The multi-center randomized Phase 3 double-blind clinical trial of Zolinza (vorinostat) or placebo in combination with Velcade (bortezomib) will be opening soon. The study will be conducted under Dr. Sundar Jagannath, Chief of the Multiple Myeloma Program at St. Vincent’s Comprehensive Cancer Center in New York.

In combination with the recently announced Phase 2B open-label clinical trial of Velcade plus Zolinza, Dr. Jagannath hopes that this Phase 3 trial will help to explore the effects of combining Zolinza and Velcade.

Zolinza, a histone deacetylase (HDAC) inhibitor, is already approved for cutaneous T-cell lymphoma.  It has also demonstrated anti-myeloma activity, alone and in combination with Velcade, in pre-clinical studies.

Previously, at the 13th congress of the European Hematology Association held in June 2008, Dr. Donna Weber et al (MD Anderson Cancer Center) reported a maximum tolerated dose of the combined drugs in her Phase 1 dose-escalation clinical trial of Zolinza plus Velcade: the standard dose of Velcade in combination with 400 mg of Zolinza in the first 14 days of a 21 day treatment. This combination of Zolinza and Velcade appeared to be effective.

At the 2008 annual meeting of the American Society of Clinical Oncology this year, Dr. Ashraf Badros et al (University of Maryland) presented the results of a similar Phase 1 trial of the two drugs combined in relapsed/refractory myeloma patients. This study further confirmed the promising effects of this combination treatment.

Other HDAC inhibitors are also in development, but approval by the FDA is a lengthy process. The opening of this Phase 3 trial is important in providing information on the combination of Zolinza and Velcade, so that patients may benefit from this treatment.

For more information, see the article "Phase III Zolinza®/Velcade® Trial Opening Soon" in the Fall 2008 issue of Myeloma Today (pdf).