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NCT03218163 · FLOW

Participant flow

MEDI-551 as Maintenance Therapy After Allogeneic Stem Cell Transplant in Multiple Myeloma · Source last updated 2019-01-14

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

groups
  1. description
    MEDI-551 maintenance therapy will be initiated on Day 60, Day 90, or Day 120 of NM-AlloSCT based on the eligibility criteria for the initiation of maintenance therapy as described in Section 3.1. MEDI-551 will be administered on 28-day cycles at a dose of 4mg/kg, as an IV infusion over 60 ±15 minutes. Infusion sets must contain a 0.2 micron in-line filter. MEDI-551 will be administered on days 1, 8, 15, and 22 of cycle 1, then 4mg/kg IV on day1 of cycles 2 through 12. Treatment may be stopped earlier if there is unacceptable toxicity, development of Grade 3 or 4 graft-versus-host disease (GVHD), documentation of disease progression, or patient withdrawal for other reasons. MEDI-551 Maintenance: Cycle 1 - Days 1, 8, 15, and 22: 4mg/kg IV Cycles 2-12 - Day 1: 4mg/kg IV
    id
    FG000
    title
    MEDI-551 Treatment Arm
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
This study enrolled 1 participant, but the study was terminated before they could be assigned to the intervention, therefore, 0 participants started the study.
Complete source fields
groups
  1. description
    MEDI-551 maintenance therapy will be initiated on Day 60, Day 90, or Day 120 of NM-AlloSCT based on the eligibility criteria for the initiation of maintenance therapy as described in Section 3.1. MEDI-551 will be administered on 28-day cycles at a dose of 4mg/kg, as an IV infusion over 60 ±15 minutes. Infusion sets must contain a 0.2 micron in-line filter. MEDI-551 will be administered on days 1, 8, 15, and 22 of cycle 1, then 4mg/kg IV on day1 of cycles 2 through 12. Treatment may be stopped earlier if there is unacceptable toxicity, development of Grade 3 or 4 graft-versus-host disease (GVHD), documentation of disease progression, or patient withdrawal for other reasons. MEDI-551 Maintenance: Cycle 1 - Days 1, 8, 15, and 22: 4mg/kg IV Cycles 2-12 - Day 1: 4mg/kg IV
    id
    FG000
    title
    MEDI-551 Treatment Arm
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
This study enrolled 1 participant, but the study was terminated before they could be assigned to the intervention, therefore, 0 participants started the study.

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

Preserved source evidence · Not medical advice