Participant flow

Desipramine Hydrochloride and Filgrastim For Stem Cell Mobilization in Patients With Multiple Myeloma Undergoing Stem Cell Transplant · Source last updated 2023-03-28

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

groups

1. description

   Participants received 100mg desipramine hydrochloride PO daily from Day -3 to Day +4 (8 days total) and filgrastim PO BID from Day +1 to Day +4. Complete blood count (CBC) and peripheral blood CD34+ counts were determined on Day +4 and Day +5. Leukapheresis was started when peripheral blood CD34+ count exceeded 10/uL. If CD34+ counts were \<10/uL on Day +5, plerixafor was added as a salvage therapy. Daily leukapheresis was performed with four times the estimated blood volume during each collection until a target cell dose of at least 5x10\^6 cells/kg was reached. If the collected CD34+ cell dose was \<0.5x10\^6 on two consecutive days, aperheris was stopped and the patient was taken off study. Despiramine hydrochloride: PO Filgrastim: PO

   id

   FG000

   title

   Treatment (Desipramine, Filgrastim)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Withdrawal by Subject

   2. reasons

      1. group Id

         FG000

         num Subjects

         2

      type

      Adverse Event

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Disease Relapse (patient with previously undiagnosed relapsing disease)

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         10

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         6

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         4

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Of the 10 participants enrolled, 1 participant dropped out after enrollment and prior to study drug initiation. Of the remaining 9 participants, 6 participants underwent stem cell transplantation and completed the full study protocol.

recruitment Details

Ten participants with multiple myeloma between 18-70 years of age eligible for Autologous Stem Cell Transplant (ASCT) were enrolled in the study between September 2013 and July 2014.

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Preserved source evidence · Not medical advice