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February 2009 St. Vincent's Comprehensive Cancer Center
www.svccc.org
  

Multiple myeloma is a complex cancer of bone marrow plasma cells, a type of white blood cell that produces antibodies called immunoglobulins and plays a critical role in the immune system. Normally, they make up a very small portion (less than 5 percent) of the cells in the bone marrow, the soft material in the center of most bones. In people with multiple myeloma, more than 10 percent and sometimes higher than 90 percent of the cells in their bone marrow are plasma cells. This is because the abnormal cells divide again and again, making more and more abnormal cells. These abnormal plasma cells build up in the bone marrow and crowd out normal cells. Though multiple myeloma affects the bone, it is considered a hematologic (blood-based) malignancy because the cancerous cells are plasma cells, not bone cells. For more information visit www.myelomatreatment.org.

Effective September 19, 2008, the Foundation for the Accreditation of Cellular Therapy (FACT) has recertified and granted St. Vincent’s accreditation for autologous stem cell transplantation. The Stem Cell Transplant program also received accreditation by the AABB, an international association of blood banks and individuals involved in activities related to transfusion and transplantation.

Medical Oncologist, Ajai Chari, MD has joined the Multiple Myeloma and Transplant Program along with Dr. Sundar Jagannath and Dr. Amitabha Mazumder. He served as an Assistant Professor of Medicine at the Columbia University College of Physicians and Surgeons, where he founded the multiple myeloma program and was a member of the stem cell transplant program.

Dr. Chari was awarded two research fellowships from the National Institutes of Health as an undergraduate, a Howard Hughes Medical Institute Fellowship during medical school, and an Amgen Research Award during hematology/oncology fellowship.

Dr. Chari has also been recognized for excellence in the education of physicians in training. At the Columbia University College of Physicians and Surgeons, he received the Best Junior Faculty Teacher Award in 2008 and the Ewig Teaching Award by the Department of Internal Medicine.

Ajai Chari graduated with a B.S. in Biology and a B.A. in Psychology from Stanford University, where he was elected to Phi Beta Kappa. He received his MD from the University of California, Los Angeles School of Medicine in 1999. He completed residency in internal medicine at New York Presbyterian Hospital, Columbia University Medical Center and subsequently completed his fellowship in Hematology/Oncology at the University of California. He is board certified in Internal Medicine, Oncology, and Hematology and is a member of the American Society of Hematology and American Society of Clinical Oncology.

St. Vincent’s Comprehensive Cancer Center has its own clinical lab, making it easy and convenient to have blood drawn and tested. Additionally, the cancer center lab has been implementing new technology that allows us to process more tests in-house and provide patients with better quality and a faster turnaround of results.

The laboratory was the first in the United States to implement the Pyrogallol Red Assay on the Ortho Fusion chemistry analyzer. This method better measures certain urine proteins in multiple myeloma which gives the clinician a better indicator of disease status.

We have also added two new tests, Free Kappa Light Chains and Free Lambda Light Chains on a new instrument called the SPA PLUS. St. Vincent’s was the first clinical laboratory in the United States to research and implement this new technology. Our laboratory participated in the FDA studies that supported method validation. Free light chain quantitation aids in the diagnosis and monitoring of multiple myeloma and related disorders. The SPA PLUS has proven to be more accurate, reproducible and reliable than the method previously in use. Turnaround time for results are dramatically reduced. Instead of 3-4 days, results are generated in about 1 hour with the new technology.

We have also recently implemented a new platelet aggregation test to measure aspirin sensitivity.

The Multiple Myeloma and Transplant Program participates in cutting edge research to assist in the development of potential novel, targeted therapies. This is being done with the hope that there will be a fast discovery of a cure for the disease. At the present time, Dr. Sundar Jagannath is the international and national Principal Investigator on two promising studies. Locally, Drs. Mazumder and Chari are co-investigators.

088-00: An International, Multicenter, Randomized, Double-Blind Study of Vorinostat (MK-0683) or Placebo in Combination with Bortezomib in Patients with Multiple Myeloma

The purpose of the study is to find out if a new drug called vorinostat is safe and can help people with multiple myeloma when the drug is added to a treatment with another drug already approved for multiple myeloma known as bortezomib.

Vorinostat has already received regulatory approval by the U.S. Food and Drug Administration (FDA) for the treatment of T cell non-Hodgkin’s lymphoma in the United States.

The use of vorinostat in multiple myeloma is experimental and has not been approved by the FDA.

Bortezomib has received approval by the U.S. Food and Drug Administration (FDA) and the European Medication Agency (EMEA) for the treatment of multiple myeloma. Everyone in this study will be treated with bortezomib. Some people will take bortezomib with vorinostat while others will take bortezomib with placebo (a pill with no active substance sometimes referred to as a sugar pill).
About 742 people ages 18 years or greater will participate in the study from all national and international sites. At SVCCC, 5-10 subjects will be taking part in this study.

CP14A011: A Phase I Study of GRN163L in Combination with Bortezomib and Dexamethasone in Patients with Relapsed or Refractory Multiple Myeloma

The main purpose of this research study is to determine the maximum tolerated dose of an experimental drug, GRN163L, in combination with bortezomib (Velcade®) with or without dexamethasone (Decadron®). Laboratory studies have shown that GRN163L stops cancer cells from growing in animals by affecting a protein in these cells called telomerase. This study will determine the maximum amount of GRN163L that can be given safely to individuals with multiple myeloma cancer who are also getting Velcade with or without Decadron. The study will also test how much GRN163L is in the subject’s blood at different times during and following the first GRN163L infusion and the effects of GRN163L on the cancer. GRNL163L is not approved by the U.S. Food and Drug Administration (FDA) and is being tested in people for the first time.

Approximately 40 patients will take part in this study. The study will be conducted at multiple centers in the United States.