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Low-dose thalidomide with pegylated liposomal doxorubicin and high-dose dexamethasone for relapsed/refractory multiple myeloma: a prospective, multicenter, phase II study
Authors:Offidani Massimo  Corvatta Laura  Marconi Monica  Visani Giuseppe  Alesiani Francesco  Brunori Marino  Galieni Piero  Catarini Massimo  Burattini Maurizio  Centurioni Riccardo  Rupoli Serena  Scortechini Anna Rita  Giuliodori Luciano  Candela Marco  Capelli Debora  Montanari Mauro  Olivieri Attilio  Piersantelli Maria-Novella  Leoni Pietro
Affiliation:Clinica di Ematologia Polo Ospedaliero-Universitario, Ospedali Riuniti Ancona Università Politecnica delle Marche. m.offidani@ao-umbertoprimo.marche.it
Abstract:The aim of this prospective, multicenter, phase II study was to investigate the combination of pegylated liposomal doxorubicin (Caelyx) 40 mg/m2 on day 1 every 28 days, dexamethasone 40 mg p.o. on days 1-4 and 9-12 and thalidomide 100 mg daily in 50 patients with advanced multiple myeloma. Twenty-six percent of patients achieved a complete response, 6% a near complete response, 6% a very good partial response, 38% a partial response, 16% a minor response and 8% progressed, for an overall response rate of 92%. The median event-free survival was 17 months and the median overall survival was not reached. Grade 3 non-hematologic toxicity occurred in 12% of patients, thromboembolic disease in 12% and severe infection in 16%. The combination of pegylated liposomal doxorubicin, dexamethasone an thalidomide is safe and very effective in advanced multiple myeloma.
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