An Open-label, Multicenter, Phase 1b Study of JNJ-54767414 (HuMax CD38) (Anti-CD38 Monoclonal Antibody) in Combination with Backbone Regimens for the Treatment of Subjects with Multiple Myeloma
ID Number 14-2073Principal Investigator(s)
Department(s) or Division(s)
Hematology and Medical Oncology
The experimental drug used in this study is called HuMax CD38 monoclonal antibody, (also referred to as daratumumab or JNJ-54767414). Daratumumab is being tested together with various drug combinations that are standard treatments for Multiple Myeloma.
Daratumumab is a monoclonal human antibody that is being developed by Janssen Research & Development LLC. The antibody recognizes a specific protein, CD38, which is highly expressed on multiple myeloma cells.
The purpose of this research study is to assess the safety, tolerability and dosing of daratumumab when given to subjects with Multiple Myeloma in combination with various backbone treatment regimens: Velcade-dexamethasone (VD), Velcade-Melphalan-predennisone (VMP), Pomalidomide-dexamethasone (Pom-dex), and Velcade-thalidomide-dexamethasone (VTD). Other purposes of this study are to find out how long daratumumab stays in and acts on the body (this is shown by laboratory blood and urine tests) when combined with the backbone treatments and how your body responds to daratumumab given with backbone treatments.
Recruiting Patients: Yes