WHITE PLAINS, N.Y., March 9 /PRNewswire/ -- The Leukemia & Lymphoma Society is encouraged by this week’s announcement from Celgene Corp. that its investigational drug Revlimid(R) has shown promise in the treatment of relapsed or refractory myeloma in two phase III clinical trials.
Celgene said that an independent committee analyzing both phase III multiple myeloma trials indicated that the tests exceeded expectations. The pharmaceutical company said the committee found a statistically significant improvement in the time it took for the disease to worsen in patients receiving Revlimid plus a steroid compared with patients receiving the steroid and a placebo.
“We need to review the details of these results, but if Revlimid proves effective in delaying the progress of myeloma then it will be an important incremental step in the treatment of a disease that has been very resistant to therapy,” said Marshall Lichtman, M.D., executive vice president, Research & Medical Programs, The Leukemia & Lymphoma Society. “This development offers hope of extended survival for myeloma patients.”
Celgene has begun discussions with the U.S. Food and Drug Administration and international regulatory authorities regarding the submission of this data for potential approval. The studies proved so effective that the company halted them early to allow all participating patients access to Revlimid. The trials enrolled 705 patients and were being conducted in 97 sites internationally.
Revlimid is not approved for clinical use in the United States or anywhere else in the world. Celgene is evaluating treatments with Revlimid for a broad range of blood and cancer conditions, including multiple myeloma, myelodysplastic syndromes (MDS) as well as solid tumor cancers.
About Myeloma
Myeloma is a disease that starts in the marrow, the spongy tissue found in the center of the bone where red and white blood cells are made. In myeloma, one type of developing white blood cell (B lymphocyte), grows continually to form a mass, or tumor, in the marrow. That takes on the appearance of plasma cells.
When there are too many plasma cells, they crowd out developing normal white and red blood cells. The plasma cells in myeloma make factors that cause bone to dissolve, leading to fractures. They also do not make antibodies to infectious agents. Fewer red blood cells result in less oxygen being carried to the tissue throughout the body, causing fatigue and shortness of breath with exercise. Fewer white blood cells make it harder to fight infection.
About 90 percent of all myelomas are found in more than one site, including the ribs, backbone, pelvis, shoulder bones, breastbone and skull, thus the most common form is known as multiple myeloma.
Nearly 55,000 people in the United States are living with myeloma. More than 15,000 new cases were diagnosed in the United States in 2004. The median age at diagnosis is 71 years of age and it rarely occurs in people under age 50. Americans of African descent have a much higher incidence rate (11.9/100,000) of myeloma than those of European descent (5.3/100,000).
Chemotherapy for myeloma has led to sustained remissions in some patients. At times, two or three drugs are used simultaneously. Velcade(R) has been approved for treating myeloma in patients that have had at least two prior therapies. Thalidomide and its derivatives have been added to the drugs and found to be very useful in the treatment of the disease. Treatment may include intensive chemotherapy followed by stem cell transplantation to restore normal blood cell production. Usually, the patient’s own stem cells are used.
For more information, readers should visit the Society’s Web site, http://www.lls.org/myelomaeducation , to find out about upcoming and archived education programs. These programs are offered at no charge. Further details of treatment and supportive care and the beneficial and adverse effects of treatment may be obtained from the Society’s information booklet Myeloma.
About The Leukemia & Lymphoma Society
The Leukemia & Lymphoma Society(R), headquartered in White Plains, NY, with 63 chapters in the United States and additional branches in Canada, is the world’s largest voluntary health organization dedicated to funding blood cancer research and providing education and patient services. The Society’s mission: Cure leukemia, lymphoma, Hodgkin’s disease and myeloma, and improve the quality of life of patients and their families. Since its founding in 1949, the Society has invested more than $360 million in research specifically targeting leukemia, lymphoma and myeloma. Last year alone, the Society made more than 812,000 contacts with patients, caregivers and healthcare professionals.
For more information about blood cancer, visit http://www.lls.org/ or call the Society’s Information Resource Center (IRC), a call center staffed by master’s level social workers, nurses and health educators who provide information, support and resources to patients and their families and caregivers. IRC information specialists are available at (800) 955-4572, Monday through Friday, 9 a.m. to 6 p.m. ET.
Contact: Andrea Greif
914-821-8958
The Leukemia & Lymphoma Society
CONTACT: Andrea Greif of The Leukemia & Lymphoma Society,+1-914-821-8958