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Multiple myeloma (MM) is an incurable disease due to the neoplastic proliferation of plasma cells. Histone deacetylase (HDAC) inhibitors are a novel class of agents that can induce tumour cell growth arrest, differentiation and/or apoptosis in vitro and inhibit tumour growth in animals. ITF2357, an orally effective member of the family of HDAC inhibitors, is a potent inducer of apoptosis and death of MM cells (Golay et al. Leukemia, 2007). It has also a potent inhibitory activity on secretion of pro-inflammatory cytokines by stromal and mesenchimal stem cells. For these properties, ITF2357 has been given safely to patients with Crohn's disease and plaque psoriasis as an anti-inflammatory drug. We report the preliminary results of a phase II multiple dose clinical trial of oral ITF2357 in patients with relapsed or progressive MM, who had received at least two previous lines of treatment. Primary endpoint was to determine …