ASCO: Celgene says blood cancer patients respond to Thalidomide

Thalidomide, a cause of severe birth defects in children in the 1950's, and currently approved for the treatment of leprosy, was found to be effective in a clinical trial for treating patients with multiple myeloma, a form of blood cancer.

Celgene said a phase III trial of patients with multiple myeloma, showed that 59 percent of the patients responded to treatment with its thalidomide drug when given along with a corticosteroid.

Celgene, which presented its data at the annual meeting of the American Society of Clinical Oncology, said only 41 percent of multiple myeloma patients responded after four months of treatment with the corticosteroid, dexamethasone, alone. Dexamethasone is commonly used alone and in combination with other types of chemotherapy for this form of blood cancer.

The clinical data will be used to support future applications for Celgene's Thalomid, which is being reviewed by the US Food and Drug Administration as a treatment for multiple myeloma.

The Phase III study enrolled 207 patients with 103 at random receiving the thalidomide/dexamethasone treatment and another 104 receiving dexamethasone alone. The company cited response data on 196 of 207 previously untreated patients in an interim analysis of the study.

The median age of patients was 65 years.

The group that received thalidomide and dexamethasone had an increase in side effects compared with the group using dexamethasone alone. These side effects included deep vein blood clots, rash, sinus bradycardia (slow heart rate) and neuropathy, and were clinically manageable, the company said.

Multiple myeloma is a cancer of plasma cells that destroys bone. The cells grow uncontrollably in the bone marrow and occasionally other parts of the body. This suppresses development of normal white blood cells, red blood cells and platelets.

Multiple myeloma affects about 50,000 people in the United States. About 14,600 new cases are diagnosed annually and approximately 11,000 people are expected to die of the disease this year.

Thalidomide was first introduced in the 1950s as a sedative and was prescribed for nausea and insomnia in pregnant women, but was not approved for distribution in the United States. It was found to be the cause of severe birth defects in children whose mothers had taken the drug in their first trimester of pregnancy.

Celgene received FDA approval in 1998 to market its Thalomid drug for leprosy.