Millennium begins pivotal multiple myeloma drug trial

The trial, named Upfront and conducted primarily at community physician networks nationwide, will compare three Velcade-based therapies. The company is developing the drug for registration in front-line MM based on strong survival data seen in earlier clinical trials.

“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,” said Ruben Niesvizky, the trial’s principal investigator.

The trial will evaluate the safety and efficacy of Velcade and dexamethasone; 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 enrollment for the trial is up to 500 patients and participants will remain in the trial on treatment for up to one year.

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. In the US, more than 50,000 individuals have MM and 20,000 new cases are diagnosed each year.