Background:Treatment of multiple myeloma has advanced tremendously with the approval of anti-CD38 antibodies. Their efficacy is impressive but still controversial in the 1q amplification subgroup (amp1q). This retrospective study aims to provide real-world data.Methods:This trial is analyzing 74 patients with relapsed/refractory multiple myeloma treated with CD38Abs at the Medical University of Innsbruck (2016–2023). High-risk (HR) cytogenetics according to R-ISS (t(4;14), t(14;16), t(14;20), del(17p)), the presence of amp(1q21), the frequency of two HR markers (double hit), and the high-risk criteria agreed at IMS 2024 (HR-IMS24) were considered.Results:The median age of the 74 patients (62.1% male) was 62 years, with a median follow-up of six years. Most patients received third-line therapy (37.8%). R-ISS HR was documented in 39.2% of patients, double hit in 13.5% of patients, and HR-IMS24 in 32.4% of patients, while amp1q was detected in 35.1% of patients. The median OS was 66 months (35–89), and the median PFS was 17 months (6.5–26.9). While neither R-ISS HR nor isolated amp1q had an impact on progression-free survival (e.g., amp1q 7.03: 1.95–22.44;p= 0.347), the occurrence of a double-hit pattern significantly impaired PFS and OS (6.2: 1.4–16.4 months;p= 0.044; OS, 42.8: 25.9–74.6 months;p= 0.035). Patients fulfilling the HR-IMS24 criteria (32.4%, 24 patients) also exhibited an impaired PFS and OS (7: 2.7–18.1 months,p= 0.023; 40.12: 21.1–74.5 months,p= 0.01).Conclusions:This retrospective study highlights the durable effect of daratumumab on cytogenetic abnormalities, particularly amp1q. However, patients who meet the criteria for double-hit myeloma or the high-risk IMS2024 criteria remain a difficult-to-treat patient population who require early access to new treatment approaches.
背景：随着抗CD38抗体的获批，多发性骨髓瘤的治疗取得了巨大进展。其疗效令人瞩目，但在1q扩增亚组（amp1q）中仍存在争议。本研究旨在提供真实世界数据。 方法：本试验分析了2016年至2023年间在因斯布鲁克医科大学接受CD38抗体治疗的74例复发/难治性多发性骨髓瘤患者。研究考虑了根据R-ISS定义的高危细胞遗传学特征（t(4;14)、t(14;16)、t(14;20)、del(17p)）、amp(1q21)的存在、两个高危标志物同时出现的频率（双重打击），以及IMS 2024共识的高危标准（HR-IMS24）。 结果：74例患者（男性占62.1%）中位年龄为62岁，中位随访时间为6年。大多数患者接受三线治疗（37.8%）。R-ISS高危患者占39.2%，双重打击患者占13.5%，HR-IMS24高危患者占32.4%，而amp1q检出率为35.1%。中位总生存期为66个月（35-89），中位无进展生存期为17个月（6.5-26.9）。虽然R-ISS高危或孤立的amp1q对无进展生存期均无显著影响（例如amp1q：7.03个月，95% CI 1.95–22.44；p=0.347），但双重打击模式显著损害无进展生存期和总生存期（6.2个月，95% CI 1.4–16.4；p=0.044；总生存期42.8个月，95% CI 25.9–74.6；p=0.035）。符合HR-IMS24标准的患者（32.4%，24例）也表现出无进展生存期和总生存期受损（7个月，95% CI 2.7–18.1；p=0.023；40.12个月，95% CI 21.1–74.5；p=0.01）。 结论：本回顾性研究强调了达雷妥尤单抗对细胞遗传学异常（特别是amp1q）的持续疗效。然而，符合双重打击骨髓瘤标准或IMS2024高危标准的患者仍然是难治性人群，需要尽早获得新的治疗方法。
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