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NCT00477971 · BASELINE

Baseline characteristics

Low-Dose Melphalan and Dexamethasone Compared With High-Dose Melphalan Followed By Autologous Stem Cell Transplant in Treating Patients With Primary Systemic Amyloidosis · Source last updated 2016-05-17

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
      34
    2. group Id
      BG001
      value
      55
    3. group Id
      BG002
      value
      89
    units
    Participants
groups
  1. description
    Patients receive low-dose melphalan 20 mg/m\^2 IV over 15-30 minutes on day 1 or 0.12 mg/kg tablet orally once daily on days 1-7 and dexamethasone 40 mg orally on days 1-4 and 22-25. Treatment repeats every 6 weeks for 10 courses. (Study treatment beyond one year is not allowed.)
    id
    BG000
    title
    Low-Dose Melphalan
  2. description
    Patients receive filgrastim (G-CSF) 10 mg/kg/day on days -7 to -3 and undergo autologous hematopoietic stem cell (HSC) collection. Patients receive high-dose melphalan 140 mg/m\^2 IV for low risk or 200 mg/m\^2 IV for high risk patients over 1 hour on days -2 and -1 and undergo autologous HSC transplantation on day 0.
    id
    BG001
    title
    High-Dose Melphalan + Autologous HSC
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          48
          upper Limit
          74
          value
          62
        2. group Id
          BG001
          lower Limit
          44
          upper Limit
          73
          value
          57
        3. group Id
          BG002
          lower Limit
          44
          upper Limit
          74
          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
          17
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          33
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          56
        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
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          32
        2. group Id
          BG001
          value
          51
        3. group Id
          BG002
          value
          83
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          34
        2. group Id
          BG001
          value
          55
        3. group Id
          BG002
          value
          89
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          50
        3. group Id
          BG002
          value
          75
      title
      0-1
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          14
      title
      2
    description
    Classifies patients according to their functional impairment. 0: Fully active, able to carry on all pre-disease performance without restriction; 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2: Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours
    param Type
    NUMBER
    title
    ECOG Performance Score
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          38
        3. group Id
          BG002
          value
          58
      title
      Low
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          31
      title
      High
    description
    Low Risk (requires all of the following): 1 or 2 organs involved, Cardiac EF \>= 50%, Age \<= 65 years, NYHA class 1 or 2, Alkaline phosphatase \<= 4 x institutional ULN, cardiac involvement fully compensated or asymptomatic, serum creatinine \<= 2.0 mg/dL High Risk (any one of the following): \>2 organs involved, Cardiac EF \<50%, Age \> 65 years, NYHA class 3, Alkaline phosphatase 4-6 x institutional ULN, symptomatic cardiac involvement, serum creatinine 2.1-3.0 mg/dL
    param Type
    NUMBER
    title
    Risk Group
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      34
    2. group Id
      BG001
      value
      55
    3. group Id
      BG002
      value
      89
    units
    Participants
groups
  1. description
    Patients receive low-dose melphalan 20 mg/m\^2 IV over 15-30 minutes on day 1 or 0.12 mg/kg tablet orally once daily on days 1-7 and dexamethasone 40 mg orally on days 1-4 and 22-25. Treatment repeats every 6 weeks for 10 courses. (Study treatment beyond one year is not allowed.)
    id
    BG000
    title
    Low-Dose Melphalan
  2. description
    Patients receive filgrastim (G-CSF) 10 mg/kg/day on days -7 to -3 and undergo autologous hematopoietic stem cell (HSC) collection. Patients receive high-dose melphalan 140 mg/m\^2 IV for low risk or 200 mg/m\^2 IV for high risk patients over 1 hour on days -2 and -1 and undergo autologous HSC transplantation on day 0.
    id
    BG001
    title
    High-Dose Melphalan + Autologous HSC
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          48
          upper Limit
          74
          value
          62
        2. group Id
          BG001
          lower Limit
          44
          upper Limit
          73
          value
          57
        3. group Id
          BG002
          lower Limit
          44
          upper Limit
          74
          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
          17
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          33
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          56
        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
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          32
        2. group Id
          BG001
          value
          51
        3. group Id
          BG002
          value
          83
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          34
        2. group Id
          BG001
          value
          55
        3. group Id
          BG002
          value
          89
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          50
        3. group Id
          BG002
          value
          75
      title
      0-1
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          14
      title
      2
    description
    Classifies patients according to their functional impairment. 0: Fully active, able to carry on all pre-disease performance without restriction; 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2: Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours
    param Type
    NUMBER
    title
    ECOG Performance Score
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          38
        3. group Id
          BG002
          value
          58
      title
      Low
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          31
      title
      High
    description
    Low Risk (requires all of the following): 1 or 2 organs involved, Cardiac EF \>= 50%, Age \<= 65 years, NYHA class 1 or 2, Alkaline phosphatase \<= 4 x institutional ULN, cardiac involvement fully compensated or asymptomatic, serum creatinine \<= 2.0 mg/dL High Risk (any one of the following): \>2 organs involved, Cardiac EF \<50%, Age \> 65 years, NYHA class 3, Alkaline phosphatase 4-6 x institutional ULN, symptomatic cardiac involvement, serum creatinine 2.1-3.0 mg/dL
    param Type
    NUMBER
    title
    Risk Group
    unit Of Measure
    participants

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

Preserved source evidence · Not medical advice