A Phase 1b/2 Multicenter, Open Label, Dose-Escalation Study to Determine the Maximum Tolerated Dose, Safety, and Efficacy of ACY-1215 (ricolinostat) in Combination with Pomalidomide and Low-dose Dexamethasone in Patients with Relapsed-and-Refractory Multiple Myeloma
ID Number 14-1209Principal Investigator(s)
Department(s) or Division(s)
Hematology and Medical Oncology
You are being invited to join a clinical study, a type of research study for an experimental drug. "Experimental" means the drug has not been approved by any authority that regulates new drugs, such as the United States (US) Food and Drug Administration (FDA), and is not available to buy on the market. Your study doctor will explain the clinical study to you.
There will be 2 parts to the study, Phase Ib and Phase II. You will be enrolling in the Phase II part of the study. To be able to take part in this part of this study, you must have already received at least two (2) prior treatments for your cancer. You also must have either not responded to your most recent treatment or had your cancer return after your most recent treatment. In addition, you do not wish to have a bone marrow transplant, cannot receive a transplant, or have relapsed after having a bone marrow transplant.
The purpose of the first part of this study is to determine the best dose and schedule of a new drug, ACY-1215, when given with pomalidomide and low dose dexamethasone (two different types of drugs to treat your type of cancer). Both pomalidomide and dexamethasone are approved by the FDA and are available by prescription. The purpose of the second part of the study is to examine the safety and effectiveness of ACY-1215 given at the best dose and schedule determined in the first part of the study.
Recruiting Patients: Yes