Abstract：
OBJECTIVE: Multiple myeloma (MM) is an incurable condition with variable clinical course. The study included a group of patients with especially poor-prognosis, individuals with relapsed/refractory multiple myeloma (RRMM) and specific cytogenetic disorders. Among the currently used therapies the ixazomib-lenalidomid-dexamethasone (IRd) is considered as a candidate to improve outcomes. The aim of the study was to evaluate the safety and efficacy of IRd regimen in the treatment of patients with RMMM.
METHODS: Nine patients aged 52-82 years who received ixazomib in the early access programme, were included in the study. All patients met the criteria for recurrent/relapsed MM and had high (t(4:14), t(14:16), del17p or +1q21) risk aberrations. Previous chemotherapy regimens included thalidomide and bortezomib. Median duration of exposure to ixazomib was 12 months.
RESULTS: One patient with multiple cytogenetic aberrations and extramedullary plasmocytoma died because of progression after two months of treatment. In the remaining patients, the objective response to treatment was reached, and in four cases it was qualified as a very good partial response (VGPR). Observed adverse effects included neutropenia, infections, and oedema (in three cases Grade 3). Eight patients continue treatment, in two cases the decision was made to reduce lenalidomide doses.
CONCLUSIONS: Preliminary results suggest potentially high efficacy and good safety profile of IRd therapy in patients with RRMM and unfavourable cytogenetics.
METHODS: Nine patients aged 52-82 years who received ixazomib in the early access programme, were included in the study. All patients met the criteria for recurrent/relapsed MM and had high (t(4:14), t(14:16), del17p or +1q21) risk aberrations. Previous chemotherapy regimens included thalidomide and bortezomib. Median duration of exposure to ixazomib was 12 months.
RESULTS: One patient with multiple cytogenetic aberrations and extramedullary plasmocytoma died because of progression after two months of treatment. In the remaining patients, the objective response to treatment was reached, and in four cases it was qualified as a very good partial response (VGPR). Observed adverse effects included neutropenia, infections, and oedema (in three cases Grade 3). Eight patients continue treatment, in two cases the decision was made to reduce lenalidomide doses.
CONCLUSIONS: Preliminary results suggest potentially high efficacy and good safety profile of IRd therapy in patients with RRMM and unfavourable cytogenetics.
摘要：
目的：多发性骨髓瘤（MM）是一种无法治愈的疾病，其临床病程可变。该研究包括一组预后特别差的患者，患有复发性/难治性多发性骨髓瘤（RRMM）和特定细胞遗传学疾病的个体。在目前使用的疗法中，艾沙佐米-来那度胺-地塞米松（IRd）被认为是改善预后的候选药物。该研究的目的是评估IRd方案治疗RMMM患者的安全性和有效性。
方法：9名年龄在52-82岁的患者在早期接入项目中接受了艾沙唑米，包括在研究中。所有患者均符合复发性/复发性MM的标准，并且高（t（4：14），t(14:16),del17p或+1q21)风险异常。以前的化疗方案包括沙利度胺和硼替佐米。艾沙佐米的平均暴露时间为12个月。
结果：1例多发性细胞遗传学畸变和髓外浆细胞瘤患者在治疗两个月后因进展死亡。在剩下的病人中，达到了对治疗的客观反应，在四种情况下，它被认为是非常好的部分反应（VGPR）。观察到的不良反应包括中性粒细胞减少，感染,和水肿（3例3级）。8名患者继续治疗,在两种情况下，决定减少来那度胺的剂量。
结论：初步结果表明，IRd治疗对RRMM和不利的细胞遗传学患者具有潜在的高疗效和良好的安全性。
方法：9名年龄在52-82岁的患者在早期接入项目中接受了艾沙唑米，包括在研究中。所有患者均符合复发性/复发性MM的标准，并且高（t（4：14），t(14:16),del17p或+1q21)风险异常。以前的化疗方案包括沙利度胺和硼替佐米。艾沙佐米的平均暴露时间为12个月。
结果：1例多发性细胞遗传学畸变和髓外浆细胞瘤患者在治疗两个月后因进展死亡。在剩下的病人中，达到了对治疗的客观反应，在四种情况下，它被认为是非常好的部分反应（VGPR）。观察到的不良反应包括中性粒细胞减少，感染,和水肿（3例3级）。8名患者继续治疗,在两种情况下，决定减少来那度胺的剂量。
结论：初步结果表明，IRd治疗对RRMM和不利的细胞遗传学患者具有潜在的高疗效和良好的安全性。
