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首页> 外文期刊>Annals of hematology >A phase II multiple dose clinical trial of histone deacetylase inhibitor ITF2357 in patients with relapsed or progressive multiple myeloma.
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A phase II multiple dose clinical trial of histone deacetylase inhibitor ITF2357 in patients with relapsed or progressive multiple myeloma.

机译：组蛋白脱乙酰基酶抑制剂ITF2357在复发或进行性多发性骨髓瘤患者中的II期多剂量临床试验。

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摘要

ITF2357, an orally effective member of the family of histone deacetylase inhibitors, is a potent inducer of apoptosis and death of multiple myeloma (MM) cells. We performed a phase-II, multiple-dose clinical trial in 19 patients with relapsed or progressive MM to determine the maximum tolerated dose (MTD) of ITF2357 administered twice daily for four consecutive days every week for 4 weeks (i.e., first cycle). The first six patients received 150 mg ITF2357 twice daily. Since two of them experienced a dose-limiting toxicity (DLT) during the first cycle, the subsequent patients received 100 mg ITF2357 twice daily. This was the MTD, as only one DLT occurred. Up to 12 weeks (i.e., three cycles) of treatment were scheduled. Oral dexamethasone was allowed to a maximum weekly amount of 20 mg. Median duration of treatment was 6 weeks, ranging from two (two patients) to 12 weeks (five patients). Four patients suffered from serious adverse events. Three patients experienced grade 3-4 gastro-intestinal toxicity and three had transient electrocardiographic abnormalities. Thrombocytopenia occurred in all but one patient (grade 3-4 in ten patients). At last follow-up, five patients were in stable disease, five had disease progression, and nine had died all of progressive MM. In conclusion, when given at a dose of 100 mg twice daily alone or combined with dexamethasone, ITF2357 proved tolerable but showed a modest clinical benefit in advanced MM.
机译：ITF2357是组蛋白脱乙酰基酶抑制剂家族的口服有效成员，是多发性骨髓瘤（MM）细胞凋亡和死亡的有效诱导剂。我们对19例复发或进行性MM患者进行了II期，多剂量临床试验，以确定ITF2357的最大耐受剂量（MTD），每天两次，连续四天每天两次，连续4周（即第一个周期）。前六名患者每天两次接受150 mg ITF2357。由于其中两个在第一个周期经历了剂量限制性毒性（DLT），因此随后的患者每天两次接受100 mg ITF2357。这是MTD，因为只有一个DLT发生。计划最多12周（即三个周期）的治疗。口服地塞米松的最大每周使用量为20毫克。中位治疗时间为6周，范围从两个（两个患者）到12个星期（五个患者）。四名患者遭受了严重的不良事件。三名患者经历了3-4级胃肠道毒性反应，三名患者出现了短暂的心电图异常。血小板减少症发生在除一名患者之外的所有患者中（十名患者为3-4级）。在最后一次随访中，五名患者病情稳定，五名患者疾病进展，九名患者全部进行性MM死亡。总之，当单独每天两次或与地塞米松联合给予100 mg剂量时，ITF2357被证明是可以耐受的，但在晚期MM中显示出一定的临床益处。

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