--Second Closure of Multi-Center Trial in 4 Weeks Reinforces Benefits of Using REVLIMID® with Low Dose Steroids in Myeloma--
--Experts consider Novel Agents as Alternatives to Bone Marrow Transplants for Front Line Treatment--
North Hollywood, CA, May 15, 2007 -- The International Myeloma Foundation (IMF) - supporting research and providing education, advocacy and support for myeloma patients, families, researchers and physicians - today said that for the second time in four weeks a multi-center myeloma trial using REVLIMID® has demonstrated positive findings and therefore has been halted early. As a result medical experts are backing the use of new, less toxic and more tolerable treatments for multiple myeloma, the second most common of the blood cancers in the United States.
- In April, the Eastern Cooperative Oncology Group (ECOG) stopped the use of high dose dexamethasone, a steroid commonly used when treating patients with REVLIMID, (lenalidomide) an oral medication from Celgene. Based on the findings, the data safety monitoring committee recommended all patients in the study be moved to a regimen of REVLIMID with low-dose dexamethasone, which demonstrated improved survival and was better tolerated.
- Now based on these findings and early analysis of its own data the Southwest Oncology Group (SWOG), the largest of the NIH sponsored multi-center cooperative group, has brought its trial of high dose dexamethasone versus Revlimid plus high dose dexamethasone to an early close and also recommended patients be transitioned to a REVLIMID/LDD regimen.
- Based on these findings, The International Myeloma Foundation’s US MYELOMA FORUM, a committee of the nation’s leading myeloma experts, is considering the first large, inter-group trial for newly-diagnosed patients using novel agents (either REVLIMID with low-dose dexamethasone or REVLIMD plus other agents such as VELCADE®with low-dose dexamethasone) without front-line transplant.
"This is an important series of steps for myeloma patients, as we now have regimens that are more tolerable and at the same time may be more effective," said Brian G.M. Durie, M.D., chairman and co-founder of the IMF and co-chair of the SWOG myeloma committee. "Based on this new clinical evidence, we believe that regimens that include REVLIMID with low dose steroid are an important option for patients with myeloma at all stages of the disease."
Susie Novis, president and co-founder of the IMF, added, "These findings are particularly exciting because the use of low dose dexamethasone was proposed by patients themselves, showing how much can be achieved when we empower patients and listen to what they have to say. In addition, closer cooperation between the two large cooperative groups, SWOG and ECOG, will provide important benefits to patients."
Myeloma, also called multiple myeloma, is a cancer of the bone marrow that affects production of red cells, white cells and stem cells. It affects an estimated 750,000 people worldwide, and in industrialized countries it is being diagnosed in growing numbers and in increasingly younger people.
ABOUT The International Myeloma Foundation
The International Myeloma Foundation is the oldest and largest myeloma organization, reaching more than 135,000 members in 113 countries worldwide. A 501 (c) 3 non-profit organization dedicated to improving the quality of life of myeloma patients and their families, the IMF focuses on four key areas: research, education, support and advocacy. To date, the IMF has conducted more than 100 educational seminars worldwide, maintains a world-renowned hotline, and operates Bank on a Cure®, a unique gene bank to advance myeloma research. The IMF can be reached at 818-487-7455. The global Website is www.myeloma.org with a companion Website in Spanish at www.myelomala.org.
|International Myeloma Foundation
|| Stephen Gendel, BioCom Partners
|| 212 918-4650