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NCT02509052 · BASELINE

Baseline characteristics

Leflunomide in Treating Patients With Relapsed or Refractory Multiple Myeloma · Source last updated 2023-10-10

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
      6
    4. group Id
      BG003
      value
      12
    units
    Participants
groups
  1. description
    Patients receive 20 mg leflunomide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    BG000
    title
    Arm 1: 20 mg Leflunomide
  2. description
    Patients receive 40 mg leflunomide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    BG001
    title
    Arm 2: 40 mg Leflunomide
  3. description
    Patients receive 60 mg leflunomide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    BG002
    title
    Arm 3: 60 mg Leflunomide
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          48
          upper Limit
          72
          value
          50
        2. group Id
          BG001
          lower Limit
          60
          upper Limit
          67
          value
          62
        3. group Id
          BG002
          lower Limit
          64
          upper Limit
          85
          value
          71
        4. group Id
          BG003
          lower Limit
          48
          upper Limit
          85
          value
          68
    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
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          6
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          6
        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
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        title
        Asian
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          4
        title
        Black
      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
        Hispanic or Latino
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          5
        title
        White, non-Hispanic
      title
      race/ethnicity
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          12
      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
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          3
        title
        Stage I
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        title
        Stage II
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        title
        Stage III
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        title
        Unknown/missing
    description
    The International Staging System (ISS) consists of the following stages: Stage I - serum beta-2 microglobulin less than 3.5 mg/L AND serum albumin greater than or equal to 3.5 g/dL :: Stage II - neither stage I nor III :: stage III - serum beta-2 microglobulin greater than or equal to 5.5 mg/L :: Higher grade predicts worse outcome. J Clin Oncol 23:3412-3420
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ISS staging at diagnosis
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          10
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
        title
        No
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior autologous transplant
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          4
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          8
        title
        No
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior radiation
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          11
        title
        Positive
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        title
        Negative
    description
    Serum protein electrophoresis refers to the separation of different types of proteins, according to the differences in the surface charge of serum proteins. Immunoglobulin (Ig) exhibits tetrapeptide chain structure, which can be divided into five categories: IgA, IgM, IgD, IgE, or IgG. Serum Ig can be used in diagnosis of MM. Immunofixation electrophoresis involves the dissociation of electrophoresis and the high specificity (antigen-antibody reaction) and high sensitivity of monoclonal immunoglobulin to detect monoclonal components in serum. J Coll Physicians Surg Pak 2021; 31(07):864-867
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Serum electrophoresis and immunofixation
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          5
        title
        IgG kappa
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        title
        IgG lambda
      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
        IgA lambda
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        title
        Serum unknown
      5. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        title
        IgA kappa
    description
    Serum protein electrophoresis refers to the separation of different types of proteins, according to the differences in the surface charge of serum proteins. Immunoglobulin (Ig) exhibits tetrapeptide chain structure, which can be divided into five categories: IgA, IgM, IgD, IgE, or IgG. Serum Ig can be used in diagnosis of MM. Immunofixation electrophoresis involves the dissociation of electrophoresis and the high specificity (antigen-antibody reaction) and high sensitivity of monoclonal immunoglobulin to detect monoclonal components in serum. J Coll Physicians Surg Pak 2021; 31(07):864-867
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    This is division of the Positive patients.
    title
    Type of positive serum electrophoresis and immunofixation patients
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          10
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
        title
        No
    description
    PI (proteasome inhibitor) refractory is disease that is non-responsive to therapy with bortezomib, or progressing within 60 days of cessation of the most recent bortezomib therapy in patients who have achieved minimal response (MR) or better.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    PI refractory
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          10
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        title
        No
    description
    IMiD (immunomodulatory drug) refractory is disease that is non-responsive to therapy with lenalidomid, or progressing within 60 days of cessation of the most recent lenalidomid therapy in patients who have achieved minimal response (MR) or better.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    IMiD refractory
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          8
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          4
        title
        No
    description
    Double refractory is disease that is non-responsive to therapy with either bortezomib or lenalidomide, or progressing within 60 days of cessation of the most recent therapy with either bortezomib or lenalidomide in patients who have achieved minimal response (MR) or better.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Double refractory (bortezomib/lenalidomide)
    unit Of Measure
    Participants
population Description
Because we obtained preclinical data indicating a synergistic effect between leflunomide and lenalidomide, we determined that investigating leflunomide-based combinational therapy was favorable over pursuing a phase 2 study of single-agent leflunomide. There were no dose de-escalations, so there were no patients accrued to the arms for 10mg, 30mg, or 50mg.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      3
    2. group Id
      BG001
      value
      3
    3. group Id
      BG002
      value
      6
    4. group Id
      BG003
      value
      12
    units
    Participants
groups
  1. description
    Patients receive 20 mg leflunomide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    BG000
    title
    Arm 1: 20 mg Leflunomide
  2. description
    Patients receive 40 mg leflunomide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    BG001
    title
    Arm 2: 40 mg Leflunomide
  3. description
    Patients receive 60 mg leflunomide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    BG002
    title
    Arm 3: 60 mg Leflunomide
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          48
          upper Limit
          72
          value
          50
        2. group Id
          BG001
          lower Limit
          60
          upper Limit
          67
          value
          62
        3. group Id
          BG002
          lower Limit
          64
          upper Limit
          85
          value
          71
        4. group Id
          BG003
          lower Limit
          48
          upper Limit
          85
          value
          68
    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
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          6
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          6
        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
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        title
        Asian
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          4
        title
        Black
      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
        Hispanic or Latino
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          5
        title
        White, non-Hispanic
      title
      race/ethnicity
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          12
      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
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          3
        title
        Stage I
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        title
        Stage II
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        title
        Stage III
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        title
        Unknown/missing
    description
    The International Staging System (ISS) consists of the following stages: Stage I - serum beta-2 microglobulin less than 3.5 mg/L AND serum albumin greater than or equal to 3.5 g/dL :: Stage II - neither stage I nor III :: stage III - serum beta-2 microglobulin greater than or equal to 5.5 mg/L :: Higher grade predicts worse outcome. J Clin Oncol 23:3412-3420
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ISS staging at diagnosis
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          10
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
        title
        No
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior autologous transplant
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          4
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          8
        title
        No
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior radiation
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          11
        title
        Positive
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        title
        Negative
    description
    Serum protein electrophoresis refers to the separation of different types of proteins, according to the differences in the surface charge of serum proteins. Immunoglobulin (Ig) exhibits tetrapeptide chain structure, which can be divided into five categories: IgA, IgM, IgD, IgE, or IgG. Serum Ig can be used in diagnosis of MM. Immunofixation electrophoresis involves the dissociation of electrophoresis and the high specificity (antigen-antibody reaction) and high sensitivity of monoclonal immunoglobulin to detect monoclonal components in serum. J Coll Physicians Surg Pak 2021; 31(07):864-867
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Serum electrophoresis and immunofixation
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          5
        title
        IgG kappa
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        title
        IgG lambda
      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
        IgA lambda
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        title
        Serum unknown
      5. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        title
        IgA kappa
    description
    Serum protein electrophoresis refers to the separation of different types of proteins, according to the differences in the surface charge of serum proteins. Immunoglobulin (Ig) exhibits tetrapeptide chain structure, which can be divided into five categories: IgA, IgM, IgD, IgE, or IgG. Serum Ig can be used in diagnosis of MM. Immunofixation electrophoresis involves the dissociation of electrophoresis and the high specificity (antigen-antibody reaction) and high sensitivity of monoclonal immunoglobulin to detect monoclonal components in serum. J Coll Physicians Surg Pak 2021; 31(07):864-867
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    This is division of the Positive patients.
    title
    Type of positive serum electrophoresis and immunofixation patients
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          10
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
        title
        No
    description
    PI (proteasome inhibitor) refractory is disease that is non-responsive to therapy with bortezomib, or progressing within 60 days of cessation of the most recent bortezomib therapy in patients who have achieved minimal response (MR) or better.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    PI refractory
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          10
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        title
        No
    description
    IMiD (immunomodulatory drug) refractory is disease that is non-responsive to therapy with lenalidomid, or progressing within 60 days of cessation of the most recent lenalidomid therapy in patients who have achieved minimal response (MR) or better.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    IMiD refractory
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          8
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          4
        title
        No
    description
    Double refractory is disease that is non-responsive to therapy with either bortezomib or lenalidomide, or progressing within 60 days of cessation of the most recent therapy with either bortezomib or lenalidomide in patients who have achieved minimal response (MR) or better.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Double refractory (bortezomib/lenalidomide)
    unit Of Measure
    Participants
population Description
Because we obtained preclinical data indicating a synergistic effect between leflunomide and lenalidomide, we determined that investigating leflunomide-based combinational therapy was favorable over pursuing a phase 2 study of single-agent leflunomide. There were no dose de-escalations, so there were no patients accrued to the arms for 10mg, 30mg, or 50mg.

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