Patient-reported outcomes with belantamab mafodotin, pomalidomide, and dexamethasone versus bortezomib, pomalidomide, and dexamethasone in patients with relapsed or refractory multiple myeloma (DREAMM-8): a phase 3, open-label, randomised controlled trial.

We present patient-reported outcomes from this trial.

我们展示了这项试验的患者报告结果。

Methods

This phase 3, open-label, randomised controlled trialwas done in 95 sites in 18 countries.

这是一项在18个国家的95个地点进行的III期、开放标签、随机对照试验。

Eligible patients were adults aged 18 years or older with relapsed or refractory multiple myeloma per International Myeloma Working Group criteria, an Eastern Cooperative Oncology Group performance status of 0-2, and previous treatment with at least one line of therapy that included lenalidomide.

符合条件的患者是年龄在18岁或以上的成人，根据国际骨髓瘤工作组的标准，患有复发或难治性多发性骨髓瘤，东密歇根州癌症研究合作组织的体能状态评分为0-2，并且之前至少接受过一种包含来那度胺的治疗方案。

Patients were randomly assigned (1:1) by a central interactive response technology system to receive 28-day cycles of intravenous belantamab mafodotin (2·5 mg/kg on day 1 of cycle 1 and 1·9 mg/kg on day 1 of cycle 2 onward) combined with oral pomalidomide (4 mg on days 1 to 21) and oral dexamethasone (40 mg on days 1, 8, 15, and 22; belantamab mafodotin group) or 21-day cycles of subcutaneous bortezomib (1·3 mg/m2 on days 1, 4, 8, and 11 of cycles 1-8 and days 1 and 8 of cycle 9 onward) combined with pomalidomide and dexamethasone at the same doses and schedules as the belantamab mafodotin group; bortezomib group).

患者通过中央互动响应技术系统随机分配（1:1），接受静脉注射belantamab mafodotin（第1个周期的第1天为2·5 mg/kg，从第2个周期的第1天起为1·9 mg/kg）联合口服pomalidomide（第1至21天每天4 mg）和口服地塞米松（第1、8、15和22天每天40 mg；belantamab mafodotin组）或接受皮下注射bortezomib（第1-8个周期的第1、4、8和11天以及从第9个周期起的第1和8天为1·3 mg/m2）联合与belantamab mafodotin组相同剂量和方案的pomalidomide和地塞米松（bortezomib组）。

Treatment continued until the occurrence of progressive disease, unacceptable adverse effects, withdrawal of consent, or death (whichever occurred first).

治疗持续进行，直到出现疾病进展、不可接受的不良反应、撤回同意或死亡（以先发生者为准）。

Secondary patient-reported outcome endpoints were change from baseline in health-related quality of life (HRQOL), measured by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, EORTC QLQ-MY20, and Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE).

次要的患者报告结果终点是通过欧洲癌症研究与治疗组织（EORTC）QLQ-C30、EORTC QLQ-MY20以及患者报告结果不良事件通用术语标准（PRO-CTCAE）测量的健康相关生活质量（HRQOL）从基线的变化。

Ocular Surface Disease Index and Functional Assessment of Chronic Illness Therapy-Item GP5 results were assessed similarly as exploratory endpoints.

类似地，作为探索性终点，评估了眼表疾病指数和慢性疾病功能评估-项目GP5的结果。

EORTC QLQ-C30 and EORTC QLQ-MY20 disease symptom domain results were analysed in the intent-to-treat population, and PRO-CTCAE results were analysed in the safety population (patients who received at least one dose of study treatment).

EORTC QLQ-C30和EORTC QLQ-MY20疾病症状领域结果在意向治疗人群中进行了分析，而PRO-CTCAE结果在安全性人群中进行了分析（接受至少一次研究治疗的患者）

For all patient-reported outcome assessments, proportions included the number and percentage of patients with available data, and changes from baseline were summarised as means with 95% CIs at each timepoint.

对于所有患者报告的结果评估，比例包括有可用数据的患者数量和百分比，基线的变化在每个时间点总结为平均值及其95%置信区间

This trial was registered with ClinicalTrials.gov, NCT04484623, and is ongoing.

该试验已在ClinicalTrials.gov上注册，编号为NCT04484623，并正在进行中。

Results

Between Oct 12, 2020, and Dec 26, 2022, 382 patients were assessed for eligibility. 80 patients were excluded and 302 patients were enrolled and randomly assigned to either the belantamab mafodotin group (n=155) or bortezomib group (n=147).

在2020年10月12日至2022年12月26日期间，共有382名患者进行了资格评估。排除了80名患者，其余302名患者被纳入研究并随机分配到belantamab mafodotin组（n=155）或bortezomib组（n=147）。

The median age in the whole population was 66·1 years (SD 9·31). 181 (60%) of 302 patients were male and 260 (86%) were White.

整个群体的中位年龄为66.1岁（标准差9.31）。在302名患者中，181名（60%）为男性，260名（86%）为白人。

At the primary analysis data cutoff (Jan 29, 2024), median follow-up was 21·8 months (IQR 13·2-27·6).

在主要分析的数据截止日期（2024年1月29日），中位随访时间为21.8个月（四分位数间距13.2-27.6）。

For all patient-reported outcome assessments during treatment, compliance was at least 90% for most visits within the first year.

在治疗期间的所有患者报告的结果评估中，第一年内大多数随访的依从性至少为90%。

Change from baseline in EORTC QLQ-C30 and QLQ-MY20 domain scores remained stable in both treatment groups over time, with a consistently greater proportion of patients in the belantamab mafodotin group than in the bortezomib group experiencing meaningful improvement (≥10 points) at most visits.

EORTC QLQ-C30和QLQ-MY20领域得分从基线开始的变化在两个治疗组中随时间保持稳定，与硼替佐米组相比，belantamab mafodotin组的患者在大多数随访中体验到有意义的改善（≥10分）的比例始终更高。

Side-effects were minimally bothersome in both groups within the first year of treatment.

在治疗的第一年内，两组的副作用对患者造成的困扰都很小。

Blurred vision was the adverse eventmost commonly reported as severe or very severe (63 [43%] of 146 patients in the belantamab mafodotin group and 13 [9%] of 139 patients in the bortezomib group), followed by fatigue (56 [38%] of patients in the belantamab mafodotin group and 49 [35%] of patients in the bortezomib group).

在belantamab mafodotin组中，有146名患者（占63人，43%）报告视力模糊为严重或非常严重，而在bortezomib组中，有139名患者（占13人，9%）报告了同样的情况，这是最常报告的不良事件。其次是疲劳，在belantamab mafodotin组中有56名患者（占38%），在bortezomib组中有49名患者（占35%）。

No clear differences between groups were observed for other symptomatic adverse events.

在其他症状性不良事件方面，两组之间未观察到明显差异。

interpretation

Patients with relapsed or refractory multiple myeloma treated with belantamab mafodotin, pomalidomide, and dexamethasone or bortezomib, pomalidomide, and dexamethasone reported stable HRQOL.

接受belantamab mafodotin、pomalidomide和地塞米松或bortezomib、pomalidomide和地塞米松治疗的复发或难治性多发性骨髓瘤患者报告了稳定的健康相关生活质量（HRQOL）。

Self-reported ocular adverse events were generally manageable and minimally bothersome within the first year of treatment.

自我报告的眼部不良事件在治疗的第一年内通常是可管理的，并且对患者的影响最小。

These findings indicate that belantamab mafodotin, pomalidomide, and dexamethasone is well tolerated, with little detriment to HRQOL, supporting its use in relapsed or refractory multiple myeloma.

这些发现表明，Belantamab mafodotin、泊马度米和地塞米松的耐受性良好，对健康相关生活质量（HRQOL）的损害很小，支持其在复发或难治性多发性骨髓瘤中的使用。

funding

GSK.

葛兰素史克。