Phase 2 trial of Intravenously Administered Plerixafor for Stem Cell Mobilization in Patients with Multiple Myeloma Following Lenalidomide Based Initial Therapy

Initial therapy of multiple myeloma with lenalidomide-based regimens can compromise stem cell collection, which can be overcome with the addition of plerixafor. Plerixafor is typically given subcutaneously (SQ), with collection approximately 11 hours later for maximum yield. Intravenous (IV) administration may allow more rapid and predictable mobilization. This trial was designed to assess the efficacy and feasibility of IV plerixafor in patients receiving initial therapy with a lenalidomide-based regimen. Patients received G-CSF at 10 μg/kg/day for 4 days followed by IV plerixafor at 0.24 mg/kg/dose starting on day 5; plerixafor administered early in the morning with apheresis 4–5 hours later. Thirty-eight (97%) patients collected at least 3×10(6) CD34+ cells/kg within 2 days of apheresis. The median CD34+ cells/kg after 1 day of collection was 3.9×10(6) (range; 0.7–9.2) and after two days of collection was 6.99×10(6) (range: 1.1–16.5). There were no grade 3 or 4 non-hematological adverse events and one patient experienced grade 4 thrombocytopenia. The most common adverse events were nausea, diarrhea and abdominal bloating. IV plerixafor is an effective strategy for mobilization with low failure rate and is well tolerated. It offers flexibility with a schedule of early morning infusion followed by apheresis later in the day.