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NCT00932698 · BASELINE

Baseline characteristics

Study of Oral Ixazomib in Adult Participants With Relapsed and/or Refractory (RR) Multiple Myeloma · Source last updated 2019-08-07

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
      3
    4. group Id
      BG003
      value
      3
    5. group Id
      BG004
      value
      3
    6. group Id
      BG005
      value
      1
    7. group Id
      BG006
      value
      4
    8. group Id
      BG007
      value
      20
    9. group Id
      BG008
      value
      12
    10. group Id
      BG009
      value
      6
    11. group Id
      BG010
      value
      2
    12. group Id
      BG011
      value
      60
    units
    Participants
groups
  1. description
    Ixazomib 0.24 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 220 days).
    id
    BG000
    title
    Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2
  2. description
    Ixazomib 0.48 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 270 days).
    id
    BG001
    title
    Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2
  3. description
    Ixazomib 0.8 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 137 days).
    id
    BG002
    title
    Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2
  4. description
    Ixazomib 1.2 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 1436 days).
    id
    BG003
    title
    Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2
  5. description
    Ixazomib 1.68 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 456 days).
    id
    BG004
    title
    Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2
  6. description
    Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 1621 days).
    id
    BG005
    title
    Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2
  7. description
    Ixazomib 2.23 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 2434 days).
    id
    BG006
    title
    Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2
  8. description
    Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months, Participants must also be refractory to their most recent therapy as evidenced by PD while on therapy or within 60 days after their last dose of therapy (Up to 1621 days).
    id
    BG007
    title
    Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^2
  9. description
    Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months. Participants with relapsed or refractory disease after \>=1 prior therapy but have relapsed after previous Velcade exposure and were not treated with any other proteasome inhibitors (Up to 1573 days).
    id
    BG008
    title
    Velcade-Relapsed (VR) Expansion Cohort: Ixazomib 2.0 mg/m^2
  10. description
    Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months. Participants with relapsed or refractory disease after \>=1 prior therapy which must include thalidomide (or lenalidomide) and corticosteroid, but who never received a proteasome inhibitor (Up to 550 days).
    id
    BG009
    title
    Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^2
  11. description
    Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months. Participants who previously received carfilzomib and had relapsed or refractory disease (Up to 123 days).
    id
    BG010
    title
    Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^2
  12. description
    Total of all reporting groups
    id
    BG011
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.02
          value
          65.3
        2. group Id
          BG001
          spread
          6.81
          value
          61.3
        3. group Id
          BG002
          spread
          12.10
          value
          69.3
        4. group Id
          BG003
          spread
          7.00
          value
          66.0
        5. group Id
          BG004
          spread
          9.85
          value
          64.0
        6. comment
          Standard deviation is not estimable for 1 participant.
          group Id
          BG005
          spread
          NA
          value
          78
        7. group Id
          BG006
          spread
          7.50
          value
          64.3
        8. group Id
          BG007
          spread
          9.58
          value
          64.4
        9. group Id
          BG008
          spread
          8.02
          value
          65.4
        10. group Id
          BG009
          spread
          6.84
          value
          64.0
        11. group Id
          BG010
          spread
          3.54
          value
          71.5
        12. group Id
          BG011
          spread
          8.25
          value
          65.2
      denoms
      1. counts
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          20
        9. group Id
          BG008
          value
          12
        10. group Id
          BG009
          value
          6
        11. group Id
          BG010
          value
          2
        12. group Id
          BG011
          value
          60
        units
        Participants
    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
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          12
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          1
        11. group Id
          BG010
          value
          2
        12. group Id
          BG011
          value
          28
        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
          2
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          8
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          5
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          32
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          20
        9. group Id
          BG008
          value
          12
        10. group Id
          BG009
          value
          6
        11. group Id
          BG010
          value
          2
        12. group Id
          BG011
          value
          60
        units
        Participants
    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
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          3
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          4
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          20
        9. group Id
          BG008
          value
          9
        10. group Id
          BG009
          value
          6
        11. group Id
          BG010
          value
          2
        12. group Id
          BG011
          value
          55
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          1
        title
        Missing
      denoms
      1. counts
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          20
        9. group Id
          BG008
          value
          12
        10. group Id
          BG009
          value
          6
        11. group Id
          BG010
          value
          2
        12. group Id
          BG011
          value
          60
        units
        Participants
    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
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          18
        9. group Id
          BG008
          value
          12
        10. group Id
          BG009
          value
          6
        11. group Id
          BG010
          value
          2
        12. group Id
          BG011
          value
          54
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          5
        title
        Black or African American
      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
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          1
        title
        Other
      denoms
      1. counts
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          20
        9. group Id
          BG008
          value
          12
        10. group Id
          BG009
          value
          6
        11. group Id
          BG010
          value
          2
        12. group Id
          BG011
          value
          60
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          20
        9. group Id
          BG008
          value
          12
        10. group Id
          BG009
          value
          6
        11. group Id
          BG010
          value
          2
        12. group Id
          BG011
          value
          60
      denoms
      1. counts
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          20
        9. group Id
          BG008
          value
          12
        10. group Id
          BG009
          value
          6
        11. group Id
          BG010
          value
          2
        12. group Id
          BG011
          value
          60
        units
        Participants
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.63
          value
          173.1
        2. group Id
          BG001
          spread
          7.60
          value
          167.5
        3. group Id
          BG002
          spread
          4.54
          value
          167.4
        4. group Id
          BG003
          spread
          14.25
          value
          180.1
        5. group Id
          BG004
          spread
          7.90
          value
          165.4
        6. comment
          Standard deviation is not estimable for 1 participant.
          group Id
          BG005
          spread
          NA
          value
          178
        7. group Id
          BG006
          spread
          12.18
          value
          169.7
        8. group Id
          BG007
          spread
          11.28
          value
          165.8
        9. group Id
          BG008
          spread
          13.26
          value
          165.7
        10. group Id
          BG009
          spread
          9.16
          value
          169.3
        11. group Id
          BG010
          spread
          6.08
          value
          156.7
        12. group Id
          BG011
          spread
          11.07
          value
          167.5
      denoms
      1. counts
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          20
        9. group Id
          BG008
          value
          12
        10. group Id
          BG009
          value
          5
        11. group Id
          BG010
          value
          2
        12. group Id
          BG011
          value
          59
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Here, number analyzed are the participants who were evaluated for this baseline measure.
    title
    Height
    unit Of Measure
    centimeter (cm)
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.560
          value
          87.50
        2. group Id
          BG001
          spread
          5.937
          value
          71.03
        3. group Id
          BG002
          spread
          5.036
          value
          74.87
        4. group Id
          BG003
          spread
          12.760
          value
          109.90
        5. group Id
          BG004
          spread
          2.542
          value
          80.77
        6. comment
          Standard deviation is not estimable for 1 participant.
          group Id
          BG005
          spread
          NA
          value
          82.3
        7. group Id
          BG006
          spread
          21.532
          value
          82.98
        8. group Id
          BG007
          spread
          23.760
          value
          77.81
        9. group Id
          BG008
          spread
          15.579
          value
          72.60
        10. group Id
          BG009
          spread
          16.811
          value
          93.20
        11. group Id
          BG010
          spread
          36.770
          value
          71.70
        12. group Id
          BG011
          spread
          19.946
          value
          80.27
      denoms
      1. counts
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          20
        9. group Id
          BG008
          value
          12
        10. group Id
          BG009
          value
          6
        11. group Id
          BG010
          value
          2
        12. group Id
          BG011
          value
          60
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Weight
    unit Of Measure
    kilogram (kg)
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.192
          value
          2.05
        2. group Id
          BG001
          spread
          0.100
          value
          1.82
        3. group Id
          BG002
          spread
          0.062
          value
          1.86
        4. group Id
          BG003
          spread
          0.229
          value
          2.34
        5. group Id
          BG004
          spread
          0.071
          value
          1.93
        6. comment
          Standard deviation is not estimable for 1 participant.
          group Id
          BG005
          spread
          NA
          value
          2.02
        7. group Id
          BG006
          spread
          0.335
          value
          1.97
        8. group Id
          BG007
          spread
          0.342
          value
          1.88
        9. group Id
          BG008
          spread
          0.237
          value
          1.82
        10. group Id
          BG009
          spread
          0.265
          value
          2.09
        11. group Id
          BG010
          spread
          0.495
          value
          1.74
        12. group Id
          BG011
          spread
          0.291
          value
          1.92
      denoms
      1. counts
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          20
        9. group Id
          BG008
          value
          12
        10. group Id
          BG009
          value
          5
        11. group Id
          BG010
          value
          2
        12. group Id
          BG011
          value
          59
        units
        Participants
    description
    Body Surface Area (m\^2)=\[Height(cm) \* Weight (kg)\]/3600)\^1/2.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Here, number analyzed are the participants who were evaluated for this baseline measure.
    title
    Body Surface Area
    unit Of Measure
    meter square
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          55
          upper Limit
          291
          value
          59.1
        2. group Id
          BG001
          lower Limit
          57
          upper Limit
          94
          value
          61.8
        3. group Id
          BG002
          lower Limit
          34
          upper Limit
          152
          value
          45.8
        4. group Id
          BG003
          lower Limit
          46
          upper Limit
          88
          value
          80.4
        5. group Id
          BG004
          lower Limit
          13
          upper Limit
          58
          value
          38.4
        6. group Id
          BG005
          lower Limit
          44.62
          upper Limit
          44.62
          value
          44.62
        7. group Id
          BG006
          lower Limit
          21
          upper Limit
          85
          value
          35.2
        8. group Id
          BG007
          lower Limit
          19
          upper Limit
          124
          value
          56.9
        9. group Id
          BG008
          lower Limit
          12
          upper Limit
          151
          value
          42.7
        10. group Id
          BG009
          lower Limit
          61
          upper Limit
          97
          value
          71.9
        11. group Id
          BG010
          lower Limit
          46
          upper Limit
          106
          value
          76.1
        12. group Id
          BG011
          lower Limit
          12
          upper Limit
          291
          value
          57.4
      denoms
      1. counts
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          20
        9. group Id
          BG008
          value
          12
        10. group Id
          BG009
          value
          6
        11. group Id
          BG010
          value
          2
        12. group Id
          BG011
          value
          60
        units
        Participants
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Time Since Primary Diagnosis to First Dose
    unit Of Measure
    months
population Description
Safety population included all participants who received at least 1 dose of ixazomib. A total of 60 participants participated in the study. There were 7 participants in Dose Escalation Cohort 6: Ixazomib 2.0 mg/m\^2 arm group, 6 out of 7 participated in both phases of the study and were counted once in the expansion cohort.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      3
    2. group Id
      BG001
      value
      3
    3. group Id
      BG002
      value
      3
    4. group Id
      BG003
      value
      3
    5. group Id
      BG004
      value
      3
    6. group Id
      BG005
      value
      1
    7. group Id
      BG006
      value
      4
    8. group Id
      BG007
      value
      20
    9. group Id
      BG008
      value
      12
    10. group Id
      BG009
      value
      6
    11. group Id
      BG010
      value
      2
    12. group Id
      BG011
      value
      60
    units
    Participants
groups
  1. description
    Ixazomib 0.24 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 220 days).
    id
    BG000
    title
    Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2
  2. description
    Ixazomib 0.48 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 270 days).
    id
    BG001
    title
    Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2
  3. description
    Ixazomib 0.8 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 137 days).
    id
    BG002
    title
    Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2
  4. description
    Ixazomib 1.2 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 1436 days).
    id
    BG003
    title
    Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2
  5. description
    Ixazomib 1.68 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 456 days).
    id
    BG004
    title
    Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2
  6. description
    Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 1621 days).
    id
    BG005
    title
    Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2
  7. description
    Ixazomib 2.23 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months (Up to 2434 days).
    id
    BG006
    title
    Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2
  8. description
    Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months, Participants must also be refractory to their most recent therapy as evidenced by PD while on therapy or within 60 days after their last dose of therapy (Up to 1621 days).
    id
    BG007
    title
    Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^2
  9. description
    Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months. Participants with relapsed or refractory disease after \>=1 prior therapy but have relapsed after previous Velcade exposure and were not treated with any other proteasome inhibitors (Up to 1573 days).
    id
    BG008
    title
    Velcade-Relapsed (VR) Expansion Cohort: Ixazomib 2.0 mg/m^2
  10. description
    Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months. Participants with relapsed or refractory disease after \>=1 prior therapy which must include thalidomide (or lenalidomide) and corticosteroid, but who never received a proteasome inhibitor (Up to 550 days).
    id
    BG009
    title
    Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^2
  11. description
    Ixazomib 2.0 mg/m\^2, capsule, orally, on Days 1, 4, 8 and 11 during a 21-day treatment cycle until progressive disease (PD) or unacceptable toxicity up to 12 months unless the investigator and sponsor determined the participant would benefit from therapy beyond 12 months. Participants who previously received carfilzomib and had relapsed or refractory disease (Up to 123 days).
    id
    BG010
    title
    Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^2
  12. description
    Total of all reporting groups
    id
    BG011
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.02
          value
          65.3
        2. group Id
          BG001
          spread
          6.81
          value
          61.3
        3. group Id
          BG002
          spread
          12.10
          value
          69.3
        4. group Id
          BG003
          spread
          7.00
          value
          66.0
        5. group Id
          BG004
          spread
          9.85
          value
          64.0
        6. comment
          Standard deviation is not estimable for 1 participant.
          group Id
          BG005
          spread
          NA
          value
          78
        7. group Id
          BG006
          spread
          7.50
          value
          64.3
        8. group Id
          BG007
          spread
          9.58
          value
          64.4
        9. group Id
          BG008
          spread
          8.02
          value
          65.4
        10. group Id
          BG009
          spread
          6.84
          value
          64.0
        11. group Id
          BG010
          spread
          3.54
          value
          71.5
        12. group Id
          BG011
          spread
          8.25
          value
          65.2
      denoms
      1. counts
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          20
        9. group Id
          BG008
          value
          12
        10. group Id
          BG009
          value
          6
        11. group Id
          BG010
          value
          2
        12. group Id
          BG011
          value
          60
        units
        Participants
    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
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          12
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          1
        11. group Id
          BG010
          value
          2
        12. group Id
          BG011
          value
          28
        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
          2
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          8
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          5
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          32
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          20
        9. group Id
          BG008
          value
          12
        10. group Id
          BG009
          value
          6
        11. group Id
          BG010
          value
          2
        12. group Id
          BG011
          value
          60
        units
        Participants
    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
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          3
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          4
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          20
        9. group Id
          BG008
          value
          9
        10. group Id
          BG009
          value
          6
        11. group Id
          BG010
          value
          2
        12. group Id
          BG011
          value
          55
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          1
        title
        Missing
      denoms
      1. counts
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          20
        9. group Id
          BG008
          value
          12
        10. group Id
          BG009
          value
          6
        11. group Id
          BG010
          value
          2
        12. group Id
          BG011
          value
          60
        units
        Participants
    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
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          18
        9. group Id
          BG008
          value
          12
        10. group Id
          BG009
          value
          6
        11. group Id
          BG010
          value
          2
        12. group Id
          BG011
          value
          54
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          5
        title
        Black or African American
      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
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          1
        title
        Other
      denoms
      1. counts
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          20
        9. group Id
          BG008
          value
          12
        10. group Id
          BG009
          value
          6
        11. group Id
          BG010
          value
          2
        12. group Id
          BG011
          value
          60
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          20
        9. group Id
          BG008
          value
          12
        10. group Id
          BG009
          value
          6
        11. group Id
          BG010
          value
          2
        12. group Id
          BG011
          value
          60
      denoms
      1. counts
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          20
        9. group Id
          BG008
          value
          12
        10. group Id
          BG009
          value
          6
        11. group Id
          BG010
          value
          2
        12. group Id
          BG011
          value
          60
        units
        Participants
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.63
          value
          173.1
        2. group Id
          BG001
          spread
          7.60
          value
          167.5
        3. group Id
          BG002
          spread
          4.54
          value
          167.4
        4. group Id
          BG003
          spread
          14.25
          value
          180.1
        5. group Id
          BG004
          spread
          7.90
          value
          165.4
        6. comment
          Standard deviation is not estimable for 1 participant.
          group Id
          BG005
          spread
          NA
          value
          178
        7. group Id
          BG006
          spread
          12.18
          value
          169.7
        8. group Id
          BG007
          spread
          11.28
          value
          165.8
        9. group Id
          BG008
          spread
          13.26
          value
          165.7
        10. group Id
          BG009
          spread
          9.16
          value
          169.3
        11. group Id
          BG010
          spread
          6.08
          value
          156.7
        12. group Id
          BG011
          spread
          11.07
          value
          167.5
      denoms
      1. counts
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          20
        9. group Id
          BG008
          value
          12
        10. group Id
          BG009
          value
          5
        11. group Id
          BG010
          value
          2
        12. group Id
          BG011
          value
          59
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Here, number analyzed are the participants who were evaluated for this baseline measure.
    title
    Height
    unit Of Measure
    centimeter (cm)
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.560
          value
          87.50
        2. group Id
          BG001
          spread
          5.937
          value
          71.03
        3. group Id
          BG002
          spread
          5.036
          value
          74.87
        4. group Id
          BG003
          spread
          12.760
          value
          109.90
        5. group Id
          BG004
          spread
          2.542
          value
          80.77
        6. comment
          Standard deviation is not estimable for 1 participant.
          group Id
          BG005
          spread
          NA
          value
          82.3
        7. group Id
          BG006
          spread
          21.532
          value
          82.98
        8. group Id
          BG007
          spread
          23.760
          value
          77.81
        9. group Id
          BG008
          spread
          15.579
          value
          72.60
        10. group Id
          BG009
          spread
          16.811
          value
          93.20
        11. group Id
          BG010
          spread
          36.770
          value
          71.70
        12. group Id
          BG011
          spread
          19.946
          value
          80.27
      denoms
      1. counts
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          20
        9. group Id
          BG008
          value
          12
        10. group Id
          BG009
          value
          6
        11. group Id
          BG010
          value
          2
        12. group Id
          BG011
          value
          60
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Weight
    unit Of Measure
    kilogram (kg)
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.192
          value
          2.05
        2. group Id
          BG001
          spread
          0.100
          value
          1.82
        3. group Id
          BG002
          spread
          0.062
          value
          1.86
        4. group Id
          BG003
          spread
          0.229
          value
          2.34
        5. group Id
          BG004
          spread
          0.071
          value
          1.93
        6. comment
          Standard deviation is not estimable for 1 participant.
          group Id
          BG005
          spread
          NA
          value
          2.02
        7. group Id
          BG006
          spread
          0.335
          value
          1.97
        8. group Id
          BG007
          spread
          0.342
          value
          1.88
        9. group Id
          BG008
          spread
          0.237
          value
          1.82
        10. group Id
          BG009
          spread
          0.265
          value
          2.09
        11. group Id
          BG010
          spread
          0.495
          value
          1.74
        12. group Id
          BG011
          spread
          0.291
          value
          1.92
      denoms
      1. counts
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          20
        9. group Id
          BG008
          value
          12
        10. group Id
          BG009
          value
          5
        11. group Id
          BG010
          value
          2
        12. group Id
          BG011
          value
          59
        units
        Participants
    description
    Body Surface Area (m\^2)=\[Height(cm) \* Weight (kg)\]/3600)\^1/2.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Here, number analyzed are the participants who were evaluated for this baseline measure.
    title
    Body Surface Area
    unit Of Measure
    meter square
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          55
          upper Limit
          291
          value
          59.1
        2. group Id
          BG001
          lower Limit
          57
          upper Limit
          94
          value
          61.8
        3. group Id
          BG002
          lower Limit
          34
          upper Limit
          152
          value
          45.8
        4. group Id
          BG003
          lower Limit
          46
          upper Limit
          88
          value
          80.4
        5. group Id
          BG004
          lower Limit
          13
          upper Limit
          58
          value
          38.4
        6. group Id
          BG005
          lower Limit
          44.62
          upper Limit
          44.62
          value
          44.62
        7. group Id
          BG006
          lower Limit
          21
          upper Limit
          85
          value
          35.2
        8. group Id
          BG007
          lower Limit
          19
          upper Limit
          124
          value
          56.9
        9. group Id
          BG008
          lower Limit
          12
          upper Limit
          151
          value
          42.7
        10. group Id
          BG009
          lower Limit
          61
          upper Limit
          97
          value
          71.9
        11. group Id
          BG010
          lower Limit
          46
          upper Limit
          106
          value
          76.1
        12. group Id
          BG011
          lower Limit
          12
          upper Limit
          291
          value
          57.4
      denoms
      1. counts
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          20
        9. group Id
          BG008
          value
          12
        10. group Id
          BG009
          value
          6
        11. group Id
          BG010
          value
          2
        12. group Id
          BG011
          value
          60
        units
        Participants
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Time Since Primary Diagnosis to First Dose
    unit Of Measure
    months
population Description
Safety population included all participants who received at least 1 dose of ixazomib. A total of 60 participants participated in the study. There were 7 participants in Dose Escalation Cohort 6: Ixazomib 2.0 mg/m\^2 arm group, 6 out of 7 participated in both phases of the study and were counted once in the expansion cohort.

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