塞利尼索联合化疗方案在复发/难治性多发性骨髓瘤治疗中的探索———来自多中心、开放标签的LAUNCH 研究中期数据结果∗

To evaluate the preliminary efficacy and safety of combination of sclincxor and dcxam-cthasonc(Sd) with chemotherapy in patients with relapsed/refractory multiple myeloma. Methods: This is a mul-ticcntcr, open label > single arm clinical study divided into two treatment arms: SDd arm: sclincxor 80 nig dl , 8, 15, 22 , dcxamcthasonc 40 mg dl , 8, 15? 22 , and liposomc doxorubicin 25-35 mg/m" dl; SCd arm: sclincxor lOOmgdl, 8, 15, 22, dcxamcthasonc 40 mg dl , 8, 15, 22, and cyclophosphamidc 300 mg/m2 dl , 8, 15, 22. 28 d per cycle in both arms, and a total of 12 cycles. The primary endpoint is the objective response rate (ORR) , while secondary endpoints include safety, progression free survival(PFS) , and overall survival(OS). Results: As of April 30, 2023, a total of 36 patients were enrolled. The median age was 59(rangc 29-74) years old, and the median time between the initial diagnosis and enrollment was 3. 5(rangc 0. 5-15. 5) years. Median number of previous treatment lines of 3 ( range 1-8). Six patients ( 16. 7 %) had cxtramcdullary disease, 12 patients (33. 3%) had high-risk cytogcnctic abnormalities, 4 paticntsO 1.1%) had previously received autologous stem cell transplantation, and 3 paticnts(8. 3 %) had previously treated with CAR-T. Previous drug exposure: bortczomib (94.4%), lcnalidomidc(80. 6 % ) , pomadolidc(4 1. 7 %) , daratumumab(27. 8% ) , doxorubicin and cyclophospha-midc(19. 4%). 1 patient had completed 12 cycles of treatment, 4 patients had received more than 10 cycles of treatment, and 12 patients were still under treatment. Median follow-up time: 2. 25(0. 25-12. 00) months. Among the 29 cvaluablc patients, the objective response ratc(ORR) was 48. 3%(14/29) , including 1 case with complete response, 1 case with very good partial response, 12 cases with partial response. The disease control rate was 89. 7 % (26/29). Median time from treatment to first response was 2 months. The median PFS was 11.6 months, the median OS was not reached, and 1-ycar OS rate was 75.0%. The ORR was 52. 6% in SDd arm(n = 19) and 40.0% in SCd arm(n = 10). The treatment related adverse events was mainly concentrated in the first two treatment cycles, most of which were grade 1-2. Through active supportive treatment or symptomatic treatment, the adverse events had improved. The most common hcmatological adverse cvcntsCall grades/grade 3-4) were throm-bocytopcnia(58. 3 %/25. 0% ) , leukopenia ( 50. 0%/30. 6 % ) , and anemia (4 1. 7 %/22. 2 %). The most common non-hcmatological adverse events (all grades/grade 3-4 ) were nausea ( 52. 8%/2. 8% ) , vomiting (38. 9%/5. 6% ) and fatiguc(30. 6%/2. 8%). Conclusion: The combination of Sd based chemotherapy drugs has been observed to have good therapeutic effects in patients with recurrent/refractory multiple myeloma. The adverse events during the treatment process can also be improved through active supportive treatment and dose adjustment, providing a positive reference for clinical application.