Results from two wide international studies revealed that patients with relapsed or refractory multiple myeloma, who were treated with Revlimid (lenalidomide) and Dexamethasone had significantly improved progression-free and overall survival compared to patients treated with dexamethasone and placebo.

Multiple myeloma is a cancer of the blood's plasma cells that causes almost 11,000 deaths each year in the United States. Specialists say that the new discoveries and the recent FDA approval of the drug should have a significant result in treating patients with multiple myeloma. This form of cancer appeared to be a very difficult disease to treat historically.

The first study was made in Canada and in the U.S. and involved 353 patients who had undergone at least one previous therapy for their disease. The second study was a multicenter effort led by Dr. Meletios Domipoulos of the University of Athens, Greece and involved 351 patients from entire Europe. Both studies had identical results.

"These newer drug therapies and drug combinations are enabling people to live with their diseases longer, to possibly get a good response, then there might be a good combination later on that they can try. It's good news to have another drug in the arsenal of this disease, which can be very difficult to treat," said Hildy Dillon, vice president of patient services disease programs at the Leukemia & Lymphoma Society in White Plains, N.Y.

The studies revealed that patients treated with the lenalidomide and dexamethasone registered an overall response rate of over 60 percent compared with about 20 percent for patients treated with dexamethasone and placebo.

"Myeloma, also called multiple myeloma, is of growing interest and concern. Statistics show the number of diagnoses is increasing in the United States where most cancers are decreasing, and myeloma is being found in increasingly younger patients. These trends give us some urgency in having potent treatments to fight this disease," said Dr. Stephanie Gregory, director of the Hematology section at the Rush University Medical Center, based in Chicago, Illinois.

The Celgene Corporatio markets Lenalidomide as Revlimid. The drug belongs to a class of drugs known as immunomodulatory agents because they change the way the immune system works. The drug has significantly changed quality of life in patients suffering from myeloma.

Revlimid is an oral drug, which can be administered at home. Patients under the treatment with this drug do not encounter the difficult side effects of chemotherapies, because the drug interferes directly with the cancer cells making them stop growing.

"Lenalidomide plus dexamethasone is superior to placebo plus dexamethasone in patients with relapsed or refractory multiple myeloma," was the conclusion of the study.

The results are reported in the November 22 issue of the New England Journal of Medicine.