Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00004088 · FLOW

Participant flow

Combination Chemo, Peripheral Stem Cell Transplant, Biological Therapy, Pamidronate and Thalidomide for Multiple Myeloma · Source last updated 2019-07-02

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

groups
  1. description
    Priming and Apheresis: Cyclophosphamide (CTX) 1.5 g/m2 and Filgrastim, 5 microgram/kg, t2x/day, until enough PBPC have been collected. This is day -10 to the first transplant. Cycle (transplant) 1: day -1: Melphalan 150 mg/m2 IV; day 0: reinfusion of half of the collected stem cells; day +1: Filgrastim 5 micrograms/kg/day IV until ANC\>1000 per microliter. Day 0 of cycle 2 (C2) is at least 12 weeks and not past 18 weeks from day 1 of cycle 1. Day -8 C2: Start Dilantin 1000 mg IV. Days -7 through -4 of C2: Busulfan 0.8 mg/kg every 6 hours, 4 x per day. Dilantin 300 micrograms/day. Day -3 C2: CTX 60 mg/kg; start IV Mesna. Day -2 C2: CTX 60 mg/kg; continue Mesna IV. Day 0 C2: Reinfuse PBPC. Start Filgrastim 5 microgram/kg daily. 12-18 weeks from day 0 of C2: alpha interferon 3 x 10 E 6 units/m2 3x per week (TIW) for 3 years. At 6 months following day 0 of C2, Thalidomide 400 mg/m2 will be administered orally to patients not in Complete Remission.
    id
    FG000
    title
    High-dose Chemotherapy Followed by PBPC Rescue
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      No C2 given due to study on hold by IRB
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Protocol Violation
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Physician Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        77
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        68
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        9
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    Priming and Apheresis: Cyclophosphamide (CTX) 1.5 g/m2 and Filgrastim, 5 microgram/kg, t2x/day, until enough PBPC have been collected. This is day -10 to the first transplant. Cycle (transplant) 1: day -1: Melphalan 150 mg/m2 IV; day 0: reinfusion of half of the collected stem cells; day +1: Filgrastim 5 micrograms/kg/day IV until ANC\>1000 per microliter. Day 0 of cycle 2 (C2) is at least 12 weeks and not past 18 weeks from day 1 of cycle 1. Day -8 C2: Start Dilantin 1000 mg IV. Days -7 through -4 of C2: Busulfan 0.8 mg/kg every 6 hours, 4 x per day. Dilantin 300 micrograms/day. Day -3 C2: CTX 60 mg/kg; start IV Mesna. Day -2 C2: CTX 60 mg/kg; continue Mesna IV. Day 0 C2: Reinfuse PBPC. Start Filgrastim 5 microgram/kg daily. 12-18 weeks from day 0 of C2: alpha interferon 3 x 10 E 6 units/m2 3x per week (TIW) for 3 years. At 6 months following day 0 of C2, Thalidomide 400 mg/m2 will be administered orally to patients not in Complete Remission.
    id
    FG000
    title
    High-dose Chemotherapy Followed by PBPC Rescue
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      No C2 given due to study on hold by IRB
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Protocol Violation
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Physician Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        77
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        68
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        9
      type
      NOT COMPLETED
    title
    Overall Study

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

Preserved source evidence · Not medical advice