Daratumumab (Dara) Plus Lenalidomide, Bortezomib, And Dexamethasone (Rvd) In Patients With Transplant-Eligible Newly Diagnosed Multiple Myeloma (Ndmm): Updated Efficacy And Safety Analysis Of The Safety Run-In Population Of Griffin

Introduction: DARA, a human IgGκ monoclonal antibody targeting CD38, is approved in combination with bortezomib, thalidomide and dexamethasone for transplant-eligible NDMM; however, RVd is the standard of care in the US for transplant-eligible NDMM. The phase 2 GRIFFIN study (NCT02874742) of DARA plus RVd (D-RVd) for transplant-eligible NDMM in the US included a safety run-in phase followed by a randomized phase. In the 16-patient safety run-in, no dose limiting toxicities (DLTs) occurred and no new safety concerns were identified for D-RVd (Voorhees P, Blood 2018 132 [Suppl 1]:151). The randomized phase of GRIFFIN met its prespecified primary endpoint with improved rate of stringent complete response (sCR) by the end of consolidation (D-RVd, 42.4% vs RVd, 32.0%; 1-sided P=0.068) (Voorhees P, Blood 2020); however, median follow-up was limited (13.5 months). Therefore, we conducted an updated analysis of efficacy and safety for the safety run-in cohort to examine longer follow-up data for D-RVd and evaluate the role of DARA plus lenalidomide (D-R) maintenance therapy.