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NCT00966693 · BASELINE

Baseline characteristics

Lenalidomide, Thalidomide and Dexamethasone in Treating Participants With Relapsed or Refractory Multiple Myeloma · Source last updated 2020-11-04

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
      3
    2. group Id
      BG001
      value
      3
    3. group Id
      BG002
      value
      9
    4. group Id
      BG003
      value
      49
    5. group Id
      BG004
      value
      64
    units
    Participants
groups
  1. description
    Oral Revlimid 15mg, Thalidomide 100mg, Dexamethasone 40mg\*21 days+ 7 days rest and reevaluation=28 day cycle
    id
    BG000
    title
    RTD (Cohort 1, Phase 1)
  2. description
    Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone \*21 days+ 7 days rest and reevaluation=28 day cycle
    id
    BG001
    title
    RTD (Cohort 2, Phase 1)
  3. description
    Oral Revlimid 25mg, Thalidomide 200mg, Dexamethasone 40mg\*21 days+ 7 days rest and reevaluation=28 day cycle
    id
    BG002
    title
    RTD (Cohort 3, Phase 1)
  4. description
    Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone \*21 days+ 7 days rest and reevaluation=28 day cycle
    id
    BG003
    title
    RTD (Cohort 2, Phase 2)
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. 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
        5. group Id
          BG004
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          26
        5. group Id
          BG004
          value
          29
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          23
        5. group Id
          BG004
          value
          35
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          19
        5. group Id
          BG004
          value
          23
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          30
        5. group Id
          BG004
          value
          41
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. calculate Pct
    false
    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
          3
        5. group Id
          BG004
          value
          3
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          46
        5. group Id
          BG004
          value
          61
        title
        Not Hispanic or Latino
      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
        5. group Id
          BG004
          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
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        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
          1
        5. group Id
          BG004
          value
          1
        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
        5. group Id
          BG004
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          10
        5. group Id
          BG004
          value
          18
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          38
        5. group Id
          BG004
          value
          45
        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
        5. group Id
          BG004
          value
          0
        title
        More than one race
      7. 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
        5. group Id
          BG004
          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
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          49
        5. group Id
          BG004
          value
          64
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  6. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          49
        5. group Id
          BG004
          value
          64
      title
      Age >= 18 years old
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          49
        5. group Id
          BG004
          value
          64
      title
      > = 1 line of previous therapy
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          44
        5. group Id
          BG004
          value
          55
      title
      Measurable levels of myeloma >=.5M serum-Protein
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          42
        5. group Id
          BG004
          value
          50
      title
      Measurable levels of myeloma >=.2 Urine-Protein
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          46
        5. group Id
          BG004
          value
          60
      title
      Abnormal Free Light Chain Ratio
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          49
        5. group Id
          BG004
          value
          64
      title
      Creatine < 2.5 mg/dL
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          47
        5. group Id
          BG004
          value
          62
      title
      Platelets > 50,000
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          49
        5. group Id
          BG004
          value
          64
      title
      Total Bilirubin < 2.0
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          49
        5. group Id
          BG004
          value
          64
      title
      AST or ALT < 3x Upper Limit
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          37
        5. group Id
          BG004
          value
          46
      title
      Anti-coagulant tolerance (PTT) normal
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          45
        5. group Id
          BG004
          value
          56
      title
      Cognitively Aware & Physically Able
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          19
        5. group Id
          BG004
          value
          32
      title
      No Pregnant/Breast Feeding Females
    description
    Measurable level of disease refractory to previous treatment, study medication tolerance, and able to comply w/ medication regime.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Relapsed/Refractory Multiple Myeloma
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      3
    2. group Id
      BG001
      value
      3
    3. group Id
      BG002
      value
      9
    4. group Id
      BG003
      value
      49
    5. group Id
      BG004
      value
      64
    units
    Participants
groups
  1. description
    Oral Revlimid 15mg, Thalidomide 100mg, Dexamethasone 40mg\*21 days+ 7 days rest and reevaluation=28 day cycle
    id
    BG000
    title
    RTD (Cohort 1, Phase 1)
  2. description
    Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone \*21 days+ 7 days rest and reevaluation=28 day cycle
    id
    BG001
    title
    RTD (Cohort 2, Phase 1)
  3. description
    Oral Revlimid 25mg, Thalidomide 200mg, Dexamethasone 40mg\*21 days+ 7 days rest and reevaluation=28 day cycle
    id
    BG002
    title
    RTD (Cohort 3, Phase 1)
  4. description
    Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone \*21 days+ 7 days rest and reevaluation=28 day cycle
    id
    BG003
    title
    RTD (Cohort 2, Phase 2)
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. 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
        5. group Id
          BG004
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          26
        5. group Id
          BG004
          value
          29
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          23
        5. group Id
          BG004
          value
          35
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          19
        5. group Id
          BG004
          value
          23
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          30
        5. group Id
          BG004
          value
          41
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. calculate Pct
    false
    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
          3
        5. group Id
          BG004
          value
          3
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          46
        5. group Id
          BG004
          value
          61
        title
        Not Hispanic or Latino
      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
        5. group Id
          BG004
          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
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        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
          1
        5. group Id
          BG004
          value
          1
        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
        5. group Id
          BG004
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          10
        5. group Id
          BG004
          value
          18
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          38
        5. group Id
          BG004
          value
          45
        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
        5. group Id
          BG004
          value
          0
        title
        More than one race
      7. 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
        5. group Id
          BG004
          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
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          49
        5. group Id
          BG004
          value
          64
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  6. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          49
        5. group Id
          BG004
          value
          64
      title
      Age >= 18 years old
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          49
        5. group Id
          BG004
          value
          64
      title
      > = 1 line of previous therapy
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          44
        5. group Id
          BG004
          value
          55
      title
      Measurable levels of myeloma >=.5M serum-Protein
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          42
        5. group Id
          BG004
          value
          50
      title
      Measurable levels of myeloma >=.2 Urine-Protein
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          46
        5. group Id
          BG004
          value
          60
      title
      Abnormal Free Light Chain Ratio
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          49
        5. group Id
          BG004
          value
          64
      title
      Creatine < 2.5 mg/dL
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          47
        5. group Id
          BG004
          value
          62
      title
      Platelets > 50,000
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          49
        5. group Id
          BG004
          value
          64
      title
      Total Bilirubin < 2.0
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          49
        5. group Id
          BG004
          value
          64
      title
      AST or ALT < 3x Upper Limit
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          37
        5. group Id
          BG004
          value
          46
      title
      Anti-coagulant tolerance (PTT) normal
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          45
        5. group Id
          BG004
          value
          56
      title
      Cognitively Aware & Physically Able
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          19
        5. group Id
          BG004
          value
          32
      title
      No Pregnant/Breast Feeding Females
    description
    Measurable level of disease refractory to previous treatment, study medication tolerance, and able to comply w/ medication regime.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Relapsed/Refractory Multiple Myeloma
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice