文章：

泊马度胺和地塞米松联合环磷酰胺治疗复发/难治性多发性骨髓瘤（AMN001）——亚洲骨髓瘤网络研究

Pomalidomide and dexamethasone combination with additional cyclophosphamide in relapsed/refractory multiple myeloma (AMN001)—a trial by the Asian Myeloma Network

原文发布日期：2019-10-08

DOI: 10.1038/s41408-019-0245-1

类型: Article

开放获取: 是

英文摘要：

Pomalidomide is a third generation immunomodulatory drug which in combination with dexamethasone, has been shown to be active in relapsed/refractory multiple myeloma. However, the data in Asian patients remain limited. We conducted a prospective phase two clinical trial in major cancer centers in Singapore, South Korea, Taiwan, Japan and Hong Kong to assess the efficacy and safety of pomalidomide and dexamethasone combination (PomDex) +/− cyclophosphamide in Asian patients with relapsed/refractory multiple myeloma who failed lenalidomide and bortezomib. Patients were treated with pomalidomide (4 mg daily for 21 days every 4 weeks) and dexamethasone (40 mg weekly). If there is less than a minimal response after three cycles of PomDex, cyclophosphamide 300 mg/m2 can be added (PomCyDex). A total of 136 patients were enrolled. The median PFS was 9 and 10.8 months for the PomDex and PomCyDex group, respectively. The median OS was 16.3 months. This regimen appears to be active across age groups and prior lines of treatment. This combination was overall well tolerated with grade 3 and 4 adverse events of mainly cytopenias. PomDex is highly active and well-tolerated in Asian patients. The addition of cyclophosphamide can improve the response and outcomes further in patients with suboptimal response to PomDex.
 

摘要翻译： 

泊马度胺是一种第三代免疫调节药物，与地塞米松联合使用已被证明在复发/难治性多发性骨髓瘤中具有活性。然而，在亚洲患者中的数据仍然有限。我们在新加坡、韩国、台湾、日本和香港的主要癌症中心进行了一项前瞻性二期临床试验，以评估泊马度胺和地塞米松联合方案（PomDex）加减环磷酰胺在对来那度胺和硼替佐米治疗失败的亚洲复发/难治性多发性骨髓瘤患者中的疗效和安全性。患者接受泊马度胺（每4周每天4毫克，持续21天）和地塞米松（每周40毫克）治疗。如果在三个周期的PomDex后反应低于最小反应，可以添加环磷酰胺300毫克/平方米（PomCyDex）。共入组了136名患者。PomDex组和PomCyDex组的中位无进展生存期分别为9个月和10.8个月。中位总生存期为16.3个月。该方案在不同年龄组和先前治疗线数中均显示出活性。该组合总体耐受良好，3级和4级不良事件主要是血细胞减少。泊马度胺在亚洲患者中具有高活性和良好耐受性。在对PomDex反应不佳的患者中，添加环磷酰胺可以进一步改善反应和结局。

原文链接：

Pomalidomide and dexamethasone combination with additional cyclophosphamide in relapsed/refractory multiple myeloma (AMN001)—a trial by the Asian Myeloma Network