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对复发性或难治性多发性骨髓瘤(RRMM)的3期临床试验

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研究单位: [1]中国医学科学院血液病医院 [2]浙江大学医学院附属第一医院 [3]首都医科大学附属北京朝阳医院 [4]河南省肿瘤医院 [5]苏州大学附属第一医院 [6]中国人民解放军空军军医大学第一附属医院 [7]吉林大学第一医院 [8]哈尔滨市第一医院 [9]浙江大学医学院附属第一医院 [10]南昌大学第一附属医院 [11]复旦大学附属中山医院 [12]中国医科大学附属盛京医院 [13]上海交通大学医学院附属瑞金医院 [14]江苏省人民医院 [15]广东省人民医院 [16]中山大学肿瘤防治中心 [17]华中科技大学同济医学院附属同济医院 [18]中国医学科学院北京协和医院 [19]北京大学第三医院 [20]北京博仁医院 [21]The Cleveland Clinic Foundation [22]UMass Memorial Medical Center [23]Dana Farber Cancer Institute [24]American Oncology Partners of Maryland,PA [25]Summit Medical Group [26]Winship Cancer Institute,Emory University [27]Sarah Cannon Research Institute [28]University of Wisconsin [29]Hematology Oncology Clinic Baton Rouge - SCRI - PPDS [30]Florida Cancer Specialists - NORTH - SCRI - PPDS [31]Florida Cancer Specialists - SOUTH - SCRI - PPDS [32]SCRI Tennessee Oncology Chattanooga [33]HCA Midwest Health - SCRI - PPDS [34]Yale University School of Medicine [35]Florida Cancer Specialists - EAST - SCRI - PPDS [36]Genesis Cancer and Blood Institute - SCRI - PPDS [37]OhioHealth Research Institute [38]MetroHealth Medical Center [39]TriHealth [40]Duke University Medical Center [41]Hospital de Clinicas de Porto Alegre (HCPA) - PPDS [42]Fundacao Pio XII - Hospital de Amor [43]Clinica Sao Germano [44]Instituto COI de Pesquisa,Educacao e Gestao [45]Hospital Amaral Carvalho [46]Instituto do Cancer do Estado de Sao Paulo ICESP [47]Instituto de Oncologia Do Parana [48]Fundacao Antonio Prudente – AC Camargo Cancer Center [49]Queen Elizabeth II Health Sciences Center [50]Cross Cancer Institute [51]Saint John Regional Hospital [52]Juravinski Cancer Centre [53]Hopital Maisonneuve-Rosemont [54]Saskatoon Cancer Center [55]CHU de Quebec-Universite Laval [56]Ottawa Hospital Research Institute [57]Eastern Regional Health Authority [58]Tom Baker Cancer Centre [59]Fraser Valley Centre British Columbia Cancer Agency [60]Princess Margaret Cancer Centre [61]Medizinische Universitat Wien (Medical University of Vienna) [62]Klinik Ottakring (früher: Wilhelminenspital) [63]Universitatsklinikum Salzburg [64]Ordensklinikum Linz GmbH [65]LKH-Universitatsklinikum Klinikum Graz [66]Universitatsklinikum St. Polten [67]Krankenhaus Hietzing [68]CHU Sart Tilman [69]AZ Sint-Jan Brugge-Oostende [70]Cliniques Universitaires Saint-Luc [71]Oslo Myeloma Center - PPDS [72]St. Olav's University Hospital [73]Haukeland Universitetssykehus [74]Helsingin Yliopistollinen Keskussairaala - PPDS [75]Turun Yliopistollinen Keskussairaala [76]Oulun Yliopistollinen Sairaala [77]Helsingborg Lasarett [78]Sodra Alvsborgs Sjukhus Boras [79]Universitatsklinikum Hamburg Eppendorf [80]Klinikum der Johann-Wolfgang Goethe-Universitat [81]Asklepios Klinik Altona [82]Universitatsklinikum Schleswig-Holstein [83]Universitatsklinikum Heidelberg [84]Universitatsklinikum Schleswig-Holstein [85]Albert Schweitzer Ziekenhuis [86]Hagaziekenhuis [87]VU Medisch Centrum [88]Odense Universitetshospital [89]Aalborg Universitetshospital [90]Sj@llands Universitetshospital,Roskilde [91]Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi [92]Azienda Ospedaliera Sant'andrea [93]Azienda Ospedaliero Universitaria Pisana [94]Ospedale Casa Sollievo Della Sofferenza IRCCS [95]Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico [96]Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli [97]Azienda Sanitaria Universitaria Friuli Centrale – PO Universitario Santa Maria della Misericordia [98]ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda [99]Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele [100]Azienda Ospedaliera S Maria Di Terni [101]A.O.U. Maggiore della Carità [102]Azienda Ospedaliera Università degli Studi di Padova [103]Fondazione IRCCS Policlinico San Matteo di Pavia [104]Arcispedale Santa Maria Nuova [105]Ospedale Policlinico San Martino [106]CHRU Lille [107]Hopital Saint Louis [108]CHRU Nantes [109]Hopital Universitaire Pitie Salpetriere [110]EDOG - Institut Claudius Regaud - PPDS [111]CHRU Nancy [112]Centre Hospitalier Departemental de Vendee [113]Hopital d'Argenteuil [114]Hopital Haut Leveque [115]Centre Henri Becquerel [116]CHUS – H. Clinico U. de Santiago [117]Hospital de San Pedro de Alcantara [118]Hospital Universitario Vall d'Hebron - PPDS [119]Hospital Universitario Virgen de la Victoria [120]Hospital Universitario Ramon y Cajal [121]Hospital de La Santa Creu i Sant Pau [122]Hospital Universitario Central de Asturias [123]Hospital Universitario Miguel Servet [124]Hospital Universitario Virgen de La Arrixaca [125]C.H. Regional Reina Sofia - PPDS [126]Hospital Universitario de La Princesa [127]ICO Badalona-H.U. Germans Trias i Pujol [128]Hospital Universitari i Politecnic La Fe de Valencia [129]Hospital Universitario Fundacion Jimenez Diaz [130]Clinica Universidad Navarra [131]Complejo Asistencial Universitario de Salamanca – H. Clinico [132]Clinica Universidad Navarra - Madrid [133]Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS [134]Centro Hospitalar de Sao Joao,E.P.E. [135]Instituto Português de Oncologia de Lisboa Francisco Gentil,E.P.E. [136]Fundacao Champalimaud [137]Centro Hospitalar E Universitário de Coimbra EPE [138]Georgios Papanikolaou General Hospital of Thessaloniki [139]Alexandra Hospital [140]Fakultni nemocnice Ostrava [141]Fakultni nemocnice Brno Bohunice [142]Univerzita Karlova v Praze a Vseobecna fakultni nemocnice v Praze [143]Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie – Panstwowy Instytut Badawczy [144]Uniwersytecki Szpital Kliniczny w Bialymstoku [145]Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu [146]SP ZOZ Szpital Uniwersytecki w Krakowie [147]Szpital Kliniczny im. H.Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu [148]Szpital Specjalistyczny im. Jedrzeja Sniadeckiego [149]Specjalistyczny Szpital im. Alfreda Sokolowskiego [150]Queen Elizabeth Hospital [151]University College London Hospitals (UCLH) [152]Nottingham City Hospital [153]Blackpool Victoria Hospital [154]Belfast City Hospital [155]Churchill Hospital [156]Kent and Canterbury Hospital [157]New Cross Hospital [158]Guy's Hospital [159]Queen Alexandra Hospital [160]The Royal Marsden NHS Foundation Trust [161]Beaumont Hospital [162]University Hospital Galway [163]Cork University Hospital [164]St James's Hospital [165]Ankara University Medical Faculty - PPDS [166]Dokuz Eylul University Medical Faculty [167]Gazi University Faculty of Medicine [168]Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi [169]Erciyes University Medical Faculty [170]Ege University Medical Faculty [171]Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi [172]Marmara University Pendik Training and Research Hospital [173]St Vincents Hospital Melbourne - PPDS [174]Alfred Hospital [175]Monash Health,Monash Medical Centre [176]Royal Adelaide Hospital [177]Royal Prince Alfred Hospital [178]Flinders Medical Centre [179]Perth Blood Institute [180]The Canberra Hospital [181]Epworth Healthcare [182]Fiona Stanley Hospital [183]Townsville Hospital [184]Kantonsspital St. Gallen [185]Kantonsspital Graubünden [186]Tel Aviv Sourasky Medical Center PPDS [187]Hadassah Medical Center - PPDS [188]Rambam Medical Center - PPDS [189]Sheba Medical Center - PPDS [190]Matsuyama Red Cross Hospital [191]Nagoya City University Hospital [192]University Hospital,Kyoto Prefectural University of Medicine [193]Kameda General Hospital [194]Toyohashi Municipal Hospital [195]National Hospital Organization Okayama Medical Center [196]Japanese Red Cross Medical Center [197]Osaka Metropolitan University Hospital [198]Kindai University Hospital [199]NTT Medical Center Tokyo [200]Aichi Cancer Center [201]National Hospital Organization Kyushu Medical Center [202]Aomori Prefectural Central Hospital [203]Sapporo Hokuyu Hospital [204]National University Corporation Tohoku University Tohoku University Hospital [205]M.S. Ramaiah Medical College and Hospital [206]Jawaharlal Institute of Postgraduate Medical Education & Research [207]Yashoda Hospital [208]Mumbai Oncocare Centre - Vile Parle [209]Amrita Institute of Medical Sciences and Research Centre [210]Narayana Multispeciality Hospital [211]Taipei Veterans General Hospital [212]National Cheng Kung University Hospital [213]China Medical University Hospital [214]Chang Gung Memorial Hospital,Linkou [215]Taichung Veterans General Hospital [216]Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital [217]National Taiwan University Hospital [218]Seoul National University Hospital [219]Samsung Medical Center - PPDS [220]Severance Hospital Yonsei University Health System - PPDS [221]National Cancer Center [222]Kyungpook National University Hospital [223]Chonnam National University Hwasun Hospital [224]The Catholic University of Korea,Seoul St. Mary's Hospital [225]Asan Medical Center - PPDS

研究目的:
主要目的: 在RRMM受试者中比较iberdomide、达雷妥尤单抗和地塞米松(IberDd)与达雷妥尤单抗、硼替佐米和地塞米松(DVd)在无进展生存期(PFS)方面的疗效 次要目的: 评价接受IberDd与DVd治疗相比的RRMM受试者的总生存期 评价接受IberDd与DVd治疗相比的RRMM受试者的其他疗效指标 在RRMM受试者中评价IberDd与DVd相比的安全性 使用欧洲癌症研究和治疗组织-生活质量C30问卷(EORTC-QLQ-C30)和欧洲生活质量多发性骨髓瘤模块MY20问卷(EORTC-QLQ-MY20)评价RRMM受试者接受IberDd与DVd治疗相比的癌症相关症状和健康相关生活质量(HRQoL)

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