苯达莫司汀联合泊马度胺、地塞米松治疗伴髓外病变的复发多发性骨髓瘤：多中心研究 Translated title: Bendamustine combined with pomalidomide and dexamethasone in relapsed multiple myeloma with extramedullary disease: a multicenter study

Abstract

目的

评估苯达莫司汀联合泊马度胺、地塞米松（BPD方案）治疗伴髓外病变的复发多发性骨髓瘤（MM）的疗效和安全性。

方法

本项开放、单臂、多中心前瞻性研究纳入2021年2月至2022年11月在青岛市市立医院等7所医院诊断并接受BPD方案治疗的30例伴髓外病变的复发MM患者，分析其疗效及不良反应。

结果

30例患者中位年龄62（47～72）岁，其中18例（60.0％）为首次复发，首次复发的18例患者的总体反应率（ORR）为100％，其中完全缓解3例（16.7％），非常好的部分缓解（VGPR）10例（55.5％），部分缓解（PR）5例（27.8％）。12例二线以上治疗后复发患者的ORR为50％，其中≥VGPR 0例，PR 6例（50％），疾病稳定3例（25％），疾病进展3例（25％）。所有患者的1年无进展生存率为65.2％（95％ CI 37.2％～83.1％），1年总生存率为90.0％（95％ CI 76.2％～95.4％）。常见的3～4级血液学不良反应包括中性粒细胞减少2例（6.7％），血小板减少1例（3.3％），总体不良反应可控。

结论

BPD方案在伴髓外病变的复发MM患者中具有良好的疗效和耐受性。

Translated abstract

Objective

To evaluate the efficacy and safety of bendamustine combined with pomalidomide and dexamethasone（BPD regimen）in the treatment of relapsed multiple myeloma（MM）with extramedullary disease.

Methods

This open, single-arm, multicenter prospective cohort study included 30 relapsed MM patients with extramedullary disease diagnosed in seven hospitals including Qingdao Municipal Hospital. The patients were treated with BPD regimen from February 2021 to November 2022. This study analyzed the efficacy and adverse reactions of the BPD regimen.

Results

The median age of the 30 patients was 62（47–72）years, of which 18（60％）had first-time recurrence. The overall response rate（ORR）of the 18 patients with first-time recurrence was 100％, of which three（16.7％）achieved complete remission, 10（55.5％）achieved very good partial remission（VGPR）, and five（27.8％）achieved partial remission（PR）. The ORR of 12 patients with recurrence after second-line or above treatment was 50％, including zero patients with ≥VGPR and six patients（50％）with PR. Three cases（25％）had stable disease, and three cases（25％）had disease progression. The one-year progression free survival rate of all patients was 65.2％（95％ CI 37.2％–83.1％）, and the 1-year overall survival rate was 90.0％（95％ CI 76.2％–95.4％）. The common grade 3–4 hematology adverse reactions included two cases（6.7％）of neutropenia and one case（3.3％）of thrombocytopenia. The overall adverse reactions are controllable.

Conclusion

The BPD regimen has good efficacy and tolerance in relapsed MM patients with extramedullary disease.