On March 5, 2014 Genmab reported that its partner, Janssen Biotech will start a Phase III study of daratumumab in relapsed or refractory multiple myeloma (Press release Genmab, MAR 5, 2014, View Source [SID:1234500247]). The study will compare daratumumab in combination with lenalidomide and dexamethasone to lenalidomide and dexamethasone alone.
This Phase III study will include approximately 500 patients who have relapsed or refractory multiple myeloma. Patients will be randomized to receive either daratumumab combined with lenalidomide and dexamethasone, or lenalidomide and dexamethasone alone. The primary endpoint of the study is progression free survival (PFS).