Infections in patients receiving daratumumab for newly diagnosed multiple myeloma: a pooled analysis of MAIA and ALCYONE.

Patients with NDMM are highly susceptible to infection; therefore, gaining a greater understanding of infection incidencemay help to mitigate future risk.

NDMM患者极易感染；因此，更深入地了解感染发生率可能有助于降低未来的风险。

We conducted a pooled analysis of infection incidence, timing, and management strategies from MAIA and ALCYONE.

我们对MAIA和ALCYONE研究中感染发生率、发生时间及管理策略进行了汇总分析。

The median (range) age of the pooled population was 72 (40-93) years.

汇总人群的中位年龄（范围）为72（40-93）岁。

Incidencewas higher with D-Rd/D-VMP vs Rd/VMP for grade 3/4 (36.9% vs 22.4%) and grade 5 (3.0% vs 1.5%) infections; however, exposure-adjusted incidencerates were generally comparable between groups.

D-Rd/D-VMP 与 Rd/VMP 相比，3/4 级感染的发生率更高（36.9% 对比 22.4%），5 级感染的发生率也更高（3.0% 对比 1.5%）；然而，调整暴露剂量后的感染发生率在各组之间大致相当。

Any-grade infections led to the discontinuation of study treatment in ∼2% of patients across treatment groups.

任何级别的感染导致研究治疗在各治疗组中约有 2% 的患者停药。

Of the timing intervals explored, the highest incidenceof grade 3/4 infection occurred within the first 6-month interval of study treatment initiation in both groups.

在探索的时间间隔中，两组在研究治疗开始后的前6个月内出现3/4级感染的发病率最高。

Median time to the first onset of grade 3/4 infections (per Kaplan-Meier estimates) was 83.3 months and not estimable in the D-Rd/D-VMP and Rd/VMP groups, respectively.

根据Kaplan-Meier估计，3/4级感染首次发作的中位时间（D-Rd/D-VMP和Rd/VMP组分别为83.3个月和无法估计。

Although the rates of D-Rd/D-VMP treatment discontinuation due to infection remained low in MAIA and ALCYONE, clinicians should remain vigilant about infections throughout treatment and follow local guidelines and International Myeloma Working Group recommendations to minimize the risk of infection.

尽管在MAIA和ALCYONE研究中，由于感染导致D-Rd/D-VMP治疗中断的比例保持较低，但临床医生在整个治疗过程中仍应保持对感染的警惕，并遵循当地指南和国际骨髓瘤工作组的建议，以最小化感染风险。

These trials were registered at www.ClinicalTrials.gov as NCT02252172 (MAIA) and NCT02195479 (ALCYONE).

这些试验已在www.ClinicalTrials.gov上注册，注册号为NCT02252172（MAIA）和NCT02195479（ALCYONE）。