文章：

西妥昔单抗（CNTO 328）联合来那度胺、硼替佐米和地塞米松治疗新诊断、既往未治的多发性骨髓瘤：一项开放标签I期临床试验

Siltuximab (CNTO 328) with lenalidomide, bortezomib and dexamethasone in newly-diagnosed, previously untreated multiple myeloma: an open-label phase I trial

原文发布日期：2016-02-12

DOI: 10.1038/bcj.2016.4

类型: Original Article

开放获取: 是

英文摘要：

The safety and efficacy of siltuximab (CNTO 328) was tested in combination with lenalidomide, bortezomib and dexamethasone (RVD) in patients with newly-diagnosed, previously untreated symptomatic multiple myeloma. Fourteen patients were enrolled in the study, eleven of whom qualified to receive therapy. A majority of patients (81.8%) completed the minimal number or more of the four required cycles, while two patients completed only three cycles. The maximum tolerated dose (MTD) of siltuximab with RVD was dose level −1 (siltuximab: 8.3 mg/kg; bortezomib: 1.3 mg/m2; lenalidomide: 25 mg; dexamethasone: 20 mg). Serious adverse events were grade 3 pneumonia and grade 4 thrombocytopenia, and no deaths occurred during the study or with follow-up (median follow-up 28.1 months). An overall response rate, after 3–4 cycles of therapy, of 90.9% (95% confidence interval (CI): 58.7%, 99.8%) (9.1% complete response (95% CI: 0.2%, 41.3%), 45.5% very good partial response (95% CI: 16.7%, 76.6%) and 36.4% partial response (95% CI: 10.9%, 69.2%)) was seen. Two patients withdrew consent, and nine patients (81.8%) opted for autologous stem cell transplantation.

摘要翻译： 

本研究评估了西妥昔单抗（CNTO 328）联合来那度胺、硼替佐米和地塞米松（RVD）方案在新诊断、未经治疗的症状性多发性骨髓瘤患者中的安全性与有效性。共入组14例患者，其中11例符合治疗条件。绝大多数患者（81.8%）完成至少四个必需周期的最低要求，两例患者仅完成三个周期治疗。西妥昔单抗联合RVD方案的最大耐受剂量为-1剂量水平（西妥昔单抗：8.3 mg/kg；硼替佐米：1.3 mg/m²；来那度胺：25 mg；地塞米松：20 mg）。严重不良事件包括3级肺炎和4级血小板减少症，研究期间及随访期（中位随访28.1个月）均无死亡病例。经3-4周期治疗后，总体缓解率达90.9%（95%置信区间：58.7%-99.8%），其中完全缓解率9.1%（95% CI：0.2%-41.3%）、非常好的部分缓解率45.5%（95% CI：16.7%-76.6%）、部分缓解率36.4%（95% CI：10.9%-69.2%）。两例患者撤回知情同意，九例患者（81.8%）选择接受自体干细胞移植。

原文链接：

Siltuximab (CNTO 328) with lenalidomide, bortezomib and dexamethasone in newly-diagnosed, previously untreated multiple myeloma: an open-label phase I trial