Peripheral Measurable Residual Disease Activity Assessment by MALDI-TOF Mass Spectrometry in Patients With Newly Diagnosed Multiple Myeloma in the Phase III GMMG-HD7 Trial.

We analyzed 3,301 serum samples from 617 patients enrolled in the phase III GMMG-HD7 trial to characterize the analytical performance and clinical relevance of MS-based measurable residual activity.

我们分析了在III期GMMG-HD7试验中注册的617名患者的3,301个血清样本，以表征基于MS的可测量残余活动的分析性能和临床相关性。

MS reliably distinguished therapeutic antibodies, tracked diagnostic M proteins longitudinally, and demonstrated strong prognostic value across defined time points.

MS 可靠地区分治疗性抗体，纵向追踪诊断性 M 蛋白，并在定义的时间点显示出强烈的预后价值。

MS negativity was associated with superior progression-free survival(PFS), with the greatest separation at later time points (12 months of maintenance: hazard ratio, 0.25 [95% CI, 0.15 to 0.43]; adjusted P < .001).

MS 阴性与优越的无进展生存期（PFS）相关，后期时间点（维持治疗 12 个月时）分离度最大（风险比，0.25 [95% 置信区间，0.15 至 0.43]；调整后 P < .001）。

Combined assessment with bone-marrow measurable residual disease (MRD) further refined risk stratification: MS/MRD double-positive patients exhibited the worst PFS, whereas all other groups showed comparably favorable outcomes.

通过骨髓可测量的残留疾病(MRD)联合评估进一步细化了风险分层：MS/MRD双阳性患者表现出最差的无进展生存期(PFS)，而所有其他组显示出相对较好的结果。

MS/MRD concordance increased over time and was influenced by immunoglobulin isotype, with expected immunoglobulin G-recycling-associated early discordance.

MS/MRD一致性随时间增加，并受到免疫球蛋白同种型的影响，预期的免疫球蛋白G循环相关的早期不一致性。

MS provided accurate M-protein detection and outperformed serum protein electrophoresis at low concentrations, reliably quantifying low-level residual disease.

MS 提供了准确的 M 蛋白检测，并在低浓度下优于血清蛋白电泳，可靠地定量了低水平的残留疾病。

These findings establish serum MS as a sensitive, reproducible, and practical biomarker that complements MRD and supports minimally invasive disease monitoring in MM, with potential integration into future response assessment and risk-adapted treatment strategies.

这些发现确立了血清 MS 作为一个敏感、可重复且实用的生物标志物，补充了微小残留病（MRD）并支持在多发性骨髓瘤（MM）中的微创疾病监测，有潜力整合到未来的反应评估和风险适应性治疗策略中。