Rationale: Giving colony-stimulating factors, such as G-CSF and plerixafor helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored. Purpose: This phase II trial is studying how well plerixafor works in patients with multiple myeloma previously treated with lenalidomide and planning to undergo autologous stem cell transplant.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Plerixafor 160mg/kg/dose by IV on days 5-8
Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8.
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Mayo Clinic
Rochester, Minnesota, United States
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.
Time frame: After 2 days of apheresis
CD34 Yield on Day 1
Number of CD34 cells/kg collected on day 1.
Time frame: Day 1
CD34 Yield Day 2
Number of CD34 cells/kg collected on day 2
Time frame: Day 2
Median Number of Days of Apheresis
Time frame: Duration of apheresis (up to 7 days)
Time to Reach 6 Million CD34 Cells
Number (median and 95% confidence interval) of days to reach 6 million CD34 cells/kg was estimated using the Kaplan Meier method. Participants were lower than 6 million CD34 cells/kg at time of last follow-up will be censored at that date.
Time frame: Duration of apheresis (up to 7 days)
Rate of Failure to Mobilize
The rate of failure to mobilize will be estimated by dividing the number of patients that fail to mobilize by the total number of evaluable patients. A patient is considered a failure if they never achieve 2.5 million CD34 cells/kg.
Time frame: Duration of apheresis (up to 7 days)
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