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Haematologica, Vol 91, Issue 1, 133-136
Copyright © 2006 by Ferrata Storti Foundation


Clinical Trial, Phase II

Low-dose thalidomide with pegylated liposomal doxorubicin and high-dose dexamethasone for relapsed/refractory multiple myeloma: a prospective, multicenter, phase II study

M Offidani, L Corvatta, M Marconi, G Visani, F Alesiani, M Brunori, P Galieni, M Catarini, M Burattini, R Centurioni, S Rupoli, AR Scortechini, L Giuliodori, M Candela, D Capelli, M Montanari, A Olivieri, MN Piersantelli, and P Leoni

Clinica di Ematologia Polo Ospedaliero-Universitario, Ospedali Riuniti Ancona Universita Politecnica delle Marche. m.offidani@ao-umbertoprimo.marche.it

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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