Oral drug sets a new survival standard for bone marrow cancer

Findings from two large, international clinical trials show "unprecedented" survival for patients with multiple myeloma, a blood cancer that occurs in the blood-making cells of bone marrow.

The findings demonstrate that with Revlimid, an oral cancer drug, all measures of myeloma showed significant improvement in patients where previous treatments had failed. Rush University Medical Center took part in the U.S. study. Results of the study were published November 21 in the New England Journal of Medicine.

In the study, a total of 353 patients were enrolled at 44 centers. Of those patients, 177 were assigned to receive Revlimid (lenalidomide) plus dexamethasone, a steroid hormone, and 176 received a placebo plus dexamethasone. According to the study results, patients who received Revlimid had a median survival of 29.6 months, compared to 20.2 months for the placebo group. In the Revlimid group, 61 percent of patients responded to therapy as compared with 19.9 percent in the placebo group.

According to the International Myeloma Foundation, follow-up data from the U.S. study and a European study report even better results. Patients treated with Revlimid had a median survival of nearly three years (35 months), the longest median survival in this difficult to treat patient group.

"Myeloma, also called multiple myeloma, is of growing interest and concern," said Dr. Stephanie Gregory, the director of the section of Hematology at Rush University Medical Center. "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."

Revlimid is an immunomodulatory agent, a drug that can modify or regulate the functioning of the immune system. It is the newest of what are called the novel therapies that have changed the outlook for myeloma patients. It is an oral drug that can be taken at home, and because it targets the cancer cells directly along with factors that support their growth, it does not have the difficult side effects associated with most chemotherapy.

"We are pleased that aggressive efforts to find effective treatments in what was considered a rare, little-known cancer, have led to drugs with broad implications for understanding, treating and eventually curing so many forms of the disease," said Susie Novis, president and co-founder of the International Myeloma Foundation. "Myeloma has been a difficult disease to cure, but with novel therapies we are developing effective, long-term treatments by using multiple drugs in sequence and in various combinations. The addition of a drug with the potency of Revlimid to this equation is especially important."

In Europe and the U.S. Revlimid has been approved for use in multiple myeloma, and in the U.S. it is also approved for a pre-leukemia condition called MDS. It is also being tested in other leukemias and lymphomas and even solid tumors.

Myeloma is a bone marrow cancer that attacks and destroys bone. It accounts for about 16,000 new cases of cancer each year. An estimated 56 thousand people in the United States are living with Myeloma and this year approximately 11,300 deaths from Myeloma are anticipated. While there is no known cure for myeloma, doctors have many approaches to help myeloma patients live better and longer.

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