RRMM におけるポマリドマイドおよびデキサメタゾンと併用した SC 対 IV イサツキシマブ (IRAKLIA)
2026年8月10日 更新者：Sanofi
再発および/または難治性多発性骨髄腫 (RRMM) の成人患者におけるポマリドマイドおよびデキサメタゾンと組み合わせたイサツキシマブの皮下投与と静脈内投与を評価する無作為化第 3 相非盲検試験
これは、少なくとも 1 回以上の治療を受けた RRMM 患者 (研究参加者) を対象に、ポマリドマイドおよびデキサメタゾン (Pd) と組み合わせたイサツキシマブの皮下 (SC) 投与と静脈内 (IV) 投与を評価する無作為化多施設第 3 相非盲検試験です。レナリドマイドとプロテアソーム阻害剤（PI）を含む一連の治療。 適格な参加者は、2つの研究群のうちの1つに1：1で無作為化されます。
アーム SC: イサツキシマブ SC + Pd
アーム IV: イサツキシマブ IV + Pd
参加者は、疾患の進行、許容できない有害事象（AE）、参加者による治療の中止要求、またはその他の理由のいずれか早い方まで、治療を継続することが許可されます。
調査の概要
状態
積極的、募集していない
条件
詳細な説明
2つの研究群は、疾患の進行、許容できない有害事象（AE）、参加者の治療中止要求、またはその他の理由のいずれか早い方まで、4週間のサイクルで治療されます。
研究の種類
介入
入学 (実際)
531
段階
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Colorado
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Aurora、Colorado、アメリカ、80012
- Rocky Mountain Cancer Centers - Aurora- Site Number : 8400021
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Florida
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Jacksonville、Florida、アメリカ、32224
- Mayo Clinic in Florida- Site Number : 8400008
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Plantation、Florida、アメリカ、33322
- Boca Raton Clinical Research Associates- Site Number : 8400030
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Mississippi
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Hattiesburg、Mississippi、アメリカ、39401
- Hattiesburg Clinic- Site Number : 8400006
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New Jersey
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Morristown、New Jersey、アメリカ、07962
- Atlantic Health System- Site Number : 8400005
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New York
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Albany、New York、アメリカ、12206
- New York Oncology Hematology - Albany Cancer Center- Site Number : 8400017
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North Carolina
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Charlotte、North Carolina、アメリカ、28207
- Novant Health Neurology & Sleep- Site Number : 8400014
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Ohio
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Canton、Ohio、アメリカ、44718
- Gabrail Cancer Center- Site Number : 8400027
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Fairfield、Ohio、アメリカ、45014
- Oncology Hematology Care - Fairfield- Site Number : 8400016
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South Carolina
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Spartanburg、South Carolina、アメリカ、29303
- Spartanburg Regional Medical Center- Site Number : 8400002
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Texas
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Dallas、Texas、アメリカ、75390
- University of Texas - Southwestern Medical Center- Site Number : 8400024
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San Antonio、Texas、アメリカ、78240
- Texas Oncology - San Antonio Medical Center - Research Drive- Site Number : 8400020
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Utah
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Salt Lake City、Utah、アメリカ、84108
- Veterans Affairs Medical Center - Salt Lake City- Site Number : 8400011
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Buenos Aires、アルゼンチン、1181
- Investigational Site Number : 0320002
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Buenos Aires、アルゼンチン、1180
- Investigational Site Number : 0320008
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Buenos Aires、アルゼンチン、1280
- Investigational Site Number : 0320007
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Buenos Aires、アルゼンチン、1417
- Investigational Site Number : 0320003
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Buenos Aires、アルゼンチン、1426
- Investigational Site Number : 0320004
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Buenos Aires、アルゼンチン、1430
- Investigational Site Number : 0320001
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Buenos Aires、アルゼンチン、1431
- Investigational Site Number : 0320005
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Córdoba、アルゼンチン、5000
- Investigational Site Number : 0320010
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Mendoza、アルゼンチン、5501
- Investigational Site Number : 0320009
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Buenos Aires
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La Plata、Buenos Aires、アルゼンチン、1900
- Investigational Site Number : 0320006
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Derbyshire
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Derby、Derbyshire、イギリス、DE22 3NE
- Investigational Site Number : 8260003
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England
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Birmingham、England、イギリス、B15 2TH
- Investigational Site Number : 8260004
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Leicestershire
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Leicester、Leicestershire、イギリス、LE1 5WW
- Investigational Site Number : 8260002
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London, City of
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London、London, City of、イギリス、W12 0HS
- Investigational Site Number : 8260005
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Norfolk
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Norwich、Norfolk、イギリス、NR4 7UY
- Investigational Site Number : 8260001
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Bologna、イタリア、40138
- Investigational Site Number : 3800002
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Brescia、イタリア、25123
- Investigational Site Number : 3800005
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Pavia、イタリア、27100
- Investigational Site Number : 3800003
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Ancona
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Torette、Ancona、イタリア、60020
- Investigational Site Number : 3800004
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Reggio Emilia
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Meldola、Reggio Emilia、イタリア、47014
- Investigational Site Number : 3800001
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Roma
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Rome、Roma、イタリア、00168
- Investigational Site Number : 3800006
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New South Wales
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Liverpool、New South Wales、オーストラリア、2170
- Investigational Site Number : 0360007
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Waratah、New South Wales、オーストラリア、2298
- Investigational Site Number : 0360004
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Wollongong、New South Wales、オーストラリア、2500
- Investigational Site Number : 0360003
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South Australia
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Adelaide、South Australia、オーストラリア、5000
- Investigational Site Number : 0360008
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Victoria
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Melbourne、Victoria、オーストラリア、3004
- Investigational Site Number : 0360006
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Melbourne、Victoria、オーストラリア、3065
- Investigational Site Number : 0360009
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Richmond、Victoria、オーストラリア、3121
- Investigational Site Number : 0360001
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Ontario
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Toronto、Ontario、カナダ、M5G 2M9
- Investigational Site Number : 1240001
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Quebec
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Greenfield Park、Quebec、カナダ、J4V 2H1
- Investigational Site Number : 1240004
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Montreal、Quebec、カナダ、H1T 2M4
- Investigational Site Number : 1240003
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Athens、ギリシャ、106 76
- Investigational Site Number : 3000002
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Athens、ギリシャ、115 28
- Investigational Site Number : 3000001
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Pátrai、ギリシャ、265 04
- Investigational Site Number : 3000003
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Thessaloniki、ギリシャ、570 10
- Investigational Site Number : 3000004
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Borås、スウェーデン、501 82
- Investigational Site Number : 7520001
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Huddinge、スウェーデン、141 57
- Investigational Site Number : 7520003
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Madrid、スペイン、28034
- Investigational Site Number : 7240005
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Salamanca、スペイン、37007
- Investigational Site Number : 7240002
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Almería
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Murcia、Almería、スペイン、30120
- Investigational Site Number : 7240006
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Barcelona [Barcelona]
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Badalona、Barcelona [Barcelona]、スペイン、08916
- Investigational Site Number : 7240004
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Cantabria
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Santander、Cantabria、スペイン、39008
- Investigational Site Number : 7240003
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Navarre
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Pamplona、Navarre、スペイン、31008
- Investigational Site Number : 7240001
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Brno、チェコ、625 00
- Investigational Site Number : 2030005
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Olomouc、チェコ、779 00
- Investigational Site Number : 2030003
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Ostrava、チェコ、708 52
- Investigational Site Number : 2030006
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Prague、チェコ、128 08
- Investigational Site Number : 2030004
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La Araucanía
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Temuco、La Araucanía、チリ、4780000
- Investigational Site Number : 1520001
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Reg Metropolitana de Santiago
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Santiago、Reg Metropolitana de Santiago、チリ、7580206
- Investigational Site Number : 1520002
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Santiago、Reg Metropolitana de Santiago、チリ、6900941
- Investigational Site Number : 1520003
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Santiago、Reg Metropolitana de Santiago、チリ、7620001
- Investigational Site Number : 1520006
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Santiago、Reg Metropolitana de Santiago、チリ、8380455
- Investigational Site Number : 1520004
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Valparaiso
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Viña del Mar、Valparaiso、チリ、2540364
- Investigational Site Number : 1520005
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Ankara、トルコ（Türkiye）、06010
- Investigational Site Number : 7920007
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Ankara、トルコ（Türkiye）、06200
- Investigational Site Number : 7920009
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Istanbul、トルコ（Türkiye）、34093
- Investigational Site Number : 7920003
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Istanbul、トルコ（Türkiye）、34098
- Investigational Site Number : 7920005
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Istanbul、トルコ（Türkiye）、34214
- Investigational Site Number : 7920008
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Istanbul、トルコ（Türkiye）、34381
- Investigational Site Number : 7920001
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Izmir、トルコ（Türkiye）、35100
- Investigational Site Number : 7920004
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Dresden、ドイツ、01307
- Investigational Site Number : 2760005
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Heidelberg、ドイツ、69120
- Investigational Site Number : 2760003
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Lübeck、ドイツ、23562
- Investigational Site Number : 2760006
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Nuremberg、ドイツ、90419
- Investigational Site Number : 2760007
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Oslo、ノルウェー、0450
- Investigational Site Number : 5780001
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Ålesund、ノルウェー、6017
- Investigational Site Number : 5780002
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Budapest、ハンガリー、1097
- Investigational Site Number : 3480004
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Budapest、ハンガリー、1085
- Investigational Site Number : 3480002
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Kaposvár、ハンガリー、7400
- Investigational Site Number : 3480003
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Pécs、ハンガリー、7623
- Investigational Site Number : 3480008
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Szombathely、ハンガリー、9700
- Investigational Site Number : 3480006
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Székesfehérvár、ハンガリー、8000
- Investigational Site Number : 3480005
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Nantes、フランス、44093
- Investigational Site Number : 2500002
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Paris、フランス、75571
- Investigational Site Number : 2500005
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Poitiers、フランス、86021
- Investigational Site Number : 2500001
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Saint-Priest-en-Jarez、フランス、42270
- Investigational Site Number : 2500009
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Toulouse、フランス、31059
- Investigational Site Number : 2500003
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Tours、フランス、37032
- Investigational Site Number : 2500007
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Rio de Janeiro、ブラジル、22775-001
- Instituto Americas - Ensino, Pesquisa e Inovação - Rio de Janeiro - Avenida Jorge Curi- Site Number : 0760004
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São Paulo、ブラジル、04537-080
- Clinica São Germano- Site Number : 0760001
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Ceará
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Fortaleza、Ceará、ブラジル、60115-280
- Núcleo de Oncologia e Hematologia do Ceará- Site Number : 0760006
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Pernambuco
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Recife、Pernambuco、ブラジル、51020-280
- MultiHemo - Recife - Rua Padre Carapuceiro- Site Number : 0760007
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Rio Grande do Sul
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Porto Alegre、Rio Grande do Sul、ブラジル、90880-480
- Hospital Mae de Deus- Site Number : 0760003
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Rio de Janeiro
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Niterói、Rio de Janeiro、ブラジル、24020-096
- CHN - Complexo Hospitalar de Niterói- Site Number : 0760008
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Lesser Poland Voivodeship
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Krakow、Lesser Poland Voivodeship、ポーランド、31-501
- Investigational Site Number : 6160005
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Lower Silesian Voivodeship
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Wroclaw、Lower Silesian Voivodeship、ポーランド、50-088
- Investigational Site Number : 6160004
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Lublin Voivodeship
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Lublin、Lublin Voivodeship、ポーランド、20-081
- Investigational Site Number : 6160001
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Beijing、中国、100191
- Investigational Site Number : 1560022
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Beijing、中国、100034
- Investigational Site Number : 1560001
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Changsha、中国、410013
- Investigational Site Number : 1560010
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Guangzhou、中国、510060
- Investigational Site Number : 1560006
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Hangzhou、中国、310003
- Investigational Site Number : 1560002
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Nanchang、中国、330006
- Investigational Site Number : 1560020
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Nanning、中国、530021
- Investigational Site Number : 1560019
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Qingdao、中国、266011
- Investigational Site Number : 1560011
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Shenyang、中国、110004
- Investigational Site Number : 1560013
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Tianjin、中国、300020
- Investigational Site Number : 1560007
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Tianjin、中国、300060
- Investigational Site Number : 1560018
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Tianjin、中国、300052
- Investigational Site Number : 1560009
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Wuhan、中国、430022
- Investigational Site Number : 1560003
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Wuhan、中国、430030
- Investigational Site Number : 1560008
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Zhengzhou、中国、450008
- Investigational Site Number : 1560004
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Kaohsiung City、台湾、833
- Investigational Site Number : 1580001
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Tainan、台湾、704
- Investigational Site Number : 1580005
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Taipei、台湾、100
- Investigational Site Number : 1580002
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Kyoto、日本、603-8151
- Investigational Site Number : 3920003
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Osaka、日本、530-8480
- Investigational Site Number : 3920011
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Tokyo、日本、150-8935
- Investigational Site Number : 3920004
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Yamagata、日本、990-9585
- Investigational Site Number : 3920009
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Aichi-ken
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Nagoya、Aichi-ken、日本、467-8602
- Investigational Site Number : 3920001
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Chiba
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Kamogawa、Chiba、日本、296-8602
- Investigational Site Number : 3920007
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Ibaraki
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Higashiibaraki、Ibaraki、日本、311-3117
- Investigational Site Number : 3920005
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Iwate
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Yahaba、Iwate、日本、028-3695
- Investigational Site Number : 3920010
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Kanagawa
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Kamakura、Kanagawa、日本、247-8533
- Investigational Site Number : 3920012
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Okayama-ken
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Okayama、Okayama-ken、日本、701-1192
- Investigational Site Number : 3920002
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
説明
包含基準:
- -レナリドマイドおよびプロテアソーム阻害剤を含む少なくとも1つの前線の治療を受けた多発性骨髄腫の参加者、および測定可能な血清Mタンパク質（≥0.5 g / dL）および/または尿Mタンパク質（≥200 mg / 24時間）および/または血清遊離軽鎖 (FLC) アッセイ (関与する FLC アッセイ ≥10 mg/dL および異常な血清 FLC 比 (1.65))
除外基準:
- -18歳未満の参加者、Eastern Cooperative Oncology Groupのパフォーマンスステータスが2以上の参加者
- 原発性難治性多発性骨髄腫の参加者
- -ウォッシュアウト期間が9か月未満または抗CD38 mAb剤に不耐性の抗CD38に不応性の参加者
- ポマリドマイドによる前治療
- -生物学的検査が不十分な参加者。
- 重大な心機能障害
- -無作為化前の3年以内に別の癌の診断または治療を受けた参加者。 ただし、皮膚の基底細胞癌または扁平上皮癌の完全切除、および in situ 悪性腫瘍、または治癒療法後の低リスク前立腺癌。
- 付随する形質細胞性白血病
- 活動性原発性アミロイドライト (AL) アミロイドーシス
- -既知の後天性免疫不全症候群（AIDS）関連疾患または抗ウイルス治療を必要とする既知のヒト免疫不全ウイルス（HIV）疾患
- アクティブな A 型肝炎感染を知っています。 -現在活動中または慢性のB型肝炎（HBV）またはC型肝炎（HCV）感染。 -抗ウイルス療法で管理されている慢性HBVまたはHCV疾患の参加者は許可されています。
- -出産の可能性のある女性、または出産の可能性のある女性を持つ男性参加者で、非常に効果的な避妊方法の使用に同意しない
上記の情報は、臨床試験への参加者の潜在的な参加に関連するすべての考慮事項を含むことを意図したものではありません
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：イサツキシマブ静脈内投与（IV）
イサツキシマブの用量は、サイクル 1 (1、8、15、および 22 日目) およびその後のサイクルの 1 日目と 15 日目の間、4 週間毎週 IV 注入によって投与されます。
各サイクルは 28 日になります。
ポマリドミドの用量は、各サイクルの 1 日目から 21 日目のイサツキシマブ投与前後の参加者にとって最も都合の良い時間に、できれば毎日同じ時間に経口摂取されます。
デキサメタゾンは、1日目、8日目、15日目、22日目に経口摂取されます（28日ごとに繰り返されます）。
参加者は、背景治療および/または救急薬として他の治療を受ける場合があります。
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剤形: 錠剤;投与経路: 経口
剤形：ハードカプセル。投与経路: 経口
他の名前：
剤形: IV 注入用の濃縮溶液。投与経路: 静脈内
他の名前：
薬形: 現地の市販品に準じます。投与経路: 経口;補助医薬品（AxMP）、つまりバックグラウンド治療。 ATCコード：H02AB02
薬形: 現地の市販品に準じます。投与経路: 経口; AxMP、つまりバックグラウンド処理。 ATCコード：R03DC03
薬形: 現地の市販品に準じます。投与経路: 経口; AxMP、つまりバックグラウンド処理。 ATCコード：N02BE01
薬形: 現地の市販品に準じます。投与経路: 前投薬として - 経口。注入反応の管理 - IV (または経口同等物); AxMP、つまりバックグラウンド治療とレスキュー投薬（注入反応の場合）。 ATCコード：R06AA02
薬形: 現地の市販品に準じます。投与経路: 前投薬として-IV;注入反応の管理用 - IV (または経口同等物)。 AxMP、つまりバックグラウンド治療とレスキュー投薬（注入反応の場合）。 ATCコード：H02AB04
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実験的：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.
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剤形: 皮下投与用溶液。投与経路：皮下（SC）
他の名前：
剤形: 錠剤;投与経路: 経口
剤形：ハードカプセル。投与経路: 経口
他の名前：
薬形: 現地の市販品に準じます。投与経路: 経口;補助医薬品（AxMP）、つまりバックグラウンド治療。 ATCコード：H02AB02
薬形: 現地の市販品に準じます。投与経路: 経口; AxMP、つまりバックグラウンド処理。 ATCコード：R03DC03
薬形: 現地の市販品に準じます。投与経路: 経口; AxMP、つまりバックグラウンド処理。 ATCコード：N02BE01
薬形: 現地の市販品に準じます。投与経路: 前投薬として - 経口。注入反応の管理 - IV (または経口同等物); AxMP、つまりバックグラウンド治療とレスキュー投薬（注入反応の場合）。 ATCコード：R06AA02
薬形: 現地の市販品に準じます。投与経路: 前投薬として-IV;注入反応の管理用 - IV (または経口同等物)。 AxMP、つまりバックグラウンド治療とレスキュー投薬（注入反応の場合）。 ATCコード：H02AB04
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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全奏効率（ORR）
時間枠：研究薬投与の初回投与時（Day 1）からPCD（2024年11月6日）まで、約28か月間
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独立審査委員会（IRC）による2016年国際骨髄腫作業部会（IMWG）基準を用いた全奏効率（ORR）：完全奏効（CR）、厳格完全奏効（sCR）、非常に良好な部分奏効（VGPR）、部分奏効（PR）を示した参加者の割合。CR：血清および尿中の免疫固定法による陰性化、軟部組織形質細胞腫（STP）の消失、骨髄穿刺液中の形質細胞<5%、正常な遊離軽鎖（FLC）比（0.26-1.65）。sCR：CRに加え、骨髄生検でクローン性細胞を認めない。VGPR：血清および尿中M蛋白が免疫固定法で検出可能（電気泳動法ではない）；血清M蛋白の90%以上減少かつ尿中M蛋白レベル<100mg/24時間；STPにおける最大垂直径の和（SPD）のベースライン比90%以上減少；FLCのみ：関与鎖と非関与鎖のFLCレベルの差が90%以上減少。PR：血清M蛋白の50%以上減少、かつ24時間尿中M蛋白が90%以上減少または<200mg/24h。上記に加え、ベースライン時に存在する場合、STPのSPDサイズの50%以上減少も必要。
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研究薬投与の初回投与時（Day 1）からPCD（2024年11月6日）まで、約28か月間
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定常状態におけるイサツキシマブ投与前観察濃度（Ctrough）
時間枠：サイクル6 日目1 投与前
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定常状態におけるCtroughは、イサツキシマブ投与サイクル6日目1（サイクル6日目1投与前と同等）の投与前採取血漿中濃度として観察された。
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サイクル6 日目1 投与前
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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イサツキシマブの4週間後のトラフ濃度（CT4W）
時間枠：サイクル2 1日目投与前（4週間時点）
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CT4Wは、イサツキシマブ投与量の第2サイクル1日目前投与時（第2サイクル1日目前投与時と同等）に採取された観察血漿中濃度であった。
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サイクル2 1日目投与前（4週間時点）
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「患者体験・満足度アンケート（PESQ-FU）の『注射方法への満足度』（項目8）において、サイクル5 15日目時点で「非常に満足」および「満足」と回答した参加者の割合
時間枠：サイクル5 15日目
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PESQ-FUは9項目から成り、注射方法（不快感、痛み、副作用、時間節約、満足度）および研究薬剤（副作用、服用価値、満足度、推奨）に関する参加者の経験と満足度を追跡するために設計されています。
この質問票は、腫瘍学参加者との質的インタビューに基づいて適応されました。
「注射方法への満足度」への回答は、指定された時点で「非常に満足、満足、どちらでもない、不満、非常に不満」として記録されました。
サイクル5日目15時点で注射方法（項目8）に非常に満足および満足した参加者の総割合をここに報告します。
割合は小数点第1位まで四捨五入されています。
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サイクル5 15日目
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イサツキシマブのトラフ
時間枠：サイクル1の8、15、22日目の投与前、サイクル2～5の1、15日目、サイクル6、7、8、9、12、15、18、21、24、27の1日目の投与前
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血漿サンプルは特定の時間ポイントで採取され、Ctroughの評価に使用されました。
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サイクル1の8、15、22日目の投与前、サイクル2～5の1、15日目、サイクル6、7、8、9、12、15、18、21、24、27の1日目の投与前
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「ベースライン時患者期待質問票（PEQ-BL）」への回答があった参加者の割合
時間枠：ベースライン（サイクル1 日1）
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ベースライン時に、注射方法による痛み、不快感、副作用の予測について「強く同意する」または「同意する」と回答した参加者、注射方法が時間を節約するという期待、研究薬が副作用を引き起こす可能性があること、および服用する価値があるという期待について「強く同意する」または「同意する」と回答した参加者の割合が報告されています。
PEQ-BLは7項目で構成されていました。
静脈内および／または皮下投与で薬剤を投与されたことのある参加者の割合も報告されています。
割合は小数点第1位まで四捨五入されています。
ベースライン値は、研究薬の開始日以前に収集された最後の非欠損値として定義されました。
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ベースライン（サイクル1 日1）
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健康リソース利用と生産性に関する質問票（HRUPQ）：ベースライン医療利用：過去6か月間に参加者が医療を受けた回数
時間枠：ベースライン（サイクル1 日1）
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ベースライン時の医療資源利用状況は、研究薬投与前のHRUPQにより収集されました。
過去6か月間に参加者がMMを含むあらゆる健康問題またはMMによる健康問題のために診療所または病院の救急室で受診した回数、ならびにMMを含むあらゆる健康問題またはMMによる健康問題のために看護師または他の医療専門家から在宅ケアを受けた回数の平均値が示されています。
ベースライン値は、研究薬開始日以前に収集された最後の非欠損値として定義されました。
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ベースライン（サイクル1 日1）
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HRUPQ: ベースライン医療リソース利用状況：参加者が過去6か月間に入院した夜数
時間枠：ベースライン（サイクル1 日1）
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研究薬投与前のベースラインにおける医療資源使用状況はHRUPQにより収集された。
過去6か月間に参加者が何らかの健康問題（MMを含む、またはMMによる）で入院した夜数および集中治療室（ICU）に入室した夜数の平均値を示す。
ベースライン値は、研究薬開始日前または開始日に収集された最後の非欠測値と定義された。
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ベースライン（サイクル1 日1）
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HRUPQ: ベースライン医療リソース利用状況：参加者が過去6か月間に医療専門家（HCP）に相談した回数
時間枠：ベースライン（サイクル1 日1）
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研究薬投与前のベースラインにおける医療リソース利用状況はHRUPQにより収集されました。
過去6か月間に参加者が以下の医療専門家に相談（面談または対話）した平均回数：様々な病気を治療する一般医またはプライマリケア臨床医（PCC）（MMまたはMM関連を含むあらゆる健康問題について）、理学療法士または作業療法士（MMまたはMM関連を含むあらゆる健康問題について）、精神保健専門家（例：精神科医、心理学者、精神科看護師）（MMまたはMM関連を含むあらゆる健康問題について）、特定の医学的疾患または問題を専門とする医師または臨床医（専門医）（MMまたはMM関連を含むあらゆる健康問題について）が提示されています。
ベースライン値は、研究薬開始日以前に収集された最後の非欠損値として定義されました。
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ベースライン（サイクル1 日1）
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HRUPQに基づく研究期間中に退職した参加者の割合
時間枠：研究薬投与の初回投与時（1日目）からPCD（2024年11月6日）まで、約28か月間
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雇用状況はHRUPQによって評価されました。
研究期間中に退職した参加者の割合を報告します。
パーセンテージは小数点以下第1位に四捨五入されています。
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研究薬投与の初回投与時（1日目）からPCD（2024年11月6日）まで、約28か月間
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HRUPQに基づくMMによる早期退職参加者の割合
時間枠：研究薬投与の初回投与時（1日目）からPCD（2024年11月6日）まで、約28か月間
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雇用状況はHRUPQを用いて評価されました。
MMにより早期退職した参加者の割合を報告します。
割合は小数点第1位まで四捨五入されています。
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研究薬投与の初回投与時（1日目）からPCD（2024年11月6日）まで、約28か月間
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Very Good Partial Response or Better Rate
時間枠：From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
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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.
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From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
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Percentage of Participants With Infusion Reactions
時間枠：From first dose of study medication (Day 1) up to 30 days after the last dose of study medication, approximately 38 months
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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.
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From first dose of study medication (Day 1) up to 30 days after the last dose of study medication, approximately 38 months
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Duration of Response (DOR)
時間枠：From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
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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.
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From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
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|
Time to First Response (TT1R)
時間枠：From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
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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.
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From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
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Time to Best Response (TTBR)
時間枠：From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
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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.
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From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
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Progression-free Survival (PFS)
時間枠：From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
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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.
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From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
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Overall Survival (OS)
時間枠：From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
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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.
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From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
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Progression Free Survival 2 (PFS2)
時間枠：From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
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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.
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From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
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Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
時間枠：From first dose of study medication (Day 1) up to 30 days after the last dose of study medication, approximately 38 months
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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.
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From first dose of study medication (Day 1) up to 30 days after the last dose of study medication, approximately 38 months
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Isa-SC + Pd: Number of Participants With Injection Site Reactions (ISRs)
時間枠：From first dose of study medication (Day 1) up to 30 days after the last dose of study medication, approximately 38 months
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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.
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From first dose of study medication (Day 1) up to 30 days after the last dose of study medication, approximately 38 months
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Isa-SC + Pd: Percentage of Successful Injections With Isatuximab Injector Device
時間枠：From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
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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.
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From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
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Number of Participants With Treatment-emergent Anti-drug Antibodies (ADA) Against Isatuximab
時間枠：From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
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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.
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From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
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Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Discomfort With Injection Method'
時間枠：Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
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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.
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Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
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Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Pain With Injection Method'
時間枠：Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
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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.
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Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
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Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Injection Method'
時間枠：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.
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Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
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Percentage of Participants Who Strongly Agreed and Agreed to 'PESQ-FU: Time Saving With Injection Method'
時間枠：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.
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Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
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Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Injection Method'
時間枠：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.
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Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
|
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Percentage of Participants Who Disagreed and Strongly Disagreed to 'PESQ-FU: Side Effects With Study Medication'
時間枠：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'
時間枠：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.
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Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
|
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Percentage of Participants Who Responded Very Satisfied and Satisfied to 'PESQ-FU: Satisfaction With Study Medication'
時間枠：Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
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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.
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Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
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Percentage of Participants Who Responded Definitely Yes and Probably Yes to 'PESQ-FU: Recommendation of Study Medication'
時間枠：Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
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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.
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Cycle 1 Days 8, 15, 22, Cycle 2 Days 1 and 15, Cycles 3 and 4 Day 1, Cycles 5 to 39 Day 15
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Percentage of Participants With Response to 'Patient Experience and Satisfaction End of Treatment Questionnaire (PESQ-EOT)'
時間枠：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)
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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.
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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)
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Participant Responses to Patient's Assessment of Treatment (PAT) Questionnaire
時間枠：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)
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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.
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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)
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Duration of Hospital Visits for Treatment Administration and Duration of Post-Treatment Monitoring Based on HRUPQ
時間枠：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)
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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.
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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)
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Percentage of Participants Who Visited Healthcare Professional for Non-trial-related Health Issues Based on HRUPQ
時間枠：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)
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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.
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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)
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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)
時間枠：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)
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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.
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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)
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Change From Baseline in EORTC QLQ-C30: Physical Functioning
時間枠：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)
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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.
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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)
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Change From Baseline in EORTC QLQ-C30: Role Functioning
時間枠：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)
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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.
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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)
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Change From Baseline in EORTC QLQ-C30: Emotional Functioning
時間枠：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)
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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.
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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)
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Change From Baseline in EORTC QLQ-C30: Cognitive Functioning
時間枠：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)
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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.
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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)
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Change From Baseline in EORTC QLQ-C30: Social Functioning
時間枠：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)
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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.
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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)
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Change From Baseline in EORTC QLQ-C30: Fatigue
時間枠：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)
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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.
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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)
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Change From Baseline in EORTC QLQ-C30: Nausea and Vomiting
時間枠：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)
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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.
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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)
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Change From Baseline in EORTC QLQ-C30: Pain
時間枠：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)
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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.
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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)
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Change From Baseline in EORTC QLQ-C30: Dyspnea
時間枠：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)
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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.
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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)
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Change From Baseline in EORTC QLQ-C30: Insomnia
時間枠：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)
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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.
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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)
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Change From Baseline in EORTC QLQ-C30: Appetite Loss
時間枠：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)
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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.
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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)
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Change From Baseline in EORTC QLQ-C30: Constipation
時間枠：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)
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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.
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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)
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Change From Baseline in EORTC QLQ-C30: Diarrhea
時間枠：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)
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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.
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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)
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Change From Baseline in EORTC QLQ-C30: Financial Difficulties
時間枠：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)
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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.
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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)
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Change From Baseline in EORTC QLQ-Myeloma Module (MY20): Disease Symptoms
時間枠：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)
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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.
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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)
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Change From Baseline in EORTC QLQ-MY20: Side Effects of Treatment
時間枠：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)
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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.
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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)
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Change From Baseline in EORTC QLQ-MY20: Future Perspective
時間枠：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)
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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.
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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)
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Change From Baseline in EORTC QLQ-MY20: Body Image
時間枠：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)
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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)
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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)
時間枠：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)
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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.
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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)
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ORR Based on at Least 1 Chromosomal Abnormality
時間枠：From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
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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.
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From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
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協力者と研究者
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- スタディディレクター：Clinical Sciences & Operations、Sanofi
出版物と役立つリンク
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2022年6月23日
一次修了 (実際)
2024年11月6日
研究の完了 (推定)
2027年10月22日
試験登録日
最初に提出
2022年5月31日
QC基準を満たした最初の提出物
2022年5月31日
最初の投稿 (実際)
2022年6月6日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月2日
QC基準を満たした最後の更新が送信されました
2026年8月10日
最終確認日
2026年8月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- EFC15951
- 2023 (米国 NIH グラント/契約：GRAMMY Museum Foundation)
- U1111-1261-5846 (レジストリ識別子：ICTRP)
- 2023-508869-32 (EudraCT番号：CTIS)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
有資格の研究者は、患者レベルのデータおよび関連する研究文書へのアクセスを要求することができます。これには、臨床研究報告、修正を含む研究プロトコル、空白の症例報告フォーム、統計分析計画、およびデータセットの仕様が含まれます。
患者レベルのデータは匿名化され、治験参加者のプライバシーを保護するために研究文書は編集されます。
サノフィのデータ共有基準、適格な研究、およびアクセスを要求するプロセスの詳細については、https://vivli.org をご覧ください。
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
はい
米国FDA規制機器製品の研究
いいえ
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