Phase III (E1 A00) Study Results Presented at ASCO
New Orleans, LA – (June 7, 2004) The International Myeloma Foundation (IMF), www.myeloma.org has commended the Eastern Cooperative Oncology Group (ECOG) report discussing the clinical benefits from a Phase III study (E1A00) using thalidomide plus dexamethasone as therapy in multiple myeloma. The clinical data was presented yesterday,
June 6, at the American Society of Clinical Oncology (ASCO) conference. According to the findings presented, results of the study indicate patients newly diagnosed with multiple myeloma, an incurable cancer of the bone marrow, responded significantly better to treatment with the oral drug combination of thalidomide plus dexamenthasone (thal/dex).
“This is a pivotal study that can clearly show the impact of thalidomide in a front line setting,” stated Brian G.M. Durie, M.D., Chairman of the International Myeloma Foundation, and National Director for Hematologic Research and Myeloma Programs Salick Research Network and
. “Reviewing thalidomide’s overall potential, the results of the study indicate an important step in regulatory approval with agencies such as the Federal Drug Administration,” said Dr. Durie.
In the just completed study, headed by S. Vincent Rajkumar, M.D., hematologist and associate professor of medicine at Mayo Clinic in Rochester MN, there was a notable statistical difference of 59 percent versus 41 percent in response rates at 4 months with thalidomide plus dexamethasone compared to dexamethasone alone. When the data were analyzed for “Best Response” in reduction in serum paraprotein concentrations, 68% responded to the thalidomide/dexamethasone arm and 46% to the dexamethasone only arm.
According to Susie Novis, President of the International Myeloma Foundation, “Patients will be offered a new therapy providing a better a quality of life during and after their treatment regime. The IMF commends the researchers and patients involved in the study. This is urgent news for us to disseminate immediately to the IMF membership.”
The International Myeloma Foundation (IMF) was founded in 1990 and is a 501(c)(3) non-profit corporation. The IMF is dedicated to finding a cure for multiple myeloma, also known as plasma cell neoplasm. The IMF is governed by a Board of Directors and guided by a Scientific Advisory Board. With a positive and expansive outreach to 120,000 members in over 100 countries, the IMF conducts educational patient seminars, clinical conferences, and scientific workshops; funds grant and scholarship programs; and offers patient and family support, advocacy and educational initiatives.
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