Daratumumab-bortezomib-thalidomide-dexamethasone for newly diagnosed myeloma: CASSIOPEIA minimal residual disease results.

Here, we present long-term MRD status and PFS outcomes after a median follow-up of 80.1 months.

在这里，我们报告了在中位随访时间为80.1个月后，长期MRD状态和PFS结果。

Patients were randomly assigned (1:1) to daratumumab plus VTd (D-VTd) or VTd induction/consolidation; patients remaining on study were rerandomized to daratumumab maintenance or observation for ≤2 years.

患者按1:1的比例随机分配至达雷妥尤单抗加VTd（D-VTd）组或VTd诱导/巩固治疗组；仍在研究中的患者被重新随机分配至达雷妥尤单抗维持治疗或观察，最长不超过2年。

MRD status was assessed at predefined time points during each study phase.

在每个研究阶段的预定时间点评估微小残留病灶（MRD）状态。

D-VTd improved overall MRD-negativity rates (10-5) after induction (34.6% vs 23.1%) and consolidation (63.7% vs 43.7%) and provided PFS benefit, regardless of postinduction MRD status, vs VTd alone.

D-VTd 在诱导治疗后和巩固治疗后提高了总体 MRD 阴性率（分别为 34.6% 对比 23.1% 和 63.7% 对比 43.7%），并提供了无进展生存期（PFS）的益处，无论诱导治疗后 MRD 状态如何，与 VTd 单药治疗相比。

Daratumumab maintenance improved overall MRD-negativity rates over observation, regardless of induction/consolidation treatment (D-VTd/daratumumab vs D-VTd/observation, 10-5 [77.3% vs 70.7%] and 10-6 [60.7% vs 52.0%]; VTd/daratumumab vs VTd/observation, 10-5 [70.9% vs 51.2%] and 10-6 [48.4% vs 30.7%]) and improved MRD-negativity rates, regardless of risk status, as defined by cytogenetic abnormalities or the revised International Staging System score.

达雷妥尤单抗维持治疗提高了总体 MRD 阴性率，无论诱导/巩固治疗如何（D-VTd/达雷妥尤单抗对比 D-VTd/观察，10^-5 [77.3% 对比 70.7%] 和 10^-6 [60.7% 对比 52.0%]；VTd/达雷妥尤单抗对比 VTd/观察，10^-5 [70.9% 对比 51.2%] 和 10^-6 [48.4% 对比 30.7%]），并提高了 MRD 阴性率，无论风险状态如何，风险状态由细胞遗传学异常或修订的国际分期系统评分定义。

Furthermore, daratumumab maintenance provided PFS benefit vs observation, regardless of induction/consolidation treatment and postconsolidation MRD status.

此外，达雷妥尤单抗维持治疗无论诱导/巩固治疗方案和巩固后微小残留病灶（MRD）状态如何，均提供了无进展生存（PFS）的益处。

D-VTd followed by daratumumab maintenance consistently produced the highest landmark, cumulative, and sustained MRD-negativity rates (10-5 and 10-6), translating to superior long-term PFS outcomes.

D-VTd方案后接受达雷妥尤单抗维持治疗，始终产生了最高的标志性、累积和持续的MRD阴性率（10^-5和10^-6），这转化为更优越的长期无进展生存（PFS）结果。

These results demonstrate that daratumumab-based induction/consolidation followed by daratumumab maintenance resulted in the deepest and most durable MRD negativity, leading to superior PFS outcomes.

这些结果表明，以达雷妥尤单抗为基础的诱导/巩固治疗后进行达雷妥尤单抗维持治疗，实现了最深且持续时间最长的微小残留病灶（MRD）阴性状态，从而带来了更优越的无进展生存（PFS）结果。

This trial was registered at www.clinicaltrials.gov as #NCT02541383.

该试验已在www.clinicaltrials.gov上注册，注册号为#NCT02541383。