Researchers from the Abramson Cancer Center of the University of Pennsylvania announced today that findings from two large, international clinical trials show unprecedented survival for patients with multiple myeloma, a cancer that occurs in the blood-making cells of bone marrow. The findings show that with the oral drug lenalidomide (REVLIMID®), in combination with the steroid dexamethasone, patients significantly improved by all measures where previous treatments had failed -- including a median survival of nearly three years -- the longest median survival known for this difficult to treat patient group. Edward A. Stadtmauer, MD, Director of the Abramson Cancer Center Bone Marrow and Stem Cell Transplant Program and lead investigator from Penn, was part of the U. S. study published in the New England Journal of Medicine alongside a companion study from Europe showing similar results. "Myeloma, also known as multiple myeloma, is a growing interest and concern of cancer clinicians and researchers, " said Stadtmauer.
The research was funded by Celgene. Dr. Stadtmauer does not have any financial ties to Celgene Corporation, the maker of REVLIMID®, but has received honoraria as part of an educational speaker's bureau sponsored by Celgene. Weber and Wang of the University of Texas MD Anderson Cancer Center have received grant funds and lecture fees from Celgene. These relationships are managed in accordance with M. D. Anderson's conflict-of-interest policies. About Multiple Myeloma Multiple myeloma is cancer of the plasma cells, the type of white blood cell present in bone marrow. Normal plasma cells are an important part of the immune system. When plasma cells grow out of control, they can produce a tumor. These tumors generally develop in the bone marrow. If there is only one tumor, it is called a plasmacytoma. The disease is called multiple myeloma because myeloma cells can occur in multiple bone marrow sites in your body. At this time, the cause of multiple myeloma is not known. However, there appears to be several factors which increase the risk of developing multiple myeloma, such as extensive exposure to radiation, chemical resins, organic solvents, pesticides, and herbicides.
These trials were designed to investigate the effectiveness and safety of cyclic dosing of REVLIMID® at 25mg combined with high-does dexamethasone (HDD) compared with placebo and HDD in previously treated patients with multiple myeloma. A total of 705 patients were enrolled in 97 sites internationally. Patients in both trials had been heavily treated prior to enrollment, many having failed three or more rounds of chemo and/or radiation therapy. In addition, more than 50 percent of patients enrolled had undergone stem cell transplantation. In these new studies REVLIMID® plus dexamethasone achieved superior results compared to dexamethasone alone regardless of the history of treatment, including the media survival of nearly three years. Such positive patient response suggests that treatment with REVLIMID® early in the course of the disease may be beneficial. These findings have caused a change in the official physician guidelines for multiple myeloma which were recently updated to add REVLIMID® as an initial treatment, instead of waiting until other treatments have failed.