeloma/prognosis/myeloma-stages/durie-salmon-staging-system/. Staging classification describes multiple myeloma tumor burden; stage 1 is a low tumor burden/myeloma cell mass, stage 2 is intermediate tumor burden/cell mass, and stage 3 is a high tumor burden/cell mass.
    param Type
    NUMBER
    title
    Durie-Salmon Classification
    unit Of Measure
    participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      III
    description
    Stage I: β2M \< 3.5 mg/l and serum albumin ≥3.5 g/100 ml (median survival 62 months); stage II, neither stage I nor stage III (median survival 44 months) and stage III β2M ≥5.5 mg/l (median survival 29 months)
    param Type
    NUMBER
    title
    International Staging System Classification
    unit Of Measure
    participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      IgG lambda Myeloma
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Free Kappa light Chain Myeloma
    param Type
    NUMBER
    title
    Immunoglobulins
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      5
    units
    Participants
groups
  1. description
    All patients were treated with the DexTR (dexamethasone / thalidomide, lenalidomide (Revlimid®)), which consisted of lenalidomide 25mg/day during days 1-21, dexamethasone 40mg/day on days 1-4, 9-12, and 17-20, and thalidomide 50mg/day for the first 7 days, followed by 100mg/day for all subsequent days, for a total of 4 cycles of 28 days each. dexamethasone: Cycles 1-4 • Dexamethasone (40mg ) will be given on days 1-4, 9-12, 17-20 of a 28-day cycle. After completing 4 cycles: * Patients who demonstrate disease progression at any time will be taken off study. * Patients who achieve a resolution of monoclonal gammopathy as detected on serum immunofixation or achieve a plateau of disease (no change in M-spike as detected on serum protein electrophoresis) for \> 2 cycles will be transitioned to maintenance therapy. * Patients who continue to respond without achieving either a plateau or a CR will continue on induction therapy until plateau for \>2 cycles or CR in the absence of unt
    id
    BG000
    title
    DexTR (All Patients)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          50
          upper Limit
          80
          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
          1
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          4
        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
          0
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          5
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          4
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          3.1
          upper Limit
          4.2
          value
          3.8
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    serum creatinine at baseline (in mg/dL)
    unit Of Measure
    mg/dL
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          1.5
          upper Limit
          5.6
          value
          4.1
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Beta-2 microglobulin at baseline (in mg/L)
    unit Of Measure
    mg/dL
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          150
          upper Limit
          225
          value
          177
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    lactage dehydrogenase at baseline (U/L)
    unit Of Measure
    U/L
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      1 (a or b)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      2a
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      2b
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      3a
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      3b
    description
    Subjects were staged according to the Durie salmon Staging Classification System. Criteria for the staging system can be found here: https://www.themmrf.org/multiple-myeloma/prognosis/myeloma-stages/durie-salmon-staging-system/. Staging classification describes multiple myeloma tumor burden; stage 1 is a low tumor burden/myeloma cell mass, stage 2 is intermediate tumor burden/cell mass, and stage 3 is a high tumor burden/cell mass.
    param Type
    NUMBER
    title
    Durie-Salmon Classification
    unit Of Measure
    participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      III
    description
    Stage I: β2M \< 3.5 mg/l and serum albumin ≥3.5 g/100 ml (median survival 62 months); stage II, neither stage I nor stage III (median survival 44 months) and stage III β2M ≥5.5 mg/l (median survival 29 months)
    param Type
    NUMBER
    title
    International Staging System Classification
    unit Of Measure
    participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      IgG lambda Myeloma
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Free Kappa light Chain Myeloma
    param Type
    NUMBER
    title
    Immunoglobulins
    unit Of Measure
    participants

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

Preserved source evidence · Not medical advice