Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00429949 · BASELINE

Baseline characteristics

A Phase II Study of Dasatinib in the Treatment of Relapsed or Plateau Phase Multiple Myeloma · Source last updated 2014-08-29

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
      21
    units
    Participants
groups
  1. description
    Dasatinib will be administered continuously at an oral dose of 70 mg BID on Days 1-28 of each 28 day cycle.
    id
    BG000
    title
    Dasatinib
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          38
          upper Limit
          76
          value
          59
    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
          7
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          14
        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
          21
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Stage IA
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Stage IIA
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          15
      title
      Stage IIIA
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Stage IIIB
    description
    Stage I: Hemoglobin (Hb) \> 10g/dL, normal calcium, normal or single plasmacytoma or osteoporosis, Serum paraprotein level \< 5 g/dL if IgG, \< 3 g/dL if IgA, Urinary light chain excretion \< 4 g/24h Stage 2: Not fufilling criteria of Stage I or III Stage III: Hb \< 8.5g/dL, calcium \> 12 mg/dL, 3 or more lytic bone lesions, Serum paraprotein \> 7g/dL if IgG, \> 5 g/dL if IgA, Urinary light chain excretion \> 12g/24h Stages I, II, and III can be divided into A or B depending on serum creatinine: A: serum creatinine \< 2 mg/dL (\< 177 μmol/L) B: serum creatinine \> 2 mg/dL (\> 177 μmol/L)
    param Type
    NUMBER
    title
    Durie-Salmon Stage
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          1
          upper Limit
          14
          value
          3
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Prior therapies
    unit Of Measure
    therapies
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          19
      title
      Immunomodulatory agents
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          10
      title
      Bortezomib
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          12
      title
      Anthracycline-containing regimens
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          19
      title
      Prior autologous stem cell transplant
    param Type
    NUMBER
    title
    Prior therapies
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          1.2
          upper Limit
          13
          value
          2.7
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Beta 2 microglobulin at study entry
    unit Of Measure
    mg/L
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          14
      title
      Relapsed
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Plateau phase
    param Type
    NUMBER
    title
    Disease status at study entry
    unit Of Measure
    participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          14
      title
      IgG
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      IgA
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Light chain only
    param Type
    NUMBER
    title
    Paraprotein
    unit Of Measure
    participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
      title
      Normal
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Del 13/13q
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Complex (including 1 with t4;14)
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      t9;16
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Del 6p
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Unavailable
    param Type
    NUMBER
    title
    Cytogenetics
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      21
    units
    Participants
groups
  1. description
    Dasatinib will be administered continuously at an oral dose of 70 mg BID on Days 1-28 of each 28 day cycle.
    id
    BG000
    title
    Dasatinib
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          38
          upper Limit
          76
          value
          59
    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
          7
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          14
        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
          21
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Stage IA
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Stage IIA
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          15
      title
      Stage IIIA
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Stage IIIB
    description
    Stage I: Hemoglobin (Hb) \> 10g/dL, normal calcium, normal or single plasmacytoma or osteoporosis, Serum paraprotein level \< 5 g/dL if IgG, \< 3 g/dL if IgA, Urinary light chain excretion \< 4 g/24h Stage 2: Not fufilling criteria of Stage I or III Stage III: Hb \< 8.5g/dL, calcium \> 12 mg/dL, 3 or more lytic bone lesions, Serum paraprotein \> 7g/dL if IgG, \> 5 g/dL if IgA, Urinary light chain excretion \> 12g/24h Stages I, II, and III can be divided into A or B depending on serum creatinine: A: serum creatinine \< 2 mg/dL (\< 177 μmol/L) B: serum creatinine \> 2 mg/dL (\> 177 μmol/L)
    param Type
    NUMBER
    title
    Durie-Salmon Stage
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          1
          upper Limit
          14
          value
          3
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Prior therapies
    unit Of Measure
    therapies
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          19
      title
      Immunomodulatory agents
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          10
      title
      Bortezomib
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          12
      title
      Anthracycline-containing regimens
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          19
      title
      Prior autologous stem cell transplant
    param Type
    NUMBER
    title
    Prior therapies
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          1.2
          upper Limit
          13
          value
          2.7
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Beta 2 microglobulin at study entry
    unit Of Measure
    mg/L
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          14
      title
      Relapsed
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Plateau phase
    param Type
    NUMBER
    title
    Disease status at study entry
    unit Of Measure
    participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          14
      title
      IgG
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      IgA
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Light chain only
    param Type
    NUMBER
    title
    Paraprotein
    unit Of Measure
    participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
      title
      Normal
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Del 13/13q
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Complex (including 1 with t4;14)
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      t9;16
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Del 6p
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Unavailable
    param Type
    NUMBER
    title
    Cytogenetics
    unit Of Measure
    participants

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

Preserved source evidence · Not medical advice