Supplementary Material for: Long-Term Effectiveness and Safety of Isatuximab in Combination with Pomalidomide and Dexamethasone in a Japanese Patient with Refractory Multiple Myeloma and 1q21 Amplification: A Case Report

Introduction: In the ICARIA-MM trial, isatuximab plus pomalidomide-dexamethasone (Pd) significantly prolonged progression-free survival, compared with Pd alone, in patients with relapsed or refractory multiple myeloma (RRMM), including those with gain or amplification of chromosome 1q, region 2, band 1 (1q21+). Case Presentation: We describe a 62-year-old Japanese man with 1q21+ RRMM, previously treated with three lines of therapy, who had a rapid and durable response to isatuximab-Pd. After the first isatuximab-Pd cycle, he had a complete response or better, which was maintained throughout 54 cycles (4.25 years). Isatuximab-Pd was generally well tolerated. The only serious AE was grade 3 cataracts. Conclusion: Our case shows that isatuximab-Pd is capable of inducing an enduring response in a patient with 1q21+ RRMM.

引言：在ICARIA-MM临床试验中，相较于单用泊马度胺-地塞米松（pomalidomide-dexamethasone, Pd）方案，艾沙妥昔单抗（isatuximab）联合泊马度胺-地塞米松（Pd）可显著延长复发难治性多发性骨髓瘤（relapsed or refractory multiple myeloma, RRMM）患者的无进展生存期（progression-free survival, PFS），该人群涵盖伴1号染色体长臂2区1带扩增/获得（1q21+）的患者。

病例报告：本文报告1例62岁日本男性复发难治性多发性骨髓瘤（RRMM）伴1q21+患者，该患者既往接受过三线治疗，对艾沙妥昔单抗-Pd方案呈现快速且持久的临床应答。首个艾沙妥昔单抗-Pd治疗周期结束后，患者即达到完全缓解或更佳（complete response or better），该缓解状态持续了54个治疗周期（即4.25年）。艾沙妥昔单抗-Pd方案整体耐受性良好，仅出现1例严重不良事件（adverse event, AE）：3级白内障。

结论：本病例证实，艾沙妥昔单抗-Pd方案可在伴1q21+的复发难治性多发性骨髓瘤患者中诱导持久的临床应答。