MMRF PRESS RELEASES
Multiple Myeloma Research Consortium (MMRC) and Merck initiate Phase II Trial of Zolinza with Velcade in Relapsed and Refractory Multiple Myeloma Patients
Multi-Center Trial to Evaluate Efficacy of HDAC Inhibitor, Proteasome Inhibitor Combination
Norwalk, CT — January 16, 2009
The Multiple Myeloma Research Consortium (MMRC) today announced the initiation of the 17th clinical trial in its clinical trial portfolio – a Phase IIb study of Zolinza® (vorinostat, Merck & Co.), an oral histone deacetylase (HDAC) inhibitor, in combination with Velcade® (bortezomib, Millennium: The Takeda Oncology Company) for Injection, a proteasome inhibitor, in patients with relapsed and refractory multiple myeloma. The study is open for enrollment.
This international, multicenter, open-label clinical trial is sponsored by Merck & Co. 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 including the following 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 (Princess Margaret Hospital). 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® (lenalidomide, Celgene Corporation) or Thalomid® (thalidomide, Celgene Corporation). 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.
"Vorinostat is one of a promising class of drugs that may offer a new treatment option for patients with multiple myeloma, particularly when combined with bortezomib," said Kenneth Anderson, MD, a member of the MMRC Steering Committee and Chief of the Division of Hematologic Neoplasia and Director of the Jerome Lipper Multiple Myeloma Center at Dana-Farber Cancer Institute. "This trial, and the others the MMRC is participating in, demonstrates the importance of collaborations between the MMRC and pharmaceutical sponsors in bringing new treatments to patients."
"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, MD, Chief Medical Officer of the MMRC.
For more information about this and other clinical trials, please visit www.myelomatrials.org or call 866-603-MMCT (6628).
Zolinza is approved in the United States for treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) who have progressive, persistent or recurrent disease on or following two systemic therapies. 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 1-3 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.
About the Multiple Myeloma Research Consortium (MMRC)
The Multiple Myeloma Research Foundation (MMRC), a 509a3 organization, was founded in 2004 by Kathy Giusti, a myeloma patient and Founder and Chief Executive Officer of the Multiple Myeloma Research Foundation (MMRF), to champion collaboration with and integration across academia and industry — while introducing high levels of accountability into the process from all involved in research and development.
At the core of the MMRC model is an Executive Committee, based in Norwalk, Conn., which provides strategic scientific and clinical oversight of the MMRC's drug development projects. The MMRC's Member Institutions include prominent multiple myeloma clinical research centers in North America: City of Hope, Dana-Farber Cancer Institute, Emory University's Winship Cancer Institute, the Cancer Center at Hackensack University Medical Center, H. Lee Moffitt Cancer Center & Research Institute, Indiana University, Mayo Clinic, Ohio State University, St. Vincent's Comprehensive Cancer Center of Saint Vincent Catholic Medical Centers of New York, University Health Network (Princess Margaret Hospital), University of Chicago, University of Michigan, University of California — San Francisco, and Washington University. The MMRC’s collaborative model also includes a Tissue and Data Bank, which serve as a "bridge" between laboratory and clinical research conducted by the MMRC members and a vital resource in advancing MMRC clinical trials and correlative science studies.
As a results-driven organization, the MMRC has, to date, partnered with pharmaceutical and academic sponsors to facilitate 17 Phase I and II clinical trials of the most promising, novel investigational compounds and new potential combination treatment approaches for myeloma. MMRC clinical trials are designed to include correlative studies, to better understand what drugs are most effective in treating various sub-groups of patients with myeloma, laying the foundation for the eventual development of additional treatment options for patients with myeloma.