Evaluation of pomalidomide in combination with high dose dexamethasone and oral cyclophosphamide in patients with relapsed and refractory myeloma
ID Number 12-1128Principal Investigator(s)
Department(s) or Division(s)
Hematology and Medical Oncology
You may qualify to take part in this research study because you have myeloma that has not responded to treatment. We want to find out if an investigational drug called pomalidomide can help people with myeloma. An “investigational drug” is a drug that is being tested and is not approved for sale in the United States by the U.S. Food and Drug Administration (FDA).
During the study in addition to pomalidomide you will also receive either dexamethasone or dexamethasone and cyclophosphamide. Dexamethasone and cyclophosphamide are FDA approved drugs for multiple myeloma and not considered experimental. The main purpose of this study is to see whether pomalidomide can help people with myeloma when used together with FDA approved drugs dexamethasone and cyclophosphamide. Researchers also want to find out if pomalidomide is safe and tolerable in combination with these other drugs.
There are two parts to this study:
The first part of this study (Phase 1) will determine an appropriate dose of the medication cyclophosphamide in combination with pomalidomide and dexamethasone.
Once an appropriate dose has been determined, this study (Phase 2) will look to see the difference in effectiveness of pomalidomide in combination with high dose dexamethasone with or without cyclophosphamide in patients who have myeloma, which has relapsed to or become refractory (not responding) to prior treatment.
Recruiting Patients: Yes