Date: 2014-11-24
Type of information: Initiation of the trial
phase: 2
Announcement: initiation of the trial
Company: Janssen R&D, a J&J company (USA - NJ) - Genmab (Denmark)
Product: daratumumab
Action
mechanism: monoclonal antibody. Daratumumab is a human CD38 monoclonal antibody with broad-spectrum killing activity. Daratumumab is in clinical development for multiple myeloma (MM). Daratumumab targets the CD38 molecule which is highly expressed on the surface of multiple myeloma cells. Daratumumab may also have potential in other cancers on which CD38 is expressed, including diffuse large B-cell lymphoma, chronic lymphocytic leukemia, acute lymphoblastic leukemia, plasma cell leukemia, acute myeloid leukemia, follicular lymphoma and mantle cell lymphoma. Daratumumab has been granted Breakthrough Therapy Designation from the FDA for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) or who are double refractory to a PI and an IMiD. In August 2012, Genmab granted Janssen Biotech, Inc. an exclusive worldwide license to develop, manufacture and commercialize daratumumab.
Disease: smoldering multiple myeloma
Therapeutic area: Cancer - Oncology
Country:
Trial
details: The SMM2001 study is a phase II study. It will be a randomized, open-label, multicenter study and will enroll approximately 120 patients with high risk smoldering multiple myeloma. Patients will be randomized to receive one of three dose schedules of daratumumab. The study will be conducted by Janssen Research & Development LLC.
Latest
news: * On November 24, 2014, Genmab announced that its collaboration partner, Janssen Biotech plans to start a Phase II study of daratumumab in smoldering multiple myeloma. The study (SMM2001) will evaluate three different dose schedules of daratumumab for the treatment of smoldering multiple myeloma. The study is expected to start enrolling patients in 2015.
