Mobilization Kinetics of Plerixafor and G-CSF in Patients With NHL and MM Undergoing Autologous Peripheral Blood Progenitor Cell Collection
The current FDA-approved timing for plerixafor is approximately 11 hours prior to apheresis.
This is a logistical problem, since plerixafor should be administered by a health care
provider, given the risk of hypotension with administration. The primary purpose of this
study is, in autologous donors with non-Hodgkins lymphoma and multiple myeloma undergoing
hematopoietic progenitor cell mobilization with plerixafor and G-CSF, to determine whether
the dosing interval can be increased to 16 hours prior to apheresis. Patients will be
admitted to a special clinical research center on the 4th day of G-CSF administration, where
the peripheral blood CD34+ count will be measured every 2 hours after plerixafor
administration at 5 pm until 9 AM the following day, at which time apheresis will commence.
The hypothesis is that plerixafor administration 16 hours prior to apheresis is as safe and
effective as plerixafor administration at 11 hours prior to apheresis.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Percent of donors obtaining a minimum CD34+ cell dose of 2 x 106/kg actual recipient weight within 2 days of collection
Patricia A Shi, MD
Mount Sinai School of Medicine
United States: Institutional Review Board
GCO # 09-0824
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