Phase I/II Study of the Combination of Arsenic Trioxide With Ascorbic Acid and High-Dose Melphalan for Patients With Multiple Myeloma

Treatment:

High-dose melphalan followed by a transplant of autologous stem cells is thought to be one of the most effective ways to treat multiple myeloma. However, the number one cause of treatment failure in these patients is the disease coming back.

High-dose melphalan has been used in multiple myeloma for more than two decades and is considered the standard of care for this disease. Recent research in the laboratory and clinical trials has shown that Arsenic trioxide is an effective treatment against multiple myeloma. It leads to tumor cell death in myeloma cell lines and in myeloma patients. Arsenic trioxide can also make melphalan a more effective antimyeloma agent. This research has also shown that vitamin C enhances the anti-myeloma activity of arsenic trioxide by making it more toxic to myeloma cells. The purpose of this study is to learn if a combination of arsenic trioxide, vitamin C, and melphalan will be safe, well-tolerated and effective in myeloma patients.

Before treatment begins, you will have several tests performed to study the status of the disease before you begin taking the study medication. You will have a bone marrow aspirate and biopsies. An aspirate is the drawing of liquid marrow with a syringe, while a biopsy is the removal of a small core of bone with a hollow needle. Aspirate can be done from the hip bone or chest, while biopsy is always from the hip bone. You will have cytogenic tests, to see if there are any genetic abnormalities in your DNA. You will have a bone survey done, where the doctor will look at X-rays of your bones for any myeloma-related bone changes.

You will have routine and specialized blood tests done (about 2 tablespoons), to measure blood counts, platelets, blood clotting, kidney function, electrolyte counts, and levels of disease in your blood. You will also have a urine test to measure level of myeloma in your urine. You will have a pulmonary function test, to check if your lungs is strong enough to withstand high-dose chemotherapy. You will have an initial electrocardiogram (EKG) and also a MUGA scan that will measure how strong your heart functions are.