This protocol will investigate the effectiveness of plerixafor in the up-front setting in avoiding a second round of mobilization and whether this translates into a clinical and economic benefit.
Peripheral blood stem cells are now considered the standard source of stem cells for autologous stem cell transplants. Unfortunately, there is still a 20-30% chance that inadequate numbers of stem cells will be collected, resulting in prolonged recovery of cell counts after transplantation and increased transfusion dependence. There is also a significant economic burden associated with remobilization and a risk that delays in collecting sufficient numbers of stem cells can result in an increased chance of disease recurrence prior to transplantation.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
72
240 mcg/kg/day based on ideal body weight will be given for the following conditions: 1. Pre-apheresis peripheral blood CD34+ count \<20 cells/μL on day 5. 2. Estimated CD34+ cell collection is \< 25% of target cell dose after 1 day of apheresis. 3. Estimated CD34+ cell collection is \< 50% of target cell dose after 2 days of apheresis.
All patients will receive filgrastim starting 4 days prior to apheresis (D1-4 mobilization). The dose and schedule of filgrastim will based upon the risk category of the patient: * Standard risk: 5 μg/kg SQ BID. * High risk: 10 μg/kg SQ BID.
Shands Cancer Hospital at the University of Florida
Gainesville, Florida, United States
Rate of successful collection with early introduction of plerixafor in patients predicted to be poor mobilizers
The primary endpoint of the study will be the rate of successful collection with early introduction of plerixafor in patients predicted to be poor mobilizers based on peripheral blood CD34+ cell counts or CD34+ cell collection efficiency after 2 consecutive days of apheresis. Success will be defined as the ability to avoid a second mobilization attempt. Results will be compared to matched historical controls.
Time frame: Day 2 of apheresis
Economic impact
The economic impact of plerixafor use will be divided into two phases, mobilization and transplantation. The comparator arm for the mobilization phase would be matched historical controls. The comparator arm for the transplant phase will be patients who did not require plerixafor for mobilization during the study period.
Time frame: Day 2 of mobilization and Day +100 after transplantation
Kinetics of CD34+ mobilization with early introduction of plerixafor
The kinetics of CD34+ cell counts during mobilization in this setting is unknown. We will attempt to determine mobilization kinetics by following peripheral blood CD34+ counts daily starting from first day of plerixafor administration until completion of apheresis. Kinetics will be analyzed according to the following parameters: * Peripheral CD34 cell counts on each day of apheresis. * Total CD34 cells collected on each day of apheresis * Multiple myeloma vs. NHL.
Time frame: On Day 1 and Day 2 of apheresis
Graft composition
Graft composition will be analyzed on each day of successful apheresis. Cell populations to be quantitated include total CD3+ lymphocytes, CD4+ lymphocytes, CD8+ lymphocytes.
Time frame: On Day 1 and Day 2 of apheresis
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