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NCT03340883 · FLOW

Participant flow

Safety and Tolerability of BION-1301 in Adults With Relapsed or Refractory Multiple Myeloma (MM) · Source last updated 2021-04-01

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

groups
  1. description
    50 mg BION-1301 will be administered once every 2 weeks as an intravenous (IV) infusion.
    id
    FG000
    title
    BION-1301 50 mg Q2W
  2. description
    150 mg BION-1301 will be administered once every 2 weeks as an IV infusion.
    id
    FG001
    title
    BION-1301 150 mg Q2W
  3. description
    450 mg BION-1301 will be administered once every 2 weeks as an IV infusion.
    id
    FG002
    title
    BION-1301 450 mg Q2W
  4. description
    1350 mg BION-1301 will be administered once every 2 weeks as an IV infusion.
    id
    FG003
    title
    BION-1301 1350 mg Q2W
  5. description
    2700 mg BION-1301 will be administered once every 2 weeks as an IV infusion.
    id
    FG004
    title
    BION-1301 2700 mg Q2W
  6. description
    1350 mg BION-1301 will be administered as an IV infusion once per week for up to 8 weeks, followed by dosing once every 2 weeks.
    id
    FG005
    title
    BION-1301 1350 mg QW*8W->Q2W
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        3
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        3
      type
      COMPLETED
    3. achievements
      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
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
Subject enrollment was stopped prematurely due to the sponsor's decision to terminate the study. Therefore, the study did not proceed to the Phase 2 portion of the study protocol. All reporting groups are for Phase 1 only.
Complete source fields
groups
  1. description
    50 mg BION-1301 will be administered once every 2 weeks as an intravenous (IV) infusion.
    id
    FG000
    title
    BION-1301 50 mg Q2W
  2. description
    150 mg BION-1301 will be administered once every 2 weeks as an IV infusion.
    id
    FG001
    title
    BION-1301 150 mg Q2W
  3. description
    450 mg BION-1301 will be administered once every 2 weeks as an IV infusion.
    id
    FG002
    title
    BION-1301 450 mg Q2W
  4. description
    1350 mg BION-1301 will be administered once every 2 weeks as an IV infusion.
    id
    FG003
    title
    BION-1301 1350 mg Q2W
  5. description
    2700 mg BION-1301 will be administered once every 2 weeks as an IV infusion.
    id
    FG004
    title
    BION-1301 2700 mg Q2W
  6. description
    1350 mg BION-1301 will be administered as an IV infusion once per week for up to 8 weeks, followed by dosing once every 2 weeks.
    id
    FG005
    title
    BION-1301 1350 mg QW*8W->Q2W
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        3
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        3
      type
      COMPLETED
    3. achievements
      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
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
Subject enrollment was stopped prematurely due to the sponsor's decision to terminate the study. Therefore, the study did not proceed to the Phase 2 portion of the study protocol. All reporting groups are for Phase 1 only.

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

Preserved source evidence · Not medical advice