The trial, named VISTA, will evaluate Velcade (bortezomib) in combination with melphalan and prednisone versus melphalan and prednisone in patients with newly diagnosed multiple myeloma (MM) who are not transplant candidates. Efficacy, overall safety and tolerability of the combination versus melphalan and prednisone alone will be assessed.
The VISTA trial was reviewed by the 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).
Velcade is currently approved in the US and Europe for the treatment of patients with relapsed and refractory MM. The FDA is currently reviewing Millennium’s supplemental sNDA, under priority review designation, for Velcade as a treatment for patients with MM who have received at least one prior therapy.
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, Velcade will be integrated into the induction regimen.
Both companies continue to investigate Velcade globally in both hematologic and solid tumors and are currently supporting more than 100 ongoing or planned clinical trials.