Date: 2013-09-10
Type of information: Initiation of the trial
phase: 2
Announcement: initiation of a study
Company: Janssen Biotech - J&J (USA) Genmab (Denmark)
Product: daratumumab
Action
mechanism: Daratumumab is a human CD38 monoclonal antibody with broad-spectrum killing activity. Daratumumab is in clinical development for multiple myeloma. The CD38 molecule is highly expressed on the surface of multiple myeloma cells. CD38 is also expressed on a number of other hematological tumors, including diffuse large B-cell lymphoma, chronic lymphocytic leukemia, acute lymphoblastic leukemia, acute myeloid leukemia, follicular lymphoma and mantle cell lymphoma.
Disease: multiple myeloma
Therapeutic area: Cancer - Oncology
Country:
Trial
details: This two-part study will enroll up to a maximum of 110 patients who have received at least three prior lines of therapy, including both a proteasome inhibitor and an IMiD or who are double refractory to a proteasome inhibitor and an IMiD. Examples of proteasome inhibitors are bortezomib or carfilzomib and examples of IMiD agents are pomalidomide or lenalidomide. Part 1 will define an optimal daratumumab regimen going forward, while part 2 is an expansion based on the optimal regimen determined in Part 1. The primary objective of the study is to define the optimal dose and dosing schedule, to determine the efficacy of two treatment regimens of daratumumab as measured by overall response rate, and to further characterize the safety of daratumumab as a single agent.
Latest
news: * On September 10, 2013, Genmab has announced that its partner, Janssen Biotech, Inc. (\"Janssen\") will start a new Phase II study of daratumumab in multiple myeloma. The Phase II study is designed in 2 parts in multiple myeloma patients who have received at least three different lines of therapy including both a proteasome inhibitor and an immunomodulatory agent (IMiD) or who are double refractory to a proteasome inhibitor and an IMiD. This is the same indication for which daratumumab was granted Breakthrough Therapy Designation from the FDA in May 2013. In August 2012, Genmab granted Janssen Biotech, an exclusive worldwide license to develop and commercialize daratumumab.
