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首页> 外文期刊>The lancet oncology >Autologous haemopoietic stem-cell transplantation followed by allogeneic or autologous haemopoietic stem-cell transplantation in patients with multiple myeloma (BMT CTN 0102): a phase 3 biological assignment trial.
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Autologous haemopoietic stem-cell transplantation followed by allogeneic or autologous haemopoietic stem-cell transplantation in patients with multiple myeloma (BMT CTN 0102): a phase 3 biological assignment trial.

机译：多发性骨髓瘤患者的自体造血干细胞移植，然后同种异体或自体造血干细胞移植（BMT CTN 0102）：3期生物学分配试验。

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BACKGROUND: Autologous haemopoietic stem-cell transplantation (HSCT) improves survival in patients with multiple myeloma, but disease progression remains an issue. Allogeneic HSCT might reduce disease progression, but can be associated with high treatment-related mortality. Thus, we aimed to assess effectiveness of allogeneic HSCT with non-myeloablative conditioning after autologous HSCT compared with tandem autologous HSCT. METHODS: In our phase 3 biological assignment trial, we enrolled patients with multiple myeloma attending 37 transplant centres in the USA. Patients (<70 years old) with adequate organ function who had completed at least three cycles of systemic antimyeloma therapy within the past 10 months were eligible for inclusion. We assigned patients to receive an autologous HSCT followed by an allogeneic HSCT (auto-allo group) or tandem autologous HSCTs (auto-auto group) on the basis of the availability of an HLA-matched sibling donor. Patients in the auto-auto group subsequently underwent a random allocation (1:1) to maintenance therapy (thalidomide plus dexamethasone) or observation. To avoid enrolment bias, we classified patients as standard risk or high risk on the basis of cytogenetics and beta2-microglobulin concentrations. We used the Kaplan-Meier method to estimate differences in 3-year progression-free survival (PFS; primary endpoint) between patients with standard-risk disease in the auto-allo group and the best results from the auto-auto group (maintenance, observation, or pooled). This study is registered with ClinicalTrials.gov, number NCT00075829. FINDINGS: Between Dec 17, 2003, and March 30, 2007, we enrolled 710 patients, of whom 625 had standard-risk disease and received an autologous HSCT. 156 (83%) of 189 patients with standard-risk disease in the auto-allo group and 366 (84%) of 436 in the auto-auto group received a second transplant. 219 patients in the auto-auto group were randomly assigned to observation and 217 to receive maintenance treatment, of whom 168 (77%) completed this treatment. PFS and overall survival did not differ between maintenance and observation groups and pooled data were used. Kaplan-Meier estimates of 3-year PFS were 43% (95% CI 36-51) in the auto-allo group and 46% (42-51) in the auto-auto group (p=0.671); overall survival also did not differ at 3 years (77% [95% CI 72-84] vs 80% [77-84]; p=0.191). Within 3 years, 87 (46%) of 189 patients in the auto-allo group had grade 3-5 adverse events as did 185 (42%) of 436 patients in the auto-auto group. The adverse events that differed most between groups were hyperbilirubinaemia (21 [11%] patients in the auto-allo group vs 14 [3%] in the auto-auto group) and peripheral neuropathy (11 [6%] in the auto-allo group vs 52 [12%] in the auto-auto group). INTERPRETATION: Non-myeloablative allogeneic HSCT after autologous HSCT is not more effective than tandem autologous HSCT for patients with standard-risk multiple myeloma. Further enhancement of the graft versus myeloma effect and reduction in transplant-related mortality are needed to improve the allogeneic HSCT approach. FUNDING: US National Heart, Lung, and Blood Institute and the National Cancer Institute.
机译：背景：自体造血干细胞移植（HSCT）可改善多发性骨髓瘤患者的生存率，但疾病进展仍是一个问题。异基因HSCT可能会降低疾病进展，但可能与高治疗相关死亡率相关。因此，我们旨在评估与串联自体HSCT相比，自体HSCT后采用非清髓性调理的同种异体HSCT的有效性。方法：在我们的3期生物学分配试验中，我们在美国的37个移植中心招募了多发性骨髓瘤患者。在过去10个月内至少完成了三个周期的全身性抗骨髓瘤治疗的器官功能正常的患者（<70岁）符合入选条件。我们根据HLA匹配的同胞供体的可用性，将患者分配为接受自体HSCT，然后接受同种异体HSCT（自体组）或串联自体HSCT（自体组）。自动组中的患者随后接受随机分配（1：1）的维持治疗（沙利度胺加地塞米松）或观察。为避免招募偏倚，我们根据细胞遗传学和β2-微球蛋白浓度将患者分为标准风险或高风险。我们使用Kaplan-Meier方法来估算自动对等组中具有标准风险的患者与自动对策组的最佳结果之间的3年无进展生存期（PFS;主要终点）的差异（维护，观察或合并）。该研究已在ClinicalTrials.gov上注册，编号为NCT00075829。结果：在2003年12月17日至2007年3月30日期间，我们招募了710名患者，其中625名患有标准风险疾病并接受了自体HSCT。自动上腹组189例标准风险患者中有156例（83％），自动上腹组436例中有366例（84％）进行了第二次移植。自动组中有219例患者被随机分配进行观察，其中217例接受了维持治疗，其中168例（77％）完成了该治疗。维持组和观察组之间的PFS和总体生存率没有差异，使用汇总数据。 Kaplan-Meier对3年PFS的估计在自动自测组中为43％（95％CI 36-51），在自动组中为46％（42-51）（p = 0.671）; 3年的总生存率也没有差异（77％[95％CI 72-84]与80％[77-84]; p = 0.191）。在3年内，自动自我组189例患者中有87（46％）名发生3-5级不良反应，自动436组中185例患者中有185（42％）发生了不良反应。两组之间差异最大的不良事件是高胆红素血症（自动Allo组为21 [11％]患者，自动汽车组为14 [3％]）和周围神经病变（自动allo中为11 [6％]）组与自动组中的52组[12％]）。解释：对于标准风险的多发性骨髓瘤患者，自体HSCT后非清髓性异基因HSCT并不比串联自体HSCT更有效。为了改善同种异体HSCT方法，需要进一步增强移植物抗骨髓瘤的作用并降低移植相关的死亡率。资金来源：美国国家心脏，肺和血液研究所和国家癌症研究所。

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