Myeloma Canada Says Pomalidomide Study Shows Overall Survival in Late-Stage Clinical Trial
<0> For Myeloma CanadaStephen Gendel, 226-782-9793 </0>
Clinical studies have shown that an investigational new drug, pomalidomide, has demonstrated overall survival in a clinical trial of myeloma patients who had undergone multiple prior treatments. The international trial that includes several sites in Canada compares pomalidomide plus the steroid dexamethasone to dexamethasone alone. A data safety board monitoring the trial said given improvements in survival, all patients getting dexamethasone-only should “cross-over” into the pomalidomide arm of the trial. The improvements measured both progression free survival (how long before the disease returns) and overall survival (extended length of life) and determined the improvement in both measures was statistically and medically significant.
Aldo Del Col, Executive Director of Myeloma Canada, noted, “Pomalidomide is promising because it demonstrates these positive results even when multiple previous treatments have stopped working. This is significant because seven new cases of multiple myeloma are diagnosed each day in Canada. It cannot yet be cured but newer drugs means it can be treated for increasingly longer periods of time.”
Pomalidomide is an investigational oral medication called an immunomodulator that attacks the cancer directly while also stimulating the body’s own defense mechanisms to attack. It is a relative of the approved drug lenalidomide (Revlimid) but studies show pomalidomide is effective even where disease has become resistant to lenalidomide as well as to drugs called proteasome inhibitors.
This past summer carfilzomib (Kyprolis), a second generation proteasome inhibitor, was approved by the Food and Drug Administration (FDA) in the United States. A decision on pomalidomide is expected early next year in the United States and later in 2013 in Europe. Neither has been scheduled for submission to Health Canada.
Multiple myeloma, a cancer of the bone marrow, is an incurable but treatable disease. The cancer starts in plasma cells, which are produced in the bone marrow. In myeloma, abnormal plasma cells, called myeloma cells, grow uncontrollably, crowding out the normal blood cells in the bone. This can bring on symptoms such as fatigue, recurrent infections and severe pain resulting from bone fractures. The disease disturbs the body's balance of minerals and prevents organs, such as the kidney, as well as nerves, from functioning properly. In Canada, approximately 2,300 people are diagnosed with multiple myeloma every year.
Myeloma Canada, the only national organization exclusively devoted to the Canadian myeloma community, is a non-profit charitable organization dedicated to supporting people living with multiple myeloma. The mission of Myeloma Canada is to: provide educational resources to patients, families and caregivers; increase awareness of the disease; promote access to new therapies, treatment options and health care resources; and advance Canadian research initiatives. Myeloma Canada works with regional support groups, international myeloma patient groups, government agencies, hospitals and leading myeloma experts to strengthen the voice and advance the cause of the Canadian myeloma community.