Bortezomib (Velcade) in Patients With Untreated Multiple Myeloma

Primary Objective • To evaluate the objective response rate (CR + PR) to bortezomib alone in patients with newly diagnosed multiple myeloma. Secondary Objectives * To evaluate the tolerability and toxicity. * To evaluate time to progression. * To assess the frequency and severity of peripheral neuropathy. * To evaluate the impact of early intervention with dose modification and explore symptomatic treatment of peripheral neuropathy. Exploratory Objectives • To perform pharmacogenomic analysis of molecular markers associated with response or non-response. Statistical Design A one stage design is used to evaluate ORR. With 60 evaluable participants, if at least 27 objective responses are observed then bortezomib will be considered promising. The probability of concluding the treatment promising is \>0.95 with a true ORR of 55% and \<0.07 with a true ORR of 35%.