Study design
MM
ONCOLOGY, MAY, RECRUITMENT
This open-label, multicenter, Phase 1b study enrolled adults with measurable NDMM ineligible for (Part A and B) or without intent for (Part B) immediate transplantation. Patients with ultra-high–risk smoldering MM fulfilling IMWG criteria were also eligible. Patients were excluded if they had an Eastern Cooperative Oncology Group performance status >2, inadequate liver or renal function, major surgery or radiation therapy within 14 days before study treatment administration, or prior systemic curative treatment for MM. The recruitment periods were May 4, 2017 – April 20, 2018 (Part A) and March 29, 2019 – January 27, 2020 (Part B). The study was conducted in accordance with consensus ethics principles derived from international ethics guidelines, including the Declaration of Helsinki, the International Council for Harmonisation guidelines for Good Clinical Practice, and all applicable laws, rules, and regulations. Written informed consent was obtained prior to conducting any study-related procedures. The study design is shown in Fig. 