Do you find that some patients don’t understand what clinical trials are?
Do some patients feel when clinical trials are recommended that this is a ‘last resort’ treatment option?
At present we have only a limited number of FDA approved drugs available for people with MDS. These are lenalidomide (Revlimid®), azacitidine (Vidaza®), and decitabine (Dacogen®). We use a few other drugs off-label, such as erythropoiesis stimulating agents (ESAs) like erythropoietin or darbepoeitin, or immunosuppressants like anti-thymoctye globulin, (ATG). My approach is that we’ll always have those three approved drugs to fall back on. But if we have a trial that is available and right for the patient, let’s try that first and if there’s no success we can always go back to those available therapies.
Can you describe some current areas of MDS clinical research?
Who are the primary sponsors of clinical trials?
Another common source of sponsorship are the drug companies themselves. Many drugs are discovered or developed by these companies, and they will conduct trials to see if the drug is safe and effective enough to be approved by the FDA – the majority of drugs have this point of origin.
What can an MDS patient in a clinical trial expect to learn?
Why is it important for MDS patients to consider participating in a clinical trial?
It’s an exciting time for MDS research, but we need MDS patients for the many clinical trials that are being planned or are in process. That’s the only way new treatments can result from the progress being made in basic research.
Mikkael A. Sekeres, MD, MS has been Medical Advisory Board Co-Chair since 2004. As a professor of medicine and director of the leukemia program, Dr. Sekeres is also Vice Chair for Clinical Research at the Cleveland Clinic Taussig Cancer Institute in Ohio. He earned his medical degree and a master’s degree in clinical epidemiology from the University of Pennsylvania School of Medicine. Dr. Sekeres completed his postgraduate training at Harvard University, finishing an internal medicine residency at Massachusetts General Hospital and a fellowship in hematology-oncology at the Dana-Farber Cancer Institute in Boston. He chaired the Oncologic Drugs Advisory Committee of the FDA.
An invited speaker at numerous meetings, grand rounds, and conferences, Dr. Sekeres is a member of the American Society of Hematology, the American Society of Clinical Oncology, and the Southwest Oncology Group—Leukemia Committee. His current research focuses on patients with MDS and older adults with acute myeloid leukemia, and he has been the national primary study investigator on several phase I/II trials. He is the author or co-author of over 230 articles and over 250 abstracts published in leading journals such as Blood, Journal of Clinical Oncology, Nature Genetics, Journal of the National Cancer Institute, PLoS One, Cancer, Haematologica, and Leukemia. He is also the co-author of 6 books; the editor-in-chief of the ASH Clinical News magazine; he is on the editorial board of several journals; and is an essayist for The New York Times and Huffington Post.