Velcade bortezomib: Phase III data

Researchers from the University Hospital of Salamanca reported data from an open-label, Spanish Phase III trial in 260 treatment-naïve patients ages 65 and older showing that induction therapy with a less-intensive Velcade-based regimen, followed by maintenance therapy, resulted in a 5% reduction in the incidence of >=grade 3 peripheral neuropathy, while maintaining efficacy, as compared to the Phase III VISTA trial evaluating a twice-weekly regimen of Velcade to treat previously untreated MM patients ineligible for stem cell transplantation. Additionally, the less-intensive Velcade-based regimen led to a 15% reduction in gastrointestinal symptoms as compared to the VISTA trial.

Patients in the Spanish Phase III trial received 6 cycles of Velcade plus melphalan and prednisone (VMP) or Velcade plus thalidomide and prednisone (VTP) as induction therapy. The first cycle consisted of twice-weekly Velcade for 6 weeks plus prednisone and either melphalan or thalidomide, followed by 5 cycles of once-weekly Velcade for 5 weeks plus prednisone and either melphalan or thalidomide. Following induction therapy, patients were randomized to maintenance therapy with Velcade plus prednisone or Velcade plus melphalan. Maintenance treatment consisted of 1 cycle of twice-weekly Velcade for 3 weeks every 3 months for up to 3 years. ...