Journal
HAEMATOLOGICA-THE HEMATOLOGY JOURNAL
Volume 93, Issue 12, Pages 1908-1911Publisher
FERRATA STORTI FOUNDATION
DOI: 10.3324/haematol.13285
Keywords
multiple myeloma; bortezomib; subcutaneous administration
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Funding
- Johnson & Johnson Pharmaceutical Research Development
- Millennium Pharmaceuticals, Inc.
- Delegation 5 la Recherche Clinique (DRC) of University Hospital, Nantes, France
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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/m(2), 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).
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