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NCT01864018 · BASELINE

Baseline characteristics

Ixazomib With Cyclophosphamide and Dexamethasone in Patients With Previously Untreated Symptomatic Multiple Myeloma or Light Chain Amyloidosis · Source last updated 2025-07-24

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
      48
    2. group Id
      BG001
      value
      35
    3. group Id
      BG002
      value
      83
    units
    Participants
groups
  1. description
    Patients with multiple myeloma\> \> INDUCTION THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\> \>\> \> \>\> MAINTENANCE THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\> \>\> \> \>\> Cyclophosphamide: Given PO\> \>\> \> \>\> Dexamethasone: Given PO\> \>\> \> \>\> Ixazomib Citrate: Given PO\> \>\> \> \>\> Laboratory Biomarker Analysis: Correlative studies\> \>\> \> \>\> Pharmacological Study: Correlative studies\> \>\> \> \>\> Quality-of-Life Assessment: Ancillary studies\> \>\> \> \>\> Questionnaire Administration: Ancillary studies
    id
    BG000
    title
    Phase I/II, Cohort A
  2. description
    Patients with biopsy proven light chain amyloidosis with organ involvement\> requiring therapy\> \> INDUCTION THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\> \>\> \> \>\> MAINTENANCE THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\> \>\> \> \>\> Cyclophosphamide: Given PO\> \>\> \> \>\> Dexamethasone: Given PO\> \>\> \> \>\> Ixazomib Citrate: Given PO\> \>\> \> \>\> Laboratory Biomarker Analysis: Correlative studies\> \>\> \> \>\> Pharmacological Study: Correlative studies\> \>\> \> \>\> Quality-of-Life Assessment: Ancillary studies\> \>\> \> \>\> Questionnaire Administration: Ancillary studies
    id
    BG001
    title
    Phase II, Cohort B
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          41
          upper Limit
          88
          value
          64.5
        2. group Id
          BG001
          lower Limit
          38
          upper Limit
          78
          value
          67
        3. group Id
          BG002
          lower Limit
          38
          upper Limit
          88
          value
          65
    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
          23
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          34
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          49
        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
          0
        3. group Id
          BG002
          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
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          46
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          81
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          48
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          83
      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
          25
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          41
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          36
      title
      1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          6
      title
      2
    description
    Grade 0 - Fully active, able to carry on all pre-disease performance without restriction\> Grade 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\> Grade 2 - Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG Performance Status
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      48
    2. group Id
      BG001
      value
      35
    3. group Id
      BG002
      value
      83
    units
    Participants
groups
  1. description
    Patients with multiple myeloma\> \> INDUCTION THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\> \>\> \> \>\> MAINTENANCE THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\> \>\> \> \>\> Cyclophosphamide: Given PO\> \>\> \> \>\> Dexamethasone: Given PO\> \>\> \> \>\> Ixazomib Citrate: Given PO\> \>\> \> \>\> Laboratory Biomarker Analysis: Correlative studies\> \>\> \> \>\> Pharmacological Study: Correlative studies\> \>\> \> \>\> Quality-of-Life Assessment: Ancillary studies\> \>\> \> \>\> Questionnaire Administration: Ancillary studies
    id
    BG000
    title
    Phase I/II, Cohort A
  2. description
    Patients with biopsy proven light chain amyloidosis with organ involvement\> requiring therapy\> \> INDUCTION THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.\> \>\> \> \>\> MAINTENANCE THERAPY: Patients receive ixazomib citrate PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\> \>\> \> \>\> Cyclophosphamide: Given PO\> \>\> \> \>\> Dexamethasone: Given PO\> \>\> \> \>\> Ixazomib Citrate: Given PO\> \>\> \> \>\> Laboratory Biomarker Analysis: Correlative studies\> \>\> \> \>\> Pharmacological Study: Correlative studies\> \>\> \> \>\> Quality-of-Life Assessment: Ancillary studies\> \>\> \> \>\> Questionnaire Administration: Ancillary studies
    id
    BG001
    title
    Phase II, Cohort B
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          41
          upper Limit
          88
          value
          64.5
        2. group Id
          BG001
          lower Limit
          38
          upper Limit
          78
          value
          67
        3. group Id
          BG002
          lower Limit
          38
          upper Limit
          88
          value
          65
    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
          23
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          34
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          49
        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
          0
        3. group Id
          BG002
          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
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          46
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          81
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          48
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          83
      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
          25
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          41
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          36
      title
      1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          6
      title
      2
    description
    Grade 0 - Fully active, able to carry on all pre-disease performance without restriction\> Grade 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\> Grade 2 - Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG Performance Status
    unit Of Measure
    Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice