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

¹ University Hospital, Nantes, France;
² University Hospital, Lille, France;
³ University Hospital, Nancy, France;
⁴ Johnson and Johnson Pharmaceutical Research & Development, Beerse, Belgium and
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

ABSTRACT

This phase I study (ClinicalTrials.gov: NCT00291538) compared pharmacokinetics and pharmacodynamics, and assessed safety and efficacy of intravenous (IV) and subcutaneous (SC) administration of bortezomib. Relapsed or refractory multiple myeloma patients were randomized to receive bortezomib by standard IV bolus (n=12) or SC 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 SC administration. Overall 20S proteasome inhibition was similar between arms. Safety profile and response rate for the SC arm did not appear inferior to the IV arm, with good local tolerance of SC injection. Based on these exploratory findings, SC administration offers an alternative option to IV injection.

Key words: multiple myeloma, bortezomib, subcutaneous administration.