To evaluate the overall response rate, safety, and the 12-cycle clearance rate of circulating plasma cells (CPCs) in patients with newly diagnosed transplant-ineligible multiple myeloma stratified as high-risk based on circulating plasma cell assessment treated with isatuximab combined with reduced-dose VRD regimen
Aged ≥ 18 years with newly diagnosed symptomatic multiple myeloma who have not received any prior anti-myeloma therapy.
Confirmed positive circulating abnormal plasma cells (CPCs) in peripheral blood via flow cytometry (CPCs ≥ 0.07%).
Deemed ineligible for autologous hematopoietic stem cell transplantation due to advanced age, poor physical performance, or underlying comorbidities precluding transplant tolerance.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3.
Diagnosis of primary plasma cell leukemia, solitary plasmacytoma, smoldering multiple myeloma or secondary multiple myeloma.
Prior exposure to any anti-myeloma agents, radiotherapy, or stem cell transplantation.
Concurrent other malignant tumors (except for in situ carcinoma cured for more than 5 years).
Severe active infection, active autoimmune disease, or severe cardiovascular and cerebrovascular diseases (NYHA class III-IV heart failure, recent myocardial infarction or cerebral infarction).