Phase II Trial of Intravenously Administered AMD3100 (Plerixafor) for Stem Cell Mobilization in Patients With Multiple Myeloma Undergoing Autologous Stem Cell Transplantation Following a Lenalidomide Based Initial Therapy
Primary Objective: I. To determine the proportion of patients reaching a stem cell yield of
3 million CD34 cells/kg by second day of apheresis with intravenously administered AMD3100
among patients receiving primary therapy for myeloma with lenalidomide. Secondary
Objectives: I. Safety and tolerability of intravenously administered AMD3100. II. Rate of
failure to mobilize. Outline: Patients receive plerixafor IV on days 5-8 and filgrastim
subcutaneously on days 1-8 in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 30 days.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Patients Achieving 3 Million CD34 Cells/kg After 2 Days of Apheresis
Number of CD34 cells/kg collected on days 1-2. Apheresis is the process when blood is taken out through a catheter in a vein in one arm, blood is sent through a machine that takes out the stem cells and the rest of the blood is then returned through a vein in your other arm.
After 2 days of apheresis
Shaji Kumar, M.D.
United States: Food and Drug Administration
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