Preliminary results from a large, randomized clinical trial for patients with newly diagnosed multiple myeloma, a cancer typically found in bone marrow, has shown that use of a low dose of the steroid dexamethasone (Decadron ®), in combination with lenalidomide (Revlimid ®) is associated with improved survival when compared to a treatment regimen with lenalidomide and a higher, standard dose of dexamethasone. 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).

The data monitoring committee overseeing the trial (known as E4A03)* recommended that the survival results from a recent interim analysis be made public because of early differences being seen in overall survival rates. Researchers found that patients in the study who received low-dose dexamethasone and lenalidomide had a one-year survival of 96 percent compared to 86 percent for patients treated with the standard-dose of dexamethasone and lenalidomide. In addition, there were fewer side effects associated with the low-dose dexamethasone and lenalidomide. Detailed results from this trial will be presented at the American Society of Clinical Oncology annual meeting in Chicago, Ill., from June 1 to 5, 2007.

"These results have major implications for myeloma therapy," noted study chair Vincent Rajkumar, M.D., Mayo Clinic, Rochester, Minn. "The results of this study, particularly lenalidomide plus low-dose dexamethasone, are very positive and in my opinion represent a real step forward in the treatment of this disease."

A total of 445 patients with newly diagnosed multiple myeloma, who had not previously received chemotherapy, were enrolled in this study between 2004 and 2006. Patients were randomized to one of two treatment arms. One patient group received lenalidomide and dexamethasone given at standard doses. The second group received standard-dose lenalidomide and low-dose dexamethasone. The primary objective was to determine if the low-dose arm would have similar response rates and lower toxicity than the standard-dose arm.

"Randomized trials are the gold standard for evaluation of the effectiveness of new treatments," said NCI Director John E. Niederhuber, M.D. "These results also emphasize once again the importance of NCI's rigorous program of oversight, which brings highly qualified clinician scientists to serve as members of data safety and monitoring committees."

Lenalidomide, a derivative of thalidomide, was approved by the U.S. Food and Drug Administration in 2006 to be used in combination with dexamethasone for the treatment of multiple myeloma in patients who received at least one prior therapy for their disease. Dexamethasone is a steroid that acts as an anti-inflammatory and as an immunosuppressant and has numerous uses in medical practice.

"ECOG has a long history in developing new treatments for multiple myeloma", according to Robert L. Comis, M.D., ECOG group chairperson. "The application of this effective and less toxic approach will benefit many patients with this disease."

Celgene, Inc., Summit, N.J., which manufactures lenalidomide, provided lenalidomide under a Clinical Trials Agreement with NCI for the clinical development of lenalidomide.

Multiple myeloma is a cancer of plasma cells that are found in blood and bone marrow. In 2007, an estimated 19,900 people in the United States will be diagnosed with multiple myeloma and an estimated 10,790 people will die of the disease.

For more information about multiple myeloma, visit the NCI Web site at http://myeloma.cancer.gov.

*E4A03: A Randomized Phase III Study of CC-5013 plus Dexamethasone vs. CC-5013 plus Low Dose Dexamethasone in Multiple Myeloma with Thalidomide plus Dexamethasone Salvage Therapy for Non-responders.

The protocol for this study can be found at http://www.cancer.gov/clinicaltrials/ECOG-E4A03 .

For more information about cancer, please visit the NCI Web site at http://www.cancer.gov, or call NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237).

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