The Multiple Myeloma Research Consortium (MMRC) announced Friday that it will partner with Merck & Co. to initiate Phase 2B clinical trials of Zolinza (vorinostat) in combination with Velcade (bortezomib). The trial is currently open for the enrollment of patients with relapsed multiple myeloma.

Zolinza, an oral histone deacetylase inhibitor that increases the cellular proteins that prevent cancer, has previously been approved for cutaneous T-cell lymphoma. Velcade has been previously approved for the treatment of multiple myeloma.

As a Phase 2 trial, this study is designed to test how the drug works and to continue safety assessments determined by Phase 1 trials. Phase 2B trials such as this are designed to test how well a drug works at the prescribed dose, while Phase 2A trials are specifically designed to test dosing requirements.

This clinical trial is part of the Vorinostat Clinical Trials in Hematologic and Solid Malignancies (VANTAGE) program and will enroll 142 patients from more than 60 clinical centers. All patients must have been nonresponsive to Velcade and have been exposed to prior therapies, such as Revlimid (lenalidomide) or thalidomide (Thalomid). The study will specifically test the response rate, progression-free survival, overall survival, time to disease progression, and tolerability of the combination.

According to Kenneth Anderson, a member of the MMRC and Director of the Multiple Myeloma Center at Dana-Farber Cancer Institute, "[Zolinza] is one of a promising class of drugs that may offer a new treatment option for patients with multiple myeloma."

For more information, see the MMRC press release about the clinical trial and the related Beacon article about how Zolinza works.