Subcutaneous (SC) Daratumumab (DARA) in Combination With Standard Multiple Myeloma (MM) Treatment Regimens: An Open-label, Multicenter Phase 2 Study (PLEIADES)

Abstract

Intravenous (IV) DARA is approved as monotherapy and in combination with standard-of-care (SoC) regimens for relapsed or refractory MM (RRMM) and transplant-ineligible newly diagnosed MM (NDMM). A SC co-formulation of DARA with recombinant human hyaluronidase PH20 (rHuPH20; ENHANZE® drug delivery technology, Halozyme, Inc.) can be administered in 3-5 minutes. This phase 2, open-label, multicenter study (PLEIADES) assessed efficacy and safety of DARA SC (D) combined with bortezomib, lenalidomide, and dexamethasone (VRd), bortezomib, melphalan, and prednisone (VMP), or lenalidomide and dexamethasone (Rd) in NDMM or RRMM patients (pts).