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Multiple Myeloma Research Consortium (MMRC) Initiates Phase IB/II Clinical Trial of Treanda?? in Combination with Revlimid?? and Dexamethasone in Patients with Relapsed Multiple Myeloma


First Clinical Trial Launched Using Innovative Platform Designed to Enhance Investigator-Led Studies in the MMRC

Norwalk, Connecticut — April 6, 2010

The Multiple Myeloma Research Consortium (MMRC) today announced the initiation of a Phase Ib/II study of bendamustine (Treanda®), an anticancer agent currently approved for the treatment of chronic lymphocytic leukemia (CLL) and B-cell non-Hodgkin’s lymphoma (NHL), in combination with lenalidomide (Revlimid®) and dexamethasone in patients with relapsed multiple myeloma. The trial, led by Shaji Kumar, MD, of Mayo Clinic, is open for enrollment at Mayo Clinic (Rochester, Minn.), City of Hope Cancer Center (Duarte, Calif.) and the University of Chicago (Chicago, Ill).

This study marks the first clinical trial to be conducted using the MMRC’s unique collaborative Investigator Sponsored Trial (IST) Platform. The MMRC IST Platform includes a range of programs developed to ensure the rapid execution of multi-site investigator initiated trials within the Consortium and to generate high-quality data from these clinical studies. These programs include protocol writing support, clinical project management, data and biostatistical management, trial data monitoring, and multi-site contract administration.

Multi-center investigator sponsored trials such as these are critical to advance promising therapeutics that may otherwise have languished for lack of resources,” said Dr. Kumar. “Our goal is to deliver meaningful data that will strengthen decisions for further clinical development and, may be used in support of regulatory submissions for drug approval.

The MMRC Collaborative IST Platform is the latest business solution developed to ensure high-quality trials are conducted as efficiently as possible within the Consortium network. Solutions such as these have helped the MMRC open its trials as much as 35 percent faster than the industry standard for oncology clinical trials. To date, 24 clinical trials have opened for enrollment.

As trials conducted through the MMRC IST Platform demonstrate, we are fully committed to sharing the risk of early-stage drug development with our partners in the biotech and pharmaceutical industry, and to implementing measures to enhance quality, and efficiency of these important investigator-initiated clinical trials,” said Susan Kelley, MD, Chief Medical Officer of the MMRC.

About the Multiple Myeloma Research Consortium (MMRC) The Multiple Myeloma Research Consortium (MMRC) is a 509(a)3 non-profit organization that integrates leading academic institutions to accelerate drug development in multiple myeloma. It is led from MMRC offices in Norwalk, Conn., and comprises 13 member institutions: University of California, San Francisco, 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, 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, and Washington University.

The MMRC was founded in 2004 by Kathy Giusti, a myeloma patient, and with the help of the scientific community. The MMRC is a sister organization to the Multiple Myeloma Research Foundation (MMRF), the world's leading funder of multiple myeloma research. The MMRC is widely recognized as an optimal research model to rapidly address critical challenges in drug development and to explore opportunities in the today's most promising research areas–genomics, compound validation, and clinical trials. The MMRC is the only consortium to join academic institutions through membership agreements, customized IT systems, and an integrated tissue bank.

For more information, please visit: www.themmrc.org. Media Contact: Terri Clevenger, 203-227-0209, tclevenger@continuumhealthcom.com