Velcade clinical trial for NHL

Millennium Pharmaceuticals, Inc. along with co-development partner Johnson & Johnson Pharmaceutical Research & Development, today announced the initiation of a Phase III clinical trial of VELCADE in combination with rituximab in patients with relapsed or refractory follicular lymphoma, a subtype of non-Hodgkin's lymphoma (NHL). This study builds on clinical data observed in previous trials of VELCADE that showed high objective response rates and a favorable safety profile across a variety of lymphomas.

The Phase III study is expected to enroll approximately 670 patients with relapsed or refractory, rituximab naïve or sensitive follicular NHL. Patients will be randomized to either the combination regimen of once-weekly VELCADE plus rituximab or rituximab alone. The primary endpoint is progression-free survival. Secondary endpoints of the study include the overall response rate and duration of response.