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).
Single group
Isatuximab
DrugNewly diagnosed transplant-ineligible multiple myeloma patients (high-risk defined by GA score and circulating plasma cells (CPCs) ≥0.07%) will receive isatuximab plus reduced-intensity VRD (VRDlite) induction therapy, as detailed below: Isatuximab (Isa) 10 mg/kg per administration. Cycle 1: administered on Days 1, 8, 15 and 22. From Cycle 2 onwards: once every two weeks (Days 1 and 15). Dose reduction of isatuximab is prohibited throughout treatment until disease progression, intolerable toxicity, or completion of scheduled therapy. Reduced-intensity VRD (VRDlite) Bortezomib (V): 1.3 mg/m², subcutaneous injection, Days 1, 8, 15, 22 per cycle. This administration route reduces the incidence of peripheral neuropathy. Lenalidomide (R): 15 mg once daily orally, Days 1-21 per cycle. Dose should be further individualized and reduced for patients with renal insufficiency according to eGFR
VRD
DrugNewly diagnosed transplant-ineligible multiple myeloma patients (high-risk defined by GA score and circulating plasma cells (CPCs) ≥0.07%) will receive isatuximab plus reduced-intensity VRD (VRDlite) induction therapy, as detailed below: Isatuximab (Isa) 10 mg/kg per administration. Cycle 1: administered on Days 1, 8, 15 and 22. From Cycle 2 onwards: once every two weeks (Days 1 and 15). Dose reduction of isatuximab is prohibited throughout treatment until disease progression, intolerable toxicity, or completion of scheduled therapy. Reduced-intensity VRD (VRDlite) Bortezomib (V): 1.3 mg/m², subcutaneous injection, Days 1, 8, 15, 22 per cycle. This administration route reduces the incidence of peripheral neuropathy. Lenalidomide (R): 15 mg once daily orally, Days 1-21 per cycle. Dose should be further individualized and reduced for patients with renal insufficiency according to eGFR Dexamethasone (D): 20 mg once daily, orally or intravenously
Overall response rate
defined as the proportion of patients achieving stringent complete response \[sCR\], complete response \[CR\], very good partial response \[VGPR\] or partial response \[PR\]
12-cycle clearance rate of circulating plasma cells (CPCs).
12-cycle clearance rate of circulating plasma cells (CPCs).
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