Modification of belantamab mafodotin dosing to balance efficacy and tolerability in the DREAMM-7 and DREAMM-8 trials.

Belamaf dose modifications managed adverse events, including belamaf-related ocular events.

Belamaf 剂量调整管理不良事件，包括与 belamaf 相关的眼部事件。

Ocular events included ocular adverse reactions (eg, dry eyes, photophobia, eye irritation) and protocol-mandated ophthalmic examination findings.

眼部事件包括眼部不良反应（例如干眼、畏光、眼刺激）和协议规定的眼科检查结果。

Protocol-recommended dose modifications for ocular events were driven by ophthalmic examination findings and included belamaf dose delays until resolution and reductions.

针对眼部事件的协议推荐剂量调整是由眼科检查结果驱动的，包括在问题解决前延迟belamaf剂量和减少剂量。

We used descriptive analyses to evaluate the impact of dose modifications on managing ocular events and treatment efficacy.

我们采用描述性分析来评估剂量调整对管理眼部事件和治疗效果的影响。

In patients with normal baseline vision who were receiving treatment, dose modifications extended belamaf dosing intervals to a median of 8 to 12 weeks by 9 months; the prevalences of reduced vision to bilateral 20/50 or worse and ocular adverse reactions were highest in the first 3 months and remained low at later time points.

在基线视力正常的患者中，接受治疗的患者通过剂量调整，belamaf的给药间隔在9个月内延长至中位数8至12周；双眼视力降低至20/50或更差的患者比例和眼部不良反应在最初的3个月内最高，随后的时间点保持较低。

The median time to resolution after grade ≥2 ophthalmic examination findings was 12 weeks.

≥2级眼科检查结果后，解决的中位时间是12周。

Rates of belamaf discontinuations due to ocular events were low.

由于眼部事件导致的belamaf停药率较低。

Almost all responders (partial response or better) required dose modifications.

几乎所有反应者（部分缓解或更好）都需要剂量调整。

Most patients achieved a response before an extended (>2 cycles) dose delay; most who had not, subsequently achieved or deepened their response.

大多数患者在延长的（>2个周期）剂量延迟之前实现了反应；那些尚未实现的患者，随后实现了或加深了他们的反应。

In DREAMM-7 and DREAMM-8, the median PFS in patients with ≥1 dose delay of ≥12 weeks was 36.6 months and not reached, respectively.

在DREAMM-7和DREAMM-8研究中，接受≥1剂延迟≥12周的患者的中位无进展生存期（PFS）分别为36.6个月和未达到。

Ocular events were common but effectively managed with dose modifications, allowing for patients to remain on treatment and derive robust efficacy benefit.

眼部事件虽然常见，但通过剂量调整可以有效管理，使患者能够继续治疗并获得显著的疗效益处。

The trials were registered at www.clinicaltrials.gov as #NCT04246047 (DREAMM-7) and #NCT04484623 (DREAMM-8).

这些试验已在www.clinicaltrials.gov上注册，编号为#NCT04246047（DREAMM-7）和#NCT04484623（DREAMM-8）。