On August 11, 2014 Genmab reported that its collaboration partner, Janssen Biotech plans to start a new Phase III study of daratumumab in multiple myeloma (Press release Genmab, AUG 11, 2014, View Source [SID:1234500695]). 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. Today’s news is the fourth daratumumab Phase III study to be announced.

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"This new study of daratumumab in front line multiple myeloma is part of the extensive development plan created under our collaboration with Janssen Biotech for our CD38 antibody daratumumab," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

About the MMY3008 study
This Phase III study is a randomized, open-label, multicenter study and 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).