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New York Weill Cornell Medical Center will be the only site for a clinical trial of a novel vaccine designed to stimulate the body's immune system to fight multiple myeloma. The trial of the vaccine, called Mylovenge and made by the Dendreon Corporation of Seattle, Wash., is expected to involve about 25 multiple myeloma patients who have already shown good responses to the drug thalidomide, a common treatment for the disease.

Dr. Michael W. Schuster, Professor of Clinical Medicine at Weill Cornell Medical College and Director of the Bone Marrow and Blood Stem Cell Transplant Program at New York Weill Cornell Medical Center, explains that in multiple myeloma, plasma cells in the blood become malignant and attack the bone, causing painful fractures and, often, death. Nearly 14,000 Americans are diagnosed each year with the disease, and over 11,000 die. Multiple myeloma accounts for approximately 10% of cancers of the blood.

"Thalidomide has been shown to reduce the levels of myeloma cells in many patients," Dr. Schuster said. "Thousands of multiple myeloma patients are now taking thalidomide and leading normal lives. But with the vaccine Mylovenge, it is thought that we might be able to reduce the levels of myeloma cells even further."

The vaccine is made specifically for each patient, using immune cells from the patient. White blood cells, including dendritic cells, are removed from the patient's blood using a device called an apheresis machine. The dendritic cells are then treated with a specific protein from each patient's myeloma cells (called an "M component") to create Mylovenge. Mylovenge is an immunoadjuvant, which means that it helps stimulate the immune response and "trains" the dendritic cells to target myeloma cells. Two days following the initial blood collection, the dendritic cells are infused back into the patient.

The clinical trial that is now beginning is a Phase 2 trial—that is, a trial of the vaccine's efficacy. The vaccine has already completed Phase 1 trials for safety. Preliminary results from these trials suggest that Mylovenge stimulates immune activity and may cause regression or stabilization of the disease. In some patients, clinical benefits were found to extend more than 18 months following treatment.

Dr. Schuster says, "Although I cannot use the word cure, this vaccine may prove to be a significant advance in treating this disease that has long been so daunting and so painful for many. The vaccine is part of a new era in cancer treatment, that of targeted cellular therapy."

For more information about participating in this trial, please call New York Weill Cornell at 212-746-2119.