Department of Medical Oncology, Jerome Lipper Multiple Myeloma Center, Dana-Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts, USA.
Oslo Myeloma Center at Oslo University Hospital, KG Jebsen Center for B-Cell Malignancies, University of Oslo, Oslo, Norway.
Eur J Haematol. 2022 Jan;108(1):73-83. doi: 10.1111/ejh.13706. Epub 2021 Sep 22.
We evaluated the efficacy and safety of pomalidomide, bortezomib, and dexamethasone (PVd) vs bortezomib and dexamethasone (Vd) by age, renal function, and high-risk cytogenetic abnormalities in lenalidomide-pretreated patients with multiple myeloma at first relapse.
OPTIMISMM was a phase 3, multicenter, open-label, randomized study (NCT01734928; N = 559). The primary endpoint was progression-free survival (PFS).
Overall, 226 patients had received one prior line of therapy. PVd significantly prolonged PFS vs Vd in patients aged ≤65 years (median, 22.0 vs 13.1 months; P = .0258) and >65 years (median, 17.6 vs 9.9 months; P = .0369). Median PFS in patients with renal impairment (RI; creatinine clearance <60 mL/min) was 15.1 months with PVd vs 9.5 months with Vd (hazard ratio [HR], 0.67 [95% CI, 0.34-1.34]). In patients without RI, median PFS was 22.0 vs 13.1 months (HR, 0.45 [95% CI, 0.27-0.76]). In patients with high-risk cytogenetics, median PFS was 14.7 vs 9.9 months (HR, 0.39 [95% CI, 0.13-1.17]). PVd significantly improved overall response rate vs Vd in all subgroups. The safety profile of PVd was consistent with previous reports.
These findings confirmed the benefits of PVd at first relapse, including in patients with poor prognostic factors.
我们评估了泊马度胺、硼替佐米和地塞米松（PVd）与硼替佐米和地塞米松（Vd）在(lenalidomide)预处理的多发性骨髓瘤首次复发患者中的疗效和安全性，根据年龄、肾功能和高危细胞遗传学异常进行分层。
OPTIMISMM 是一项 3 期、多中心、开放标签、随机研究（NCT01734928；N=559）。主要终点是无进展生存期（PFS）。
总体而言，226 例患者接受了一线治疗。在年龄≤65 岁（中位 PFS：22.0 个月比 13.1 个月；P=0.0258）和>65 岁（中位 PFS：17.6 个月比 9.9 个月；P=0.0369）的患者中，PVd 显著延长了 PFS。肾功能不全（RI；肌酐清除率<60ml/min）患者的 PVd 中位 PFS 为 15.1 个月，Vd 为 9.5 个月（HR，0.67[95%CI，0.34-1.34]）。无 RI 患者的中位 PFS 为 22.0 个月比 13.1 个月（HR，0.45[95%CI，0.27-0.76]）。高危细胞遗传学患者的中位 PFS 为 14.7 个月比 9.9 个月（HR，0.39[95%CI，0.13-1.17]）。PVd 显著提高了所有亚组的总体缓解率。PVd 的安全性与之前的报告一致。
这些发现证实了首次复发时 PVd 的获益，包括在预后不良的患者中。
