Phase 1b Study of Isatuximab in Combination With Bortezomib, Cyclophosphamide, and Dexamethasone in Newly Diagnosed, Transplant-ineligible Multiple Myeloma Patients

tandard-of-care therapies for patients with newly diag- nosed multiple myeloma (NDMM) include proteasome inhibitors, immunomodulatory drugs, chemotherapy, dexamethasone, or prednisone in various combination regimens. 1 Addition of an anti-CD38 monoclonal antibody to standard regimens in the first-line setting can result in deep and sustained responses. 1,2 Prognosis for patients with MM may depend on disease-related characteristics such as overall tumor burden and biology, as well as patient-related factors including older age, functional status, extent of renal impairment, and other potential comorbidities. Although recent therapeutic advances contributed to improve clinical outcomes in NDMM, patients not eligible for autologous stem cell transplantation still have limited survival, as they often receive less intensive therapy owing to their advanced age and/or the presence of comorbidities. 1–3 Bortezomib-cyclophosphamide-dexamethasone (VCd) is an effective and generally tolerable 3-drug regimen used in NDMM, including treatment of both transplant-eligible and transplant-ineligible patients. 4–6 Furthermore, VCd was pre-viously considered a standard-of-care treatment for NDMM patients in the 2017 European Society for Medical Oncology (ESMO) clinical practice guidelines. 6 The monoclonal antibody isatuximab (Isa) targets a spe- cific epitope of CD38 and kills MM cells through multiple mechanisms of action; it is approved in various countries in combination with pomalidomide-dexamethasone