Date: 2014-08-11
Type of information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: Janssen Biotech - J&J (USA) Genmab (Denmark)
Product: daratumumab in combination with lenalidomide and dexamethasone
Action
mechanism: Daratumumab is a human CD38 monoclonal antibody with broad-spectrum killing activity. Daratumumab is in clinical development for multiple myeloma. 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 and commercialize daratumumab.
Disease: front line multiple myeloma
Therapeutic area: Cancer - Oncology - Rare diseases
Country:
Trial
details: The MMY3008 study is a Phase III, randomized, open-label, multicenter study. It will include approximately 700 newly diagnosed, chemotherapy naïve multiple myeloma patients ineligible for stem cell transplantation (SCT). Patients will be randomized to receive either daratumumab combined with lenalidomide (an immunomodulatory agent) and dexamethasone (a corticosteroid) or lenalidomide and dexamethasone alone. The primary endpoint of the study is progression free survival (PFS).
Latest
news: * On August 11, 2014, Genmab announced that its collaboration partner, Janssen Biotech, plans to start a new Phase III study of daratumumab in multiple myeloma. The study (MMY3008) will compare daratumumab in combination with lenalidomide and dexamethasone to lenalidomide and dexamethasone alone as front line treatment for patients who are not considered candidates for stem cell transplantation (SCT). The study is planned to start in the first half of 2015. The first Phase III study in front line multiple myeloma was announced in July and is expected to start towards the end of this year. This latest study is the fourth daratumumab Phase III study to be announced.
