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SC 与 IV 伊沙妥昔单抗联合泊马度胺和地塞米松治疗 RRMM (IRAKLIA)

2026年8月10日 更新者：Sanofi

一项随机、3 期、开放标签研究，评估 Isatuximab 联合泊马度胺和地塞米松皮下给药与静脉给药对复发和/或难治性多发性骨髓瘤 (RRMM) 成年患者的疗效

这是一项随机、多中心、3 期、开放标签研究，评估皮下 (SC) 与静脉内 (IV) 伊沙妥昔单抗联合泊马度胺和地塞米松 (Pd) 对既往至少接受过 1 次治疗的 RRMM 患者（研究参与者）的疗效治疗线包括来那度胺和蛋白酶体抑制剂 (PI)。 符合条件的参与者将以 1:1 的比例随机分配到 2 个研究组中的 1 个：

手臂 SC：Isatuximab SC + Pd

IV 组：Isatuximab IV + Pd

参与者将被允许继续治疗，直到疾病进展、出现不可接受的不良事件 (AE)、参与者要求停止治疗或任何其他原因，以先发生者为准。

研究概览

地位

主动，不招人

条件

干预/治疗

详细说明

两个研究组将以 4 周为周期接受治疗，直到疾病进展、出现不可接受的不良事件 (AE)、参与者要求停止治疗或任何其他原因，以先发生者为准。

研究类型

介入性

注册 (实际的)

531

阶段

  • 第三阶段

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、100191
        • Investigational Site Number : 1560022
      • Beijing、中国、100034
        • Investigational Site Number : 1560001
      • Changsha、中国、410013
        • Investigational Site Number : 1560010
      • Guangzhou、中国、510060
        • Investigational Site Number : 1560006
      • Hangzhou、中国、310003
        • Investigational Site Number : 1560002
      • Nanchang、中国、330006
        • Investigational Site Number : 1560020
      • Nanning、中国、530021
        • Investigational Site Number : 1560019
      • Qingdao、中国、266011
        • Investigational Site Number : 1560011
      • Shenyang、中国、110004
        • Investigational Site Number : 1560013
      • Tianjin、中国、300020
        • Investigational Site Number : 1560007
      • Tianjin、中国、300060
        • Investigational Site Number : 1560018
      • Tianjin、中国、300052
        • Investigational Site Number : 1560009
      • Wuhan、中国、430022
        • Investigational Site Number : 1560003
      • Wuhan、中国、430030
        • Investigational Site Number : 1560008
      • Zhengzhou、中国、450008
        • Investigational Site Number : 1560004
  • 加拿大
    • Ontario
      • Toronto、Ontario、加拿大、M5G 2M9
        • Investigational Site Number : 1240001
    • Quebec
      • Greenfield Park、Quebec、加拿大、J4V 2H1
        • Investigational Site Number : 1240004
      • Montreal、Quebec、加拿大、H1T 2M4
        • Investigational Site Number : 1240003
  • 匈牙利
      • Budapest、匈牙利、1097
        • Investigational Site Number : 3480004
      • Budapest、匈牙利、1085
        • Investigational Site Number : 3480002
      • Kaposvár、匈牙利、7400
        • Investigational Site Number : 3480003
      • Pécs、匈牙利、7623
        • Investigational Site Number : 3480008
      • Szombathely、匈牙利、9700
        • Investigational Site Number : 3480006
      • Székesfehérvár、匈牙利、8000
        • Investigational Site Number : 3480005
  • 台湾
      • Kaohsiung City、台湾、833
        • Investigational Site Number : 1580001
      • Tainan、台湾、704
        • Investigational Site Number : 1580005
      • Taipei、台湾、100
        • Investigational Site Number : 1580002
  • 土耳其（türkiye）
      • Ankara、土耳其（türkiye）、06010
        • Investigational Site Number : 7920007
      • Ankara、土耳其（türkiye）、06200
        • Investigational Site Number : 7920009
      • Istanbul、土耳其（türkiye）、34093
        • Investigational Site Number : 7920003
      • Istanbul、土耳其（türkiye）、34098
        • Investigational Site Number : 7920005
      • Istanbul、土耳其（türkiye）、34214
        • Investigational Site Number : 7920008
      • Istanbul、土耳其（türkiye）、34381
        • Investigational Site Number : 7920001
      • Izmir、土耳其（türkiye）、35100
        • Investigational Site Number : 7920004
  • 巴西
      • Rio de Janeiro、巴西、22775-001
        • Instituto Americas - Ensino, Pesquisa e Inovação - Rio de Janeiro - Avenida Jorge Curi- Site Number : 0760004
      • São Paulo、巴西、04537-080
        • Clinica São Germano- Site Number : 0760001
    • Ceará
      • Fortaleza、Ceará、巴西、60115-280
        • Núcleo de Oncologia e Hematologia do Ceará- Site Number : 0760006
    • Pernambuco
      • Recife、Pernambuco、巴西、51020-280
        • MultiHemo - Recife - Rua Padre Carapuceiro- Site Number : 0760007
    • Rio Grande do Sul
      • Porto Alegre、Rio Grande do Sul、巴西、90880-480
        • Hospital Mae de Deus- Site Number : 0760003
    • Rio de Janeiro
      • Niterói、Rio de Janeiro、巴西、24020-096
        • CHN - Complexo Hospitalar de Niterói- Site Number : 0760008
  • 希腊
      • Athens、希腊、106 76
        • Investigational Site Number : 3000002
      • Athens、希腊、115 28
        • Investigational Site Number : 3000001
      • Pátrai、希腊、265 04
        • Investigational Site Number : 3000003
      • Thessaloniki、希腊、570 10
        • Investigational Site Number : 3000004
  • 德国
      • Dresden、德国、01307
        • Investigational Site Number : 2760005
      • Heidelberg、德国、69120
        • Investigational Site Number : 2760003
      • Lübeck、德国、23562
        • Investigational Site Number : 2760006
      • Nuremberg、德国、90419
        • Investigational Site Number : 2760007
  • 意大利
      • Bologna、意大利、40138
        • Investigational Site Number : 3800002
      • Brescia、意大利、25123
        • Investigational Site Number : 3800005
      • Pavia、意大利、27100
        • Investigational Site Number : 3800003
    • Ancona
      • Torette、Ancona、意大利、60020
        • Investigational Site Number : 3800004
    • Reggio Emilia
      • Meldola、Reggio Emilia、意大利、47014
        • Investigational Site Number : 3800001
    • Roma
      • Rome、Roma、意大利、00168
        • Investigational Site Number : 3800006
  • 挪威
      • Oslo、挪威、0450
        • Investigational Site Number : 5780001
      • Ålesund、挪威、6017
        • Investigational Site Number : 5780002
  • 捷克语
      • Brno、捷克语、625 00
        • Investigational Site Number : 2030005
      • Olomouc、捷克语、779 00
        • Investigational Site Number : 2030003
      • Ostrava、捷克语、708 52
        • Investigational Site Number : 2030006
      • Prague、捷克语、128 08
        • Investigational Site Number : 2030004
  • 日本
      • Kyoto、日本、603-8151
        • Investigational Site Number : 3920003
      • Osaka、日本、530-8480
        • Investigational Site Number : 3920011
      • Tokyo、日本、150-8935
        • Investigational Site Number : 3920004
      • Yamagata、日本、990-9585
        • Investigational Site Number : 3920009
    • Aichi-ken
      • Nagoya、Aichi-ken、日本、467-8602
        • Investigational Site Number : 3920001
    • Chiba
      • Kamogawa、Chiba、日本、296-8602
        • Investigational Site Number : 3920007
    • Ibaraki
      • Higashiibaraki、Ibaraki、日本、311-3117
        • Investigational Site Number : 3920005
    • Iwate
      • Yahaba、Iwate、日本、028-3695
        • Investigational Site Number : 3920010
    • Kanagawa
      • Kamakura、Kanagawa、日本、247-8533
        • Investigational Site Number : 3920012
    • Okayama-ken
      • Okayama、Okayama-ken、日本、701-1192
        • Investigational Site Number : 3920002
  • 智利
    • La Araucanía
      • Temuco、La Araucanía、智利、4780000
        • Investigational Site Number : 1520001
    • Reg Metropolitana de Santiago
      • Santiago、Reg Metropolitana de Santiago、智利、7580206
        • Investigational Site Number : 1520002
      • Santiago、Reg Metropolitana de Santiago、智利、6900941
        • Investigational Site Number : 1520003
      • Santiago、Reg Metropolitana de Santiago、智利、7620001
        • Investigational Site Number : 1520006
      • Santiago、Reg Metropolitana de Santiago、智利、8380455
        • Investigational Site Number : 1520004
    • Valparaiso
      • Viña del Mar、Valparaiso、智利、2540364
        • Investigational Site Number : 1520005
  • 法国
      • Nantes、法国、44093
        • Investigational Site Number : 2500002
      • Paris、法国、75571
        • Investigational Site Number : 2500005
      • Poitiers、法国、86021
        • Investigational Site Number : 2500001
      • Saint-Priest-en-Jarez、法国、42270
        • Investigational Site Number : 2500009
      • Toulouse、法国、31059
        • Investigational Site Number : 2500003
      • Tours、法国、37032
        • Investigational Site Number : 2500007
  • 波兰
    • Lesser Poland Voivodeship
      • Krakow、Lesser Poland Voivodeship、波兰、31-501
        • Investigational Site Number : 6160005
    • Lower Silesian Voivodeship
      • Wroclaw、Lower Silesian Voivodeship、波兰、50-088
        • Investigational Site Number : 6160004
    • Lublin Voivodeship
      • Lublin、Lublin Voivodeship、波兰、20-081
        • Investigational Site Number : 6160001
  • 澳大利亚
    • New South Wales
      • Liverpool、New South Wales、澳大利亚、2170
        • Investigational Site Number : 0360007
      • Waratah、New South Wales、澳大利亚、2298
        • Investigational Site Number : 0360004
      • Wollongong、New South Wales、澳大利亚、2500
        • Investigational Site Number : 0360003
    • South Australia
      • Adelaide、South Australia、澳大利亚、5000
        • Investigational Site Number : 0360008
    • Victoria
      • Melbourne、Victoria、澳大利亚、3004
        • Investigational Site Number : 0360006
      • Melbourne、Victoria、澳大利亚、3065
        • Investigational Site Number : 0360009
      • Richmond、Victoria、澳大利亚、3121
        • Investigational Site Number : 0360001
  • 瑞典
      • Borås、瑞典、501 82
        • Investigational Site Number : 7520001
      • Huddinge、瑞典、141 57
        • Investigational Site Number : 7520003
  • 美国
    • Colorado
      • Aurora、Colorado、美国、80012
        • Rocky Mountain Cancer Centers - Aurora- Site Number : 8400021
    • Florida
      • Jacksonville、Florida、美国、32224
        • Mayo Clinic in Florida- Site Number : 8400008
      • Plantation、Florida、美国、33322
        • Boca Raton Clinical Research Associates- Site Number : 8400030
    • Mississippi
      • Hattiesburg、Mississippi、美国、39401
        • Hattiesburg Clinic- Site Number : 8400006
    • New Jersey
      • Morristown、New Jersey、美国、07962
        • Atlantic Health System- Site Number : 8400005
    • New York
      • Albany、New York、美国、12206
        • New York Oncology Hematology - Albany Cancer Center- Site Number : 8400017
    • North Carolina
      • Charlotte、North Carolina、美国、28207
        • Novant Health Neurology & Sleep- Site Number : 8400014
    • Ohio
      • Canton、Ohio、美国、44718
        • Gabrail Cancer Center- Site Number : 8400027
      • Fairfield、Ohio、美国、45014
        • Oncology Hematology Care - Fairfield- Site Number : 8400016
    • South Carolina
      • Spartanburg、South Carolina、美国、29303
        • Spartanburg Regional Medical Center- Site Number : 8400002
    • Texas
      • Dallas、Texas、美国、75390
        • University of Texas - Southwestern Medical Center- Site Number : 8400024
      • San Antonio、Texas、美国、78240
        • Texas Oncology - San Antonio Medical Center - Research Drive- Site Number : 8400020
    • Utah
      • Salt Lake City、Utah、美国、84108
        • Veterans Affairs Medical Center - Salt Lake City- Site Number : 8400011
  • 英国
    • Derbyshire
      • Derby、Derbyshire、英国、DE22 3NE
        • Investigational Site Number : 8260003
    • England
      • Birmingham、England、英国、B15 2TH
        • Investigational Site Number : 8260004
    • Leicestershire
      • Leicester、Leicestershire、英国、LE1 5WW
        • Investigational Site Number : 8260002
    • London, City of
      • London、London, City of、英国、W12 0HS
        • Investigational Site Number : 8260005
    • Norfolk
      • Norwich、Norfolk、英国、NR4 7UY
        • Investigational Site Number : 8260001
  • 西班牙
      • Madrid、西班牙、28034
        • Investigational Site Number : 7240005
      • Salamanca、西班牙、37007
        • Investigational Site Number : 7240002
    • Almería
      • Murcia、Almería、西班牙、30120
        • Investigational Site Number : 7240006
    • Barcelona [Barcelona]
      • Badalona、Barcelona [Barcelona]、西班牙、08916
        • Investigational Site Number : 7240004
    • Cantabria
      • Santander、Cantabria、西班牙、39008
        • Investigational Site Number : 7240003
    • Navarre
      • Pamplona、Navarre、西班牙、31008
        • Investigational Site Number : 7240001
  • 阿根廷
      • Buenos Aires、阿根廷、1181
        • Investigational Site Number : 0320002
      • Buenos Aires、阿根廷、1180
        • Investigational Site Number : 0320008
      • Buenos Aires、阿根廷、1280
        • Investigational Site Number : 0320007
      • Buenos Aires、阿根廷、1417
        • Investigational Site Number : 0320003
      • Buenos Aires、阿根廷、1426
        • Investigational Site Number : 0320004
      • Buenos Aires、阿根廷、1430
        • Investigational Site Number : 0320001
      • Buenos Aires、阿根廷、1431
        • Investigational Site Number : 0320005
      • Córdoba、阿根廷、5000
        • Investigational Site Number : 0320010
      • Mendoza、阿根廷、5501
        • Investigational Site Number : 0320009
    • Buenos Aires
      • La Plata、Buenos Aires、阿根廷、1900
        • Investigational Site Number : 0320006

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

18年 及以上 (成人、年长者)

接受健康志愿者

不

描述

纳入标准：

  • 多发性骨髓瘤参与者，之前至少接受过一种治疗，包括来那度胺和一种蛋白酶体抑制剂，并且血清 M 蛋白 (≥ 0.5 g/dL) 和/或尿液 M 蛋白（≥ 200 mg/24 小时）可测量和/或血清游离轻链 (FLC) 检测（受累 FLC 检测≥10 mg/dL 且血清 FLC 比率异常 (1.65)）

排除标准：

  • 参与者小于 18 岁，东部合作肿瘤组表现状态超过 2 的参与者
  • 原发性难治性多发性骨髓瘤参与者
  • 抗 CD38 耐药且清除期少于 9 个月或抗 CD38 mAb 药物不耐受的参与者
  • 既往接受泊马度胺治疗
  • 生物测试不充分的参与者。
  • 明显的心功能不全
  • 参与者在随机分组前 3 年内被诊断或接受过另一种癌症的治疗，完全切除基底细胞癌或皮肤鳞状细胞癌、原位恶性肿瘤或治愈性治疗后的低风险前列腺癌除外
  • 并发浆细胞白血病
  • 活动性原发性淀粉样轻型 (AL) 淀粉样变性
  • 已知的获得性免疫缺陷综合症 (AIDS) 相关疾病或已知的需要抗病毒治疗的人类免疫缺陷病毒 (HIV) 疾病
  • 了解活动性甲型肝炎感染。 当前活动性或慢性乙型肝炎 (HBV) 或丙型肝炎 (HCV) 感染。 允许患有在抗病毒治疗下得到控制的慢性 HBV 或 HCV 疾病的参与者。
  • 不同意使用高效节育方法的育龄妇女或育龄妇女男性参与者

上述信息并非旨在包含与参与者可能参与临床试验相关的所有考虑因素

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
有源比较器：伊沙妥昔单抗静脉注射 (IV)
在第 1 周期（第 1、8、15 和 22 天）以及后续周期的第 1 和 15 天期间，伊沙妥昔单抗剂量将通过每周静脉输注给药，持续 4 周。 每个周期为28天。 泊马度胺剂量将在每个周期的第 1 天至第 21 天在伊沙妥昔单抗给药之前或之后对参与者最方便的时间口服，优选每天的同一时间。 地塞米松将在第 1、8、15 和 22 天口服（每 28 天重复一次）。 参与者可能会接受其他治疗作为背景治疗和/或救援药物。
药品：地塞米松
药物剂型：片剂；给药途径：口服
药品：泊马度胺
药物剂型：硬胶囊；给药途径：口服
其他名称：
  • Pomalyst 或同等水平
药品：伊沙妥昔单抗 IV
剂型：静脉输液用浓缩液；给药途径：静脉内
其他名称：
  • SAR650984
  • 萨丽莎®
药品：地塞米松
剂型：按照当地商品；给药途径：口服；辅助药品（AxMP），即背景治疗；空管代码：H02AB02
药品：孟鲁司特
剂型：按照当地商品；给药途径：口服； AxMP 即背景处理；空管代码：R03DC03
药品：扑热息痛/对乙酰氨基酚
剂型：按照当地商品；给药途径：口服； AxMP 即背景处理；空管代码：N02BE01
药品：苯海拉明
剂型：按照当地商品；给药途径：作为术前用药-口服；用于管理输注反应-IV（或口服等效物）； AxMP，即背景治疗和救援药物（如果发生输液反应）；空管代码：R06AA02
药品：甲基强的松龙
剂型：按照当地商品；给药途径：作为术前用药-IV；用于管理输液反应 - IV（或口服等效物）； AxMP，即背景治疗和救援药物（如果发生输液反应）；空管代码：H02AB04
实验性的：Isatuximab Subcutaneous (SC)
Isatuximab dose will administered SC weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and Day 1 and 15 of subsequent cycles. Each cycle will be 28 days in duration. Pomalidomide dose will be taken orally on Day 1 to Day 21 of each cycle at the time that is the most convenient for the participants prior to or after isatuximab administration, preferably at the same time every day. Dexamethasone will be taken orally on Day 1, 8, 15 and 22 (to be repeated every 28 days). Participants may receive other treatments as background treatment and/or rescue medication.
药品：伊沙妥昔单抗SC
药物剂型：皮下给药溶液；给药途径：皮下（SC）
其他名称：
  • SAR650984
药品：地塞米松
药物剂型：片剂；给药途径：口服
药品：泊马度胺
药物剂型：硬胶囊；给药途径：口服
其他名称：
  • Pomalyst 或同等水平
药品：地塞米松
剂型：按照当地商品；给药途径：口服；辅助药品（AxMP），即背景治疗；空管代码：H02AB02
药品：孟鲁司特
剂型：按照当地商品；给药途径：口服； AxMP 即背景处理；空管代码：R03DC03
药品：扑热息痛/对乙酰氨基酚
剂型：按照当地商品；给药途径：口服； AxMP 即背景处理；空管代码：N02BE01
药品：苯海拉明
剂型：按照当地商品；给药途径：作为术前用药-口服；用于管理输注反应-IV（或口服等效物）； AxMP，即背景治疗和救援药物（如果发生输液反应）；空管代码：R06AA02
药品：甲基强的松龙
剂型：按照当地商品；给药途径：作为术前用药-IV；用于管理输液反应 - IV（或口服等效物）； AxMP，即背景治疗和救援药物（如果发生输液反应）；空管代码：H02AB04

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
总缓解率（ORR）
大体时间：自首次研究药物给药（第1天）起至方案规定截止日期（2024年11月6日），约28个月
由独立评审委员会（IRC）依据2016年国际骨髓瘤工作组（IMWG）标准评估的客观缓解率（ORR）：达到完全缓解（CR）、严格完全缓解（sCR）、非常好的部分缓解（VGPR）和部分缓解（PR）的参与者百分比。CR：血清和尿免疫固定电泳阴性、软组织浆细胞瘤（STP）消失、骨髓穿刺浆细胞比例<5%且游离轻链（FLC）比值正常（0.26-1.65）。sCR：达到CR标准且骨髓活检无克隆性细胞。VGPR：血清和尿M蛋白仅通过免疫固定电泳检测（非电泳法）；血清M蛋白降低≥90%且尿M蛋白水平<100mg/24小时；STP最大垂直直径总和（SPD）较基线降低≥90%；仅FLC指标：受累与未受累FLC水平差值降低≥90%。PR：血清M蛋白降低≥50%且24小时尿M蛋白降低≥90%或降至<200mg/24小时；若基线存在STP，还需满足SPD缩小≥50%。
自首次研究药物给药（第1天）起至方案规定截止日期（2024年11月6日），约28个月
稳态下伊沙妥昔单抗给药前观察浓度（Ctrough）
大体时间：第6周期第1天给药前
稳态谷浓度是指在伊沙妥昔单抗给药第6周期第1天给药前（相当于第6周期第1天前）采集的观察血浆浓度。
第6周期第1天给药前

次要结果测量

结果测量
措施说明
大体时间
伊沙妥昔单抗第4周谷浓度（CT4W）
大体时间：第2周期第1天给药前（第4周时）
CT4W是在isatuximab给药剂量第2周期第1天给药前（相当于第2周期第1天之前）采集的观察血浆浓度。
第2周期第1天给药前（第4周时）
在周期5第15天对'患者体验与满意度问卷（PESQ-FU）'中'对注射方法的满意度'（第8项）回答'非常满意'和'满意'的受试者百分比
大体时间：周期5第15天
PESQ-FU问卷包含9个项目，旨在跟踪参与者对注射方法（不适感、疼痛、副作用、时间节省和满意度）和研究药物（副作用、服用价值、满意度和推荐意愿）的体验与满意度。 该问卷基于对肿瘤科参与者的定性访谈进行了适应性调整。 在指定时间点，将'对注射方法的满意度'回答记录为'非常满意、满意、既非满意也非不满意、不满意、非常不满意'。 此处报告在第5周期第15天对注射方法（项目8）表示非常满意和满意的参与者总百分比。 百分比四舍五入至小数点后一位。
周期5第15天
伊沙妥昔单抗谷浓度
大体时间：第1周期第8、15和22天给药前，第2至5周期第1和15天，第6、7、8、9、12、15、18、21、24和27周期第1天
在指定时间点采集血浆样本用于评估Ctrough。
第1周期第8、15和22天给药前，第2至5周期第1和15天，第6、7、8、9、12、15、18、21、24和27周期第1天
基线患者期望问卷（PEQ-BL）应答参与者百分比
大体时间：基线（第1周期第1天）
报告了在基线时强烈同意或同意以下期望的参与者百分比：注射方法会带来疼痛、不适和副作用预期，注射方法能节省时间，研究药物可能导致副作用但值得服用。 PEQ-BL包含7个条目。 同时报告了曾通过静脉和/或皮下给药方式接受过药物治疗的参与者百分比。 百分比四舍五入至小数点后一位。 基线值定义为在研究药物开始日期当天或之前收集的最后一个非缺失值。
基线（第1周期第1天）
健康资源利用与生产力问卷（HRUPQ）：基线医疗资源利用情况：过去6个月内参与者接受护理的次数
大体时间：基线（第1周期第1天）
通过HRUPQ收集研究药物给药前基线期的医疗资源使用情况。 数据显示参与者在过去6个月内因任何健康问题（包括MM或由于MM）在诊所或医院急诊室接受治疗的平均次数，以及因任何健康问题（包括MM或由于MM）接受护士或其他医疗专业人员上门护理的平均次数。 基线值定义为在研究药物开始日期或之前收集的最后一个非缺失值。
基线（第1周期第1天）
HRUPQ：基线医疗资源使用情况：过去6个月内参与者住院夜数
大体时间：基线（周期1第1天）
通过HRUPQ收集了研究用药前基线期的医疗资源使用情况。 展示了参与者在过去6个月内因任何健康问题（包括MM）或因MM住院的平均夜数，以及因任何健康问题（包括MM）或因MM入住重症监护室（ICU）的平均夜数。 基线值定义为在研究用药开始当天或之前收集的最后一个非缺失值。
基线（周期1第1天）
HRUPQ：基线医疗资源使用情况：参与者在过去6个月内咨询医疗保健专业人员（HCP）的次数
大体时间：基线（第1周期第1天）
通过HRUPQ收集了研究用药前基线期的医疗资源使用情况。 呈现了参与者在过去6个月内咨询以下医疗专业人员的平均次数：全科医生或初级保健临床医生（PCC）——针对包括MM或与MM相关的任何健康问题治疗多种疾病；物理或职业治疗师——针对包括MM或与MM相关的任何健康问题；心理健康专业人员（如精神科医生、心理学家、精神科护士）——针对包括MM或与MM相关的任何健康问题；专科医生或临床医生——针对包括MM或与MM相关的特定医学疾病或问题的任何健康问题。 基线值定义为在研究用药开始日期或之前收集的最后一个非缺失值。
基线（第1周期第1天）
基于HRUPQ的研究期间曾退休参与者的百分比
大体时间：自首次研究药物给药（第1天）起至方案规定截止日期（2024年11月6日），约28个月
就业状况通过HRUPQ进行评估。 报告了研究期间曾退休的参与者百分比。 百分比四舍五入至小数点后一位。
自首次研究药物给药（第1天）起至方案规定截止日期（2024年11月6日），约28个月
基于HRUPQ的因多发性骨髓瘤提前退休参与者百分比
大体时间：从首次研究药物给药（第1天）起至方案规定截止日期（2024年11月6日），约28个月
就业状况通过HRUPQ进行评估。 报告因多发性骨髓瘤而提前退休的参与者百分比。 百分比四舍五入至小数点后第十位。
从首次研究药物给药（第1天）起至方案规定截止日期（2024年11月6日），约28个月
Very Good Partial Response or Better Rate
大体时间：From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
VGPR or better rate by IRC using 2016 IMWG criteria: Percentage of participants with sCR, CR, and VGPR. CR: negative immunofixation on serum and urine, disappearance of any STP, <5% plasma cells in BM aspirates & normal FLC ratio (0.26-1.65). sCR: CR plus no clonal cells in BM biopsy. VGPR: serum and urine M-protein detectable by immunofixation, not electrophoresis;>=90% reduction in serum M-protein plus urine M-protein level<100mg/24h;>=90% decrease in SPD compared to baseline in STP; FLC only:>=90% decrease in difference between involved and uninvolved FLC levels. Percentages are rounded off to the tenth decimal place.
From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
Percentage of Participants With Infusion Reactions
大体时间：From first dose of study medication (Day 1) up to 30 days after the last dose of study medication, approximately 38 months
Infusion reactions were graded using National Cancer Institute-Common Terminology Criteria for AE (NCI-CTCAE) version (v)5.0 criteria: Grade 1: mild transient reaction; infusion interruption not indicated; intervention not indicated. Grade 2: moderate reaction; therapy or infusion interruption indicated but responds promptly to symptomatic treatment; prophylactic medications indicated for <=24 hours. Grade 3/4: severe or life-threatening reaction (Grade 3: prolonged [not rapidly responsive to symptomatic medication and/or brief interruption of infusion]; recurrence of symptoms following initial improvement; hospitalization indicated for clinical sequelae. Grade 4: life-threatening consequences; urgent intervention indicated). Percentage of participants who observed AE of infusion reactions were collected through the electronic case report form (eCRF) as assessed by investigators. Percentages are rounded off to the tenth decimal place.
From first dose of study medication (Day 1) up to 30 days after the last dose of study medication, approximately 38 months
Duration of Response (DOR)
大体时间：From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
DOR: Time from the date of first response to the date of first occurrence of progressive disease (PD) determined by IRC or death from any cause, whichever occurred first.DOR was determined only for participants who achieved a response (PR or better).If PD/death not observed, participant was censored at date of last valid disease assessment performed prior to initiating further anti-myeloma treatment or analysis cut-off date, whichever occurred first. As per IMWG criteria: PD: increase of >=25% from lowest confirmed value in any 1 of following: serum M-protein (absolute increase>=0.5 gram/deciliter[g/dL]),serum M-protein increase>=1g/dL if lowest M-component >=5g/dL, urine M-component (absolute increase >=200mg/24h), appearance of new lesion(s),>=50% increase from nadir in SPD of >1 lesion or >=50% increase in longest diameter of a previous lesion >1 centimeter (cm) in short axis. PR: as defined in OM1.
From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
Time to First Response (TT1R)
大体时间：From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
TT1R was defined as the time from randomization to the date of first IRC determined response (PR or better) that was subsequently confirmed. PR as per IMWG criteria was defined as >=50% reduction of serum M-protein and reduction in 24h urine M-protein by >=90% or to <200mg/24h. In addition to above, if present at baseline, >=50% reduction in the size SPD of STPs was also required.
From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
Time to Best Response (TTBR)
大体时间：From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
TTBR was defined as the time from randomization to the date of first occurrence of IRC determined best overall response (PR or better) that was subsequently confirmed. PR as per IMWG criteria was defined as >=50% reduction of serum M-protein and reduction in 24h urine M-protein by >=90% or to <200mg/24h. In addition to above, if present at baseline,>=50% reduction in the size SPD of STPs was also required.
From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
Progression-free Survival (PFS)
大体时间：From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
PFS was defined as the time from the date of randomization to the date of first documentation of PD as determined by IRC or the date of death from any cause, whichever came first. Responses were determined according to IMWG criteria. PFS was censored at the date of the last valid disease assessment not showing PD performed prior to initiation of a further anti-myeloma treatment (if any) or the analysis cut-off date, whichever came first.
From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
Overall Survival (OS)
大体时间：From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
OS was defined as the time from the date of randomization to death from any cause. Participants without death prior to the analysis cut-off date were censored at the last date the participant was known to be alive or the cut-off date, whichever was first.
From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
Progression Free Survival 2 (PFS2)
大体时间：From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
PFS2 was defined as time from the date of randomization to the date of first documentation of PD (as assessed by Investigator) after initiation of further anti-myeloma treatment or death from any cause, whichever happened first. Same censoring rule applies as in the PFS endpoint.
From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
大体时间：From first dose of study medication (Day 1) up to 30 days after the last dose of study medication, approximately 38 months
An AE was defined as any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. SAEs were any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was a medically important event. TEAEs were defined as AEs that developed, worsened or became serious during the TE period.
From first dose of study medication (Day 1) up to 30 days after the last dose of study medication, approximately 38 months
Isa-SC + Pd: Number of Participants With Injection Site Reactions (ISRs)
大体时间：From first dose of study medication (Day 1) up to 30 days after the last dose of study medication, approximately 38 months
The ISRs are defined as AEs related to medication administration with onset typically within 24 hours from the start of the infusion and are graded using NCI-CTCAE v5.0 criteria: Grade 1: tenderness with or without associated symptoms (warmth, erythema, itching). Grade 2: pain; lipodystrophy; edema; phlebitis. Grade 3: ulceration or necrosis severe tissue damage operative intervention indicated. Grade 4: life-threatening consequences; urgent intervention indicated. ISRs were collected through the eCRF. Number of participants with at least 1 ISR is reported. ISRs were applicable only for the SC administration.
From first dose of study medication (Day 1) up to 30 days after the last dose of study medication, approximately 38 months
Isa-SC + Pd: Percentage of Successful Injections With Isatuximab Injector Device
大体时间：From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
Percentage of successful injections with investigational isatuximab injector device was defined as completion of administration per provided instructions for use with no use errors or technical issues divided by the total number of injections x 100. Delivery performance of the device was analyzed based on the successful injection rate in the Isa-SC + Pd arm as the investigational isatuximab injector device was used only for SC administration.
From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
Number of Participants With Treatment-emergent Anti-drug Antibodies (ADA) Against Isatuximab
大体时间：From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
A participant with treatment-emergent ADA was a participant with at least 1 treatment induced or treatment boosted ADA at any time during the treatment or follow-up observation period. Treatment-induced ADA was defined as ADAs developed de novo (seroconversion) following administration of the biotherapeutic (ie, formation of ADAs any time after the initial study medication administration in a participant without pre-existing ADAs). Treatment-boosted ADA was defined as pre-existing ADAs that were boosted to a higher level following administration of biotherapeutic (ie, any time after the initial study medication administration) the ADA titer was significantly higher than the baseline titer. Number of participants with treatment-emergent ADAs is presented.
From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
大体时间：Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
The PESQ-FU consisting of 9 items has been designed to follow up on participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation). This questionnaire has been adapted based on qualitative interviews with oncology participants. The responses to 'discomfort with injection method' were recorded as 'strongly agree, agree, neither agree nor disagree, disagree and strongly disagree' at specified timepoints. Percentage of participants who disagreed and strongly disagreed that they experienced any discomfort with the injection method are reported here. Percentages are rounded off to the tenth decimal place.
Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
大体时间：Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
The PESQ-FU consisting of 9 items has been designed to follow up on participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation). This questionnaire has been adapted based on qualitative interviews with oncology participants. The responses to 'pain with injection method' were recorded as 'strongly agree, agree, neither agree nor disagree, disagree and strongly disagree' at specified timepoints. Percentage of participants who disagreed and strongly disagreed that they experienced any pain with the injection method are reported here. Percentages are rounded off to the tenth decimal place.
Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
大体时间：Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
The PESQ-FU consisting of 9 items has been designed to follow up on participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation). This questionnaire has been adapted based on qualitative interviews with oncology participants. The responses to 'side effects with injection method' were recorded as 'strongly agree, agree, neither agree nor disagree, disagree and strongly disagree' at specified timepoints. Percentage of participants who disagreed and strongly disagreed that they experienced any side effects with the injection method are reported here. Percentages are rounded off to the tenth decimal place.
Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
大体时间：Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
The PESQ-FU consisting of 9 items has been designed to follow up on participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation). This questionnaire has been adapted based on qualitative interviews with oncology participants. The responses to 'time saving with injection method' were recorded as 'strongly agree, agree, neither agree nor disagree, disagree and strongly disagree' at specified timepoints. Percentage of participants who strongly agreed and agreed that they experienced time saving with the injection method are reported here. Percentages are rounded off to the tenth decimal place.
Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
大体时间：Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
The PESQ-FU consisting of 9 items has been designed to follow up on participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation). This questionnaire has been adapted based on qualitative interviews with oncology participants. The responses to 'satisfaction with injection method' were recorded as 'very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied and very dissatisfied' at specified timepoints. Percentage of participants who were very satisfied and satisfied with the injection method are reported here. Percentages are rounded off to the tenth decimal place.
Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
大体时间：Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
The PESQ-FU consisting of 9 items has been designed to follow up on participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation). This questionnaire has been adapted based on qualitative interviews with oncology participants. The responses to 'side effects with study medication' were recorded as 'strongly agree, agree, neither agree nor disagree, disagree and strongly disagree' at specified timepoints. Percentage of participants who disagreed and strongly disagreed that they experienced any side effects with study medication are reported here. Percentages are rounded off to the tenth decimal place.
Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Study Medication Worth Taking'
大体时间：Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
The PESQ-FU consisting of 9 items has been designed to follow up on participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation). This questionnaire has been adapted based on qualitative interviews with oncology participants. The responses to 'study medication worth taking' were recorded as 'strongly agree, agree, neither agree nor disagree, disagree and strongly disagree' at specified timepoints. Percentage of participants who strongly agreed and agreed that the study medication was worth taking are reported here. Percentages are rounded off to the tenth decimal place.
Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
大体时间：Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
The PESQ-FU consisting of 9 items has been designed to follow up on participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation). This questionnaire has been adapted based on qualitative interviews with oncology participants. The responses to satisfaction with study medication were recorded as 'very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied and very dissatisfied' at specified timepoints. Percentage of participants who were very satisfied and satisfied with the study medication are reported here. Percentages are rounded off to the tenth decimal place.
Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
大体时间：Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
The PESQ-FU consisting of 9 items has been designed to follow up on participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation). This questionnaire has been adapted based on qualitative interviews with oncology participants. The responses to 'recommendation of the study medication' were recorded as 'definitely yes, probably yes, unsure, probably not and definitely not' at specified timepoints. Percentage of participants who responded definitely yes and probably yes to the recommendation of study medication are reported here. Percentages are rounded off to the tenth decimal place.
Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
Percentage of Participants With Response to 'Patient Experience and Satisfaction End of Treatment Questionnaire (PESQ-EOT)'
大体时间：EOT visit (up to DCO date: 29-Aug-2025) (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 38 months)
The PESQ-EOT consisting of 17 items assessed participant experience and satisfaction regarding the injection method (discomfort, pain, side effects, time saving and satisfaction) and study medication (side effects, worth taking, satisfaction and recommendation) and has been adapted based on qualitative interviews with oncology participants. In addition to the above, this questionnaire also includes additional items to assess whether participants received oncology medications in the past 2 years and if a participant received both IV and SC in the past 2 years, then participant preference on injection method (whether SC or IV). Percentage of participants with response to these additional items (received oncology medications in the past 2 years via IV/SC/both and if received both IV and SC; then the participant preference on injection method) are reported here. Percentages are rounded off to the tenth decimal place.
EOT visit (up to DCO date: 29-Aug-2025) (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 38 months)
Participant Responses to Patient's Assessment of Treatment (PAT) Questionnaire
大体时间：EOT visit (up to DCO date: 29-Aug-2025) (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 38 months)
The 4-item PAT is an internally developed non-disease specific and self-administered assessment which has been debriefed with oncology patients during qualitative interviews. It provided participant insights on the benefits and disadvantages of treatment. Benefits and disadvantages were respectively rated on a 0-10 scale wherein 0=none (not beneficial at all or no disadvantages at all) and 10=maximum (extremely beneficial or extremely disadvantageous). Disadvantages vs benefits were rated on a scale of -3 to 3 wherein -3=disadvantages significantly outweigh the benefits, 0=equal benefits and disadvantages and 3=benefits significantly outweigh the disadvantages. Mean of benefits, disadvantages and disadvantages vs benefits is presented here.
EOT visit (up to DCO date: 29-Aug-2025) (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 38 months)
Duration of Hospital Visits for Treatment Administration and Duration of Post-Treatment Monitoring Based on HRUPQ
大体时间：From Cycle 2 Day 1 up to EOT visit (up to PCD: 06-Nov-2024) (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)
Medical resource utilization was collected through HRUPQ. Participants were asked to indicate the duration of their hospital visit (from arrival to departure) and the duration of post-treatment monitoring based on their most recent isatuximab administration. The median duration across all visits (starting from Cycle 2) was calculated and reported here.
From Cycle 2 Day 1 up to EOT visit (up to PCD: 06-Nov-2024) (30 days after last study medication administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)
Percentage of Participants Who Visited Healthcare Professional for Non-trial-related Health Issues Based on HRUPQ
大体时间：Cycle 1 Days 8, 15 and 22, Cycle 2 Day 1, Cycles 3 to 29 Day 15 and EOT visit (up to PCD: 06-Nov-2024) (30 days after last drug administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)
Medical resource utilization was collected through HRUPQ. Percentage of participants with healthcare professional visit not required by clinical trial since last isatuximab administration was recorded. Percentages are rounded off to the tenth decimal place.
Cycle 1 Days 8, 15 and 22, Cycle 2 Day 1, Cycles 3 to 29 Day 15 and EOT visit (up to PCD: 06-Nov-2024) (30 days after last drug administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)
Change From Baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30): Global Health Status (GHS)/Quality of Life (QoL)
大体时间：Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For GHS/QoL: overall health and quality of life were assessed, rated on a 7-point scale (1: very poor to 7: excellent). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score for GHS/QoL and a positive change from baseline represents a healthy/better level of QoL. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
Change From Baseline in EORTC QLQ-C30: Physical Functioning
大体时间：Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For functional scales: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score and a positive change from baseline represents a better level of physical functioning. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
Change From Baseline in EORTC QLQ-C30: Role Functioning
大体时间：Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For functional scales: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score and a positive change from baseline represents a better level of role functioning. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
Change From Baseline in EORTC QLQ-C30: Emotional Functioning
大体时间：Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For functional scales: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score and a positive change from baseline represents a better level of emotional functioning. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
Change From Baseline in EORTC QLQ-C30: Cognitive Functioning
大体时间：Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For functional scales: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score and a positive change from baseline represents a better level of cognitive functioning. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
Change From Baseline in EORTC QLQ-C30: Social Functioning
大体时间：Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For functional scales: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score and a positive change from baseline represents a better level of social functioning. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
Change From Baseline in EORTC QLQ-C30: Fatigue
大体时间：Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For symptom scales: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score for symptoms and a positive change from baseline represents a higher level of symptomatology. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
Change From Baseline in EORTC QLQ-C30: Nausea and Vomiting
大体时间：Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For symptom scales: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score for symptoms and a positive change from baseline represents a higher level of symptomatology. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
Change From Baseline in EORTC QLQ-C30: Pain
大体时间：Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For symptom scales: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score for symptoms and a positive change from baseline represents a higher level of symptomatology. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
Change From Baseline in EORTC QLQ-C30: Dyspnea
大体时间：Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score for symptom items and a positive change from baseline represents a higher level of symptomatology. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
Change From Baseline in EORTC QLQ-C30: Insomnia
大体时间：Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score for symptom items and a positive change from baseline represents a higher level of symptomatology. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
Change From Baseline in EORTC QLQ-C30: Appetite Loss
大体时间：Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score for symptom items and a positive change from baseline represents a higher level of symptomatology. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
Change From Baseline in EORTC QLQ-C30: Constipation
大体时间：Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score for symptom items and a positive change from baseline represents a higher level of symptomatology. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
Change From Baseline in EORTC QLQ-C30: Diarrhea
大体时间：Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score for symptom items and a positive change from baseline represents a higher level of symptomatology. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
Change From Baseline in EORTC QLQ-C30: Financial Difficulties
大体时间：Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much). All of the scales and single-item measures range in score from 0 to 100; mean is presented here. A higher score for symptom items and a positive change from baseline represents a higher level of financial difficulties. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
Change From Baseline in EORTC QLQ-Myeloma Module (MY20): Disease Symptoms
大体时间：Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
The EORTC QLQ-MY20 was used in conjunction with the EORTC QLQ-C30 to assess symptoms and side effects due to the treatment or the disease which impacts health related QoL in participants with MM. It contains 20 items, 4 independent subscales covering 2 functional domains: symptom scales which include disease symptoms (6 items) and side-effects of treatment (10 items) and function scale which include future perspective (3 items) and body image (1 item). Scores for each subscale are based on the 4-point Likert scale ranging from (1: not at all to 4: very much) and transformed from raw scores to linear scales ranging from 0 to 100; mean is presented here. A higher score for disease symptoms and a positive change from baseline represents more symptoms, worse QoL. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
Change From Baseline in EORTC QLQ-MY20: Side Effects of Treatment
大体时间：Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
The EORTC QLQ-MY20 was used in conjunction with the EORTC QLQ-C30 to assess symptoms and side effects due to the treatment or the disease which impacts health related QoL in participants with MM. It contains 20 items, 4 independent subscales covering 2 functional domains: symptom scales which include disease symptoms (6 items) and side-effects of treatment (10 items) and function scale which include future perspective (3 items) and body image (1 item). Scores for each subscale are based on the 4-point Likert scale ranging from (1: not at all to 4: very much) and transformed from raw scores to linear scales ranging from 0 to 100; mean is presented here. A higher score for side effects of treatment and a positive change from baseline represents more side effects, worse QoL. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
Change From Baseline in EORTC QLQ-MY20: Future Perspective
大体时间：Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
The EORTC QLQ-MY20 was used in conjunction with the EORTC QLQ-C30 to assess symptoms and side effects due to the treatment or the disease which impacts health related QoL in participants with MM. It contains 20 items, 4 independent subscales covering 2 functional domains: symptom scales which include disease symptoms (6 items) and side-effects of treatment (10 items) and function scale which include future perspective (3 items) and body image (1 item). Scores for each subscale are based on the 4-point Likert scale ranging from (1: not at all to 4: very much) and transformed from raw scores to linear scales ranging from 0 to 100; mean is presented here. A higher score for future perspectives and a positive change from baseline represents better outcomes, better QoL. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
Change From Baseline in EORTC QLQ-MY20: Body Image
大体时间：Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
The EORTC QLQ-MY20 was used in conjunction with the EORTC QLQ-C30 to assess symptoms and side effects due to the treatment or the disease which impacts health related QoL in participants with MM. It contains 20 items, 4 independent subscales covering 2 functional domains: symptom scales which include disease symptoms (6 items) and side-effects of treatment (10 items) and function scale which include future perspective (3 items) and body image (1 item). Scores for each subscale are based on the 4-point Likert scale ranging from (1: not at all to 4: very much) and transformed from raw scores to linear scales ranging from 0 to 100; mean is presented here. A higher score for body image and a positive change from baseline represents better outcomes, better QoL. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
Change From Baseline in European Quality of Life Group Measure With 5 Dimensions and 5 Levels Per Dimension (EQ-5D-5L): Visual Analogue Scale (VAS)
大体时间：Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (up to PCD: 06-Nov-2024) (30 days after last drug administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)
The EQ-5D-5L is a standardized measure of health status that provides a simple, generic measure of health utility, and consists of 2 sections: descriptive and a VAS. The descriptive system consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The VAS records the respondent's self-rated health on a 20-cm vertical scale ranging from 0: the worst health you can imagine to 100: the best health you can imagine. Change from baseline in VAS is reported here. A higher score in VAS and positive change from baseline represents a better level of QoL. The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (up to PCD: 06-Nov-2024) (30 days after last drug administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)
ORR Based on at Least 1 Chromosomal Abnormality
大体时间：From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
BM aspirate was collected for fluorescent in situ hybridization for analysis of del[17p], t[4;14], t[14;16]) and 1q21+. ORR was also evaluated based on IRC assessment by disease characteristics. ORR for participants with at least 1 chromosomal abnormality i.e. [del(17p)] or [1q21+ and t(4;14) or t(14;16)] is presented. Percentages are rounded off to the tenth decimal place.
From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months

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Sanofi

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  • 研究主任：Clinical Sciences & Operations、Sanofi

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2022年6月23日

初级完成 (实际的)

2024年11月6日

研究完成 (估计的)

2027年10月22日

研究注册日期

首次提交

2022年5月31日

首先提交符合 QC 标准的

2022年5月31日

首次发布 (实际的)

2022年6月6日

研究记录更新

最后更新发布 (实际的)

2026年9月2日

上次提交的符合 QC 标准的更新

2026年8月10日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • EFC15951
  • 2023 (美国 NIH 拨款/合同：GRAMMY Museum Foundation)
  • U1111-1261-5846 (注册表标识符：ICTRP)
  • 2023-508869-32 (EudraCT编号：CTIS)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

合格的研究人员可以请求访问患者水平的数据和相关研究文件，包括临床研究报告、带有任何修订的研究方案、空白病例报告表、统计分析计划和数据集规范。 患者层面的数据将被匿名化，研究文件将被编辑以保护试验参与者的隐私。 有关赛诺菲数据共享标准、合格研究和请求访问流程的更多详细信息，请访问：https://vivli.org。

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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