An open-label, single-arm, phase 2 study of single-agent carfilzomib in patients with relapsed and/or refractory multiple myeloma who have been previously treated with bortezomib.
An open-label, single-arm, phase 2 study of single-agent carfilzomib in patients with relapsed and/or refractory multiple myeloma who have been previously treated with bortezomib.
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DOI：
10.1111/j.1365-2141.2012.09232.x
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发表时间：
2012-09
影响因子：
6.5
通讯作者：
Wang M
中科院分区：
文献类型：
--
作者：
Vij R;Siegel DS;Jagannath S;Jakubowiak AJ;Stewart AK;McDonagh K;Bahlis N;Belch A;Kunkel LA;Wear S;Wong AF;Wang M
卡非佐米是下一代蛋白酶体抑制剂，可选择性且不可逆地结合其靶点。在临床研究中，卡非佐米已在复发性和/或难治性多发性骨髓瘤（MM）患者中显示出疗效，并证明了可耐受的安全性特征。在这项II期、开放标签、多中心临床试验中，35例接受1-3种既往治疗（包括至少一种基于硼替佐米的治疗方案）的复发性和/或难治性MM患者接受卡非佐米20 mg/m2，每周两次，召唤日给药方案，持续≤12个月周期。最佳总体缓解率（ORR）为17.1%，临床获益缓解率（ORR +最小缓解）为31.4%。中位缓解持续时间>10.6个月，中位进展时间为4.6个月。最常见的不良事件为疲乏（62.9%）、恶心（60.0%）和呕吐（42.9%）。未观察到基线周围神经病变恶化。卡非佐米单药治疗通常耐受良好，长达12个治疗周期，在既往接受过硼替佐米治疗的复发性和/或难治性MM患者中显示出活性。这些数据结合可接受的毒性特征，支持卡非佐米在复发性和/或难治性MM患者中的潜在用途，并保证继续研究卡非佐米单药或与其他药物联合治疗。
Carfilzomib is a next-generation proteasome inhibitor that selectively and irreversibly binds to its target. In clinical studies, carfilzomib has shown efficacy in patients with relapsed and/or refractory multiple myeloma (MM) and has demonstrated a tolerable safety profile. In this phase 2, open-label, multicentre clinical trial, 35 patients with relapsed and/or refractory MM following 1–3 prior therapies, including at least one bortezomib-based regimen, received carfilzomib 20 mg/m2 in a twice-weekly, consecutive-day dosing schedule for ≤12 monthly cycles. The best overall response rate (ORR) was 17.1% and the clinical benefit response rate (ORR + minimal response) was 31.4%. The median duration of response was >10.6 months and the median time to progression was 4.6 months. The most common adverse events were fatigue (62.9%), nausea (60.0%), and vomiting (42.9%). No exacerbation of baseline peripheral neuropathy was observed. Single-agent carfilzomib was generally well tolerated for up to 12 treatment cycles and showed activity in patients with relapsed and/or refractory MM who had received prior treatment with bortezomib. These data, combined with an acceptable toxicity profile, support the potential use of carfilzomib in patients with relapsed and/or refractory MM and warrant continued investigation of carfilzomib as single agent or in combination with other agents.
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DOI：
10.1016/j.jpain.2011.04.008
发表时间：
2011-09
期刊：
The journal of pain
影响因子：
--
作者：
Boyette-Davis JA;Cata JP;Zhang H;Driver LC;Wendelschafer-Crabb G;Kennedy WR;Dougherty PM
通讯作者：
Dougherty PM
影响因子：
51.1
作者：
Moreau, Philippe;Pylypenko, Halyna;Harousseau, Jean-Luc
通讯作者：
Harousseau, Jean-Luc
DOI：
10.3324/haematol.2009.012674
发表时间：
2010-02-01
期刊：
HAEMATOLOGICA-THE HEMATOLOGY JOURNAL
影响因子：
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作者：
Mohty, Bilal;El-Cheikh, Jean;Mohty, Mohamad
通讯作者：
Mohty, Mohamad
影响因子：
11.4
作者：
Durie, B. G. M.;Harousseau, J-L;Rajkumar, S. V.
通讯作者：
Rajkumar, S. V.
影响因子：
20.3
作者：
Parlati, Francesco;Lee, Susan J.;Bennett, Mark K.
通讯作者：
Bennett, Mark K.