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NCT00538733 · BASELINE

Baseline characteristics

Phase II Study of Thalidomide, Clarithromycin, Lenalidomide, and Dexamethasone for Newly Diagnosed Multiple Myeloma · Source last updated 2021-05-24

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
      26
    units
    Participants
groups
  1. description
    All patients that enrolled on the study and received treatment with T-BiRD are included in this analysis.
    id
    BG000
    title
    T-BiRD Therapy (All Patients)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          40
          upper Limit
          82
          value
          61
    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
          11
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          15
        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
          3
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          23
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          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
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          2
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          20
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          4
        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
          12
      title
      Stage 1A
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          9
      title
      Stage 2A
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      Stage 3A
    description
    The Durie Salmon Staging System was used to assess patients clinical status. Stage 1A is associated with a better outcome and a low tumor burden, stage 2A is associated with a intermediate outcome and tumor burden, and stage 3A is associated with a worse outcome and higher tumor burden. Patients are classified into each stage based on multiple criteria including hemoglobin and calcium values, disease burden, and renal function. The Durie Salmon Staging System can be found here: https://www.themmrf.org/multiple-myeloma/prognosis/myeloma-stages/durie-salmon-staging-system/
    param Type
    NUMBER
    title
    Durie-Salmon Classification
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          18
      title
      standard risk
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      high risk
    description
    Cytogenetic analysis was done on all patients to determine if they were of standard or high risk. Cytogenetics were performed on bone marrow cultures. Standard risk was defined by the presence of one or more of the following on : t(11;14); hyperdiploidy; del 13q14 detected using florescence in situ hybridization (FISH); no abnormality High risk was defined by the presence of one or more of the following: del 17p; karyotype del 13q; amp 1q/del 1p; t(14;20); t(14;16); t(4;14)
    param Type
    NUMBER
    title
    Cytogenetics
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      IgA myeloma
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          15
      title
      IgG myeloma
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      light chain only myeloma
    param Type
    NUMBER
    title
    Immunoglobulins
    unit Of Measure
    participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
      title
      90% (or better)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          12
      title
      80%
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      70%
    description
    Normal, no complaints = 100%; Able to carry on normal activities. Minor signs or symptoms of disease = 90%; Normal activity with effort = 80%; Care for self. Unable to carry on normal activity or to do active work = 70%; Requires occasional assistance, but able to care for most of his needs= 60% Requires considerable assistance \& frequent medical care = 50%; Disabled. Requires special care \& assistance = 40%; Severely disabled. Hospitalization indicated though death nonimminent = 30%; Very Sick, hospitalization necessary. Active supportive treatment necessary = 20%; moribund =10%; dead = 0%
    param Type
    NUMBER
    title
    karnofsky performance status
    unit Of Measure
    participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          9
      title
      Stage I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          13
      title
      Stage II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      Stage III
    description
    Stage I ß2-M \< 3.5 mg/dL and albumin =3.5 g/dL Stage II Neither stage I nor stage III Stage III ß2-M ≥ 5.5 mg/L
    param Type
    NUMBER
    title
    International Staging System Classification
    unit Of Measure
    participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          9.1
          upper Limit
          15.4
          value
          11.95
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Hemoglobin at baseline (in g/dL)
    unit Of Measure
    g/dL
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0.5
          upper Limit
          1.9
          value
          0.85
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    serum creatinine at baseline (in mg/dL)
    unit Of Measure
    mg/dL
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          87
          upper Limit
          383
          value
          241
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    platelet count at baseline (in 1000/uL)
    unit Of Measure
    1000/uL
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      26
    units
    Participants
groups
  1. description
    All patients that enrolled on the study and received treatment with T-BiRD are included in this analysis.
    id
    BG000
    title
    T-BiRD Therapy (All Patients)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          40
          upper Limit
          82
          value
          61
    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
          11
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          15
        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
          3
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          23
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          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
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          2
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          20
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          4
        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
          12
      title
      Stage 1A
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          9
      title
      Stage 2A
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      Stage 3A
    description
    The Durie Salmon Staging System was used to assess patients clinical status. Stage 1A is associated with a better outcome and a low tumor burden, stage 2A is associated with a intermediate outcome and tumor burden, and stage 3A is associated with a worse outcome and higher tumor burden. Patients are classified into each stage based on multiple criteria including hemoglobin and calcium values, disease burden, and renal function. The Durie Salmon Staging System can be found here: https://www.themmrf.org/multiple-myeloma/prognosis/myeloma-stages/durie-salmon-staging-system/
    param Type
    NUMBER
    title
    Durie-Salmon Classification
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          18
      title
      standard risk
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      high risk
    description
    Cytogenetic analysis was done on all patients to determine if they were of standard or high risk. Cytogenetics were performed on bone marrow cultures. Standard risk was defined by the presence of one or more of the following on : t(11;14); hyperdiploidy; del 13q14 detected using florescence in situ hybridization (FISH); no abnormality High risk was defined by the presence of one or more of the following: del 17p; karyotype del 13q; amp 1q/del 1p; t(14;20); t(14;16); t(4;14)
    param Type
    NUMBER
    title
    Cytogenetics
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      IgA myeloma
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          15
      title
      IgG myeloma
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      light chain only myeloma
    param Type
    NUMBER
    title
    Immunoglobulins
    unit Of Measure
    participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
      title
      90% (or better)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          12
      title
      80%
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      70%
    description
    Normal, no complaints = 100%; Able to carry on normal activities. Minor signs or symptoms of disease = 90%; Normal activity with effort = 80%; Care for self. Unable to carry on normal activity or to do active work = 70%; Requires occasional assistance, but able to care for most of his needs= 60% Requires considerable assistance \& frequent medical care = 50%; Disabled. Requires special care \& assistance = 40%; Severely disabled. Hospitalization indicated though death nonimminent = 30%; Very Sick, hospitalization necessary. Active supportive treatment necessary = 20%; moribund =10%; dead = 0%
    param Type
    NUMBER
    title
    karnofsky performance status
    unit Of Measure
    participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          9
      title
      Stage I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          13
      title
      Stage II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      Stage III
    description
    Stage I ß2-M \< 3.5 mg/dL and albumin =3.5 g/dL Stage II Neither stage I nor stage III Stage III ß2-M ≥ 5.5 mg/L
    param Type
    NUMBER
    title
    International Staging System Classification
    unit Of Measure
    participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          9.1
          upper Limit
          15.4
          value
          11.95
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Hemoglobin at baseline (in g/dL)
    unit Of Measure
    g/dL
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0.5
          upper Limit
          1.9
          value
          0.85
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    serum creatinine at baseline (in mg/dL)
    unit Of Measure
    mg/dL
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          87
          upper Limit
          383
          value
          241
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    platelet count at baseline (in 1000/uL)
    unit Of Measure
    1000/uL

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Preserved source evidence · Not medical advice