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NCT03506373 · BASELINE

Baseline characteristics

Ibrutinib and Ixazomib Citrate in Treating Newly Diagnosed, Relapsed or Refractory Waldenstrom Macroglobulinemia · Source last updated 2026-05-05

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
      21
    units
    Participants
groups
  1. description
    Patients receive ixazomib citrate PO on days 1, 8, and 15 and ibrutinib PO daily on days 1-28. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.\> \> Ibrutinib: Given PO\> \> Ixazomib Citrate: Given PO\> \> Laboratory Biomarker Analysis: Correlative studies\> \> Pharmacodynamic Study: Correlative studies\> \> Pharmacokinetic Study: Correlative studies
    id
    BG000
    title
    Treatment (Ixazomib Citrate, Ibrutinib)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.16
          value
          69
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        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
          0
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          20
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          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
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        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
          21
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          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
          21
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          9
      title
      1
    description
    0 Fully active, able to carry on all pre-disease performance without restriction\> 1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work\> 2. Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours\> 3. Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours\> 4. Completely disabled; cannot carry on any selfcare; totally confined to bed or chair\> 5. Dead
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG Performance Status
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      21
    units
    Participants
groups
  1. description
    Patients receive ixazomib citrate PO on days 1, 8, and 15 and ibrutinib PO daily on days 1-28. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.\> \> Ibrutinib: Given PO\> \> Ixazomib Citrate: Given PO\> \> Laboratory Biomarker Analysis: Correlative studies\> \> Pharmacodynamic Study: Correlative studies\> \> Pharmacokinetic Study: Correlative studies
    id
    BG000
    title
    Treatment (Ixazomib Citrate, Ibrutinib)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.16
          value
          69
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        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
          0
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          20
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          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
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        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
          21
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          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
          21
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          9
      title
      1
    description
    0 Fully active, able to carry on all pre-disease performance without restriction\> 1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work\> 2. Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours\> 3. Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours\> 4. Completely disabled; cannot carry on any selfcare; totally confined to bed or chair\> 5. Dead
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG Performance Status
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice