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NCT00240162 · BASELINE

Baseline characteristics

PTK/ZK as Post Transplant Maintenance Therapy in Patients With Multiple Myeloma · Source last updated 2014-09-17

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
    Initially patients will receive a dose of 500mg (2, 250mg tablets) in the morning and 250mg (1, 250mg tablet) in the afternoon for 2 weeks (cycle 1, days 1-14), then 500mg (2, 250mg tablets) bid for 2 weeks (cycle 1, days 15-28) and finally 750mg (3, 250mg tablets) in the morning and 500mg (2, 250mg tablets) in the afternoon for the remainder of treatment duration (cycle 2, day 1 and onwards). Each 28 days of drug administration will constitute one cycle of therapy.
    id
    BG000
    title
    PTK787/ZK 222584
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          38
          upper Limit
          76
          value
          57
    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
          7
      title
      Stage IA
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Stage IIA
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Stage IIIA
    description
    * Stage I:Hemoglobin (hgb) level \>10.5 g/dL \& calcium level is normal or ≤12 mg/dL \& Low M-protein levels (IgG level is \<5 g/dL; IgA level \<3 g/dL) \& Urine light chains \<4 g per 24 hours, \& Bone X-ray normal bone structure or a solitary bone plasmacytoma * Stage IIA:Levels of hgb, calcium, M-protein and Bence Jones protein fall somewhere between stages I and III \& No kidney failure (creatinine ≤2 mg/dL) * Stage III: High M protein (IgG is\>7 g/dL; IgA is \>5g/dL) \& Urine light chains \>12 g per 24 hours \& hgb \<8.5 g/dL \& calcium \>2 m/dL) \& X-ray studies of bone \>3 lytic bone lesions
    param Type
    NUMBER
    title
    Durie-Salmon stage at study entry
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          17
      title
      Stage I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Stage II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Stage III
    description
    * Stage I:Beta 2-microglobulin level \<3.5 mg/L \& Albumin level ≥3.5 g/dL * Stage II Beta 2-microglobulin level \<3.5 g/L \& Albumin level \<3.5 g/dL OR Beta 2-microglobulin level is 3.5 to 5.5 mg/L * Stage III Beta 2-microglobulin level is ≥5.5 mg/L
    param Type
    NUMBER
    title
    International Staging System (ISS) at study entry
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          1.2
          upper Limit
          5.65
          value
          2.3
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Beta-2 Microglobulin at study entry
    unit Of Measure
    mg/L
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          18
      title
      IgG
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      IgA
    param Type
    NUMBER
    title
    Paraprotein at study entry
    unit Of Measure
    participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0
          upper Limit
          2.4
          value
          0.5
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Serum M-spike at study entry
    unit Of Measure
    g/dL
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0
          upper Limit
          15
          value
          5
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Bone marrow aspirate plasma
    unit Of Measure
    percentage of cells at study entry
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      Normal karyotype
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Monosomy 13
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Hypodiploid karyotype with t(11;14)
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Monosomy 13 and t(4:14)
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      Others
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      No available cytogenetics
    param Type
    NUMBER
    title
    Conventional cytogenetics
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      21
    units
    Participants
groups
  1. description
    Initially patients will receive a dose of 500mg (2, 250mg tablets) in the morning and 250mg (1, 250mg tablet) in the afternoon for 2 weeks (cycle 1, days 1-14), then 500mg (2, 250mg tablets) bid for 2 weeks (cycle 1, days 15-28) and finally 750mg (3, 250mg tablets) in the morning and 500mg (2, 250mg tablets) in the afternoon for the remainder of treatment duration (cycle 2, day 1 and onwards). Each 28 days of drug administration will constitute one cycle of therapy.
    id
    BG000
    title
    PTK787/ZK 222584
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          38
          upper Limit
          76
          value
          57
    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
          7
      title
      Stage IA
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Stage IIA
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Stage IIIA
    description
    * Stage I:Hemoglobin (hgb) level \>10.5 g/dL \& calcium level is normal or ≤12 mg/dL \& Low M-protein levels (IgG level is \<5 g/dL; IgA level \<3 g/dL) \& Urine light chains \<4 g per 24 hours, \& Bone X-ray normal bone structure or a solitary bone plasmacytoma * Stage IIA:Levels of hgb, calcium, M-protein and Bence Jones protein fall somewhere between stages I and III \& No kidney failure (creatinine ≤2 mg/dL) * Stage III: High M protein (IgG is\>7 g/dL; IgA is \>5g/dL) \& Urine light chains \>12 g per 24 hours \& hgb \<8.5 g/dL \& calcium \>2 m/dL) \& X-ray studies of bone \>3 lytic bone lesions
    param Type
    NUMBER
    title
    Durie-Salmon stage at study entry
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          17
      title
      Stage I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Stage II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Stage III
    description
    * Stage I:Beta 2-microglobulin level \<3.5 mg/L \& Albumin level ≥3.5 g/dL * Stage II Beta 2-microglobulin level \<3.5 g/L \& Albumin level \<3.5 g/dL OR Beta 2-microglobulin level is 3.5 to 5.5 mg/L * Stage III Beta 2-microglobulin level is ≥5.5 mg/L
    param Type
    NUMBER
    title
    International Staging System (ISS) at study entry
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          1.2
          upper Limit
          5.65
          value
          2.3
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Beta-2 Microglobulin at study entry
    unit Of Measure
    mg/L
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          18
      title
      IgG
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      IgA
    param Type
    NUMBER
    title
    Paraprotein at study entry
    unit Of Measure
    participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0
          upper Limit
          2.4
          value
          0.5
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Serum M-spike at study entry
    unit Of Measure
    g/dL
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0
          upper Limit
          15
          value
          5
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Bone marrow aspirate plasma
    unit Of Measure
    percentage of cells at study entry
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      Normal karyotype
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Monosomy 13
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Hypodiploid karyotype with t(11;14)
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Monosomy 13 and t(4:14)
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      Others
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      No available cytogenetics
    param Type
    NUMBER
    title
    Conventional cytogenetics
    unit Of Measure
    participants

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Preserved source evidence · Not medical advice