Participant flow

Trial of Activated Marrow Infiltrating Lymphocytes Alone or in Conjunction With an Allogeneic Granulocyte Macrophage Colony-stimulating Factor (GM-CSF)-Based Myeloma Cellular Vaccine in the Autologous Transplant Setting in Multiple Myeloma · Source last updated 2021-04-09

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

groups

1. description

   Cyclophosphamide and filgrastim will be given to mobilize peripheral blood stem cells. Leukapheresis will be performed to collect peripheral blood from which activated marrow infiltrating lymphocytes will be produced. A melphalan conditioning regimen will be used prior to autologous stem cell transplant, and the MILs product will be administered on Days 3 and 4. Activated marrow infiltrating lymphocytes: Administered on Days 3 and 4. Cyclophosphamide: Administered at 2.5 g/m\^2. Filgrastim: Administered post cyclophosphamide daily until leukapheresis. Leukapheresis: Performed approximately 12 days post cyclophosphamide. Exact date depends on peripheral blood CD34+ cell counts. Melphalan: 100 mg/m\^2/day given on Days -2 and -1. Autologous stem cell transplant: Infused on Day 0.

   id

   FG000

   title

   ASCT + MILs

2. description

   Cyclophosphamide and filgrastim will be given to mobilize peripheral blood stem cells. Leukapheresis will be performed to collect peripheral blood from which activated marrow infiltrating lymphocytes will be produced. A melphalan conditioning regimen will be used prior to autologous stem cell transplant, and the MILs product will be administered on Days 3 and 4. The allogeneic myeloma vaccine will be administered on Days 21, 60, 180, and 300. Activated marrow infiltrating lymphocytes: Administered on Days 3 and 4. Allogeneic Myeloma Vaccine: Allogeneic granulocyte macrophage colony-stimulating factor (GM-CSF)-based myeloma cellular vaccine. Administered on Days 21, 60, 180, and 300. Cyclophosphamide: Administered at 2.5 g/m\^2. Filgrastim: Administered post cyclophosphamide daily until leukapheresis. Leukapheresis: Performed approximately 12 days post cyclophosphamide. Exact date depends on peripheral blood CD34+ cell counts. Melphalan: 100 mg/m\^2/day given on Days -2

   id

   FG001

   title

   ASCT + MILs + Vaccine

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         2

      type

      Physician Decision

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Lost to Follow-up

   3. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         0

      type

      Lack of Efficacy

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         17

      2. group Id

         FG001

         num Subjects

         18

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         11

      2. group Id

         FG001

         num Subjects

         15

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         3

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

One subject was a screen failure.

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Preserved source evidence · Not medical advice