Millennium Pharmaceuticals today announced, in collaboration with Johnson & Johnson Pharmaceutical Research & Development, LLC, the initiation of VISTA (Velcadeas Initial Standard Therapy in multiple myeloma: Assessment with melphalan and prednisone), a multicenter, international phase III clinical trial of Velcadein combination with melphalan and prednisone versus melphalan and prednisone in patients with newly diagnosed multiple myeloma (MM) 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.
The VISTA trial was reviewed by the U.S. Food and Drug Administration (FDA) through the special protocol assessment (SPA) process. An SPA is a binding agreement between the FDA and the sponsor of a clinical trial requiring that the study design meets the scientific and regulatory requirements of the FDA to support a New Drug Application (NDA) or supplemental New Drug Application (sNDA).
Velcadeis currently approved in the United States and Europe for the treatment of patients with relapsed and refractory MM. The FDA is currently reviewing the Company's supplemental sNDA, under Priority Review designation, for Velcadeas a treatment for patients with MM who have received at least one prior therapy.
"Millennium, and our partner Johnson and Johnson, are committed to strategically and expeditiously developing Velcadeas the cornerstone of care across the multiple myeloma treatment paradigm," said David Schenkein, M.D., vice president, clinical oncology development, Millennium. "The frontline data seen to date have been very promising, and we are eager to explore the potential of Velcadein combination with other therapies so that we may be able to offer new options for patients in need."
Millennium and Johnson & Johnson are also planning to support two additional large, multi-national phase III frontline MM trials scheduled to be initiated in the first half of this year. These trials will be for patients who plan to undergo stem cell transplantation. In these trials, which are planned to be conducted by major European hematology cooperative groups, Velcadewill be integrated into the induction regimen.