阶段1 b的研究isatuximab + pomalidomide /地塞米松在复发/难治性多发性骨髓瘤。

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理查森Mikhael J, P, Usmani SZ,中央邦N, Bensinger W,卡兰C,坎帕纳F, Kanagavel D, F杜宾,刘问,Semiond D,安德森K

阶段1 b的研究isatuximab + pomalidomide /地塞米松在复发/难治性多发性骨髓瘤。

血。2019年7月11日,134 (2):123 - 133。doi: 10.1182 / - 2019 - 02 - 895193血。Epub 2019年3月12日。

PubMed ID

30862646 (在PubMed

]

文摘

这一阶段1 b剂量研究评估isatuximab + pomalidomide /复发/难治性多发性骨髓瘤患者地塞米松(RRMM)。患者接受> / = 2毫米疗法之前,包括lenalidomide和蛋白酶抑制剂(PI),登记和接收isatuximab在5、10、20毫克/公斤(每周4周,其次是每2周),pomalidomide 4毫克(21)和地塞米松40毫克(每周)在28天周期,直到进展/不可容忍的毒性。主要目标是确定的安全性和推荐剂量isatuximab组合。二级目标包括评估药物动力学、免疫原性和有效性。收到isatuximab 45例(5 (n = 8) 10 (n = 31)或20 n = 6毫克/公斤)。患者接受平均3(范围1 - 10)之前行;耐火材料中绝大多数都是他们最后的方案(91%)、PI-refractory lenalidomide-refractory为82%和84%。平均治疗时间是9.6个月;19例(42%)仍在治疗。最常见的不良事件包括疲劳(62%),上呼吸道感染(42%)、输液反应(42%),呼吸困难(40%)。 The most common grade >/=3 treatment-emergent adverse event was pneumonia, which occurred in 8 patients (17.8%). Hematologic laboratory abnormalities were common (lymphopenia, leukopenia, anemia, 98% each; neutropenia, 93%; and thrombocytopenia, 84%). Overall response rate was 62%; median duration of response was 18.7 months; median progression-free survival was 17.6 months. These results demonstrate potential meaningful clinical activity and a manageable safety profile of isatuximab plus pomalidomide/dexamethasone in heavily pretreated patients with RRMM. The 10 mg/kg weekly/every 2 weeks isatuximab dose was selected for future studies. This trial was registered at www.clinicaltrials.gov as #NCT02283775.

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药物

Isatuximab