The results showed that Velcade in combination with melphalan and prednisone (V-MP) appeared significantly superior to melphalan and prednisone (MP) alone in treating elderly patients with newly diagnosed multiple myeloma who were ineligible for stem cell transplantation.
The multi-center, phase I/II study evaluating the safety and efficacy of Velcade based therapy demonstrated an overall response rate of 89%, including a complete and near complete response rate of 43%. This compares favorably to historical control data for MP, a widely used therapy that rarely induces complete response.
“Approximately half of patients presenting with multiple myeloma are elderly and not eligible for transplantation. New treatments that produce very high complete responses and molecular remissions are desperately needed,” said lead investigator Jesus San Miguel, professor of medicine at the University Hospital in Salamanca, Spain. “With only one cycle of V-MP, we achieved a higher response rate than our historical controls of six cycles of MP and the proportion and quality of completed responses increased with subsequent cycles.”