Abstract
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 ∼11 h later for maximum yield. Intravenous 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 was administered early in the morning with apheresis 4–5 h later. Thirty-eight (97%) patients collected at least 3 × 106 CD34+ cells/kg within 2 days of apheresis. The median CD34+ cells/kg after 1 day of collection was 3.9 × 106 (range: 0.7–9.2) and after 2 days of collection was 6.99 × 106 (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.
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Acknowledgements
This work is supported in part by the Mayo Clinic Hematological Malignancies Program, Paul Calabresi K12 Award (CA96028), Mayo Clinic Cancer Center and the Mayo Foundation. Clinical trial support is provided by Genzyme Corporation.
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SKK has research support for clinical trials from Celgene, Millennium, Novartis and Genzyme and is a consultant for Merck. AD and MQL received clinical trial support from Celgene.
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SKK, BL and KL designed the study, collected and analyzed the data and wrote the manuscript; JM, MQL, FKB, DD, MAG, TM, MM, LB, SRHG, CR, AKS and AD contributed patients and were involved in writing the manuscript; DAG and JLW managed the apheresis unit and were involved in writing the manuscript.
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Kumar, S., Mikhael, J., LaPlant, B. et al. Phase 2 trial of intravenously administered plerixafor for stem cell mobilization in patients with multiple myeloma following lenalidomide-based initial therapy. Bone Marrow Transplant 49, 201–205 (2014). https://doi.org/10.1038/bmt.2013.175
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DOI: https://doi.org/10.1038/bmt.2013.175