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NCT01415882 · BASELINE

Baseline characteristics

Ixazomib Citrate in Treating Patients With Relapsed Multiple Myeloma That Is Not Refractory to Bortezomib · Source last updated 2026-06-23

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
      33
    2. group Id
      BG001
      value
      36
    3. group Id
      BG002
      value
      35
    4. group Id
      BG003
      value
      37
    5. group Id
      BG004
      value
      24
    6. group Id
      BG005
      value
      165
    units
    Participants
groups
  1. description
    Patients receive ixazomib citrate PO on days 1, 8, and 15. Patients with lack of minor response by the end of the second cycle or lack of partial response by the end of the fourth cycle also receive dexamethasone PO on days 1, 2, 8, 9, 15, and 16. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    BG000
    title
    Arm A (Ixazomib Citrate and Dexamethasone, Closed to Accrual)
  2. description
    Patients receive ixazomib citrate PO on days 1, 8, and 15 and dexamethasone PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    BG001
    title
    Arm B (Ixazomib Citrate and Dexamethasone)
  3. description
    Patients receive higher doses of ixazomib citrate PO on days 1, 8, and 15 and dexamethasone PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    BG002
    title
    Arm C (Higher-dose Ixazomib Citrate and Dexamethasone)
  4. description
    Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO (cycles 1-18 only) and dexamethasone PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    BG003
    title
    Arm D (Ixazomib Citrate, Dexamethasone, and Cyclophosphamide)
  5. description
    Patients receive ixazomib citrate PO on days 1, 8, and 15, cyclophosphamide PO (cycles 1-12 only) on days 1, 8, 15, 22, and daratumumab IV on days 1, 8, 15, 22 (cycles 1-2), days 1 and 15 (cycles 3-6), and day 1 in all subsequent cycles. Patients also receive dexamethasone IV or PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    BG004
    title
    Arm E (Ixazomib Citrate, Cyclophosphamide, Daratumumab)
  6. description
    Total of all reporting groups
    id
    BG005
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.4
          value
          66.3
        2. group Id
          BG001
          spread
          8.4
          value
          70.0
        3. group Id
          BG002
          spread
          7.9
          value
          67.8
        4. group Id
          BG003
          spread
          10.6
          value
          69.1
        5. group Id
          BG004
          spread
          8.7
          value
          68.1
        6. group Id
          BG005
          spread
          9.1
          value
          68.3
    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
          15
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          15
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          68
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          22
        4. group Id
          BG003
          value
          22
        5. group Id
          BG004
          value
          18
        6. group Id
          BG005
          value
          97
        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
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          6
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          32
        4. group Id
          BG003
          value
          36
        5. group Id
          BG004
          value
          24
        6. group Id
          BG005
          value
          156
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          3
        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
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          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
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        title
        Asian
      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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. 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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          33
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          35
        4. group Id
          BG003
          value
          36
        5. group Id
          BG004
          value
          24
        6. group Id
          BG005
          value
          164
        title
        White
      6. 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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        More than one race
      7. 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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      33
    2. group Id
      BG001
      value
      36
    3. group Id
      BG002
      value
      35
    4. group Id
      BG003
      value
      37
    5. group Id
      BG004
      value
      24
    6. group Id
      BG005
      value
      165
    units
    Participants
groups
  1. description
    Patients receive ixazomib citrate PO on days 1, 8, and 15. Patients with lack of minor response by the end of the second cycle or lack of partial response by the end of the fourth cycle also receive dexamethasone PO on days 1, 2, 8, 9, 15, and 16. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    BG000
    title
    Arm A (Ixazomib Citrate and Dexamethasone, Closed to Accrual)
  2. description
    Patients receive ixazomib citrate PO on days 1, 8, and 15 and dexamethasone PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    BG001
    title
    Arm B (Ixazomib Citrate and Dexamethasone)
  3. description
    Patients receive higher doses of ixazomib citrate PO on days 1, 8, and 15 and dexamethasone PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    BG002
    title
    Arm C (Higher-dose Ixazomib Citrate and Dexamethasone)
  4. description
    Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO (cycles 1-18 only) and dexamethasone PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    BG003
    title
    Arm D (Ixazomib Citrate, Dexamethasone, and Cyclophosphamide)
  5. description
    Patients receive ixazomib citrate PO on days 1, 8, and 15, cyclophosphamide PO (cycles 1-12 only) on days 1, 8, 15, 22, and daratumumab IV on days 1, 8, 15, 22 (cycles 1-2), days 1 and 15 (cycles 3-6), and day 1 in all subsequent cycles. Patients also receive dexamethasone IV or PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    BG004
    title
    Arm E (Ixazomib Citrate, Cyclophosphamide, Daratumumab)
  6. description
    Total of all reporting groups
    id
    BG005
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.4
          value
          66.3
        2. group Id
          BG001
          spread
          8.4
          value
          70.0
        3. group Id
          BG002
          spread
          7.9
          value
          67.8
        4. group Id
          BG003
          spread
          10.6
          value
          69.1
        5. group Id
          BG004
          spread
          8.7
          value
          68.1
        6. group Id
          BG005
          spread
          9.1
          value
          68.3
    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
          15
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          15
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          68
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          22
        4. group Id
          BG003
          value
          22
        5. group Id
          BG004
          value
          18
        6. group Id
          BG005
          value
          97
        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
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          6
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          32
        4. group Id
          BG003
          value
          36
        5. group Id
          BG004
          value
          24
        6. group Id
          BG005
          value
          156
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          3
        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
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          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
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        title
        Asian
      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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. 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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          33
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          35
        4. group Id
          BG003
          value
          36
        5. group Id
          BG004
          value
          24
        6. group Id
          BG005
          value
          164
        title
        White
      6. 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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        More than one race
      7. 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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants

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

Preserved source evidence · Not medical advice