【Abstract】 Objective To investigate the efficacy and safety of daratumumab in the treatment of plasma cell diseases. Method The clinical data of 96 patients with plasma cell disease (78 cases of multiple myeloma, 17 cases of systemic light amyloidosis, and 1 case of POEMS syndrome) treated with daratumumab in Sichuan Provincial People's Hospital from January 2020 to July 2022 were retrospectively analyzed. Results All patients were treated with daratumumab-based regimens (including DBd, DKd, Dd, etc.), in which 61 patients were qualified to evaluated for efficacy, and there were 51 patients with multiple myeloma, 6 patients (7.7%) with mSMART score standard risk, and 45 patients (57.7%) with high risk. In chemotherapy regimens, 31 patients were treated with DVd (daratumumab + bortezomib + dexamethasone) , 6 patients were treated with DKd (daratumumab + carfilzomib + dexamethasone) , and 14 patients were treated with other regimens. After one course of treatment with the daratumumab-based regimens, the overall response rate (ORR) of multiple myeloma patients was 80.4%[complete response (CR) rate was 29.4%], the median follow-up time was 7(0.25-26.5) months, and the progression-free survival (PFS) time was 6.5(0.25-26.5) months. The median overall survival (OS) time was not reached. The overall response rate (ORR) was 84.6%[complete response rate (CR) 34.6%] in newly diagnosed patients receiving daratumumab and 75%[complete response rate (CR) 25%] in the relapsed and refractory patients. Among the multiple myeloma patients, 30 patients had renal impairment, of whom 19 patients(63.3%) improved renal function after daratumumab treatment, 9 patients(30%) achieved complete renal function recovery, 11 patients(36.7%) progressed to renal function deterioration, and 7 patients (23.3%) were on hemodialysis. For systemic light amyloidosis patients, after one course of the daratumuab-based regimen, the overall response rate (ORR) was 100%[complete response (CR) rate 22.2%], the median follow-up time was 7.25(1.4-20.4) months, and the median progression-free survival (PFS) time was 7.25(1.4-20.4) months. A patient with POEMS achieved CR after treatment. The major adverse events of daratumumab were myelosuppression, infusion-related adverse events, and infection. Conclusion The daratumuab-based regimens have good efficacy and safety in the treatment of plasma cell diseases.

Key Words:plasma cell diseases;daratumuab;efficacy

No relevant conflicts of interest to declare.

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