Published online 2 September 2008
Haematologica, Vol 93, Issue 12, 1908-1911 doi:10.3324/haematol.13285
Copyright © 2008 by Ferrata Storti Foundation
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Multiple Myeloma

Prospective comparison of subcutaneous versus intravenous administration of bortezomib in patients with multiple myeloma

Philippe Moreau1, Valerie Coiteux2, Cyrille Hulin3, Xavier Leleu2, Helgi van de Velde4, Milin Acharya5, Jean-Luc Harousseau1

1 University Hospital, Nantes, France
2 University Hospital, Lille, France
3 University Hospital, Nancy, France
4 Johnson and Johnson Pharmaceutical Research & Development, Beerse, Belgium
5 Johnson and Johnson Pharmaceutical Research & Development, L.L.C., Raritan, NJ, USA

Correspondence: Philippe Moreau, MD, Department of Hematology, University Hospital, Hôtel-Dieu, Place Ricordeau, 44093, Nantes cedex 01, France. E-mail:philippe.moreau{at}chu-nantes.fr

This phase I study compared pharmacokinetics and pharmacodynamics, and assessed safety and efficacy of intravenous and subcutaneous administration of bortezomib. Relapsed or refractory multiple myeloma patients were randomized to receive bortezomib by standard intravenous bolus (n=12) or subcutaneous injection (n=12) at the recommended dose and schedule (1.3 mg/m2, days 1, 4, 8, 11; eight 21-day cycles). Plasma bortezomib concentration and percent 20S proteasome inhibition were measured at multiple time points on days 1 and 11, cycle 1. Systemic bortezomib exposure was similar between arms. As expected, mean maximum plasma concentration was lower and took longer to reach following subcutaneous administration. Overall 20S proteasome inhibition was similar between arms. Safety profile and response rate for the subcutaneous arm did not appear inferior to the intravenous arm, with good local tolerance of subcutaneous injection. Based on these exploratory findings, subcutaneous administration offers an alternative option to intravenous injection (ClinicalTrials.gov identifier: NCT00291538).

Key words: multiple myeloma, bortezomib, subcutaneous administration.