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The Multiple Myeloma Research Consortium (MMRC) Announces Initiation of First Four-Drug Combination Study to Treat Newly Diagnosed Multiple Myeloma Patients


NORWALK, Conn. — August 13, 2008
MMRC and University of Michigan Spearhead Clinical Trial with Four FDA-Approved Drugs

(BUSINESS WIRE)--The Multiple Myeloma Research Consortium (MMRC) today announced the initiation of a four-drug combination study with REVLIMID® (lenalidomide), VELCADE® (bortezomib) for Injection, DOXIL® (doxorubicin HCl liposome injection) and dexamethasone for the treatment of multiple myeloma in patients who are previously untreated.

The University of Michigan, one of fifteen MMRC member institutions, will evaluate the safety and efficacy of the drug combination in patients who have not received any prior therapy for multiple myeloma. "This four drug combination study is a pivotal study for newly diagnosed multiple myeloma patients as they may benefit from the synergistic effects of four currently available drugs," said Principal Investigator, Andrzej Jakubowiak, MD, PhD, Associate Professor, Hematology/Oncology at the University of Michigan. "We look forward to testing this promising new combination." The multi-center, open-label, multiple dose, dose-escalation Phase I/II study will enroll up to 40 patients in the first phase and an additional 35 patients in the second phase.

"The MMRC is proud to advance this combination trial as it aligns with our commitment to expand our portfolio of treatment options for multiple myeloma patients — especially those that show the most potential in effectively treating patients," said Kathy Giusti, Founder and Chief Executive Officer of the MMRC, and a myeloma patient.

About REVLIMID

REVLIMID, discovered and manufactured by Celgene Corporation, is approved for use in the EU, US Switzerland and Argentina for the treatment of multiple myeloma in combination with dexamethasone in patients who have received at least one prior therapy, and Australia for patients with multiple myeloma whose disease has progressed after one therapy. REVLIMID is an IMiDs compound, a member of a proprietary group of novel immunomodulatory agents. For more information, visit www.revlimid.com.

About DOXIL

DOXIL, manufactured by Ortho Biotech Products, L.P., is indicated in combination with Velcade® (bortezomib) for the treatment of patients with multiple myeloma who have not previously received Velcade and have received at least one prior therapy, and for the treatment of ovarian cancer whose disease has progressed or recurred after prior platinum based therapy. For more information, visit www.doxil.com.

About VELCADE

VELCADE is being co-developed by Millennium: The Takeda Oncology Company, and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Millennium is responsible for commercialization of VELCADE in the U.S. and Janssen-Cilag is responsible for commercialization in Europe and the rest of the world. Janssen Pharmaceutical K.K. is responsible for commercialization in Japan. For more information about VELCADE clinical trials, patients and physicians can contact the Millennium Medical Product Information Department at 1-866-VELCADE (1-866-835-2233).

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, to accelerate the development of novel and combination treatments for patients with multiple myeloma by facilitating innovative clinical trials and correlative studies.

At the core of the MMRC model is an exceptional Executive Committee, based in Norwalk, Conn., which provides strategic oversight of the MMRC's drug development projects. The MMRC's 15 Member Institutions are among the prominent academic research centers worldwide: 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, Roswell Park Cancer Institute, 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 model also includes an advanced Tissue and Data Bank, which serve as a "bridge" between laboratory and clinical research conducted by the MMRC and a vital resource in advancing MMRC clinical trials and correlative science studies.

As a results-driven organization, the MMRC has facilitated to date 15 Phase I and II clinical trials of the most promising novel compounds and combination approaches. MMRC clinical trials are designed to include correlative studies to better understand what drugs are most effective in treating various sub-groups of myeloma patients, laying the foundation for the eventual development of personalized medicines as a treatment for myeloma.

For more information, visit www.themmrc.org.