We are international
Donate
TEXT SIZE   


THE INTERNATIONAL MYELOMA FOUNDATION SAYS ECOG RESULTS COULD IMPROVE SURVIVAL WHILE REDUCING SIDE EFFECTS FOR MANY PATIENTS
Findings Challenge Traditional Assumption that More-Is-Better when Treating Cancer
04.04.07
- Findings Show Survival Improvement with Lower Doses of Dexamethasone, the Steroid Commonly Used with REVLIMID® and other Drugs in Newly Diagnosed Myeloma -

- Findings Challenge Traditional Assumption that More-Is-Better when Treating Cancer -

North Hollywood, CA, USA, April 4, 2007 - The International Myeloma Foundation (IMF)—supporting research and providing education, advocacy and support for myeloma patients, families, researchers and physicians—today said physicians should consider lowering the dose of the steroid dexamethasone when treating patients with multiple myeloma. High dose dexamethasone has been used as standard therapy for the treatment of myeloma alone and in combination with other drugs. However, interim findings from a large ongoing clinical trial of REVLIMID® plus dexamethasone in newly diagnosed patients, suggest lowering the "dex" dose may not only reduce side effects, but also may improve survival.

The trial, known as E4A03, is sponsored by the National Cancer Institute and led by the Eastern Cooperative Oncology Group (ECOG). Based on these findings, ECOG has suspended further patient enrollment for this trial and has recommended that lower dose "dex" be considered for patients currently being treated on the high dose arm of the trial. Because of the public health implications, these findings are being made public immediately. The complete details will be presented at a cancer conference later this spring.

"Improved survival with low dose 'dex' and REVLIMID is an important finding because it further improves the outcome for an already successful treatment, while low dose dexamethasone is better tolerated by patients," said Brian G. M. Durie, M.D., chairman and co-founder of the International Myeloma Foundation. "We are recommending that physicians consider these findings when treating their patients across all stages of myeloma and that patients discuss these findings with their physicians."

Susie Novis, president and co-founder of the IMF, added, "These findings may also have wider implications for cancer treatments because they challenge the traditional notion that patients should be treated with the highest dose of medicine they can tolerate. Now we have evidence that in some situations, less may be more when treating cancer."

REVLIMID from the Celgene Corporation is the newest of the group of medicines called novel therapies that have significantly improved the outlook for patients with myeloma. Preliminary analysis of the ECOG data shows patients taking REVLIMID plus low dose dexamethasone had a 96% survival rate after one year with a reduced risk of side effects. One year survival for those taking the higher dose of dexamethasone was 86%. The findings are expected to prompt review of the dexamethasone dose when paired with other medications used in myeloma such as THALOMID®, and discussions are already underway to change dosing in other clinical trials using REVLIMID with dexamethasone.

"This is a very exciting finding for patients," said Michael Katz, who, as a 16-year myeloma survivor, is a vice president of the IMF and co-chair of ECOG's Patient Representatives Committee. "When ECOG's patient representatives proposed adding a lower dose 'dex' arm to this trial, we were just looking for a way to make the treatment more tolerable; we never expected that the outcome for patients would actually improve. We are grateful to all of the patients who participated and to ECOG Group chair, Dr. Robert Comis and Myeloma Committee chair, Dr. Vincent Rajkumar, for supporting the notion of testing lower doses and making this trial happen."

Mr. Katz continued: "This result sends an important signal to physicians that maximum tolerated dose is not always the right answer when treating patients with cancers like myeloma that are incurable, but highly treatable."

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. The REVLIMID/dexamethasone combination is approved for use in the United States by the FDA and has been recommended for approval by the European Medicines Agency.

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 +1 818-487-7455. The global Website is www.myeloma.org with a companion Website in Spanish at www.myelomala.org.

CONTACT:
International Myeloma Foundation
800 452-2873

Media:
Stephen Gendel, BioCom Partners
212 918-4650


 related articles
National Cancer Institute Press Release: Low-dose Steroid Combined with Lenalidomide Prolongs Survival Compared with High-dose Steroid for Multiple Myeloma Treatment
Mayo Clinic Press Release: Multiple Myeloma Clinical Trial Closes Early Due to Superior Results of Comparative Treatment
Celgene Press Release: ECOG Phase III Newly Diagnosed Multiple Myeloma Trial (E4A03) Reports LENALIDOMIDE Plus Low-Dose Dexamethasone Suggests Survival Advantage for Patients with Multiple Myeloma
Abstract: Phase III trial of lenalidomide plus high-dose dexamethasone compared to lenalidomide plus low-dose dexamethasone in newly diagnosed multiple myeloma
Understanding Revlimid®
Understanding Thalidomide Therapy
Understanding Dexamethasone and Other Steroids
National Institute Of Health Release: Low-dose Steroid Combined with Lenalidomide Prolongs Survival Compared with High-dose Steroid for Multiple Myeloma Treatment


You might also be interested in:

National Cancer Institute Press Release: Low-dose Steroid Combined with Lenalidomide Prolongs Survival Compared with High-dose Steroid for Multiple Myeloma Treatment

Mayo Clinic Press Release: Multiple Myeloma Clinical Trial Closes Early Due to Superior Results of Comparative Treatment
Mayo Clinic Cancer Center announced today that a multiple myeloma clinical trial has shown a significant improvement in survival with lenalidomide plus low-dose dexamethasone therapy compared to lenalidomide plus high-dose dexamethasone.

Celgene Press Release: ECOG Phase III Newly Diagnosed Multiple Myeloma Trial (E4A03) Reports LENALIDOMIDE Plus Low-Dose Dexamethasone Suggests Survival Advantage for Patients with Multiple Myeloma

Abstract: Phase III trial of lenalidomide plus high-dose dexamethasone compared to lenalidomide plus low-dose dexamethasone in newly diagnosed multiple myeloma
(E4A03): A trial coordinated by the Eastern Cooperative Oncology Group.
S. V. Rajkumar, S. Jacobus, N. Callander, R. Fonseca, D. Vesole, M. Williams, R. Abonour, D. Siegel, P. Greipp

Understanding Revlimid®
Learn more about Revlimid® (lenalidomide), approved by the FDA for use in myeloma.

Understanding Thalidomide Therapy
Using thalidomide to treat myeloma is a new idea, but thalidomide itself has been studied for many decades.

Understanding Dexamethasone and Other Steroids
What dexamethasone is, how it works, possible side effects, and more.

National Institute Of Health Release: Low-dose Steroid Combined with Lenalidomide Prolongs Survival Compared with High-dose Steroid for Multiple Myeloma Treatment
The clinical trial was sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health, and conducted by a network of researchers led by the Eastern Cooperative Oncology Group (ECOG).