Bortezomib- and lenalidomide-containing regimens are well-established therapies in multiple myeloma (MM). However, despite their extensive use, head-to-head comparisons have never been performed. Therefore, we compared bortezomib and lenalidomide in fixed-duration therapies. In this open-label, phase III study, we randomized MM patients at first relapse to receive either nine cycles of bortezomib plus cyclophosphamide plus dexamethasone (VCD) or lenalidomide plus cyclophosphamide plus dexamethasone (RCD). The primary endpoint was achievement of a very good partial response (VGPR) or better at six weeks after nine treatment cycles. From March 2011 to February 2015, 155 patients were randomized. VGPR or better was achieved by 12 patients (15%) in the VCD arm and 14 patients (18%) in the RCD arm (P = 0·70). Median progression-free survival (PFS) was 16·3 (95% CI: 12·1-22·4) with VCD and 18·6 months (95% CI: 14·7-25·5) with RCD, and the two-year overall survival (OS) was 75% (95% CI: 66-86%) and 74% (95% CI: 64-85%) respectively. In subgroup analyses, no differences in PFS were observed in bortezomib- and lenalidomide-naïve patients, nor in patients who received a bortezomib-based regimen in first line. Adverse events were consistent with the well-established safety profiles of both drugs. Bortezomib and lenalidomide treatments were equally effective in terms of depth of response, PFS, and OS in MM patients at first relapse.

中文翻译：

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在多发性骨髓瘤患者首​​次复发时，硼替佐米，环磷酰胺，地塞米松与来那度胺，环磷酰胺，地塞米松的比较。

含硼替佐米和来那度胺的方案在多发性骨髓瘤（MM）中是行之有效的疗法。但是，尽管已广泛使用它们，但从未进行过头对头比较。因此，我们在固定持续时间的疗法中比较了硼替佐米和来那度胺。在这项开放标签的III期研究中，我们将首次复发的MM患者随机分为9个周期的硼替佐米+环磷酰胺+地塞米松（VCD）或来那度胺+环磷酰胺+地塞米松（RCD）。主要终点是在九个治疗周期后六周达到很好的局部缓解（VGPR）或更好的效果。从2011年3月至2015年2月，随机抽取155名患者。VCD组的12例患者（15％）和RCD组的14例患者（18％）达到了VGPR或更好（P = 0·70）。VCD的中位无进展生存期（PFS）为16·3（95％CI：12·1-22·4），RCD的中位无进展生存期（PFS）为18·6个月（95％CI：14·7-25·5），两年总生存率（OS）分别为75％（95％CI：66-86％）和74％（95％CI：64-85％）。在亚组分析中，未接受过硼替佐米和来那度胺治疗的患者以及在一线接受基于硼替佐米治疗的患者均未观察到PFS的差异。不良事件与两种药物均已确立的安全性一致。在首次复发时，硼替佐米和来那度胺治疗对MM患者的反应深度，PFS和OS均有效。在未接受过硼替佐米和来那度胺的患者中，以及在一线接受基于硼替佐米的方案的患者中，均未观察到PFS的差异。不良事件与两种药物均已确立的安全性一致。在首次复发时，硼替佐米和来那度胺治疗对MM患者的反应深度，PFS和OS均有效。在未接受过硼替佐米和来那度胺的患者中，以及在一线接受基于硼替佐米的方案的患者中，均未观察到PFS的差异。不良事件与两种药物均已确立的安全性一致。在首次复发时，硼替佐米和来那度胺治疗对MM患者的反应深度，PFS和OS均有效。