期刊
EUROPEAN JOURNAL OF HAEMATOLOGY
卷 108, 期 1, 页码 73-83出版社
WILEY
DOI: 10.1111/ejh.13706
关键词
aged; chromosome aberrations; multiple myeloma; pomalidomide; renal insufficiency
类别
资金
- Bristol-Myers Squibb
This study showed that PVd significantly prolonged PFS in lenalidomide-pretreated patients with multiple myeloma at first relapse, across different age groups, renal function status, and cytogenetic abnormalities. PVd also improved overall response rate in all subgroups, with a safety profile consistent with previous reports.
Objective 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. Methods OPTIMISMM was a phase 3, multicenter, open-label, randomized study (NCT01734928; N = 559). The primary endpoint was progression-free survival (PFS). Results 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. Conclusions These findings confirmed the benefits of PVd at first relapse, including in patients with poor prognostic factors.
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