Participant flow

Non-myeloablative Allogeneic Transplantation for the Treatment of Multiple Myeloma · Source last updated 2018-01-18

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

groups

1. description

   Auto-HCT mobilization is cyclophosphamide 4 g/m2 + filgrastim 10 µg/kg/day for peripheral blood progenitor cell (PBPC) collection by apheresis. Transplant conditioning is high-dose melphalan 200 mg/m2, followed by PBPC infusion as melphalan rescue \[ie, autologous hematopoietic cells transplant (Auto-HCT)\]. Post-infusion support is filgrastim 5 µg/kg/day, starting 6 days after melphalan. Stable/responsive disease at 4 weeks continues to allogenic HCT (Allo-HCT) from sibling donor fully-matched for human leukocyte antigen (HLA). Allo-HCT conditioning is total body irradiation (TBI) 200 centigray (cGy) + cyclosporine (CSP) 6.25 mg/kg + mycophenolate mofetil (MMF) 15 mg/kg. Donor mobilization is filgrastim 16 µg/kg/day on day -4 to Day 0; apheresis collections on Day -1 \& Day 0, to a target of \> 5 x 10e6 CD34 cells/kg. Allo-HCT is infused to participant on Day 0, with premedication hydrocortisone 100 mg IV \& diphenhydramine 50 mg IV. CSP tapering on Day 56 to Day 180, adjusted as needed.

   id

   FG000

   title

   Auto- Then Allo-HCT

periods

1. milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         63

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         63

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Autologous HCT (Auto-HCT)

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Physician Decision

   2. reasons

      1. group Id

         FG000

         num Subjects

         2

      type

      Relapse

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Lack of allogenic donor

   milestones

   1. achievements

      1. comment

         Not all participants who received autologous transplant continued to receive allogeneic transplant.

         group Id

         FG000

         num Subjects

         63

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         59

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         4

      type

      NOT COMPLETED

   title

   Inter-treatment Period

3. milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         59

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         59

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Allogenic HCT (Allo-HCT)

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

Preserved source evidence · Not medical advice