Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02561962 · BASELINE

Baseline characteristics

A Phase 1 Study in Subjects With Relapsed or Refractory Multiple Myeloma · Source last updated 2024-02-01

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
      6
    6. group Id
      BG005
      value
      6
    7. group Id
      BG006
      value
      5
    8. group Id
      BG007
      value
      9
    9. group Id
      BG008
      value
      2
    10. group Id
      BG009
      value
      40
    units
    Participants
groups
  1. description
    Participants were administered AMG 224 Dose A as an intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle, where each cycle is 3 weeks.
    id
    BG000
    title
    Dose Exploration: AMG 224 Dose A
  2. description
    Participants were administered AMG 224 Dose B as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
    id
    BG001
    title
    Dose Exploration: AMG 224 Dose B
  3. description
    Participants were administered AMG 224 Dose C as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
    id
    BG002
    title
    Dose Exploration: AMG 224 Dose C
  4. description
    Participants were administered AMG 224 Dose D as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
    id
    BG003
    title
    Dose Exploration: AMG 224 Dose D
  5. description
    Participants were administered AMG 224 Dose E as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
    id
    BG004
    title
    Dose Exploration: AMG 224 Dose E
  6. description
    Participants were administered AMG 224 Dose F as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
    id
    BG005
    title
    Dose Exploration: AMG 224 Dose F
  7. description
    Participants were administered AMG 224 Dose G as an intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle, where each cycle is 3 weeks.
    id
    BG006
    title
    Dose Exploration: AMG 224 Dose G
  8. description
    Participants who had prior treatment with CD38-targeting antibody were administered AMG 224 Dose H (the maximum tolerated dose \[MTD\] identified based on the dose exploration phase) as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
    id
    BG007
    title
    Dose Expansion: AMG 224 Dose H + Prior CD38 Targeting Antibody Treatment
  9. description
    Participants who had no prior treatment with CD38-targeting antibody were administered AMG 224 Dose H (the MTD identified based on the dose exploration phase) as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
    id
    BG008
    title
    Dose Expansion: AMG 224 Dose H + no Prior CD38 Targeting Antibody Treatment
  10. description
    Total of all reporting groups
    id
    BG009
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.0
          value
          63.3
        2. group Id
          BG001
          spread
          3.8
          value
          63.7
        3. group Id
          BG002
          spread
          11.2
          value
          64.3
        4. group Id
          BG003
          spread
          4.0
          value
          70.7
        5. group Id
          BG004
          spread
          7.1
          value
          60.5
        6. group Id
          BG005
          spread
          5.7
          value
          65.0
        7. group Id
          BG006
          spread
          6.0
          value
          58.2
        8. group Id
          BG007
          spread
          8.7
          value
          71.3
        9. group Id
          BG008
          spread
          9.9
          value
          53.0
        10. group Id
          BG009
          spread
          8.4
          value
          64.5
    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
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          21
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          19
        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
          2
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          8
        title
        Hispanic or Latino
      2. 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
          4
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          8
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          32
        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
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        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
          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
          1
        title
        Asian
      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
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          6
        title
        Black (or African American)
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          7
        9. group Id
          BG008
          value
          2
        10. group Id
          BG009
          value
          25
        title
        White
      4. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          8
        title
        Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Safety analysis set: all participants that are enrolled and received at least 1 dose of AMG 224.
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
      6
    6. group Id
      BG005
      value
      6
    7. group Id
      BG006
      value
      5
    8. group Id
      BG007
      value
      9
    9. group Id
      BG008
      value
      2
    10. group Id
      BG009
      value
      40
    units
    Participants
groups
  1. description
    Participants were administered AMG 224 Dose A as an intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle, where each cycle is 3 weeks.
    id
    BG000
    title
    Dose Exploration: AMG 224 Dose A
  2. description
    Participants were administered AMG 224 Dose B as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
    id
    BG001
    title
    Dose Exploration: AMG 224 Dose B
  3. description
    Participants were administered AMG 224 Dose C as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
    id
    BG002
    title
    Dose Exploration: AMG 224 Dose C
  4. description
    Participants were administered AMG 224 Dose D as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
    id
    BG003
    title
    Dose Exploration: AMG 224 Dose D
  5. description
    Participants were administered AMG 224 Dose E as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
    id
    BG004
    title
    Dose Exploration: AMG 224 Dose E
  6. description
    Participants were administered AMG 224 Dose F as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
    id
    BG005
    title
    Dose Exploration: AMG 224 Dose F
  7. description
    Participants were administered AMG 224 Dose G as an intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle, where each cycle is 3 weeks.
    id
    BG006
    title
    Dose Exploration: AMG 224 Dose G
  8. description
    Participants who had prior treatment with CD38-targeting antibody were administered AMG 224 Dose H (the maximum tolerated dose \[MTD\] identified based on the dose exploration phase) as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
    id
    BG007
    title
    Dose Expansion: AMG 224 Dose H + Prior CD38 Targeting Antibody Treatment
  9. description
    Participants who had no prior treatment with CD38-targeting antibody were administered AMG 224 Dose H (the MTD identified based on the dose exploration phase) as an IV infusion Q3W on Day 1 of each cycle, where each cycle is 3 weeks.
    id
    BG008
    title
    Dose Expansion: AMG 224 Dose H + no Prior CD38 Targeting Antibody Treatment
  10. description
    Total of all reporting groups
    id
    BG009
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.0
          value
          63.3
        2. group Id
          BG001
          spread
          3.8
          value
          63.7
        3. group Id
          BG002
          spread
          11.2
          value
          64.3
        4. group Id
          BG003
          spread
          4.0
          value
          70.7
        5. group Id
          BG004
          spread
          7.1
          value
          60.5
        6. group Id
          BG005
          spread
          5.7
          value
          65.0
        7. group Id
          BG006
          spread
          6.0
          value
          58.2
        8. group Id
          BG007
          spread
          8.7
          value
          71.3
        9. group Id
          BG008
          spread
          9.9
          value
          53.0
        10. group Id
          BG009
          spread
          8.4
          value
          64.5
    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
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          21
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          19
        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
          2
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          8
        title
        Hispanic or Latino
      2. 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
          4
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          8
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          32
        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
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        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
          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
          1
        title
        Asian
      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
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          6
        title
        Black (or African American)
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          7
        9. group Id
          BG008
          value
          2
        10. group Id
          BG009
          value
          25
        title
        White
      4. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          8
        title
        Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Safety analysis set: all participants that are enrolled and received at least 1 dose of AMG 224.

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

Preserved source evidence · Not medical advice