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TRINITAS CANCER CENTER ANNOUNCES CLINICAL TRIAL TO BEGIN FOR PREVIOUSLY UNTREATED PATIENTS WITH
MULTIPLE MYELOMA
A Phase II Trial with VELCADE® (PS-341), Cytoxan (cyclophosphamide), Dexamethasone and Thalomid® (VEL-CTD)
Aptium Oncology Research Network Protocol* #05-MM-01
Trinitas Comprehensive Cancer Center (Trinitas CCC) announced today its participation in a nationwide, multi-center clinical trial for previously untreated patients with multiple myeloma. As part of the Aptium Oncology Research Network, Trinitas CCC is working in partnership with several U.S. cancer centers and principal investigators. Dr. Gerardo Capo is serving as the principle investigator locally at Trinitas CCC. Participation in the 05-MM-01 study is currently available in NJ through the Trinitas Comprehensive Cancer Center, which is currently one of 10 medical facilities in the United States accepting volunteers for this Phase II study.
Heading the study for the Aptium Oncology Research Network is Dr. Brian Durie from the Cedars Sinai Outpatient Cancer Center in Los Angeles. Dr. Durie is the National Director for Hematology Malignancies for Aptium Oncology and Chairman of the International Myeloma Foundation. Also leading this study and collaborating with Trinitas CCC is Dr. Sundar Jagannath, Chief of the Multiple Myeloma Program and Bone Marrow and Stem Cell Transplantation Program at St. Vincent's Comprehensive Cancer Center in New York City and Editor-in-Chief of Clinical Lymphoma & Myeloma.
Trinitas CCC researchers hope to move rapidly to begin this clinical trial. The Phase II study is open label, single arm and multi-institutional. It will evaluate an investigational* treatment regimen that includes sequential use of multiple myeloma drugs. The drugs in this study consist of VELCADE® (developed and provided by Millennium Pharmaceuticals, Inc.), Cytoxan (commercially available), dexamethasone (commercially available), and Thalomid® [provided by Celgene Corporation through the PTAP (Protocol Treatment Assistance Program)] and will be administered in varying doses and combinations in six treatment cycles.
Over the past three decades, the treatment for multiple myeloma has been mainly palliative with a median life expectancy of 3 years and less than 10% living 10 years or longer. "Nearly all patients experience a relapse after their initial treatment, and unfortunately, there is still no cure," said Gerardo Capo, Medical Oncology and Hematology specialist at the Trinitas Comprehensive Cancer Center. "The best therapies we have still only provide a controlled remission in the most successful instances. There is clearly an urgent need for more therapies. This clinical trial may offer an option for multiple myeloma."
Participants in the 05-MM-01 clinical trial must meet the following eligibility:
• A confirmed diagnosis of multiple myeloma requiring treatment
• No prior chemotherapy, immunotherapy, vaccine, or other agents for the treatment of active multiple myeloma
• Adequate cardiac, liver and kidney function
• Age 18 or older
"We have some of the best minds in Multiple Myeloma research working on this clinical trial," said Gary Horan, President of Trinitas Hospital. "Cancer is a major focus of our clinical research activities at Trinitas and this clinical trial is a prime example of our commitment to discover possible ways to fight cancer."
For additional information on this clinical trial, please visit our web site at www.trinitasccc.org or contact Maria Serrano, Clinical Research Manager at 908-994-8539.
* The treatment regimens in this study are considered investigational due to the fact that there has not been FDA approval of the use of the drugs in these combinations for the treatment of newly diagnosed multiple myeloma. VELCADE® is currently approved by the United States Food and Drug Administration (US FDA) and it is registered in Europe for the treatment of multiple myeloma patients who have received at least one prior therapy.
Click here for more information about Multiple
Myeloma.