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Medline ® Abstract for Reference 89

of 'Treatment of relapsed or refractory multiple myeloma'

A prospective, international phase 2 study of bortezomib retreatment in patients with relapsed multiple myeloma.
Petrucci MT, Giraldo P, Corradini P, Teixeira A, Dimopoulos MA, Blau IW, Drach J, Angermund R, Allietta N, Broer E, Mitchell V, BladéJ
Br J Haematol. 2013 Mar;160(5):649-59. Epub 2013 Jan 7.
Multiple myeloma (MM) typically follows a relapsing course with many patients requiring multiple therapies. This single-arm phase 2 study prospectively evaluated the efficacy and safety of bortezomib retreatment in MM patients who had relapsed after achieving at least a partial response (≥PR) to prior bortezomib-based therapy. Patients aged≥18 years, with measurable, secretory MM, who relapsed≥6 months after prior bortezomib treatment were eligible. Patients received up to eight cycles of bortezomib (±dexamethasone). The primary endpoint was best confirmed response at retreatment; secondary endpoints included duration of response (DOR), time to progression (TTP), and safety. Adverse events (AEs) were graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0. A total of 130 patients (median of two prior lines of therapy) were enrolled and received retreatment. At retreatment, 28% and 72% of patients received bortezomib and bortezomib-dexamethasone, respectively. Overall response rate was 40%. In patients who achieved≥PR, median DOR and TTP were 6.5 and 8.4 months, respectively. Thrombocytopenia was the most common grade≥3 AE (35%). Forty percent of patients experienced neuropathy events, which improved and resolved in a median of 1.5 and 8.9 months, respectively. In conclusion, bortezomib retreatment was effective and tolerable in relapsed MM patients, with no evidence of cumulative toxicities.
Department of Cellular Biotechnology and Haematology, Sapienza University of Rome, Rome, Italy. petrucci@bce.uniroma1.it