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单药 Belantamab Mafodotin 与 Pomalidomide 加低剂量地塞米松 (Pom/Dex) 在复发/难治性多发性骨髓瘤 (RRMM) 参与者中的研究 (DREAMM-3)

2026年6月5日 更新者：GlaxoSmithKline

一项 III 期、开放标签、随机研究，旨在评估单药 Belantamab Mafodotin 与泊马度胺加低剂量地塞米松 (Pom/Dex) 在复发/难治性多发性骨髓瘤 (RRMM) 参与者中的疗效和安全性 (DREAMM 3)

这项开放标签、随机研究旨在评估单一药物 belantamab mafodotin 与 pom/dex 在 RRMM 参与者中的疗效和安全性。 参与者将以 2:1 的比例随机分配接受单一药物 belantamab mafodotin 或 pom/dex。 Belantamab mafodotin 将在第 1 天（D1）每 3 周（Q3W）给药一次。 Pomalidomide 将在每个 28 天周期的第 1 至 21 天每天给药，地塞米松每周给药一次（第 1、8、15 和 22 天）。 双臂的参与者将接受治疗，直到疾病进展、死亡、不可接受的毒性、撤回同意、失访或研究结束，以先到者为准。

研究概览

地位

主动，不招人

条件

干预/治疗

研究类型

介入性

注册 (实际的)

325

阶段

  • 第三阶段

扩展访问

可用的 查看扩展访问记录。

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 中国
      • Beijing、中国、100050
        • GSK Investigational Site
      • Beijing、中国、100191
        • GSK Investigational Site
      • Beijing、中国、100730
        • GSK Investigational Site
      • Beijing、中国、100000
        • GSK Investigational Site
      • Changsha、中国、130012
        • GSK Investigational Site
      • Chengdu、中国、610041
        • GSK Investigational Site
      • Guangzhou、中国、510080
        • GSK Investigational Site
      • Hangzhou、中国、310009
        • GSK Investigational Site
      • Nanchang、中国、330006
        • GSK Investigational Site
      • Shenzhen、中国、518029
        • GSK Investigational Site
      • Tianjin、中国、300020
        • GSK Investigational Site
      • Tianjin、中国、300060
        • GSK Investigational Site
      • Xuzhou、中国、221006
        • GSK Investigational Site
      • Zhengzhou、中国、450052
        • GSK Investigational Site
  • 俄罗斯
      • Kaluga、俄罗斯、248007
        • GSK Investigational Site
      • Kirov、俄罗斯、610027
        • GSK Investigational Site
      • Krasnoyarsk、俄罗斯、660022
        • GSK Investigational Site
      • Nizhny Novgorod、俄罗斯、603137
        • GSK Investigational Site
      • Novosibirsk、俄罗斯、630087
        • GSK Investigational Site
      • Saint Petersburg、俄罗斯、191024
        • GSK Investigational Site
      • Saint Petersburg、俄罗斯、197341
        • GSK Investigational Site
      • Samara、俄罗斯、443099
        • GSK Investigational Site
      • Sochi、俄罗斯、354057
        • GSK Investigational Site
      • Syktyvkar、俄罗斯、167904
        • GSK Investigational Site
      • Tula、俄罗斯、300053
        • GSK Investigational Site
      • Yekaterinburg、俄罗斯、620102
        • GSK Investigational Site
  • 保加利亚
      • Pleven、保加利亚、5800
        • GSK Investigational Site
      • Plovdiv、保加利亚、4000
        • GSK Investigational Site
      • Sofia、保加利亚、1606
        • GSK Investigational Site
      • Sofia、保加利亚、1407
        • GSK Investigational Site
      • Sofia、保加利亚、1000
        • GSK Investigational Site
      • Sofia、保加利亚、01431
        • GSK Investigational Site
  • 加拿大
    • Alberta
      • Edmonton、Alberta、加拿大、T6G 1Z2
        • GSK Investigational Site
  • 匈牙利
      • Budapest、匈牙利、1083
        • GSK Investigational Site
      • Budapest、匈牙利、1097
        • GSK Investigational Site
      • Budapest、匈牙利、1088
        • GSK Investigational Site
      • Debrecen、匈牙利、4012
        • GSK Investigational Site
      • Kaposvár、匈牙利、7400
        • GSK Investigational Site
      • Nyíregyháza、匈牙利、4400
        • GSK Investigational Site
  • 巴西
      • Curitiba、巴西、80530-010
        • GSK Investigational Site
      • Fortaleza、巴西、60115-281
        • GSK Investigational Site
      • Porto Alegre、巴西、90110-270
        • GSK Investigational Site
      • Rio de Janeiro、巴西、22793-080
        • GSK Investigational Site
      • São Paulo、巴西、04537-080
        • GSK Investigational Site
      • São Paulo、巴西、01321001
        • GSK Investigational Site
      • São Paulo、巴西、01509-900
        • GSK Investigational Site
      • São Paulo、巴西、05651-901
        • GSK Investigational Site
    • Rio Grande do Sul
      • Porto Alegre、Rio Grande do Sul、巴西、90035-903
        • GSK Investigational Site
  • 希腊
      • Athens、希腊、10676
        • GSK Investigational Site
      • Athens、希腊、115 28
        • GSK Investigational Site
      • Haidari - Athens、希腊、12462
        • GSK Investigational Site
      • Larissa、希腊、41 110
        • GSK Investigational Site
      • Pátrai、希腊、26500
        • GSK Investigational Site
      • Thessaloniki、希腊、57010
        • GSK Investigational Site
      • Thessaloniki、希腊、54007
        • GSK Investigational Site
  • 德国
      • Berlin、德国、13125
        • GSK Investigational Site
      • Tübingen、德国、72076
        • GSK Investigational Site
  • 意大利
      • Bologna、意大利、40138
        • GSK Investigational Site
      • Brescia、意大利、25123
        • GSK Investigational Site
      • Catanzaro、意大利、88100
        • GSK Investigational Site
      • Milan、意大利、20122
        • GSK Investigational Site
      • Milan、意大利、20141
        • GSK Investigational Site
      • Pavia、意大利、27100
        • GSK Investigational Site
      • Perugia、意大利、05100
        • GSK Investigational Site
      • Ravenna、意大利、48123
        • GSK Investigational Site
      • Roma、意大利、00161
        • GSK Investigational Site
      • San Giovanni Rotondo FG、意大利、71013
        • GSK Investigational Site
      • Siena、意大利、53100
        • GSK Investigational Site
  • 日本
      • Aichi、日本、467-8602
        • GSK Investigational Site
      • Chiba、日本、277-8567
        • GSK Investigational Site
      • Ehime、日本、790-8524
        • GSK Investigational Site
      • Fukushima、日本、960-1295
        • GSK Investigational Site
      • Gifu、日本、503-8502
        • GSK Investigational Site
      • Gunma、日本、377-0280
        • GSK Investigational Site
      • Hokkaido、日本、060-8648
        • GSK Investigational Site
      • Kyoto、日本、602-8566
        • GSK Investigational Site
      • Kyoto、日本、603-8151
        • GSK Investigational Site
      • Osaka、日本、565-0871
        • GSK Investigational Site
      • Tokyo、日本、108-8639
        • GSK Investigational Site
    • Tokyo
      • Shibuya-Ku、Tokyo、日本、150-8935
        • GSK Investigational Site
  • 比利时
      • Bruges、比利时、8000
        • GSK Investigational Site
      • Brussels、比利时、1200
        • GSK Investigational Site
      • Brussels、比利时、1090
        • GSK Investigational Site
      • Edegem、比利时、2650
        • GSK Investigational Site
      • Kortrijk、比利时、8500
        • GSK Investigational Site
      • Yvoir、比利时、5530
        • GSK Investigational Site
  • 法国
      • Le Mans、法国、72015
        • GSK Investigational Site
      • Montpellier、法国、34295
        • GSK Investigational Site
      • Poitiers、法国、86021
        • GSK Investigational Site
  • 波兰
      • Gdansk、波兰、80-214
        • GSK Investigational Site
      • Krakow、波兰、30510
        • GSK Investigational Site
      • Torun、波兰、87-100
        • GSK Investigational Site
  • 澳大利亚
      • St Albans、澳大利亚、03021
        • GSK Investigational Site
    • New South Wales
      • Gosford NSW、New South Wales、澳大利亚、2250
        • GSK Investigational Site
      • Liverpool、New South Wales、澳大利亚、2170
        • GSK Investigational Site
      • St Leonards、New South Wales、澳大利亚、2065
        • GSK Investigational Site
    • South Australia
      • Woodville、South Australia、澳大利亚、5011
        • GSK Investigational Site
    • Tasmania
      • Hobart、Tasmania、澳大利亚、7000
        • GSK Investigational Site
    • Victoria
      • Clayton、Victoria、澳大利亚、3168
        • GSK Investigational Site
      • Fitzroy、Victoria、澳大利亚、3065
        • GSK Investigational Site
      • Geelong、Victoria、澳大利亚、3220
        • GSK Investigational Site
    • Western Australia
      • Nedlands、Western Australia、澳大利亚、6009
        • GSK Investigational Site
  • 美国
    • Arizona
      • Tucson、Arizona、美国、85715
        • GSK Investigational Site
    • Colorado
      • Pueblo、Colorado、美国、81008
        • GSK Investigational Site
    • Michigan
      • Detroit、Michigan、美国、48202
        • GSK Investigational Site
    • Nebraska
      • Omaha、Nebraska、美国、68130
        • GSK Investigational Site
    • New York
      • Clifton Park、New York、美国、12065
        • GSK Investigational Site
    • Ohio
      • Cincinnati、Ohio、美国、45236
        • GSK Investigational Site
    • Oregon
      • Corvallis、Oregon、美国、97330
        • GSK Investigational Site
      • Eugene、Oregon、美国、97401
        • GSK Investigational Site
    • Texas
      • Tyler、Texas、美国、75702
        • GSK Investigational Site
    • Wisconsin
      • Milwaukee、Wisconsin、美国、53226
        • GSK Investigational Site
  • 英国
      • Airdrie、英国、ML6 0JS
        • GSK Investigational Site
      • Dundee、英国、DD1 9SY
        • GSK Investigational Site
      • Edinburgh、英国、EH4 2XU
        • GSK Investigational Site
      • London、英国、W12 0NN
        • GSK Investigational Site
      • London、英国、EC1 7ED
        • GSK Investigational Site
      • Nottingham、英国、NG5 1PB
        • GSK Investigational Site
      • Oxford、英国、OX3 7LJ
        • GSK Investigational Site
      • Plymouth、英国、PL6 8D8
        • GSK Investigational Site
      • Stoke-on-Trent、英国、ST4 6QG
        • GSK Investigational Site
  • 荷兰
      • Amersfoort、荷兰、3813 TZ
        • GSK Investigational Site
  • 西班牙
      • Barcelona、西班牙、08036
        • GSK Investigational Site
      • Barcelona、西班牙、08916
        • GSK Investigational Site
      • L'Hospitalet de Llobrega、西班牙、08908
        • GSK Investigational Site
      • Málaga、西班牙、29004
        • GSK Investigational Site
      • PamplonaNavarra、西班牙、31008
        • GSK Investigational Site
      • Pozuelo de AlarcOn Madr、西班牙、28223
        • GSK Investigational Site
      • Santiago de Compostela、西班牙、15706
        • GSK Investigational Site
  • 韩国
      • Gyeonggi-do、韩国、10408
        • GSK Investigational Site
      • Hwasun、韩国、58128
        • GSK Investigational Site
      • Incheon、韩国、21565
        • GSK Investigational Site
      • Seongnam-si Gyeonggi-do、韩国、13620
        • GSK Investigational Site
      • Seoul、韩国、03080
        • GSK Investigational Site
      • Seoul、韩国、06591
        • GSK Investigational Site
      • Seoul、韩国、05505
        • GSK Investigational Site

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

14年 及以上 (成人、年长者)

接受健康志愿者

不

描述

纳入标准：

  • 能够签署知情同意书。
  • 在签署知情同意书时，参与者必须年满 18 岁。 在大韩民国，参与者在签署知情同意书时必须年满 19 岁（含）。
  • 东部肿瘤合作组 (ECOG) 表现状态为 0 至 2。
  • 根据 IMWG 的定义，经组织学或细胞学证实诊断为多发性骨髓瘤 (MM)，并且： 已接受自体干细胞移植 (SCT)，或被认为不适合移植；已接受至少 2 线抗骨髓瘤治疗，包括至少 2 个连续周期的来那度胺和蛋白酶体抑制剂（单独或联合给药），并且必须在完成治疗时或 60 天内记录疾病进展最后一次治疗或在最后一次治疗时必须无反应，其中无反应定义为在 2 个完整治疗周期后未达到至少最小反应 (MR)。 在这种情况下，必须在最后一次治疗后至少 4 周内确定未达到至少 MR。
  • 患有具有以下至少一项的可测量疾病： 血清 M 蛋白 >=0.5 克每分升 (g/dL)（>=5 克每升）；尿液 M 蛋白 >=200 mg/24 小时；血清游离轻链 (FLC) 测定：涉及的 FLC 水平 >=10 毫克/分升 (mg/dL) (>=100 mg/L) 且血清 FLC 比率异常 (1.65)。
  • 具有自体 SCT 病史的参与者有资格参加研究，前提是满足以下资格标准：移植时间在开始研究治疗前 >100 天；没有活动性感染。
  • 足够的器官系统功能定义如下：绝对中性粒细胞计数 (ANC) >=1.0*10^9/L； 血红蛋白 >= 8.0 克/分升；血小板 >= 50x10^9/L；总胆红素 1.5*ULN 是可接受的，如果胆红素是分馏的和直接胆红素
  • 男性或女性使用避孕药具应符合当地有关临床研究参与者避孕方法的规定。 如果男性参与者在干预期间和最后一次研究干预后 6 个月同意以下内容，则他们有资格参与，以允许清除任何改变的精子： 避免捐献精子 加上： 戒除异性性交他们喜欢的和通常的生活方式（长期和持续戒酒）并同意保持戒酒或dex），即使他们成功进行了输精管切除术：同意在整个研究治疗期间使用男用避孕套，包括 6 个月的随访期，即使他们已经成功进行输精管切除术并且女性伴侣使用额外的高效避孕方法失败率
  • 女性参与者如果未怀孕或未哺乳，则有资格参与，并且至少满足以下条件之一： 不是育龄妇女 (WOCBP) 或 是 WOCBP 并同意遵守以下条款： 第 1 组 ( belantamab mafodotin）：使用高效的避孕方法（失败率为
  • 所有先前的治疗相关毒性（由美国国家癌症研究所 - 不良事件通用毒性标准 [NCI-CTCAE]，5.0 版，2017 年定义）必须

排除标准：

  • 症状性淀粉样变性、活动性 POEMS 综合征（多发性神经病、器官肿大、内分泌病、骨髓瘤蛋白和皮肤改变）；筛选时为活动性浆细胞白血病。
  • 全身性抗骨髓瘤治疗或使用研究药物
  • 在接受第一剂研究干预之前的 30 天内使用抗 MM 单克隆抗体进行过预先治疗。
  • 先前的 B 细胞成熟抗原 (BCMA) 靶向治疗或先前的泊马度胺治疗。
  • 第一次研究干预前 7 天内进行血浆置换。
  • 先前的同种异体干细胞移植。 （只有在没有移植物抗宿主病 [GvHD] 病史或目前处于活动状态的情况下，才允许接受同基因移植的参与者）。
  • 最近 4 周内进行过任何大手术。
  • 存在活动性肾脏疾病（感染、需要透析或任何其他可能影响参与者安全的疾病）。 患有 MM 引起的孤立性蛋白尿的参与者符合条件，前提是他们符合纳入标准中所述的标准。
  • 任何可能影响参与者安全、获得知情同意或遵守研究程序的严重和/或不稳定的预先存在的医疗、精神障碍或其他状况（包括实验室异常）。
  • 需要类固醇的（非传染性）肺炎病史，或当前肺炎。
  • 活动性粘膜或内出血的证据。
  • 根据研究者评估的当前不稳定肝脏或胆道疾病，定义为存在腹水、脑病、凝血病、低白蛋白血症、食道或胃底静脉曲张、持续性黄疸或肝硬化。 （稳定的慢性肝病 [包括吉尔伯特综合征或无症状胆结石] 或恶性肿瘤的肝胆受累是可以接受的，如果参与者在其他方面符合入组标准）
  • 除多发性骨髓瘤外，既往或并发恶性肿瘤的参与者被排除在外，除非第二种恶性肿瘤被认为在医学上稳定至少 2 年。 除了针对这种疾病的激素治疗外，参与者不得接受积极治疗。 （允许患有治愈性非黑色素瘤皮肤癌的参与者不受 2 年限制）。
  • 心血管风险的证据，包括以下任何一项： 当前有临床意义的不受控制的心律失常的证据，包括有临床意义的心电图 (ECG) 异常，包括 2 度（Mobitz II 型）或 3 度房室传导阻滞；筛选后 3 个月内有心肌梗塞、急性冠脉综合征（包括不稳定型心绞痛）、冠脉血管成形术或支架置入术或旁路移植术的病史；纽约心脏协会 (NYHA) 功能分类系统定义的 III 级或 IV 级心力衰竭；不受控制的高血压。
  • 已知对与 belantama mafodotin、泊马度胺、地塞米松或研究干预的任何成分化学相关的药物有立即或延迟的超敏反应或异质性。
  • 怀孕或哺乳期的女性。
  • 需要治疗的活动性感染。
  • 已知的人类免疫缺陷病毒 (HIV)，除非参与者可以满足以下所有条件： 已建立至少 4 周的抗逆转录病毒疗法 (ART) 和 HIV 病毒载量
  • 乙型肝炎参与者将被排除，除非可以满足以下标准： 如果参与者是乙型肝炎核心抗体 (HbcAb) 阳性或乙型肝炎表面抗原 (HbsAg) 阴性，则乙型肝炎病毒 (HBV) 脱氧核糖核酸 (DNA) 应在筛选时无法检测到；如果筛查时 HbsAg+ 或
  • 丙型肝炎抗体检测结果阳性或丙型肝炎核糖核酸 (RNA) 检测结果在筛选时或研究治疗首次给药前 3 个月内呈阳性，除非参与者符合以下标准：需要病毒治疗（通常持续 8 周），然后在至少 4 周的清除期后进行 HCV RNA 检测阴性（肝炎 RNA 是可选的，丙型肝炎抗体检测阴性的参与者不需要也进行丙型肝炎 RNA 检测).
  • 无法耐受血栓栓塞预防的参与者。
  • 除轻度点状角膜病变外，目前存在角膜上皮疾病。

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：接受 Belantamab mafodotin 的参与者
参与者将在 Q3W 的第 1 天接受 belantamab mafodotin 单剂剂量
药品：贝兰他单抗
将使用 Belantamab mafodotin。
有源比较器：参与者接收 pom/dex
参与者将在每个 28 天周期的第 1 至 21 天每天服用泊马度胺，并在第 1、8、15 和 22 天每周服用一次地塞米松。
药品：Pom/dex（泊马度胺加低剂量地塞米松）
将给予泊马度胺和地塞米松。

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Progression-Free Survival (PFS) Based on Investigator-Assessed Response as Per International Myeloma Working Group (IMWG)
大体时间：Up to 27 months
PFS is time from randomization until earliest date of progressive disease (PD), or death due to any cause per investigator-assessed response per IMWG. PD is ≥25% increase from nadir in any of following: serum M-protein (absolute increase ≥0.5 gram per deciliter [g/dL]),urine M-protein(absolute increase ≥200 mg/24hr),difference between involved/uninvolved FLC levels (absolute increase >10 mg/dL) in patients without measurable serum and urine M-protein levels, or bone marrow plasma-cell percentage irrespective of baseline status (absolute increase ≥10%) in patients without measurable serum and urine M-protein levels and without measurable involved FLC levels; appearance of new lesion,≥50% increase in longest diameter of a lesion previously measured >1cm in short axis, or ≥50% increase from nadir in sum of products of two longest perpendicular diameters of more than 1 lesion; ≥50% increase in circulating plasma cells (minimum of 200 cells/microliter) if this is only measure of disease.
Up to 27 months

次要结果测量

结果测量
措施说明
大体时间
Overall Survival (OS)
大体时间：Up to approximately 263 weeks
OS is defined as the time from randomization until death due to any cause.
Up to approximately 263 weeks
Overall Response Rate (ORR)
大体时间：Up to approximately 263 weeks
Overall Response Rate is defined as the percentage of participants with a confirmed partial response (PR) or better (i.e., PR, very good partial response [VGPR], complete response [CR] and stringent complete response [sCR]), according to the International Myeloma Working Group (IMWG) Response Criteria. PR: ≥50% reduction of serum M-protein and reduction in 24-hour (h) urinary M-protein by ≥90% or to <200 mg/24-h; VGPR: serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component <100 mg/24-h; CR:negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND <5% plasmacytomas in the bone marrow; sCR:stringent complete response, CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.
Up to approximately 263 weeks
Clinical Benefit Rate (CBR)
大体时间：Up to approximately 263 weeks
Clinical benefit rate is defined as the percentage of participants with a confirmed minimal response (MR) or better according to the IMWG Response Criteria. MR is >= 25% but < 49% reduction of serum M-protein and reduction in 24-hour urinary M-protein by 50-89%.
Up to approximately 263 weeks
Duration of Response (DoR)
大体时间：Up to approximately 263 weeks
Duration of response is defined as the time from first documented evidence of PR or better, to the time when disease progression (PD) is documented per IMWG response criteria; or death due to PD occurs among participants who achieve an overall response, i.e. confirmed PR or better. PD= Increase of 25% from lowest confirmed response value in 1 or more of the following criteria: Serum M-protein with absolute increase of >= 0.5 g/dL; Serum M-protein increase >= 1 g/dL if the lowest M-component was >=5 g/dL; Urinary M-protein (absolute increase must be >= 200 mg per 24 h). PR = ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥ 90% or to <200 mg/24 h.
Up to approximately 263 weeks
Time to Response (TTR)
大体时间：Up to approximately 263 weeks
TTR is defined as the time between the date of randomization and the first documented evidence of response (PR or better) among participants who achieve confirmed PR or better. PR: >=50% reduction of serum M-protein & reduction in 24h urinary M-protein by >=90%/<200mg/24 h.
Up to approximately 263 weeks
Time to Progression (TTP)
大体时间：Up to approximately 263 weeks
TTP is defined as the time from the date of randomization until the earliest date of documented PD (per IMWG Response Criteria) or death due to PD. PD: increase of >=25% from lowest confirmed value in any 1 of following criteria: serum M-protein (absolute increase must be >=0.5 g/dL), serum M-protein increase >=1g/dL if lowest M component was >=5g/dL; urine M-component (absolute increase must be >=200mg/24 hour),appearance of new lesion(s), >=50% increase from nadir in Sum of the Products of the maximal perpendicular Diameters of measured lesions (SPD) of >1 lesion, or >=50% increase in the longest diameter of previous lesion >1 cm in short axis.
Up to approximately 263 weeks
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
大体时间：Up to approximately 263 weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. TEAE is an event that emerged during treatment having been absent pre-treatment or worsened relative to the pre-treatment state. AEs were to be coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.
Up to approximately 263 weeks
Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-baseline Relative to Baseline
大体时间：Baseline (Day 1) and up to approximately 263 weeks
Blood samples were collected for evaluation of hematology parameters. The summaries of worst-case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values have been presented. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. [Basophils (Baso), Mean Corpuscular Hemoglobin Concentration (MCHC), Mean Corpuscular Hemoglobin (MCH), Mean Corpuscular Volume (MCV), Erythrocytes (Ery), Hematocrit (Hct), Monocytes (Mono), Reticulocytes (Ret), Leukocytes (Leu), Eosinophils (Eosi), Lymphocytes (Lym), Neutrophils (Neu)]
Baseline (Day 1) and up to approximately 263 weeks
Number of Participants With Maximum Grade Increase Post-Baseline Relative to Baseline in Hematology
大体时间：Baseline (Day 1) and up to approximately 263 weeks
Blood samples were collected for evaluation of hematology parameters. The summaries of maximum grade increase from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE version 5.0. Grade 1 (G1): mild; Grade 2 (G2): moderate; Grade 3 (G3): severe; Grade 4 (G4) life-threatening or disabling. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. [White Blood Cells (WBC)]
Baseline (Day 1) and up to approximately 263 weeks
Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-baseline Relative to Baseline
大体时间：Baseline (Day 1) and up to approximately 263 weeks
Blood samples were collected for evaluation of clinical chemistry parameters. The summaries of worst-case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values have been presented. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. [Kappa Light (K Lt), Lambda (λ),Monoclonal (Mc), Protein (P), Change (Cge), Alpha (α), Beta (β), Creatine Kinase (CK), Gamma (γ) ,Immunoglobulin (I-Globulin), Indirect (In.)]
Baseline (Day 1) and up to approximately 263 weeks
Number of Participants With Maximum Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry
大体时间：Baseline (Day 1) and Up to approximately 263 weeks
Blood samples were collected for evaluation of clinical chemistry parameters. The summaries of maximum grade increase from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.Grade 1 (G1): mild; Grade 2 (G2): moderate; Grade 3 (G3): severe; Grade 4 (G4) life-threatening or disabling. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. [Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Aspartate Aminotransferase (AST), Creatine Kinase (CPK), Gamma Glutamyl Transferase (GGT)]
Baseline (Day 1) and Up to approximately 263 weeks
Number of Participants With Shift in Urine Albumin Creatinine Ratio From Baseline to Worst Post-Baseline
大体时间：Baseline (Day 1) and Up to approximately 263 weeks
Urine samples were analyzed for spot urine albumin/creatinine ratio (UACR)[milligrams/grams (mg/g)]. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. The "worst post-baseline value" is defined as the highest UACR measurement recorded for a participant after the baseline assessment and up to the end of the study observation period. The "shift" will be calculated as the difference between this worst post-baseline UACR value and the baseline UACR value (Worst Post-Baseline UACR - Baseline UACR). Each category is reported as "Baseline category, Worst post-baseline category." Ranges are inclusive and expressed as [lower-upper].
Baseline (Day 1) and Up to approximately 263 weeks
Number of Participants With Maximum Worst-case Change From Baseline in Best Corrected Visual Acuity Test (BCVA) Scores
大体时间：Baseline (Day 1) and up to approximately 263 weeks
BCVA score was assessed individually for each eye. BCVA score was calculated based on the Logarithm of the Minimum Angle of Resolution (logMAR score). Any worst-case change from baseline categories are presented for right and left eyes. BCVA test scores were categorized as no change/improved vision, possible worsened vision and definite worsened vision. No change/improved vision was defined as a change from baseline <0.12 logMAR score; a possible worsened vision was defined as a change from baseline >=0.12 to <0.3 logMAR score; a definite worsened vision was defined as a change from baseline >=0.3 logMAR score. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Baseline (Day 1) and up to approximately 263 weeks
Observed Plasma Concentrations of Belantamab Mafodotin- Antibody-drug Conjugate (ADC)
大体时间：Pre-dose on Day (D)1 of Cycles(C)1,2,3,4,6,9,12,18,24,30,36,42; End of Infusion (EOI) on D1 of C1,2,3,4&6; Start of infusion (SOI) + 2 hours(h) on D1,SOI + 24 h on D1; D4,D8-15,D22 of C1&C3; D1 of C2,3,4&6; C3D2; & End of Treatment(EOT) (~242 weeks)
Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin
Pre-dose on Day (D)1 of Cycles(C)1,2,3,4,6,9,12,18,24,30,36,42; End of Infusion (EOI) on D1 of C1,2,3,4&6; Start of infusion (SOI) + 2 hours(h) on D1,SOI + 24 h on D1; D4,D8-15,D22 of C1&C3; D1 of C2,3,4&6; C3D2; & End of Treatment(EOT) (~242 weeks)
Observed Plasma Concentrations of Belantamab Mafodotin- Total Monoclonal Antibody (mAb)
大体时间：Pre-dose on Day (D)1 of Cycles (C)1,2,3,4,6,9,12,18,24,30,36,42; EOI on D1 of C1,2,3, 4 & 6; SOI + 24h on D1&2 of C1&3; D4, D8-15, D22 of C1&3; D1of C2,3,4 & 6; D2 of C3; and EOT (~242 weeks)
Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin
Pre-dose on Day (D)1 of Cycles (C)1,2,3,4,6,9,12,18,24,30,36,42; EOI on D1 of C1,2,3, 4 & 6; SOI + 24h on D1&2 of C1&3; D4, D8-15, D22 of C1&3; D1of C2,3,4 & 6; D2 of C3; and EOT (~242 weeks)
Observed Plasma Concentrations of Belantamab Mafodotin-Cys-mc Microtubular Inhibitor Monomethyl Auristatin-F (MMAF)
大体时间：Pre-dose on Day (D)1 of Cycles (C)1,2,3,4,6,9,12,18,24,30,36,42; EOI on D1 of C1,2,3, 4 & 6; D1 SOI + 2 h of C1&3; D2 SOI + 24h of C1&3; D4, D8-15, D22 of C1&3; D1 of C2,3,4,6,9,12,18,24 & 30; D2 of C3; and EOT (~242 weeks)
Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin
Pre-dose on Day (D)1 of Cycles (C)1,2,3,4,6,9,12,18,24,30,36,42; EOI on D1 of C1,2,3, 4 & 6; D1 SOI + 2 h of C1&3; D2 SOI + 24h of C1&3; D4, D8-15, D22 of C1&3; D1 of C2,3,4,6,9,12,18,24 & 30; D2 of C3; and EOT (~242 weeks)
Number of Participants With Post-baseline Positive Anti-Drug Antibody (ADAs) Against Belantamab Mafodotin
大体时间：Upto approximately 263 weeks
Serum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples were tested in screening assay, and positive samples were further characterized for antibody titers.
Upto approximately 263 weeks
Titers of ADAs Against Belantamab Mafodotin
大体时间：Up to approximately 263 weeks
Serum samples were collected and tested for the presence of antibodies against belantamab mafodotin . Confirmed positive ADA samples were further analyzed to obtain the titer of the antibodies. Titers of anti-drug antibodies against belantamab mafodotin is presented.
Up to approximately 263 weeks
Number of Participants With Symptomatic Adverse Effects as Measured by the Patient Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
大体时间：Up to approximately 263 weeks
PRO-CTCAE is a patient-reported outcome measure developed to evaluate symptomatic toxicity in participants on cancer clinical trials. The PRO-CTCAE includes an item library of 124 items representing 78 symptomatic toxicities drawn from the CTCAE. It includes symptomatic toxicities drawn from the CTCAE like blurred vision, chills, constipation, decreased appetite, fatigue, general pain, mouth/throat sores, nausea, nosebleed, shortness of breath, vomiting, watery eyes, cough, itchy, loose/watery stools, Numb/Tingling Hands/Feet (N/T H/F), Pain/Burning (P/B) and Problems Tasting Food/Drink (Prob Tasting F/D) . Items are scored individually on a 0 to 4 scale for severity, frequency and interference. A score of 0 indicates no symptom or interference, while higher score of 4 signify increasing severity, frequency, and interference with daily activities.
Up to approximately 263 weeks
Change From Baseline (CFB) in Ocular Surface Disease Index (OSDI) Total Score
大体时间：Baseline (Day 1) and Up to approximately 263 weeks
OSDI is 12-item patient-reported outcomes questionnaire designed to provide rapid assessment of range of ocular surface symptoms, including symptoms related to chronic dry eye, severity, and impact on patient's ability to function. In addition to an overall score, there are three subscales of OSDI: ocular symptoms, vision-related function, and environmental triggers. OSDI items are scored on a 0 to 4 Likert-type scale, where 0 = None of the time and 4 = All of the time. Total OSDI score = ([sum of scores for all questions answered×100]/[total number of questions answered×4]). Subscale scores are computed similarly with only questions from each subscale used to generate its own score. Any subscales analyzed separately would also have a maximum possible score of 100. A score of 100=to complete disability, while a score of 0=to no disability. Decrease in score from baseline means improvement
Baseline (Day 1) and Up to approximately 263 weeks
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score.
大体时间：Baseline (Day 1), every three weeks(Q3W) starting from week 4 until week 238, End of Treatment (~242 weeks) and Follow up (~ 263 weeks)
The EORTC QLQ-C30 includes 30-items with single and multi-item scales. These included five functional scales (physical functioning [PF], role functioning [RF], emotional functioning [EF] cognitive functioning [CF] and social functioning [SF]), three symptom scales (fatigue, nausea/vomiting [N/V] and pain), a global health status (GHS)/ Quality-of-Life (QoL) scale, and six single items (dyspnea, insomnia, appetite loss [AL], constipation, diarrhea and financial difficulties [FD]). Response options are 1 to 4. Scores were averaged and transformed to 0 to 100, a high score for functional scales/ GHS/QoL represent better functioning ability or health-related quality-of-life (HRQoL), whereas a high score for symptom scales/ single items represent significant symptomatology. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Baseline (Day 1), every three weeks(Q3W) starting from week 4 until week 238, End of Treatment (~242 weeks) and Follow up (~ 263 weeks)
Change From Baseline (CFB) in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score
大体时间：Baseline (Day 1), every three weeks(Q3W) starting from week 4 until week 238, End of Treatment (~242 weeks) and Follow up (~263 weeks)
The EORTC QLQ-MY20 is a supplement to the QLQ-C30 instrument used in participants with multiple myeloma. The module comprised of 20 questions that addressed four myeloma-specific HRQoL domains: disease symptoms (DS), side effects of treatment (SET), future perspective (FP) and body image (BI). Responses are 1 to 4. Scores were averaged and scales were transformed to 0 to 100 scale. A high score for disease symptoms and side effects of treatment represented a high level of symptomatology or problems, whereas a high score for future perspective and body image represented better outcomes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Baseline (Day 1), every three weeks(Q3W) starting from week 4 until week 238, End of Treatment (~242 weeks) and Follow up (~263 weeks)
Change From Baseline (CFB) in EORTC IL52 Score
大体时间：Baseline (Day 1), every three weeks(Q3W) starting from week 4 until week 238
European Organization for Research and Treatment of Cancer Item Library 52 (EORTC-QLQ-IL52) is disease symptoms domain from EORTC Quality of Life Questionnaire 20-item Multiple Myeloma module) (EORTC QLQ-MY20). Disease symptoms domain of IL52 contain 6 items covering following concepts: bone aches or pain, back pain, hip pain, arm or shoulder pain, chest pain, and pain increasing with activity. IL52 items are scored on 1 to 4 Likert-type scale, where 1 = Not at all, 2 = A little, 3 = Quite a bit, and 4 = Very much. A raw score is then calculated as mean of completed item responses across 6 disease symptom items. For symptom scales, this raw score is linearly transformed to a 0 to 100 scale using the formula: [(raw score - 1) / 3] × 100. Under this approach, a score of 0 indicates no symptoms across items, while a score of 100 indicates the highest level of symptom burden. Accordingly, higher scores indicate greater symptom burden or worse disease symptoms
Baseline (Day 1), every three weeks(Q3W) starting from week 4 until week 238
Number of Participants With Minimal Residual Disease (MRD) Negativity Rate
大体时间：Up to approximately 263 weeks
MRD negativity rate is defined as the percentage of participants who are MRD negative by Next generation sequencing (NGS) method. The number of participants with MRD negativity has been presented
Up to approximately 263 weeks

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  • 研究主任：GSK Clinical Trials、GlaxoSmithKline

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研究主要日期

学习开始 (实际的)

2020年4月2日

初级完成 (实际的)

2022年9月12日

研究完成 (估计的)

2027年3月11日

研究注册日期

首次提交

2019年11月11日

首先提交符合 QC 标准的

2019年11月11日

首次发布 (实际的)

2019年11月14日

研究记录更新

最后更新发布 (实际的)

2026年7月1日

上次提交的符合 QC 标准的更新

2026年6月5日

最后验证

2026年6月1日

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其他研究编号

  • 207495
  • 2018-004252-38 (EudraCT编号)

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