A Phase I Study of the Combination of a Selective Inhibitor of Nuclear Export (SINE), Selinexor, with Carfilzomib and Dexamethasone in Patients with Relapsed or Relapsed/Refractory Multiple Myeloma
ID Number 14-2001Principal Investigator(s)
Department(s) or Division(s)
Hematology and Medical Oncology
This study is being done to learn more about a combination of 3 drugs called Selinexor, carfilzomib, and dexamethasone given to persons with multiple myeloma who have gotten worse and are not responding to the standard drugs for multiple myeloma, like bortezomib (Velcade), thalidomide, and corticosteroids.
Selinexor (KPT-330) is considered experimental, which means it has not been approved by the U.S. Food and Drug Administration (FDA). This study drug Selinexor works by trapping "tumor suppressing proteins" within the cell and thus causing the cancer cells to die or stop growing.
Carfilzomib (Kyprolis) is approved by FDA to be used only in certain people with relapsed and refractory multiple myeloma that have tried and failed other therapies. It has not been approved to be used for any other disease or condition. in this study, carfilzomib is considered an experimental study drug because it is being used at higher doses than are currently approved by the FDA.
Dexamethasone is an FDA approved drug that is commonly used, either alone, or in combination with other drugs, to treat multiple myeloma.
This study is being done to find the safest dose and side effects of Selinexor and carfilzomib in combination with dexamethasone in people with multiple myeloma that has not responded to prior treatments including carfilzomib alone. It is also being done to learn how well the combination of drugs works against multiple myeloma.
Recruiting Patients: Yes