Recapturing Disease Response: A Phase II Study of High Dose Carfilzomib in Patients with Relapsed or Refractory Multiple Myeloma Who Have Progressed on Standard Dose Carfilzomib
ID Number 12-1506Principal Investigator(s)
Department(s) or Division(s)
Hematology and Medical Oncology
Cafilzomib (KyprolisTM) is approved by the U.S. Food and Drug Administration (FDA) to be used only in certain people in the U.S. 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 an investigational study drug because it is not approved for use in all people in the United States, and it is not approved by some regulatory authorities (the agencies that are responsible for approving the use of a medicine in a country such as the European Medicines Agency and Health Canada).
Carfilzomib is a type of drug called a proteasome inhibitor. Proteasome inhibitors block the action of proteasomes. Proteasomes are found inside all cells, normal and cancerous, and have the important role of identifying and marking damaged proteins so they can be broken down. By blocking the action of proteasomes, damaged protein will accumulate within the cells and cause them to die. Cancer cells are more susceptible to this effect than normal cells.
The purpose of this study is to determine the safety and activity of the investigational drug known as carfilzomib in the treatment of multiple myeloma (MM) when it is given at doses above the usual dose after the standard dosing has become ineffective. The other purpose of this study is to understand what causes the multiple myeloma to become resistant to carfilzomib and whether this can be overcome in the laboratory.
To be able to participate in this research study a person must have been diagnosed multiple myeloma requiring treatment.
Recruiting Patients: Yes