The Multiple Myeloma Research Consortium (MMRC) and Merck initiated a Phase IIb study of Zolinza (Merck’s vorinostat), an oral histone deacetylase (HDAC) inhibitor, in combination with Velcade (Millennium’s bortezomib) for Injection, a proteasome inhibitor, in patients with relapsed and refractory multiple myeloma. 

The multicenter, open-label trial is sponsored by Merck and is part of the VANTAGE (Vorinostat Clinical Trials in Hematologic and Solid Malignancies) program. The trial will enroll 142 patients from more than 60 clinical centers. 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 response rate as well as progression-free survival, overall survival, time to disease progression and tolerability of the combination.

“The MMRC is particularly excited about this trial because data presented at the recent American Society of Hematology Annual Meeting demonstrated that combining histone deacetylase inhibitors, such as vorinostat, with the proteasome inhibitor, bortezomib, may help to overcome prior resistance to bortezomib. 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,” said Susan Kelley, M.D., chief medical officer of the MMRC.