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NCT00790842 · BASELINE

Baseline characteristics

Lenalidomide and Low-Dose Dexamethasone in Patients With Previously Treated Multiple Myeloma and Kidney Dysfunction · Source last updated 2018-10-24

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
      29
    2. group Id
      BG001
      value
      19
    3. group Id
      BG002
      value
      14
    4. group Id
      BG003
      value
      62
    units
    Participants
groups
  1. description
    Lenalidomide days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Phase I will determine the dose of lenalidomide to be used in Phase II. Group A=30-60 CrCl (mL/min): Each Cycle=28 days. Lenalidomide by mouth days 1-21 and Dexamethasone 40 mg by mouth days 1, 8, 15 and 22. There is a 7 day rest (days 22-28) from lenalidomide. Continue until disease progression or unacceptable toxicity. Phase I will determine the dose of lenalidomide to be used in Phase II.
    id
    BG000
    title
    Group A=30-60 CrCl (mL/Min)
  2. description
    Lenalidomide days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Phase I will determine the dose of lenalidomide to be used in Phase II. Group B=CrCL\<30 mL/min not on dialysis: Each Cycle=28 days. Lenalidomide by mouth days 1-21 and Dexamethasone 40 mg by mouth days 1, 8, 15 and 22. There is a 7 day rest (days 22-28) from lenalidomide. Continue until disease progression or unacceptable toxicity. Phase I will determine the dose of lenalidomide to be used in Phase II.
    id
    BG001
    title
    Group B=CrCL<30 mL/Min Not on Dialysis
  3. description
    Lenalidomide days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Phase I will determine the dose of lenalidomide to be used in Phase II. Group C=CrCL\<30 mL/min and on dialysis: Each Cycle=28 days. Lenalidomide by mouth days 1-21 and Dexamethasone 40 mg by mouth days 1, 8, 15 and 22. There is a 7 day rest (days 22-28) from lenalidomide. Continue until disease progression or unacceptable toxicity. Phase I will determine the dose of lenalidomide to be used in Phase II. Dialysis includes hemodialysis or peritoneal dialysis. When lenalidomide and/or dexamethasone treatment occurs on a dialysis day, lenalidomide and/or dexamethasone must be taken after dialysis.
    id
    BG002
    title
    Group C=CrCL<30 mL/Min and on Dialysis
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          68
          upper Limit
          78
          value
          73
        2. group Id
          BG001
          lower Limit
          62
          upper Limit
          79
          value
          72
        3. group Id
          BG002
          lower Limit
          57
          upper Limit
          70
          value
          64
        4. group Id
          BG003
          lower Limit
          64
          upper Limit
          77
          value
          71.5
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          31
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          31
        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
        4. group Id
          BG003
          value
          0
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          61
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        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
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          8
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          52
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        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
          37.0
          upper Limit
          51.2
          value
          42.6
        2. group Id
          BG001
          lower Limit
          15.7
          upper Limit
          25.4
          value
          22.8
        3. group Id
          BG002
          lower Limit
          9.7
          upper Limit
          17.2
          value
          11.5
        4. group Id
          BG003
          lower Limit
          15.7
          upper Limit
          42.1
          value
          27.4
    description
    Serum creatinine clearance, mL/minute
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    title
    Creatinine Clearance
    unit Of Measure
    mL/min
population Description
Eligible, treated patients
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      29
    2. group Id
      BG001
      value
      19
    3. group Id
      BG002
      value
      14
    4. group Id
      BG003
      value
      62
    units
    Participants
groups
  1. description
    Lenalidomide days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Phase I will determine the dose of lenalidomide to be used in Phase II. Group A=30-60 CrCl (mL/min): Each Cycle=28 days. Lenalidomide by mouth days 1-21 and Dexamethasone 40 mg by mouth days 1, 8, 15 and 22. There is a 7 day rest (days 22-28) from lenalidomide. Continue until disease progression or unacceptable toxicity. Phase I will determine the dose of lenalidomide to be used in Phase II.
    id
    BG000
    title
    Group A=30-60 CrCl (mL/Min)
  2. description
    Lenalidomide days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Phase I will determine the dose of lenalidomide to be used in Phase II. Group B=CrCL\<30 mL/min not on dialysis: Each Cycle=28 days. Lenalidomide by mouth days 1-21 and Dexamethasone 40 mg by mouth days 1, 8, 15 and 22. There is a 7 day rest (days 22-28) from lenalidomide. Continue until disease progression or unacceptable toxicity. Phase I will determine the dose of lenalidomide to be used in Phase II.
    id
    BG001
    title
    Group B=CrCL<30 mL/Min Not on Dialysis
  3. description
    Lenalidomide days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days. Phase I will determine the dose of lenalidomide to be used in Phase II. Group C=CrCL\<30 mL/min and on dialysis: Each Cycle=28 days. Lenalidomide by mouth days 1-21 and Dexamethasone 40 mg by mouth days 1, 8, 15 and 22. There is a 7 day rest (days 22-28) from lenalidomide. Continue until disease progression or unacceptable toxicity. Phase I will determine the dose of lenalidomide to be used in Phase II. Dialysis includes hemodialysis or peritoneal dialysis. When lenalidomide and/or dexamethasone treatment occurs on a dialysis day, lenalidomide and/or dexamethasone must be taken after dialysis.
    id
    BG002
    title
    Group C=CrCL<30 mL/Min and on Dialysis
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          68
          upper Limit
          78
          value
          73
        2. group Id
          BG001
          lower Limit
          62
          upper Limit
          79
          value
          72
        3. group Id
          BG002
          lower Limit
          57
          upper Limit
          70
          value
          64
        4. group Id
          BG003
          lower Limit
          64
          upper Limit
          77
          value
          71.5
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          31
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          31
        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
        4. group Id
          BG003
          value
          0
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          61
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        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
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          8
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          52
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        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
          37.0
          upper Limit
          51.2
          value
          42.6
        2. group Id
          BG001
          lower Limit
          15.7
          upper Limit
          25.4
          value
          22.8
        3. group Id
          BG002
          lower Limit
          9.7
          upper Limit
          17.2
          value
          11.5
        4. group Id
          BG003
          lower Limit
          15.7
          upper Limit
          42.1
          value
          27.4
    description
    Serum creatinine clearance, mL/minute
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    title
    Creatinine Clearance
    unit Of Measure
    mL/min
population Description
Eligible, treated patients

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Preserved source evidence · Not medical advice