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Results of a phase I/II clinical trial of combination therapy bortezomib, melphalan and prednisone have suggest a high degree of efficacy in treating newly diagnosed multiple myeloma patients, ineligible for stem cell transplantation.
The study found one of the highest reported complete remission (CR) rates at 32% of patients, indicating a good chance of long-term survival. The results also yielded the highest three-year survival rate reported in a non-transplant setting, with 85% of patients alive after three years.
The results will provide the basis for a phase III trial, called Vista.
Manufacturers of bortezomib (brand name: Velcade), Millennium Pharmaceuticals, Inc, submitted a supplemental New Drug Application to the US Food and Drug Administration in December 2007 for the expansion of bortezomib into the treatment of multiple myeloma. The FDA is scheduled to make its decision on June 20, this year.
Millennium’s co-development partner, Johnson & Johnson Pharmaceutical Research & Development LLC, has filed a similar application with the European regulatory body, the European Medicines Evaluation Agency (EMEA).
Nancy Simonian, MD, Chief Medical Officer, Millennium, said: “We are confident that Velcade will be a key component of the standard of care in this patient setting.”