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www.fdanews.com/articles/67411-velcade-for-injection-phase-iii-trial-initiated-in-patients-with-newly-diagnosed-multiple-myeloma

VELCADE FOR INJECTION PHASE III TRIAL INITIATED IN PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA

January 11, 2005

Millennium Pharmaceuticals, in collaboration with Johnson & Johnson Pharmaceutical Research & Development, has initiated VISTA (VELCADE as Initial Standard Therapy in multiple myeloma: Assessment with melphalan and prednisone), a Phase III clinical trial of VELCADE in combination with melphalan and prednisone versus melphalan and prednisone in patients with newly diagnosed multiple myeloma who are not transplant candidates.

This large, international randomized study will assess efficacy, overall safety and tolerability of the combination versus melphalan and prednisone alone.