MMRC and Merck initiate Phase II myeloma trial

This international, multicenter, open-label clinical trial is sponsored by Merck & Co and is part of the Vantage program. The trial will enroll 142 patients from more than 60 clinical centers including the following Multiple Myeloma Research Consortium (MMRC) member institutions: City of Hope, Dana-Farber Cancer Institute, Emory University’s Winship Cancer Institute, Hackensack University Medical Center, St Vincent’s Comprehensive Cancer Center of Saint Vincent Catholic Medical Centers of New York, and University Health Network.

Patients must be refractory to Velcade taken alone or in combination with other anti-myeloma therapies and have been exposed to prior immunomodulatory therapies, such as Revlimid or Thalomid. The study will assess the objective response rate as well as progression-free survival, overall survival, time to disease progression and tolerability of the combination.

In addition to the Phase II-b study, Merck has also initiated a Phase III, global, randomized, double-blind, placebo-controlled, multi-center trial (Vantage 088) investigating Zolinza in combination with Velcade in patients with relapsed multiple myeloma after one to three prior anti-myeloma regimen.

The Phase III trial will enroll 742 patients at more than 200 centers. The study will compare progression-free survival in patients taking Velcade in combination with either Zolinza or placebo. The study is open for enrollment.

Susan Kelley, chief medical officer of the MMRC, said: This Phase II trial will provide important clinical data to assess whether this combination may offer benefit to patients who have progressed on prior standard therapy for myeloma.