SC versus IV Isatuximabe em combinação com pomalidomida e dexametasona em RRMM (IRAKLIA)
10 de agosto de 2026 atualizado por: Sanofi
Um estudo randomizado, de fase 3, aberto avaliando a administração subcutânea versus intravenosa de isatuximabe em combinação com pomalidomida e dexametasona em pacientes adultos com mieloma múltiplo recidivado e/ou refratário (RRMM)
Este é um estudo randomizado, multicêntrico, de Fase 3, aberto avaliando a administração subcutânea (SC) versus intravenosa (IV) de isatuximabe em combinação com pomalidomida e dexametasona (Pd) em pacientes com RRMM (participantes do estudo) que receberam pelo menos 1 linha de terapia incluindo lenalidomida e um inibidor de proteassoma (IP). Os participantes elegíveis serão randomizados 1:1 em 1 de 2 braços de estudo:
Braço SC: Isatuximabe SC + Pd
Braço IV: Isatuximabe IV + Pd
Os participantes poderão continuar a terapia até a progressão da doença, eventos adversos inaceitáveis (EAs), solicitação do participante para descontinuar a terapia ou qualquer outro motivo, o que ocorrer primeiro.
Visão geral do estudo
Status
Ativo, não recrutando
Descrição detalhada
Dois braços do estudo serão tratados em ciclos de 4 semanas até a progressão da doença, eventos adversos (EAs) inaceitáveis, solicitação do participante para descontinuar a terapia ou qualquer outro motivo, o que ocorrer primeiro.
Tipo de estudo
Intervencional
Inscrição (Real)
531
Estágio
- Fase 3
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Dresden, Alemanha, 01307
- Investigational Site Number : 2760005
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Heidelberg, Alemanha, 69120
- Investigational Site Number : 2760003
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Lübeck, Alemanha, 23562
- Investigational Site Number : 2760006
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Nuremberg, Alemanha, 90419
- Investigational Site Number : 2760007
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Buenos Aires, Argentina, 1181
- Investigational Site Number : 0320002
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Buenos Aires, Argentina, 1180
- Investigational Site Number : 0320008
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Buenos Aires, Argentina, 1280
- Investigational Site Number : 0320007
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Buenos Aires, Argentina, 1417
- Investigational Site Number : 0320003
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Buenos Aires, Argentina, 1426
- Investigational Site Number : 0320004
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Buenos Aires, Argentina, 1430
- Investigational Site Number : 0320001
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Buenos Aires, Argentina, 1431
- Investigational Site Number : 0320005
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Córdoba, Argentina, 5000
- Investigational Site Number : 0320010
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Mendoza, Argentina, 5501
- Investigational Site Number : 0320009
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Buenos Aires
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La Plata, Buenos Aires, Argentina, 1900
- Investigational Site Number : 0320006
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New South Wales
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Liverpool, New South Wales, Austrália, 2170
- Investigational Site Number : 0360007
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Waratah, New South Wales, Austrália, 2298
- Investigational Site Number : 0360004
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Wollongong, New South Wales, Austrália, 2500
- Investigational Site Number : 0360003
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South Australia
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Adelaide, South Australia, Austrália, 5000
- Investigational Site Number : 0360008
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Victoria
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Melbourne, Victoria, Austrália, 3004
- Investigational Site Number : 0360006
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Melbourne, Victoria, Austrália, 3065
- Investigational Site Number : 0360009
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Richmond, Victoria, Austrália, 3121
- Investigational Site Number : 0360001
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Rio de Janeiro, Brasil, 22775-001
- Instituto Americas - Ensino, Pesquisa e Inovação - Rio de Janeiro - Avenida Jorge Curi- Site Number : 0760004
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São Paulo, Brasil, 04537-080
- Clinica São Germano- Site Number : 0760001
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Ceará
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Fortaleza, Ceará, Brasil, 60115-280
- Núcleo de Oncologia e Hematologia do Ceará- Site Number : 0760006
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Pernambuco
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Recife, Pernambuco, Brasil, 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, Brasil, 90880-480
- Hospital Mae de Deus- Site Number : 0760003
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Rio de Janeiro
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Niterói, Rio de Janeiro, Brasil, 24020-096
- CHN - Complexo Hospitalar de Niterói- Site Number : 0760008
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Ontario
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Toronto, Ontario, Canadá, M5G 2M9
- Investigational Site Number : 1240001
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Quebec
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Greenfield Park, Quebec, Canadá, J4V 2H1
- Investigational Site Number : 1240004
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Montreal, Quebec, Canadá, H1T 2M4
- Investigational Site Number : 1240003
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La Araucanía
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Temuco, La Araucanía, Chile, 4780000
- Investigational Site Number : 1520001
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Reg Metropolitana de Santiago
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Santiago, Reg Metropolitana de Santiago, Chile, 7580206
- Investigational Site Number : 1520002
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Santiago, Reg Metropolitana de Santiago, Chile, 6900941
- Investigational Site Number : 1520003
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Santiago, Reg Metropolitana de Santiago, Chile, 7620001
- Investigational Site Number : 1520006
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Santiago, Reg Metropolitana de Santiago, Chile, 8380455
- Investigational Site Number : 1520004
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Valparaiso
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Viña del Mar, Valparaiso, Chile, 2540364
- Investigational Site Number : 1520005
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Beijing, China, 100191
- Investigational Site Number : 1560022
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Beijing, China, 100034
- Investigational Site Number : 1560001
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Changsha, China, 410013
- Investigational Site Number : 1560010
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Guangzhou, China, 510060
- Investigational Site Number : 1560006
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Hangzhou, China, 310003
- Investigational Site Number : 1560002
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Nanchang, China, 330006
- Investigational Site Number : 1560020
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Nanning, China, 530021
- Investigational Site Number : 1560019
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Qingdao, China, 266011
- Investigational Site Number : 1560011
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Shenyang, China, 110004
- Investigational Site Number : 1560013
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Tianjin, China, 300020
- Investigational Site Number : 1560007
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Tianjin, China, 300060
- Investigational Site Number : 1560018
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Tianjin, China, 300052
- Investigational Site Number : 1560009
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Wuhan, China, 430022
- Investigational Site Number : 1560003
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Wuhan, China, 430030
- Investigational Site Number : 1560008
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Zhengzhou, China, 450008
- Investigational Site Number : 1560004
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Madrid, Espanha, 28034
- Investigational Site Number : 7240005
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Salamanca, Espanha, 37007
- Investigational Site Number : 7240002
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Almería
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Murcia, Almería, Espanha, 30120
- Investigational Site Number : 7240006
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Barcelona [Barcelona]
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Badalona, Barcelona [Barcelona], Espanha, 08916
- Investigational Site Number : 7240004
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Cantabria
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Santander, Cantabria, Espanha, 39008
- Investigational Site Number : 7240003
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Navarre
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Pamplona, Navarre, Espanha, 31008
- Investigational Site Number : 7240001
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Colorado
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Aurora, Colorado, Estados Unidos, 80012
- Rocky Mountain Cancer Centers - Aurora- Site Number : 8400021
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Florida
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Jacksonville, Florida, Estados Unidos, 32224
- Mayo Clinic in Florida- Site Number : 8400008
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Plantation, Florida, Estados Unidos, 33322
- Boca Raton Clinical Research Associates- Site Number : 8400030
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Mississippi
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Hattiesburg, Mississippi, Estados Unidos, 39401
- Hattiesburg Clinic- Site Number : 8400006
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New Jersey
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Morristown, New Jersey, Estados Unidos, 07962
- Atlantic Health System- Site Number : 8400005
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New York
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Albany, New York, Estados Unidos, 12206
- New York Oncology Hematology - Albany Cancer Center- Site Number : 8400017
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North Carolina
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Charlotte, North Carolina, Estados Unidos, 28207
- Novant Health Neurology & Sleep- Site Number : 8400014
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Ohio
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Canton, Ohio, Estados Unidos, 44718
- Gabrail Cancer Center- Site Number : 8400027
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Fairfield, Ohio, Estados Unidos, 45014
- Oncology Hematology Care - Fairfield- Site Number : 8400016
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South Carolina
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Spartanburg, South Carolina, Estados Unidos, 29303
- Spartanburg Regional Medical Center- Site Number : 8400002
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Texas
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Dallas, Texas, Estados Unidos, 75390
- University of Texas - Southwestern Medical Center- Site Number : 8400024
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San Antonio, Texas, Estados Unidos, 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, Estados Unidos, 84108
- Veterans Affairs Medical Center - Salt Lake City- Site Number : 8400011
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Nantes, França, 44093
- Investigational Site Number : 2500002
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Paris, França, 75571
- Investigational Site Number : 2500005
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Poitiers, França, 86021
- Investigational Site Number : 2500001
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Saint-Priest-en-Jarez, França, 42270
- Investigational Site Number : 2500009
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Toulouse, França, 31059
- Investigational Site Number : 2500003
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Tours, França, 37032
- Investigational Site Number : 2500007
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Athens, Grécia, 106 76
- Investigational Site Number : 3000002
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Athens, Grécia, 115 28
- Investigational Site Number : 3000001
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Pátrai, Grécia, 265 04
- Investigational Site Number : 3000003
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Thessaloniki, Grécia, 570 10
- Investigational Site Number : 3000004
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Budapest, Hungria, 1097
- Investigational Site Number : 3480004
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Budapest, Hungria, 1085
- Investigational Site Number : 3480002
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Kaposvár, Hungria, 7400
- Investigational Site Number : 3480003
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Pécs, Hungria, 7623
- Investigational Site Number : 3480008
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Szombathely, Hungria, 9700
- Investigational Site Number : 3480006
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Székesfehérvár, Hungria, 8000
- Investigational Site Number : 3480005
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Bologna, Itália, 40138
- Investigational Site Number : 3800002
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Brescia, Itália, 25123
- Investigational Site Number : 3800005
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Pavia, Itália, 27100
- Investigational Site Number : 3800003
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Ancona
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Torette, Ancona, Itália, 60020
- Investigational Site Number : 3800004
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Reggio Emilia
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Meldola, Reggio Emilia, Itália, 47014
- Investigational Site Number : 3800001
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Roma
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Rome, Roma, Itália, 00168
- Investigational Site Number : 3800006
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Kyoto, Japão, 603-8151
- Investigational Site Number : 3920003
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Osaka, Japão, 530-8480
- Investigational Site Number : 3920011
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Tokyo, Japão, 150-8935
- Investigational Site Number : 3920004
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Yamagata, Japão, 990-9585
- Investigational Site Number : 3920009
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Aichi-ken
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Nagoya, Aichi-ken, Japão, 467-8602
- Investigational Site Number : 3920001
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Chiba
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Kamogawa, Chiba, Japão, 296-8602
- Investigational Site Number : 3920007
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Ibaraki
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Higashiibaraki, Ibaraki, Japão, 311-3117
- Investigational Site Number : 3920005
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Iwate
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Yahaba, Iwate, Japão, 028-3695
- Investigational Site Number : 3920010
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Kanagawa
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Kamakura, Kanagawa, Japão, 247-8533
- Investigational Site Number : 3920012
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Okayama-ken
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Okayama, Okayama-ken, Japão, 701-1192
- Investigational Site Number : 3920002
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Oslo, Noruega, 0450
- Investigational Site Number : 5780001
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Ålesund, Noruega, 6017
- Investigational Site Number : 5780002
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Lesser Poland Voivodeship
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Krakow, Lesser Poland Voivodeship, Polônia, 31-501
- Investigational Site Number : 6160005
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Lower Silesian Voivodeship
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Wroclaw, Lower Silesian Voivodeship, Polônia, 50-088
- Investigational Site Number : 6160004
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Lublin Voivodeship
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Lublin, Lublin Voivodeship, Polônia, 20-081
- Investigational Site Number : 6160001
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Derbyshire
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Derby, Derbyshire, Reino Unido, DE22 3NE
- Investigational Site Number : 8260003
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England
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Birmingham, England, Reino Unido, B15 2TH
- Investigational Site Number : 8260004
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Leicestershire
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Leicester, Leicestershire, Reino Unido, LE1 5WW
- Investigational Site Number : 8260002
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London, City of
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London, London, City of, Reino Unido, W12 0HS
- Investigational Site Number : 8260005
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Norfolk
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Norwich, Norfolk, Reino Unido, NR4 7UY
- Investigational Site Number : 8260001
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Borås, Suécia, 501 82
- Investigational Site Number : 7520001
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Huddinge, Suécia, 141 57
- Investigational Site Number : 7520003
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Kaohsiung City, Taiwan, 833
- Investigational Site Number : 1580001
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Tainan, Taiwan, 704
- Investigational Site Number : 1580005
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Taipei, Taiwan, 100
- Investigational Site Number : 1580002
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Brno, Tcheca, 625 00
- Investigational Site Number : 2030005
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Olomouc, Tcheca, 779 00
- Investigational Site Number : 2030003
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Ostrava, Tcheca, 708 52
- Investigational Site Number : 2030006
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Prague, Tcheca, 128 08
- Investigational Site Number : 2030004
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Ankara, Turquia (Türkiye), 06010
- Investigational Site Number : 7920007
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Ankara, Turquia (Türkiye), 06200
- Investigational Site Number : 7920009
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Istanbul, Turquia (Türkiye), 34093
- Investigational Site Number : 7920003
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Istanbul, Turquia (Türkiye), 34098
- Investigational Site Number : 7920005
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Istanbul, Turquia (Türkiye), 34214
- Investigational Site Number : 7920008
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Istanbul, Turquia (Türkiye), 34381
- Investigational Site Number : 7920001
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Izmir, Turquia (Türkiye), 35100
- Investigational Site Number : 7920004
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Descrição
Critério de inclusão:
- Participantes com mieloma múltiplo que receberam pelo menos uma linha anterior de terapia, incluindo lenalidomida e um inibidor de proteassoma, e com proteína M sérica mensurável (≥ 0,5 g/dL) e/ou proteína M na urina (≥ 200 mg/24 horas) e/ou ensaio de cadeia leve livre (FLC) no soro (ensaio de FLC envolvido ≥10 mg/dL e taxa de FLC sérica anormal (1,65))
Critério de exclusão:
- Participantes com menos de 18 anos, participantes com status de desempenho do Eastern Cooperative Oncology Group superior a 2
- Participantes do mieloma múltiplo refratário primário
- Participantes refratários ao anti-CD38 com um período de wash-out inferior a 9 meses ou intolerantes aos agentes mAb anti-CD38
- Terapia prévia com pomalidomida
- Participantes com testes biológicos inadequados.
- Disfunção cardíaca significativa
- Participantes diagnosticados ou tratados para outro câncer dentro de 3 anos antes da randomização, com exceção de ressecção completa de carcinoma basocelular ou carcinoma espinocelular da pele e malignidade in situ ou câncer de próstata de baixo risco após terapia curativa
- Leucemia de células plasmáticas concomitante
- Amiloidose leve-amilóide (AL) primária ativa
- Doença conhecida relacionada à síndrome da imunodeficiência adquirida (AIDS) ou doença conhecida pelo vírus da imunodeficiência humana (HIV) que requer tratamento antiviral
- Conheça a infecção ativa por hepatite A. Infecção atual ou crônica por hepatite B (HBV) ou hepatite C (HCV). Participantes com doença crônica por HBV ou HCV controlada por terapia antiviral são permitidos.
- Mulheres com potencial para engravidar ou participantes do sexo masculino com mulheres com potencial para engravidar que não concordam em usar métodos anticoncepcionais altamente eficazes
As informações acima não pretendem conter todas as considerações relevantes para a participação potencial de um participante em um estudo clínico
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador Ativo: Isatuximabe intravenoso (IV)
A dose de isatuximabe será administrada por infusão IV semanalmente durante 4 semanas durante o Ciclo 1 (Dias 1, 8, 15 e 22) e Dias 1 e 15 dos ciclos subsequentes.
Cada ciclo terá 28 dias.
A dose de pomalidomida será tomada por via oral no Dia 1 ao Dia 21 de cada ciclo no horário que for mais conveniente para os participantes antes ou após a administração de isatuximabe, de preferência no mesmo horário todos os dias.
A dexametasona será administrada por via oral nos dias 1, 8, 15 e 22 (a ser repetida a cada 28 dias).
Os participantes podem receber outros tratamentos como tratamento de base e/ou medicação de resgate.
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Forma farmacêutica: Comprimido; Via de administração: Oral
Forma farmacêutica: cápsulas duras; Via de administração: Oral
Outros nomes:
Forma farmacêutica: Solução concentrada para infusão IV; Via de administração: Intravenosa
Outros nomes:
Forma farmacêutica: Conforme produto comercial local; Via de administração: Oral; Medicamento Auxiliar (AxMP), ou seja, tratamento de base; Código ATC: H02AB02
Forma farmacêutica: Conforme produto comercial local; Via de administração: Oral; AxMP, isto é, tratamento de base; Código ATC: R03DC03
Forma farmacêutica: Conforme produto comercial local; Via de administração: Oral; AxMP, isto é, tratamento de base; Código ATC: N02BE01
Forma farmacêutica: Conforme produto comercial local; Via de administração: Como pré-medicação – oral; para tratamento de reações à infusão IV (ou equivalente oral); AxMP, ou seja, tratamento de base e medicação de resgate (em caso de reações à infusão); Código ATC: R06AA02
Forma farmacêutica: Conforme produto comercial local; Via de administração: Como pré-medicação-IV; para manejo de reações à infusão – IV (ou equivalente oral); AxMP, ou seja, tratamento de base e medicação de resgate (em caso de reações à infusão); Código ATC: H02AB04
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Experimental: 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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Forma farmacêutica: Solução para administração subcutânea; Via de administração: Subcutânea (SC)
Outros nomes:
Forma farmacêutica: Comprimido; Via de administração: Oral
Forma farmacêutica: cápsulas duras; Via de administração: Oral
Outros nomes:
Forma farmacêutica: Conforme produto comercial local; Via de administração: Oral; Medicamento Auxiliar (AxMP), ou seja, tratamento de base; Código ATC: H02AB02
Forma farmacêutica: Conforme produto comercial local; Via de administração: Oral; AxMP, isto é, tratamento de base; Código ATC: R03DC03
Forma farmacêutica: Conforme produto comercial local; Via de administração: Oral; AxMP, isto é, tratamento de base; Código ATC: N02BE01
Forma farmacêutica: Conforme produto comercial local; Via de administração: Como pré-medicação – oral; para tratamento de reações à infusão IV (ou equivalente oral); AxMP, ou seja, tratamento de base e medicação de resgate (em caso de reações à infusão); Código ATC: R06AA02
Forma farmacêutica: Conforme produto comercial local; Via de administração: Como pré-medicação-IV; para manejo de reações à infusão – IV (ou equivalente oral); AxMP, ou seja, tratamento de base e medicação de resgate (em caso de reações à infusão); Código ATC: H02AB04
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Taxa de Resposta Global (TRG)
Prazo: Desde a primeira dose da medicação do estudo (Dia 1) até ao PCD (06-Nov-2024), aproximadamente 28 meses
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ORR pelo comité de revisão independente (IRC) utilizando os critérios de 2016 do grupo internacional de trabalho sobre mieloma (IMWG): Percentagem de participantes com resposta completa (CR), resposta completa rigorosa (sCR), resposta parcial muito boa (VGPR) e resposta parcial (PR). CR: imunofixação negativa no soro e urina, desaparecimento de quaisquer plasmocitomas de tecidos moles (STP), <5% de células plasmáticas em aspirados de medula óssea (BM) e um rácio normal de cadeias leves livres (FLC) (0,26-1,65). sCR: CR mais ausência de células clonais na biópsia de BM. VGPR: proteína M no soro e urina detetável por imunofixação, não por eletroforese; redução >=90% na proteína M sérica mais nível de proteína M urinária <100mg/24horas(h); diminuição >=90% na soma do diâmetro perpendicular máximo (SPD) comparado com a linha de base em STP; apenas FLC: diminuição >=90% na diferença entre os níveis de FLC envolvido e não envolvido. PR: redução >=50% da proteína M sérica e redução na proteína M urinária de 24h por >=90% ou para <200mg/24h. Além do acima, se presente na linha de base, redução >=50% no tamanho SPD dos STPs também é necessária.
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Desde a primeira dose da medicação do estudo (Dia 1) até ao PCD (06-Nov-2024), aproximadamente 28 meses
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Concentração Observada Antes da Administração (Ctrough) de Isatuximab em Estado Estacionário
Prazo: Pré-dose no Ciclo 6 Dia 1
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A concentração residual (Ctrough) em estado estacionário foi a concentração plasmática observada recolhida antes da administração da dose no Ciclo 6 Dia 1 (equivalente a antes do Ciclo 6 Dia 1) da administração de isatuximab.
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Pré-dose no Ciclo 6 Dia 1
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Ctrough do Isatuximabe às 4 Semanas (CT4W)
Prazo: Pré-dose no Ciclo 2 Dia 1 (às 4 semanas)
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As concentrações plasmáticas observadas do CT4W foram recolhidas antes da dose no Dia 1 do Ciclo 2 (equivalente a anterior ao Dia 1 do Ciclo 2) da administração da dose de isatuximab.
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Pré-dose no Ciclo 2 Dia 1 (às 4 semanas)
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Percentagem de Participantes que Responderam Muito Satisfeitos e Satisfeitos ao 'Questionário de Experiência e Satisfação do Doente (PESQ-FU)': Satisfação com o Método de Injeção' (Item-8) no Ciclo 5 Dia 15
Prazo: Ciclo 5 Dia 15
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O PESQ-FU, composto por 9 itens, foi concebido para acompanhar a experiência e satisfação dos participantes relativamente ao método de injeção (desconforto, dor, efeitos secundários, poupança de tempo e satisfação) e à medicação do estudo (efeitos secundários, valer a pena tomar, satisfação e recomendação).
Este questionário foi adaptado com base em entrevistas qualitativas com participantes oncológicos.
As respostas à 'satisfação com o método de injeção' foram registadas como 'muito satisfeito, satisfeito, nem satisfeito nem insatisfeito, insatisfeito e muito insatisfeito' em momentos específicos.
A percentagem total de participantes que ficaram muito satisfeitos e satisfeitos com o método de injeção (item-8) no Ciclo 5 Dia 15 é aqui reportada.
As percentagens são arredondadas à décima casa decimal.
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Ciclo 5 Dia 15
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Ctrough do Isatuximab
Prazo: Pré-dose no Ciclo 1 Dias 8, 15 e 22, Ciclos 2 a 5 Dias 1 e 15, Ciclos 6, 7, 8, 9, 12, 15, 18, 21, 24 e 27 Dia 1
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As amostras de plasma foram recolhidas em pontos de tempo específicos para a avaliação de Ctrough.
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Pré-dose no Ciclo 1 Dias 8, 15 e 22, Ciclos 2 a 5 Dias 1 e 15, Ciclos 6, 7, 8, 9, 12, 15, 18, 21, 24 e 27 Dia 1
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Percentagem de Participantes com Resposta ao 'Questionário de Expectativas do Doente na Linha de Base (PEQ-BL)'
Prazo: Linha de Base (Ciclo 1 Dia 1)
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Percentagem de participantes que responderam que concordam totalmente ou concordam no início do estudo com as expectativas de dor, desconforto e efeitos secundários do método de injeção, que o método de injeção pouparia tempo, que a medicação do estudo pode resultar em efeitos secundários e que valeria a pena tomar são relatadas.
O PEQ-BL consistiu em 7 itens.
A percentagem de participantes que alguma vez receberam medicação por via IV e/ou SC também é relatada.
As percentagens são arredondadas à décima casa decimal.
O valor de base foi definido como o último valor não omisso recolhido na data de início da medicação do estudo ou antes desta.
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Linha de Base (Ciclo 1 Dia 1)
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Questionário de Utilização de Recursos de Saúde e Produtividade (HRUPQ): Utilização de Cuidados de Saúde na Linha de Base: Número de Vezes nos Últimos 6 Meses que um Participante Recebeu Cuidados
Prazo: Baseline (Ciclo 1 Dia 1)
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A utilização de cuidados de saúde na linha de base antes da administração da medicação do estudo foi recolhida através do HRUPQ.
É apresentado o número médio de vezes nos últimos 6 meses que um participante recebeu cuidados numa clínica ou serviço de urgência hospitalar por qualquer problema de saúde incluindo MM ou devido a MM e cuidados domiciliários de um enfermeiro ou outro profissional de saúde por qualquer problema de saúde incluindo MM ou devido a MM.
O valor da linha de base foi definido como o último valor não em falta recolhido na data de início da medicação do estudo ou antes desta.
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Baseline (Ciclo 1 Dia 1)
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HRUPQ: Utilização de Cuidados de Saúde na Linha de Base: Número de Noites nos Últimos 6 Meses que um Participante Permaneceu no Hospital
Prazo: Referência (Ciclo 1 Dia 1)
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A utilização de cuidados de saúde na linha de base antes da administração da medicação do estudo foi recolhida através do HRUPQ.
É apresentado o número médio de noites nos últimos 6 meses em que um participante permaneceu no hospital por qualquer problema de saúde incluindo MM ou devido a MM e permaneceu na unidade de cuidados intensivos (UCI) por qualquer problema de saúde incluindo MM ou devido a MM.
O valor da linha de base foi definido como o último valor não em falta recolhido na data de início da medicação do estudo ou antes desta.
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Referência (Ciclo 1 Dia 1)
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HRUPQ: Utilização de Cuidados de Saúde na Linha de Base: Número de Vezes nos Últimos 6 Meses que um Participante Consultou um Profissional de Saúde (HCP)
Prazo: Baseline (Ciclo 1 Dia 1)
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A utilização de cuidados de saúde na linha de base antes da administração da medicação do estudo foi recolhida através do HRUPQ.
O número médio de vezes nos últimos 6 meses que um participante consultou (viu ou falou com) os seguintes profissionais de saúde: médico geral ou clínico de cuidados primários (PCC) que trata uma variedade de doenças para qualquer problema de saúde incluindo MM ou relacionado com MM, fisioterapeuta ou terapeuta ocupacional para qualquer problema de saúde incluindo MM ou relacionado com MM, profissional de saúde mental (por exemplo,
psiquiatra, psicólogo, enfermeiro psiquiátrico) para qualquer problema de saúde incluindo MM ou relacionado com MM, médico ou clínico que se especializa em doença ou problema médico específico (especialista) para qualquer problema de saúde incluindo MM ou relacionado com MM é apresentado.
O valor da linha de base foi definido como o último valor não em falta recolhido na data de início da medicação do estudo ou antes.
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Baseline (Ciclo 1 Dia 1)
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Percentagem de Participantes que se Reformaram Durante o Estudo com Base no HRUPQ
Prazo: Desde a primeira dose da administração do medicamento do estudo (Dia 1) até ao PCD (06-Nov-2024), aproximadamente 28 meses
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O estado de emprego foi avaliado através do HRUPQ.
É reportada a percentagem de participantes que se reformaram durante o estudo.
As percentagens são arredondadas à décima casa decimal.
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Desde a primeira dose da administração do medicamento do estudo (Dia 1) até ao PCD (06-Nov-2024), aproximadamente 28 meses
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Percentagem de Participantes que se Reformaram Antecipadamente Devido a MM com Base no HRUPQ
Prazo: Desde a primeira dose da administração do medicamento do estudo (Dia 1) até ao PCD (06-Nov-2024), aproximadamente 28 meses
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O estado de emprego foi avaliado através do HRUPQ.
É reportada a percentagem de participantes que se reformaram antecipadamente devido ao MM.
As percentagens são arredondadas à décima casa decimal.
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Desde a primeira dose da administração do medicamento do estudo (Dia 1) até ao PCD (06-Nov-2024), aproximadamente 28 meses
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Very Good Partial Response or Better Rate
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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'
Prazo: 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'
Prazo: 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'
Prazo: 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 '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'
Prazo: 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 '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'
Prazo: 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 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'
Prazo: 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 '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.
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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: Study Medication Worth Taking'
Prazo: 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 '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'
Prazo: 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'
Prazo: 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)'
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
|
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For functional scales: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score and a positive change from baseline represents a better level of physical functioning.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
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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
Prazo: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
|
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For functional scales: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score and a positive change from baseline represents a better level of role functioning.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
|
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-C30: Emotional Functioning
Prazo: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
|
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For functional scales: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score and a positive change from baseline represents a better level of emotional functioning.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
|
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-C30: Cognitive Functioning
Prazo: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
|
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For functional scales: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score and a positive change from baseline represents a better level of cognitive functioning.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
|
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-C30: Social Functioning
Prazo: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
|
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For functional scales: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score and a positive change from baseline represents a better level of social functioning.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
|
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-C30: Fatigue
Prazo: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
|
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For symptom scales: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score for symptoms and a positive change from baseline represents a higher level of symptomatology.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
|
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-C30: Nausea and Vomiting
Prazo: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
|
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For symptom scales: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score for symptoms and a positive change from baseline represents a higher level of symptomatology.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
|
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-C30: Pain
Prazo: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
|
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For symptom scales: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score for symptoms and a positive change from baseline represents a higher level of symptomatology.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
|
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-C30: Dyspnea
Prazo: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
|
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score for symptom items and a positive change from baseline represents a higher level of symptomatology.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
|
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-C30: Insomnia
Prazo: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
|
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score for symptom items and a positive change from baseline represents a higher level of symptomatology.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
|
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-C30: Appetite Loss
Prazo: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
|
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score for symptom items and a positive change from baseline represents a higher level of symptomatology.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
|
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-C30: Constipation
Prazo: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
|
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score for symptom items and a positive change from baseline represents a higher level of symptomatology.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
|
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-C30: Diarrhea
Prazo: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
|
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score for symptom items and a positive change from baseline represents a higher level of symptomatology.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
|
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-C30: Financial Difficulties
Prazo: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
|
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score for symptom items and a positive change from baseline represents a higher level of financial difficulties.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
|
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-Myeloma Module (MY20): Disease Symptoms
Prazo: 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
Prazo: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
|
The EORTC QLQ-MY20 was used in conjunction with the EORTC QLQ-C30 to assess symptoms and side effects due to the treatment or the disease which impacts health related QoL in participants with MM.
It contains 20 items, 4 independent subscales covering 2 functional domains: symptom scales which include disease symptoms (6 items) and side-effects of treatment (10 items) and function scale which include future perspective (3 items) and body image (1 item).
Scores for each subscale are based on the 4-point Likert scale ranging from (1: not at all to 4: very much) and transformed from raw scores to linear scales ranging from 0 to 100; mean is presented here.
A higher score for side effects of treatment and a positive change from baseline represents more side effects, worse QoL.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
|
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-MY20: Future Perspective
Prazo: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
|
The EORTC QLQ-MY20 was used in conjunction with the EORTC QLQ-C30 to assess symptoms and side effects due to the treatment or the disease which impacts health related QoL in participants with MM.
It contains 20 items, 4 independent subscales covering 2 functional domains: symptom scales which include disease symptoms (6 items) and side-effects of treatment (10 items) and function scale which include future perspective (3 items) and body image (1 item).
Scores for each subscale are based on the 4-point Likert scale ranging from (1: not at all to 4: very much) and transformed from raw scores to linear scales ranging from 0 to 100; mean is presented here.
A higher score for future perspectives and a positive change from baseline represents better outcomes, better QoL.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
|
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-MY20: Body Image
Prazo: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
|
The EORTC QLQ-MY20 was used in conjunction with the EORTC QLQ-C30 to assess symptoms and side effects due to the treatment or the disease which impacts health related QoL in participants with MM.
It contains 20 items, 4 independent subscales covering 2 functional domains: symptom scales which include disease symptoms (6 items) and side-effects of treatment (10 items) and function scale which include future perspective (3 items) and body image (1 item).
Scores for each subscale are based on the 4-point Likert scale ranging from (1: not at all to 4: very much) and transformed from raw scores to linear scales ranging from 0 to 100; mean is presented here.
A higher score for body image and a positive change from baseline represents better outcomes, better QoL.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
|
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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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)
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: Clinical Sciences & Operations, Sanofi
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
23 de junho de 2022
Conclusão Primária (Real)
6 de novembro de 2024
Conclusão do estudo (Estimado)
22 de outubro de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
31 de maio de 2022
Enviado pela primeira vez que atendeu aos critérios de CQ
31 de maio de 2022
Primeira postagem (Real)
6 de junho de 2022
Atualizações de registro de estudo
Última Atualização Postada (Real)
2 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
10 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Doenças Vasculares
- Doenças cardiovasculares
- Neoplasias
- Doenças do sistema imunológico
- Neoplasias por Tipo Histológico
- Doenças Hematológicas
- Distúrbios Linfoproliferativos
- Distúrbios imunoproliferativos
- Distúrbios hemostáticos
- Paraproteinemias
- Distúrbios das Proteínas Sanguíneas
- Distúrbios hemorrágicos
- Mieloma múltiplo
- Neoplasias de Células Plasmáticas
- Produtos químicos orgânicos
- Hidrocarbonetos
- Hidrocarbonetos, cíclicos
- Hidrocarbonetos, aromáticos
- Compostos policíclicos
- Anilides
- Amidas
- Compostos de anilina
- Aminas
- Acetanilidas
- Pregada
- Pregnas
- Esteróides
- Compostos de anel fundido
- Esteróides, fluorados
- Derivados de benzeno
- Pregadienetriols
- Etilaminas
- Prednisolona
- Compostos benzhydryl
- Dexametasona
- Paracetamol
- Metilprednisolona
- Difenidramina
- pomalidomida
- isatuximab
- Montelukast
Outros números de identificação do estudo
- EFC15951
- 2023 (Concessão/Contrato do NIH dos EUA: GRAMMY Museum Foundation)
- U1111-1261-5846 (Identificador de registro: ICTRP)
- 2023-508869-32 (Número EudraCT: CTIS)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
Pesquisadores qualificados podem solicitar acesso aos dados do paciente e documentos de estudo relacionados, incluindo o relatório do estudo clínico, protocolo do estudo com quaisquer alterações, formulário de relatório de caso em branco, plano de análise estatística e especificações do conjunto de dados.
Os dados do paciente serão anonimizados e os documentos do estudo serão editados para proteger a privacidade dos participantes do estudo.
Mais detalhes sobre os critérios de compartilhamento de dados da Sanofi, estudos elegíveis e processo de solicitação de acesso podem ser encontrados em: https://vivli.org.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Sim
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .