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NCT03499808 · BASELINE

Baseline characteristics

S1702 Isatuximab in Treating Patients With Relapsed or Refractory Primary Amyloidosis · Source last updated 2025-09-09

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
      35
    units
    Participants
groups
  1. description
    Patients receive isatuximab IV on days 1, 8, 15, and 22 of course 1 and on days 1 and 15 of subsequent courses. Treatment repeats every 28 days for 24 courses in the absence of disease progression or unacceptable toxicity. Isatuximab: Given IV Laboratory Biomarker Analysis: Correlative studies
    id
    BG000
    title
    Treatment (Isatuximab)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          40.1
          upper Limit
          79.5
          value
          70
    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
          16
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          19
        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
          1
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          32
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          2
        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
          1
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          29
        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
          8
      title
      PS 0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          25
      title
      PS 1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      PS 2
    description
    PS 0 - Fully active, able to carry on all pre-disease performance without restriction PS 1 - Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work. PS 2- Ambulatory and capable of self-care but unable to carry out any work activities; up and about more than 50% of waking hours.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Performance Status
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        title
        Kappa
      2. measurements
        1. group Id
          BG000
          value
          23
        title
        Lambda
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        None
      4. measurements
        1. group Id
          BG000
          value
          1
        title
        Unknown
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Involved Light Chain
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          141
          upper Limit
          1689
          value
          700
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    IgG (mg/dL)
    unit Of Measure
    mg/dL
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        title
        Single Organ Involvement
      2. measurements
        1. group Id
          BG000
          value
          17
        title
        Multiple Organ involvement
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Organ Involvement
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        title
        Stage I
      2. measurements
        1. group Id
          BG000
          value
          8
        title
        Stage II
      3. measurements
        1. group Id
          BG000
          value
          8
        title
        Stage III
      4. measurements
        1. group Id
          BG000
          value
          1
        title
        Stage IV
      5. measurements
        1. group Id
          BG000
          value
          1
        title
        Unknown
      6. measurements
        1. group Id
          BG000
          value
          10
        title
        Not assessed - no cardiac involvement at baseline
    description
    Stage I: all below cutoff Stage II: 1 above Stage III: 2 above Stage IV: 3 above cTnT ≥0.025 ng/ml NT-proBNP ≥1,800 pg/ml FLC-diff ≥18 mg/dl
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Mayo Cardiac Biomarker Stage
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0
          upper Limit
          30
          value
          6
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Plasma Cells (%, Bone Marrow)
    unit Of Measure
    % of Bone Marrow
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          14
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          21
        title
        No
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Kidney Involvement
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          26
        title
        No
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Nervous System Involvement
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      35
    units
    Participants
groups
  1. description
    Patients receive isatuximab IV on days 1, 8, 15, and 22 of course 1 and on days 1 and 15 of subsequent courses. Treatment repeats every 28 days for 24 courses in the absence of disease progression or unacceptable toxicity. Isatuximab: Given IV Laboratory Biomarker Analysis: Correlative studies
    id
    BG000
    title
    Treatment (Isatuximab)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          40.1
          upper Limit
          79.5
          value
          70
    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
          16
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          19
        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
          1
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          32
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          2
        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
          1
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          29
        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
          8
      title
      PS 0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          25
      title
      PS 1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      PS 2
    description
    PS 0 - Fully active, able to carry on all pre-disease performance without restriction PS 1 - Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work. PS 2- Ambulatory and capable of self-care but unable to carry out any work activities; up and about more than 50% of waking hours.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Performance Status
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        title
        Kappa
      2. measurements
        1. group Id
          BG000
          value
          23
        title
        Lambda
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        None
      4. measurements
        1. group Id
          BG000
          value
          1
        title
        Unknown
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Involved Light Chain
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          141
          upper Limit
          1689
          value
          700
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    IgG (mg/dL)
    unit Of Measure
    mg/dL
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        title
        Single Organ Involvement
      2. measurements
        1. group Id
          BG000
          value
          17
        title
        Multiple Organ involvement
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Organ Involvement
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        title
        Stage I
      2. measurements
        1. group Id
          BG000
          value
          8
        title
        Stage II
      3. measurements
        1. group Id
          BG000
          value
          8
        title
        Stage III
      4. measurements
        1. group Id
          BG000
          value
          1
        title
        Stage IV
      5. measurements
        1. group Id
          BG000
          value
          1
        title
        Unknown
      6. measurements
        1. group Id
          BG000
          value
          10
        title
        Not assessed - no cardiac involvement at baseline
    description
    Stage I: all below cutoff Stage II: 1 above Stage III: 2 above Stage IV: 3 above cTnT ≥0.025 ng/ml NT-proBNP ≥1,800 pg/ml FLC-diff ≥18 mg/dl
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Mayo Cardiac Biomarker Stage
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0
          upper Limit
          30
          value
          6
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Plasma Cells (%, Bone Marrow)
    unit Of Measure
    % of Bone Marrow
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          14
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          21
        title
        No
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Kidney Involvement
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          26
        title
        No
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Nervous System Involvement
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice