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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
15
Newly 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): 1.0 mg/m² subcutaneously on Days 1, 8, 15 and 22 of each cycle. Lenalidomide (R): 10 mg orally once daily on Days 1-21 of each cycle; individualized dose reduction shall be performed for patients with renal impairment according to estimated glomerular filtration rate (eGFR).
Newly 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): 1.0 mg/m² subcutaneously on Days 1, 8, 15 and 22 of each cycle. Lenalidomide (R): 10 mg orally once daily on Days 1-21 of each cycle; individualized dose reduction shall be performed for patients with renal impairment according to estimated glomerular filtration rate (eGFR).
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 \[PR\]
Time frame: 12months
12-cycle clearance rate of circulating plasma cells (CPCs).
12-cycle clearance rate of circulating plasma cells (CPCs).
Time frame: 12months
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