ASH 2020 | DARAZADEX: a Phase II trial of daratumumab plus azacitidine and dexamethasone in R/R myeloma
Nina Shah, MD, University of California-San Francisco, San Francisco, CA, shares the details of an ongoing Phase II trial (NCT04407442) of daratumumab, an anti-CD38 monoclonal antibody, in combination with azacitidine and dexamethasone in relapsed/refractory (R/R) multiple myeloma patients. The trial, named DARAZADEX, will investigate the safety and efficacy of this combination in myeloma patients with prior daratumumab exposure. Based on pre-clinical evidence of CD38 upregulation attributable to azacitidine and correlated enhancement of antibody dependent cellular cytotoxicity (ADCC), azacitidine is hypothesized to increase daratumumab efficacy and ADCC. An initial safety lead-in cohort will be treated, followed by further enrollment based on the responses seen. Evaluating efficacy is the primary objective, while safety, toxicity, duration of response, impact of CD38 expression changes on responses, and survival will also be investigated. This interview took place during the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, 2020.
Disclosures
Research funding: Celgene/BMS, Janssen, Bluebird Bio, Sutro Biopharma, Teneobio, Poseida, Nektar
Advisory role: GSK, Amgen, Indapta Therapeutics, Sanofi, BMS, CareDx, Kite, Karyopharm
