A Phase I/Pilot Study of Intravenous PLERIXAFOR Following Cyclophosphamide Mobilization in Patients With Multiple Myeloma
I. To assess the safety and tolerability of intravenous(IV) PLERIXAFOR when given in
combination with cyclophosphamide and G-CSF as a mobilization regimen in patients with
I. To determine if intravenous PLERIXAFOR, given with a cyclophosphamide and G-CSF
mobilizing regimen, will allow collection of greater than or equal to 5 x 10^6 CD34+
cells/kg in 2 or less apheresis days.
II. To review the timing of intravenous plerixafor administration prior to apheresis and
describe our experience.
MOBILIZATION: Patients receive cyclophosphamide intravenously (IV). Patients also receive
filgrastim subcutaneously (SC) daily beginning approximately 24 hours later.
TREATMENT/APHERESIS: Beginning 10 days after cyclophosphamide, patients receive plerixafor
IV over 30 minutes followed by filgrastim SC on each day of apheresis.
Following the collection of an adequate number of stem cells, patients undergo high-dose
chemotherapy and autologous stem cell rescue. Patients are followed post-autologous stem
cell transplant for engraftment.
After completion of study treatment, patients are followed periodically.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess the MTD ( maximum tolerated dose) of IV plerixafor when given post cyclophosphamide and GCSF for stem cell priming.Dose limiting toxicity will be defined as any grade 3 or 4 nonhematologic toxicity.
12 to 18 months
Beckman Research Institute
United States: Institutional Review Board
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