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NCT02939183 · BASELINE

Baseline characteristics

Phase 1b Study Evaluating OPomD in Relapsed or Refractory Multiple Myeloma · Source last updated 2024-09-26

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
      5
    2. group Id
      BG001
      value
      8
    3. group Id
      BG002
      value
      4
    4. group Id
      BG003
      value
      4
    5. group Id
      BG004
      value
      8
    6. group Id
      BG005
      value
      5
    7. group Id
      BG006
      value
      10
    8. group Id
      BG007
      value
      8
    9. group Id
      BG008
      value
      7
    10. group Id
      BG009
      value
      59
    units
    Participants
groups
  1. description
    In Part 1, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.
    id
    BG000
    title
    Oprozomib IR 150 mg/Day + Dexamethsone
  2. description
    In Part 1, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.
    id
    BG001
    title
    Oprozomib GR 150 mg/Day + Dexamethasone
  3. description
    In Part 2, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
    id
    BG002
    title
    Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone
  4. description
    In Part 2, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
    id
    BG003
    title
    Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone
  5. description
    In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
    id
    BG004
    title
    Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone
  6. description
    In Part 2, participants received oprozomib GR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib GR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
    id
    BG005
    title
    Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone
  7. description
    In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 225 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
    id
    BG006
    title
    Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone
  8. description
    In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 250 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
    id
    BG007
    title
    Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone
  9. description
    Eligible participants who had enrolled on separate Amgen oprozomib studies (2011-001 \[NCT01416428\], 2012-001 \[NCT01832727\], OPZ003 \[NCT01881789\], OPZ007 \[NCT01999335\], and OPZ009 \[NCT02244112\]) and were receiving oprozomib as monotherapy, or a combination of oprozomib with dexamethasone, continued treatment in research centers within the United States only. Participants continued receiving the previous dose/schedule of oprozomib GR formulation until disease progression, death, or unacceptable toxicity.
    id
    BG008
    title
    Open-label Roll-over
  10. description
    Total of all reporting groups
    id
    BG009
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          17.2
          value
          69.0
        2. group Id
          BG001
          spread
          8.1
          value
          59.6
        3. group Id
          BG002
          spread
          8.7
          value
          62.5
        4. group Id
          BG003
          spread
          5.9
          value
          63.5
        5. group Id
          BG004
          spread
          9.8
          value
          64.3
        6. group Id
          BG005
          spread
          8.2
          value
          62.0
        7. group Id
          BG006
          spread
          10.2
          value
          63.1
        8. group Id
          BG007
          spread
          10.5
          value
          65.9
        9. group Id
          BG008
          spread
          8.7
          value
          70.4
        10. group Id
          BG009
          spread
          9.9
          value
          63.6
    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
          4
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          19
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          7
        8. group Id
          BG007
          value
          7
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          40
        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
        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
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          7
        8. group Id
          BG007
          value
          8
        9. group Id
          BG008
          value
          7
        10. group Id
          BG009
          value
          56
        title
        Not Hispanic or Latino
      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
          3
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          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
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          10
        title
        Black (or African American)
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          7
        8. group Id
          BG007
          value
          7
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          46
        title
        White
      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
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          3
        title
        Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
The safety analysis set included all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone. One participant in arm Oprozomib IR 200 mg/day + pomalidomide + dexamethasone received oprozomib IR 150 mg + pomalidomide + dexamethasone, and their baseline characteristics data were included in the Oprozomib IR 150 mg + pomalidomide + dexamethasone arm. Participants enrolled from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      5
    2. group Id
      BG001
      value
      8
    3. group Id
      BG002
      value
      4
    4. group Id
      BG003
      value
      4
    5. group Id
      BG004
      value
      8
    6. group Id
      BG005
      value
      5
    7. group Id
      BG006
      value
      10
    8. group Id
      BG007
      value
      8
    9. group Id
      BG008
      value
      7
    10. group Id
      BG009
      value
      59
    units
    Participants
groups
  1. description
    In Part 1, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.
    id
    BG000
    title
    Oprozomib IR 150 mg/Day + Dexamethsone
  2. description
    In Part 1, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months.
    id
    BG001
    title
    Oprozomib GR 150 mg/Day + Dexamethasone
  3. description
    In Part 2, participants received oprozomib IR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
    id
    BG002
    title
    Oprozomib IR 150 mg/Day + Pomalidomide + Dexamethasone
  4. description
    In Part 2, participants received oprozomib GR 150 mg/day administered orally every week on 2 consecutive days (2/7 schedule) in combination with dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), for up to 10 months. Participants also received pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
    id
    BG003
    title
    Oprozomib GR 150 mg/Day + Pomalidomide + Dexamethasone
  5. description
    In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
    id
    BG004
    title
    Oprozomib IR 200 mg/Day + Pomalidomide + Dexamethasone
  6. description
    In Part 2, participants received oprozomib GR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib GR 200 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
    id
    BG005
    title
    Oprozomib GR 200 mg/Day + Pomalidomide + Dexamethasone
  7. description
    In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 225 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
    id
    BG006
    title
    Oprozomib IR 225 mg/Day + Pomalidomide + Dexamethasone
  8. description
    In Part 2, participants received oprozomib IR 150 mg/day on days 1 and 2 of cycle 1, and oprozomib IR 250 mg/day administered orally every week on 2 consecutive days from cycle 1 day 8 onwards (2/7 schedule), for up to 10 months. Participants also received dexamethasone 20 mg orally (days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle), and pomalidomide 4 mg orally once daily on days 1 to 21 of each 28-day cycle.
    id
    BG007
    title
    Oprozomib IR 250 mg/Day + Pomalidomide + Dexamethasone
  9. description
    Eligible participants who had enrolled on separate Amgen oprozomib studies (2011-001 \[NCT01416428\], 2012-001 \[NCT01832727\], OPZ003 \[NCT01881789\], OPZ007 \[NCT01999335\], and OPZ009 \[NCT02244112\]) and were receiving oprozomib as monotherapy, or a combination of oprozomib with dexamethasone, continued treatment in research centers within the United States only. Participants continued receiving the previous dose/schedule of oprozomib GR formulation until disease progression, death, or unacceptable toxicity.
    id
    BG008
    title
    Open-label Roll-over
  10. description
    Total of all reporting groups
    id
    BG009
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          17.2
          value
          69.0
        2. group Id
          BG001
          spread
          8.1
          value
          59.6
        3. group Id
          BG002
          spread
          8.7
          value
          62.5
        4. group Id
          BG003
          spread
          5.9
          value
          63.5
        5. group Id
          BG004
          spread
          9.8
          value
          64.3
        6. group Id
          BG005
          spread
          8.2
          value
          62.0
        7. group Id
          BG006
          spread
          10.2
          value
          63.1
        8. group Id
          BG007
          spread
          10.5
          value
          65.9
        9. group Id
          BG008
          spread
          8.7
          value
          70.4
        10. group Id
          BG009
          spread
          9.9
          value
          63.6
    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
          4
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          19
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          7
        8. group Id
          BG007
          value
          7
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          40
        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
        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
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          7
        8. group Id
          BG007
          value
          8
        9. group Id
          BG008
          value
          7
        10. group Id
          BG009
          value
          56
        title
        Not Hispanic or Latino
      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
          3
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          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
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          10
        title
        Black (or African American)
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          7
        8. group Id
          BG007
          value
          7
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          46
        title
        White
      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
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          3
        title
        Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
The safety analysis set included all participants who received any amount of oprozomib, pomalidomide and/or dexamethasone. One participant in arm Oprozomib IR 200 mg/day + pomalidomide + dexamethasone received oprozomib IR 150 mg + pomalidomide + dexamethasone, and their baseline characteristics data were included in the Oprozomib IR 150 mg + pomalidomide + dexamethasone arm. Participants enrolled from other Amgen studies were included in a single roll-over arm, as pre-specified in the SAP.

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

Preserved source evidence · Not medical advice