A randomized phase II, open-label and multicenter study of combination regimens of bortezomib at two doses by subcutaneous injection for newly diagnosed multiple myeloma patients
A randomized phase II, open-label and multicenter study of combination regimens of bortezomib at two doses by subcutaneous injection for newly diagnosed multiple myeloma patients
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两剂量硼替佐米皮下注射联合治疗新诊断多发性骨髓瘤患者的随机 II 期、开放标签、多中心研究
DOI：
10.1007/s00432-019-02967-3
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发表时间：
2019-09-01
影响因子：
3.6
通讯作者：
Zhai, Yong-Ping
中科院分区：
文献类型：
--
作者：
Li, Feng;Yao, Fu-Sheng;Zhai, Yong-Ping
目的硼替佐米（万珂）、环磷酰胺和地塞米松联合治疗初治多发性骨髓瘤（NDMM）有显著疗效和安全性。在这项研究中，我们比较了改良VCD方案与硼替佐米剂量和时间表的新变化对NDMM的疗效和安全性。（1.6 mg/m2）（A组）或低剂量（1.3 mg/m2）（组B）硼替佐米，在第1、6、11和16天皮下给药，以4周为一个周期，共9个周期，联合地塞米松40 mg静脉滴注硼替佐米d，环磷酰胺300 mg/m2静脉滴注第1-3天。A组完全缓解（CR）或以上者（43.6%）高于B组（12.8%）（P= 0.002）。在诱导期，对于R-ISS III期患者，A组的CR或更好率上级B组（P= 0.01）。< 65岁的患者，A组完全缓解或好转率明显上级B组（P= 0.004）。A组CR起效快（P< 0.01）。同时，A组3-4次腹泻的发生率较高（P= 0.03），这导致≥ 65岁患者的剂量减少率较高（P= 0.041）。两组患者的PFS和OS无显著差异。ConclusionsThe studied high-dose VCD as inductive program has a improved CR rate，尤其是在< 65岁或R-ISS III期患者中，并且对于年轻和高危患者是可行的。Trial registrationClinicalTrials.gov：NCT 02086942.
PurposeCombinations of bortezomib (Velcade), cyclophosphamide and dexamethasone have shown significant efficacy and safety for patients of newly diagnosed multiple myeloma (NDMM). In this study, we compared the efficacy and safety of modified VCD regimens with novel changes in bortezomib dose and schedule for NDMM.MethodsEighty-five NDMM patients from multiple centers were randomly assigned to a high-dose (1.6 mg/m2) (group A) or a low-dose (1.3 mg/m2) (group B) bortezomib, administrated on days 1, 6, 11, and 16 subcutaneously in a 4-week cycle for nine cycles, combined with 40 mg dexamethasone on bortezomib days and cyclophosphamide 300 mg/m2on days 1–3 intravenously.ResultsAfter four cycles, complete response (CR) or better in group A (43.6%) was higher than that in group B (12.8%) (P= 0.002). During induction, for patients with R-ISS stage III, the CR or better rate in group A was superior to that in group B (P= 0.01). Of patients < 65, the CR or better rate of group A was superior to that of group B (P= 0.004). Rapid onset of CR occurred in group A (P< 0.01). Meanwhile, rate of 3–4 diarrhea was higher in group A (P= 0.03), which caused higher rate of dose reduction for patients ≥ 65 (P= 0.041). No significant difference between the two groups in PFS and OS.ConclusionsThe studied high-dose VCD as induction regimen had an improved CR rate, especially in patients < 65 or with R-ISS stage III, and is feasible for young and high-risk patients.Trial registrationClinicalTrials.gov: NCT02086942.