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NCT02675452 · FLOW

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AMG 176 First in Human Trial in Participants With Relapsed or Refractory Multiple Myeloma and Participants With Relapsed or Refractory Acute Myeloid Leukemia · Source last updated 2025-07-09

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    Participants with MM received AMG 176 Dose A BIW. AMG 176 was administered as an intravenous (IV) infusion in a 4-week cycle.
    id
    FG000
    title
    Part 1A Cohort 1 (MM): AMG 176 Dose A Twice Weekly (BIW)
  2. description
    Participants with MM received AMG 176 Dose B IV BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
    id
    FG001
    title
    Part 1A Cohort 2 (MM): AMG 176 Dose B BIW
  3. description
    Participants with MM received AMG 176 Dose C BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
    id
    FG002
    title
    Part 1A Cohort 3 (MM): AMG 176 Dose C BIW
  4. description
    Participants with MM received AMG 176 Dose D BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
    id
    FG003
    title
    Part 1A Cohort 4 (MM): AMG 176 Dose D BIW
  5. description
    Participants with MM received AMG 176 Dose E BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
    id
    FG004
    title
    Part 1A Cohort 5 (MM): AMG 176 Dose E BIW
  6. description
    Participants with MM received AMG 176 Dose G BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
    id
    FG005
    title
    Part 1A Cohort 6 (MM): AMG 176 Dose G BIW
  7. description
    Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose F BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
    id
    FG006
    title
    Part 1A Cohort 7 (MM): AMG 176 Dose E Then Dose F BIW
  8. description
    Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose G BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
    id
    FG007
    title
    Part 1A Cohort 8 (MM): AMG 176 Dose E Then Dose G BIW
  9. description
    Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose H BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
    id
    FG008
    title
    Part 1A Cohort 9 (MM): AMG 176 Dose E Then Dose H BIW
  10. description
    Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose I BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
    id
    FG009
    title
    Part 1A Cohort 10 (MM): AMG 176 Dose E Then Dose I BIW
  11. description
    Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose F QW. AMG 176 was administered as an IV infusion in a 4-week cycle.
    id
    FG010
    title
    Part 1B Cohort 1 (MM): AMG 176 Dose E Then Dose F Once Weekly (QW)
  12. description
    Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose G QW. AMG 176 was administered as an IV infusion in a 4-week cycle.
    id
    FG011
    title
    Part 1B Cohort 2 (MM): AMG 176 Dose E Then Dose G QW
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        1
      11. group Id
        FG010
        num Subjects
        0
      12. group Id
        FG011
        num Subjects
        0
      type
      Sponsor decision
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        1
      11. group Id
        FG010
        num Subjects
        0
      12. group Id
        FG011
        num Subjects
        1
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        1
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      12. group Id
        FG011
        num Subjects
        0
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      12. group Id
        FG011
        num Subjects
        0
      type
      Lost to Follow-up
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      12. group Id
        FG011
        num Subjects
        0
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        4
      8. group Id
        FG007
        num Subjects
        4
      9. group Id
        FG008
        num Subjects
        5
      10. group Id
        FG009
        num Subjects
        5
      11. group Id
        FG010
        num Subjects
        3
      12. group Id
        FG011
        num Subjects
        3
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        4
      8. group Id
        FG007
        num Subjects
        4
      9. group Id
        FG008
        num Subjects
        5
      10. group Id
        FG009
        num Subjects
        5
      11. group Id
        FG010
        num Subjects
        3
      12. group Id
        FG011
        num Subjects
        3
      type
      Received AMG 176
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        4
      8. group Id
        FG007
        num Subjects
        4
      9. group Id
        FG008
        num Subjects
        4
      10. group Id
        FG009
        num Subjects
        3
      11. group Id
        FG010
        num Subjects
        3
      12. group Id
        FG011
        num Subjects
        2
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        1
      10. group Id
        FG009
        num Subjects
        2
      11. group Id
        FG010
        num Subjects
        0
      12. group Id
        FG011
        num Subjects
        1
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Participants with multiple myeloma (MM) or with acute myeloid leukemia (AML) were enrolled into 29 cohorts. Dosing of AMG 176 was from Dose A (lowest) to Dose I (highest).
recruitment Details
Participants were enrolled at 21 study centers in the United States, Canada, Australia, Germany, and Japan, and participated from June 2016 to May 2024. The study was conducted in multiple parts and Part 5 did not enroll any participants due to early termination of the study. Part 2 was removed during a protocol amendment.
Complete source fields
groups
  1. description
    Participants with MM received AMG 176 Dose A BIW. AMG 176 was administered as an intravenous (IV) infusion in a 4-week cycle.
    id
    FG000
    title
    Part 1A Cohort 1 (MM): AMG 176 Dose A Twice Weekly (BIW)
  2. description
    Participants with MM received AMG 176 Dose B IV BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
    id
    FG001
    title
    Part 1A Cohort 2 (MM): AMG 176 Dose B BIW
  3. description
    Participants with MM received AMG 176 Dose C BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
    id
    FG002
    title
    Part 1A Cohort 3 (MM): AMG 176 Dose C BIW
  4. description
    Participants with MM received AMG 176 Dose D BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
    id
    FG003
    title
    Part 1A Cohort 4 (MM): AMG 176 Dose D BIW
  5. description
    Participants with MM received AMG 176 Dose E BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
    id
    FG004
    title
    Part 1A Cohort 5 (MM): AMG 176 Dose E BIW
  6. description
    Participants with MM received AMG 176 Dose G BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
    id
    FG005
    title
    Part 1A Cohort 6 (MM): AMG 176 Dose G BIW
  7. description
    Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose F BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
    id
    FG006
    title
    Part 1A Cohort 7 (MM): AMG 176 Dose E Then Dose F BIW
  8. description
    Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose G BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
    id
    FG007
    title
    Part 1A Cohort 8 (MM): AMG 176 Dose E Then Dose G BIW
  9. description
    Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose H BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
    id
    FG008
    title
    Part 1A Cohort 9 (MM): AMG 176 Dose E Then Dose H BIW
  10. description
    Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose I BIW. AMG 176 was administered as an IV infusion in a 4-week cycle.
    id
    FG009
    title
    Part 1A Cohort 10 (MM): AMG 176 Dose E Then Dose I BIW
  11. description
    Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose F QW. AMG 176 was administered as an IV infusion in a 4-week cycle.
    id
    FG010
    title
    Part 1B Cohort 1 (MM): AMG 176 Dose E Then Dose F Once Weekly (QW)
  12. description
    Participants with MM received AMG 176 Dose E in cycle 1 week 1, then received Dose G QW. AMG 176 was administered as an IV infusion in a 4-week cycle.
    id
    FG011
    title
    Part 1B Cohort 2 (MM): AMG 176 Dose E Then Dose G QW
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        1
      11. group Id
        FG010
        num Subjects
        0
      12. group Id
        FG011
        num Subjects
        0
      type
      Sponsor decision
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        1
      11. group Id
        FG010
        num Subjects
        0
      12. group Id
        FG011
        num Subjects
        1
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        1
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      12. group Id
        FG011
        num Subjects
        0
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      12. group Id
        FG011
        num Subjects
        0
      type
      Lost to Follow-up
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      12. group Id
        FG011
        num Subjects
        0
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        4
      8. group Id
        FG007
        num Subjects
        4
      9. group Id
        FG008
        num Subjects
        5
      10. group Id
        FG009
        num Subjects
        5
      11. group Id
        FG010
        num Subjects
        3
      12. group Id
        FG011
        num Subjects
        3
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        4
      8. group Id
        FG007
        num Subjects
        4
      9. group Id
        FG008
        num Subjects
        5
      10. group Id
        FG009
        num Subjects
        5
      11. group Id
        FG010
        num Subjects
        3
      12. group Id
        FG011
        num Subjects
        3
      type
      Received AMG 176
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        4
      8. group Id
        FG007
        num Subjects
        4
      9. group Id
        FG008
        num Subjects
        4
      10. group Id
        FG009
        num Subjects
        3
      11. group Id
        FG010
        num Subjects
        3
      12. group Id
        FG011
        num Subjects
        2
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        1
      10. group Id
        FG009
        num Subjects
        2
      11. group Id
        FG010
        num Subjects
        0
      12. group Id
        FG011
        num Subjects
        1
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Participants with multiple myeloma (MM) or with acute myeloid leukemia (AML) were enrolled into 29 cohorts. Dosing of AMG 176 was from Dose A (lowest) to Dose I (highest).
recruitment Details
Participants were enrolled at 21 study centers in the United States, Canada, Australia, Germany, and Japan, and participated from June 2016 to May 2024. The study was conducted in multiple parts and Part 5 did not enroll any participants due to early termination of the study. Part 2 was removed during a protocol amendment.

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