Objective: To investigate the efficacy and safety of pomalidomide based regimen in the treatment of high-risk multiple myeloma (MM).
Methods: Clinical data of 27 high-risk MM patients treated in Shanxi Bethune Hospital from January 2021 to December 2022 were retrospectively analyzed. All patients were treated with pomadomide based regimen for at least 2 consecutive cycles, and the early therapeutic effect and safety were observed.
Results: Overall remission rate (ORR) was 63.0%(17/27 cases) and deep remission rate was 22.2%(6/27 cases) after 2 cycles of treatment; ORR was 90.5%(19/21 cases) and deep remission rate was 66.7%(14/21 cases) after 4 cycles of treatment. Both ORR and deep remission rate were significantly higher after 4 cycles of treatment than 2 cycles (P=0.044, P=0.003). Beyond that, in the newly diagnosed and relapsed refractory MM groups, ORR after 2 cycles of treatment were 75%(9/12 cases) and 60%(9/15 cases), and deep remission rates were 25%(3/12 cases) and 20%(3/15 cases), respectively; ORR after 4 cycles of treatment were 100%(9/9 cases) and 83.3%(10/12 cases), and deep remission rates were 77.8%(7/9 cases) and 58.3%(7/12 cases), respectively, while there was no significant difference in remission rates between the two groups (P>0.05). In the group of creatinine ≥177 μmol/L, the serum creatinine level was significantly decreased after 2 cycles of treatment compared with that pre-treatment (P=0.001). The 1q21 amplified subgroup accounted for the largest proportion (21/27 cases), ORR was 66.7%(14/21 cases) and deep remission rate was 23.8%(5/21 cases) after 2 cycles of treatment, ORR was 88.9%(16/18 cases) and deep remission rate was 66.7%(12/18 cases) after 4 cycles of treatment. In all the symptoms, the most common adverse reactions were pulmonary infection in 9 cases and hematological adverse reactions of grade 1-2 in 8 cases.
Conclusion: The pomalidomide-based treatment regimen has good early curative effect on the newly diagnosed and relapsed refractory high-risk MM, and also benefits to the high-risk cytogenetic MM, or MM with renal impairment. Therefore, this treatment regimen showed a good safety, and the long-term curative effect needs to be further assessed by more clinical data.
题目: 基于泊马度胺的方案对高危多发性 骨髓瘤早期疗效观察.
目的: 探讨以泊马度胺为基础的方案治疗高危多发性骨髓瘤（MM）的疗效及安全性.
方法: 回顾性分析山西白求恩医院2021年1月-2022年12月收治的27例高危MM患者的临床资料，且患者均至少连续使用2周期以泊马度胺为基础的方案治疗，观察其早期治疗效果及安全性.
结果: 2周期治疗后评估总缓解率（ORR） 为63.0%（17/27例）、深度缓解率为22.2%（6/27例），4周期治疗后评估ORR为90.5%（19/21例）、深度缓解率为66.7%（14/21例），无论ORR还是深度缓解率4周期较2周期明显提高（P=0.044，P=0.003）。新诊断和复发难治MM组2周期治疗后ORR分别为75%（9/12例）和60%（9/15例），深度缓解率分别为25%（3/12例）和20%（3/15例）；4周期治疗后ORR分别为100%（9/9例）和83.3%（10/12例），深度缓解率分别为77.8%（7/9例）和58.3%（7/12例），两组之间缓解率无明显差异（P＞0.05）。肌酐≥177 μmol/L组患者2周期治疗后评估血清肌酐水平较治疗前明显下降（P=0.001）。1q21扩增亚组占比最大77.8%（21/27例），2周期治疗后评估ORR为66.7%（14/21例）, 深度缓解率为23.8%（5/21例），4周期治疗后评估ORR为88.9%（16/18例），深度缓解率为66.7%（12/18例）。最常见的不良反应为肺部感染9例，血液学不良反应1-2级8例.
结论: 以泊马度胺为基础的治疗方案对新诊断、复发/难治的高危MM均有较好的早期疗效，对伴有肾功能损害、高危细胞遗传学的MM同样受益，且安全性良好，但远期疗效需要进一步观察.
Keywords: efficacy; high risk; multiple myeloma; pomalidomide.