Millennium Pharmaceuticals, Inc. has announced the initiation of a randomised, multi-centre, company-sponsored phase III trial to determine the most effective Velcade based combination therapy with approved agents for the treatment of newly diagnosed multiple myeloma (MM) patients, ineligible for stem cell transplantation.
The trial named Upfront and conducted primarily at community physician networks nationwide, will compare three Velcade based therapies. Velcade, currently the market leader in relapsed MM, is being developed for registration in front-line MM based on strong survival data seen in earlier clinical trials.
"Velcade has delivered some of the highest complete remission and survival rates, rarely seen with the exception of high-dose therapy and stem cell transplantation," said Ruben Niesvizky, MD, New York Presbyterian Hospital and Weill-Cornell Medical Centre, and the Upfront Principal Investigator. "Our goal with the Upfront trial is to further evaluate Velcade in combination with standards of care and identify the optimal combination that will potentially extend survival in newly diagnosed multiple myeloma patients."
The Upfront (Untreated Patients receiving therapy For multiple myeloma in a Randomised trial Of three novel regimens for patients Not intending to receive Transplant therapy) trial will evaluate the safety and efficacy of Velcade and dexamethasone (VD); Velcade, thalidomide and dexamethasone (VTD); and Velcade, melphalan and prednisone (VMP).
The primary endpoint of the trial is progression-free survival with secondary endpoints including duration of response, overall survival and overall safety / tolerability. Target enrolment for the trial is up to 500 patients and participants will remain in the trial on treatment for up to one year.
Upfront has a unique, adaptive design, providing the flexibility to modify the therapies (following an interim analysis) should a new standard of care be established in the marketplace. The adaptive design will help ensure that the most effective treatment options are evaluated in the most efficient way.
Multiple myeloma is the second most common hematologic malignancy and although the disease is predominantly a cancer of the elderly (the average age of onset is 65 to 70 years of age), recent statistics indicate both increasing incidence and younger age of onset.