Isatuximab SC versus IV en combinación con pomalidomida y dexametasona en RRMM (IRAKLIA)
10 de agosto de 2026 actualizado por: Sanofi
Un estudio aleatorizado, de fase 3, abierto, que evalúa la administración subcutánea versus intravenosa de isatuximab en combinación con pomalidomida y dexametasona en pacientes adultos con mieloma múltiple en recaída o refractario (RRMM)
Este es un estudio aleatorizado, multicéntrico, de fase 3, abierto, que evalúa la administración subcutánea (SC) frente a la intravenosa (IV) de isatuximab en combinación con pomalidomida y dexametasona (Pd) en pacientes con RRMM (participantes del estudio) que han recibido al menos 1 línea de terapia que incluye lenalidomida y un inhibidor del proteasoma (PI). Los participantes elegibles serán aleatorizados 1:1 en 1 de 2 brazos del estudio:
Brazo SC: Isatuximab SC + Pd
Brazo IV: Isatuximab IV + Pd
A los participantes se les permitirá continuar la terapia hasta la progresión de la enfermedad, los eventos adversos (EA) inaceptables, la solicitud del participante de suspender la terapia o cualquier otro motivo, lo que ocurra primero.
Descripción general del estudio
Estado
Activo, no reclutando
Condiciones
Descripción detallada
Se tratarán dos brazos del estudio en ciclos de 4 semanas hasta la progresión de la enfermedad, eventos adversos inaceptables (AE), solicitud del participante para suspender la terapia o cualquier otro motivo, lo que ocurra primero.
Tipo de estudio
Intervencionista
Inscripción (Actual)
531
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Dresden, Alemania, 01307
- Investigational Site Number : 2760005
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Heidelberg, Alemania, 69120
- Investigational Site Number : 2760003
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Lübeck, Alemania, 23562
- Investigational Site Number : 2760006
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Nuremberg, Alemania, 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, Australia, 2170
- Investigational Site Number : 0360007
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Waratah, New South Wales, Australia, 2298
- Investigational Site Number : 0360004
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Wollongong, New South Wales, Australia, 2500
- Investigational Site Number : 0360003
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South Australia
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Adelaide, South Australia, Australia, 5000
- Investigational Site Number : 0360008
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Victoria
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Melbourne, Victoria, Australia, 3004
- Investigational Site Number : 0360006
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Melbourne, Victoria, Australia, 3065
- Investigational Site Number : 0360009
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Richmond, Victoria, Australia, 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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Brno, Chequia, 625 00
- Investigational Site Number : 2030005
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Olomouc, Chequia, 779 00
- Investigational Site Number : 2030003
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Ostrava, Chequia, 708 52
- Investigational Site Number : 2030006
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Prague, Chequia, 128 08
- Investigational Site Number : 2030004
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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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Madrid, España, 28034
- Investigational Site Number : 7240005
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Salamanca, España, 37007
- Investigational Site Number : 7240002
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Almería
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Murcia, Almería, España, 30120
- Investigational Site Number : 7240006
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Barcelona [Barcelona]
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Badalona, Barcelona [Barcelona], España, 08916
- Investigational Site Number : 7240004
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Cantabria
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Santander, Cantabria, España, 39008
- Investigational Site Number : 7240003
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Navarre
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Pamplona, Navarre, España, 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, Francia, 44093
- Investigational Site Number : 2500002
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Paris, Francia, 75571
- Investigational Site Number : 2500005
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Poitiers, Francia, 86021
- Investigational Site Number : 2500001
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Saint-Priest-en-Jarez, Francia, 42270
- Investigational Site Number : 2500009
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Toulouse, Francia, 31059
- Investigational Site Number : 2500003
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Tours, Francia, 37032
- Investigational Site Number : 2500007
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Athens, Grecia, 106 76
- Investigational Site Number : 3000002
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Athens, Grecia, 115 28
- Investigational Site Number : 3000001
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Pátrai, Grecia, 265 04
- Investigational Site Number : 3000003
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Thessaloniki, Grecia, 570 10
- Investigational Site Number : 3000004
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Budapest, Hungría, 1097
- Investigational Site Number : 3480004
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Budapest, Hungría, 1085
- Investigational Site Number : 3480002
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Kaposvár, Hungría, 7400
- Investigational Site Number : 3480003
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Pécs, Hungría, 7623
- Investigational Site Number : 3480008
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Szombathely, Hungría, 9700
- Investigational Site Number : 3480006
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Székesfehérvár, Hungría, 8000
- Investigational Site Number : 3480005
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Bologna, Italia, 40138
- Investigational Site Number : 3800002
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Brescia, Italia, 25123
- Investigational Site Number : 3800005
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Pavia, Italia, 27100
- Investigational Site Number : 3800003
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Ancona
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Torette, Ancona, Italia, 60020
- Investigational Site Number : 3800004
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Reggio Emilia
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Meldola, Reggio Emilia, Italia, 47014
- Investigational Site Number : 3800001
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Roma
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Rome, Roma, Italia, 00168
- Investigational Site Number : 3800006
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Kyoto, Japón, 603-8151
- Investigational Site Number : 3920003
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Osaka, Japón, 530-8480
- Investigational Site Number : 3920011
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Tokyo, Japón, 150-8935
- Investigational Site Number : 3920004
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Yamagata, Japón, 990-9585
- Investigational Site Number : 3920009
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Aichi-ken
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Nagoya, Aichi-ken, Japón, 467-8602
- Investigational Site Number : 3920001
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Chiba
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Kamogawa, Chiba, Japón, 296-8602
- Investigational Site Number : 3920007
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Ibaraki
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Higashiibaraki, Ibaraki, Japón, 311-3117
- Investigational Site Number : 3920005
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Iwate
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Yahaba, Iwate, Japón, 028-3695
- Investigational Site Number : 3920010
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Kanagawa
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Kamakura, Kanagawa, Japón, 247-8533
- Investigational Site Number : 3920012
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Okayama-ken
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Okayama, Okayama-ken, Japón, 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, Polonia, 31-501
- Investigational Site Number : 6160005
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Lower Silesian Voivodeship
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Wroclaw, Lower Silesian Voivodeship, Polonia, 50-088
- Investigational Site Number : 6160004
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Lublin Voivodeship
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Lublin, Lublin Voivodeship, Polonia, 20-081
- Investigational Site Number : 6160001
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Beijing, Porcelana, 100191
- Investigational Site Number : 1560022
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Beijing, Porcelana, 100034
- Investigational Site Number : 1560001
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Changsha, Porcelana, 410013
- Investigational Site Number : 1560010
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Guangzhou, Porcelana, 510060
- Investigational Site Number : 1560006
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Hangzhou, Porcelana, 310003
- Investigational Site Number : 1560002
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Nanchang, Porcelana, 330006
- Investigational Site Number : 1560020
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Nanning, Porcelana, 530021
- Investigational Site Number : 1560019
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Qingdao, Porcelana, 266011
- Investigational Site Number : 1560011
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Shenyang, Porcelana, 110004
- Investigational Site Number : 1560013
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Tianjin, Porcelana, 300020
- Investigational Site Number : 1560007
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Tianjin, Porcelana, 300060
- Investigational Site Number : 1560018
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Tianjin, Porcelana, 300052
- Investigational Site Number : 1560009
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Wuhan, Porcelana, 430022
- Investigational Site Number : 1560003
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Wuhan, Porcelana, 430030
- Investigational Site Number : 1560008
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Zhengzhou, Porcelana, 450008
- Investigational Site Number : 1560004
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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, Suecia, 501 82
- Investigational Site Number : 7520001
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Huddinge, Suecia, 141 57
- Investigational Site Number : 7520003
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Kaohsiung City, Taiwán, 833
- Investigational Site Number : 1580001
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Tainan, Taiwán, 704
- Investigational Site Number : 1580005
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Taipei, Taiwán, 100
- Investigational Site Number : 1580002
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Ankara, Turquía (Türkiye), 06010
- Investigational Site Number : 7920007
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Ankara, Turquía (Türkiye), 06200
- Investigational Site Number : 7920009
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Istanbul, Turquía (Türkiye), 34093
- Investigational Site Number : 7920003
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Istanbul, Turquía (Türkiye), 34098
- Investigational Site Number : 7920005
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Istanbul, Turquía (Türkiye), 34214
- Investigational Site Number : 7920008
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Istanbul, Turquía (Türkiye), 34381
- Investigational Site Number : 7920001
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Izmir, Turquía (Türkiye), 35100
- Investigational Site Number : 7920004
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Descripción
Criterios de inclusión:
- Participantes con mieloma múltiple que hayan recibido al menos una línea de tratamiento anterior que incluya lenalidomida y un inhibidor del proteasoma, y con proteína M medible en suero (≥ 0,5 g/dl) y/o proteína M en orina (≥ 200 mg/24 horas) y/o ensayo de cadenas ligeras libres (FLC) en suero (ensayo de FLC implicado ≥10 mg/dl y relación de FLC en suero anormal (1,65))
Criterio de exclusión:
- Participantes menores de 18 años, participantes con estado funcional del Eastern Cooperative Oncology Group de más de 2
- Participantes con mieloma múltiple refractario primario
- Participantes refractarios a anti-CD38 con un período de lavado inferior a 9 meses o intolerantes a los agentes mAb anti-CD38
- Tratamiento previo con pomalidomida
- Participantes con pruebas biológicas inadecuadas.
- Disfunción cardíaca significativa
- Participantes diagnosticados o tratados por otro cáncer dentro de los 3 años anteriores a la aleatorización, con la excepción de la resección completa del carcinoma de células basales o el carcinoma de células escamosas de la piel, y la malignidad in situ o el cáncer de próstata de bajo riesgo después de la terapia curativa.
- Leucemia de células plasmáticas concomitante
- Amiloidosis primaria amiloide ligera (AL) activa
- Enfermedad conocida relacionada con el síndrome de inmunodeficiencia adquirida (SIDA) o enfermedad conocida por el virus de la inmunodeficiencia humana (VIH) que requiere tratamiento antiviral
- Conoce la infección activa por Hepatitis A. Infección actual activa o crónica por hepatitis B (VHB) o hepatitis C (VHC). Se permiten participantes con enfermedad crónica por VHB o VHC que se controle con terapia antiviral.
- Mujeres en edad fértil o participantes masculinos con mujeres en edad fértil que no aceptan utilizar un método anticonceptivo altamente eficaz
La información anterior no pretende contener todas las consideraciones relevantes para la posible participación de un participante en un ensayo clínico.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: Isatuximab intravenoso (IV)
La dosis de isatuximab se administrará mediante infusión intravenosa semanalmente durante 4 semanas durante el ciclo 1 (días 1, 8, 15 y 22) y los días 1 y 15 de los ciclos posteriores.
Cada ciclo será de 28 días.
La dosis de pomalidomida se tomará por vía oral del día 1 al día 21 de cada ciclo en el momento que sea más conveniente para los participantes antes o después de la administración de isatuximab, preferiblemente a la misma hora todos los días.
La dexametasona se tomará por vía oral los días 1, 8, 15 y 22 (que se repetirá cada 28 días).
Los participantes pueden recibir otros tratamientos como tratamiento de base y/o medicación de rescate.
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Forma farmacéutica: Tableta; Vía de administración: Oral
Forma farmacéutica: cápsulas duras; Vía de administración: Oral
Otros nombres:
Forma farmacéutica: Solución concentrada para perfusión IV; Vía de administración: Intravenosa
Otros nombres:
Forma farmacéutica: Según producto comercial local; Vía de administración: Oral; Medicamento auxiliar (AxMP), es decir, tratamiento de base; Código ATC: H02AB02
Forma farmacéutica: Según producto comercial local; Vía de administración: Oral; AxMP es decir, tratamiento de fondo; Código ATC: R03DC03
Forma farmacéutica: Según producto comercial local; Vía de administración: Oral; AxMP es decir, tratamiento de fondo; Código ATC: N02BE01
Forma farmacéutica: Según producto comercial local; Vía de administración: Como premedicación: oral; para el tratamiento de reacciones a la infusión IV (o equivalente oral); AxMP, es decir, tratamiento de base y medicación de rescate (en caso de reacciones a la infusión); Código ATC: R06AA02
Forma farmacéutica: Según producto comercial local; Vía de administración: Como premedicación-IV; para el tratamiento de reacciones a la infusión: IV (o equivalente oral); AxMP, es decir, tratamiento de base y medicación de rescate (en caso de reacciones a la infusión); 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 farmacéutica: Solución para administración subcutánea; Vía de administración: Subcutánea (SC)
Otros nombres:
Forma farmacéutica: Tableta; Vía de administración: Oral
Forma farmacéutica: cápsulas duras; Vía de administración: Oral
Otros nombres:
Forma farmacéutica: Según producto comercial local; Vía de administración: Oral; Medicamento auxiliar (AxMP), es decir, tratamiento de base; Código ATC: H02AB02
Forma farmacéutica: Según producto comercial local; Vía de administración: Oral; AxMP es decir, tratamiento de fondo; Código ATC: R03DC03
Forma farmacéutica: Según producto comercial local; Vía de administración: Oral; AxMP es decir, tratamiento de fondo; Código ATC: N02BE01
Forma farmacéutica: Según producto comercial local; Vía de administración: Como premedicación: oral; para el tratamiento de reacciones a la infusión IV (o equivalente oral); AxMP, es decir, tratamiento de base y medicación de rescate (en caso de reacciones a la infusión); Código ATC: R06AA02
Forma farmacéutica: Según producto comercial local; Vía de administración: Como premedicación-IV; para el tratamiento de reacciones a la infusión: IV (o equivalente oral); AxMP, es decir, tratamiento de base y medicación de rescate (en caso de reacciones a la infusión); Código ATC: H02AB04
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Tasa de Respuesta Global (TRG)
Periodo de tiempo: Desde la primera dosis de administración del medicamento del estudio (Día 1) hasta el PCD (06-nov-2024), aproximadamente 28 meses
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Tasa de respuesta objetiva (TRO) por comité de revisión independiente (CRI) utilizando los criterios de 2016 del Grupo Internacional de Trabajo sobre Mieloma (IMWG): Porcentaje de participantes con respuesta completa (RC), respuesta completa estricta (RCE), respuesta parcial muy buena (RPMB) y respuesta parcial (RP). RC: inmunofijación negativa en suero y orina, desaparición de cualquier plasmocitoma de tejidos blandos (PTB), <5% de células plasmáticas en aspirados de médula ósea (MO) y una proporción normal de cadenas ligeras libres (CLL) (0,26-1,65). RCE: RC más ausencia de células clonales en biopsia de MO. RPMB: proteína M en suero y orina detectable por inmunofijación, no por electroforesis; reducción ≥90% de la proteína M sérica más nivel de proteína M en orina <100 mg/24 horas (h); disminución ≥90% de la suma del diámetro perpendicular máximo (DPM) en comparación con el valor basal en PTB; solo CLL: disminución ≥90% de la diferencia entre los niveles de CLL implicada y no implicada. RP: reducción ≥50% de la proteína M sérica y reducción de la proteína M en orina de 24 h en ≥90% o a <200 mg/24 h. Además de lo anterior, si estaba presente al inicio, también se requiere una reducción ≥50% del tamaño del DPM de los PTB.
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Desde la primera dosis de administración del medicamento del estudio (Día 1) hasta el PCD (06-nov-2024), aproximadamente 28 meses
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Concentración Observada Antes de la Dosificación (Ctrough) de Isatuximab en Estado Estacionario
Periodo de tiempo: Predosis en el Ciclo 6 Día 1
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La Ctrough en estado estacionario fue la concentración plasmática observada recogida en la predosis del Día 1 del Ciclo 6 (equivalente a antes del Día 1 del Ciclo 6) de la administración de la dosis de isatuximab.
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Predosis en el Ciclo 6 Día 1
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Valor de Ctrough de Isatuximab a las 4 Semanas (CT4W)
Periodo de tiempo: Pre-dosis en el Ciclo 2 Día 1 (a las 4 semanas)
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Las concentraciones plasmáticas observadas del CT4W se recogieron antes de la dosis en el Ciclo 2 Día 1 (equivalente a antes del Ciclo 2 Día 1) de la administración de la dosis de isatuximab.
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Pre-dosis en el Ciclo 2 Día 1 (a las 4 semanas)
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Porcentaje de participantes que respondieron 'Muy satisfecho' y 'Satisfecho' en el 'Cuestionario de Experiencia y Satisfacción del Paciente (PESQ-FU)': Satisfacción con el Método de Inyección (Ítem-8) en el Ciclo 5 Día 15
Periodo de tiempo: Ciclo 5 Día 15
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El PESQ-FU, que consta de 9 ítems, ha sido diseñado para realizar un seguimiento de la experiencia y satisfacción de los participantes con respecto al método de inyección (molestias, dolor, efectos secundarios, ahorro de tiempo y satisfacción) y la medicación del estudio (efectos secundarios, valor de tomarlo, satisfacción y recomendación).
Este cuestionario se ha adaptado en base a entrevistas cualitativas con participantes oncológicos.
Las respuestas a 'satisfacción con el método de inyección' se registraron como 'muy satisfecho, satisfecho, ni satisfecho ni insatisfecho, insatisfecho y muy insatisfecho' en los momentos específicos.
Aquí se reporta el porcentaje total de participantes que estuvieron muy satisfechos y satisfechos con el método de inyección (ítem-8) en el Ciclo 5 Día 15.
Los porcentajes se redondean a la décima decimal.
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Ciclo 5 Día 15
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Ctrough de Isatuximab
Periodo de tiempo: Pre-dosis en el Ciclo 1 Días 8, 15 y 22, Ciclos 2 a 5 Días 1 y 15, Ciclos 6, 7, 8, 9, 12, 15, 18, 21, 24 y 27 Día 1
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Las muestras de plasma se recolectaron en puntos de tiempo específicos para la evaluación de Ctrough.
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Pre-dosis en el Ciclo 1 Días 8, 15 y 22, Ciclos 2 a 5 Días 1 y 15, Ciclos 6, 7, 8, 9, 12, 15, 18, 21, 24 y 27 Día 1
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Porcentaje de participantes con respuesta al 'Cuestionario de Expectativas del Paciente al Inicio (PEQ-BL)'
Periodo de tiempo: Línea de base (Ciclo 1 Día 1)
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Se informa el porcentaje de participantes que respondieron que están muy de acuerdo o de acuerdo en la línea de base con las expectativas de dolor, molestias y efectos secundarios del método de inyección, que el método de inyección ahorraría tiempo, que el medicamento del estudio podría resultar en efectos secundarios y que valdría la pena tomarlo.
El PEQ-BL constaba de 7 ítems.
También se informa el porcentaje de participantes que alguna vez recibieron medicación por vía intravenosa y/o subcutánea.
Los porcentajes se redondean al décimo decimal.
El valor basal se definió como el último valor no faltante recogido en o antes de la fecha de inicio de la medicación del estudio.
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Línea de base (Ciclo 1 Día 1)
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Cuestionario de Utilización de Recursos Sanitarios y Productividad (HRUPQ): Utilización Sanitaria Inicial: Número de Veces en los Últimos 6 Meses que un Participante Recibió Atención
Periodo de tiempo: Línea de base (Ciclo 1 Día 1)
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La utilización de servicios sanitarios en el periodo basal antes de la administración del medicamento del estudio se recopiló mediante el HRUPQ.
Se presenta el número medio de veces en los últimos 6 meses que un participante recibió atención en una clínica o servicio de urgencias hospitalario por cualquier problema de salud incluyendo MM o debido a MM, y atención domiciliaria de un enfermero u otro profesional sanitario por cualquier problema de salud incluyendo MM o debido a MM.
El valor basal se definió como el último valor no ausente recogido en o antes de la fecha de inicio del medicamento del estudio.
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Línea de base (Ciclo 1 Día 1)
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HRUPQ: Utilización Sanitaria Basal: Número de Noches en los Últimos 6 Meses que un Participante Permaneció en el Hospital
Periodo de tiempo: Línea de base (Ciclo 1 Día 1)
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La utilización de la atención sanitaria en el momento basal antes de la administración del medicamento del estudio se recopiló mediante el HRUPQ.
Se presenta el número medio de noches en los últimos 6 meses que un participante permaneció en el hospital por cualquier problema de salud, incluido MM o debido a MM, y permaneció en la unidad de cuidados intensivos (UCI) por cualquier problema de salud, incluido MM o debido a MM.
El valor basal se definió como el último valor no faltante recogido en la fecha de inicio del medicamento del estudio o antes de esta.
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Línea de base (Ciclo 1 Día 1)
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HRUPQ: Utilización Sanitaria Inicial: Número de Veces en los Últimos 6 Meses que un Participante Consultó a un Profesional Sanitario (HCP)
Periodo de tiempo: Línea de base (Ciclo 1 Día 1)
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La utilización de la atención sanitaria en la línea de base antes de la administración del medicamento del estudio se recopiló mediante HRUPQ.
Se presenta el número medio de veces en los últimos 6 meses que un participante consultó (había visto o hablado con) los siguientes profesionales sanitarios: médico general o clínico de atención primaria (CAP) que trata una variedad de enfermedades por cualquier problema de salud incluida la EM o relacionado con la EM, fisioterapeuta o terapeuta ocupacional por cualquier problema de salud incluida la EM o relacionado con la EM, profesional de la salud mental (p. ej.
psiquiatra, psicólogo, enfermero psiquiátrico) por cualquier problema de salud incluida la EM o relacionado con la EM, médico o clínico que se especializa en una enfermedad o problema médico particular (especialista) por cualquier problema de salud incluida la EM o relacionado con la EM.
El valor basal se definió como el último valor no faltante recopilado en la fecha de inicio del medicamento del estudio o antes de esta.
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Línea de base (Ciclo 1 Día 1)
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Porcentaje de participantes que se jubilaron durante el estudio según el HRUPQ
Periodo de tiempo: Desde la primera dosis de administración del medicamento del estudio (Día 1) hasta el PCD (06-nov-2024), aproximadamente 28 meses
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El estado laboral se evaluó mediante el HRUPQ.
Se informa el porcentaje de participantes que se jubilaron durante el estudio.
Los porcentajes se redondean al décimo lugar decimal.
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Desde la primera dosis de administración del medicamento del estudio (Día 1) hasta el PCD (06-nov-2024), aproximadamente 28 meses
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Porcentaje de participantes que se retiraron anticipadamente debido a MM según HRUPQ
Periodo de tiempo: Desde la primera dosis de administración del medicamento del estudio (Día 1) hasta la FDC (06-nov-2024), aproximadamente 28 meses
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El estado laboral se evaluó mediante el HRUPQ.
Se informa el porcentaje de participantes que se jubilaron anticipadamente debido al MM.
Los porcentajes se redondean al décimo decimal.
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Desde la primera dosis de administración del medicamento del estudio (Día 1) hasta la FDC (06-nov-2024), aproximadamente 28 meses
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Very Good Partial Response or Better Rate
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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'
Periodo de tiempo: 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'
Periodo de tiempo: 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'
Periodo de tiempo: 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'
Periodo de tiempo: 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'
Periodo de tiempo: 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'
Periodo de tiempo: 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'
Periodo de tiempo: 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'
Periodo de tiempo: 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'
Periodo de tiempo: 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)'
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.
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Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-Myeloma Module (MY20): Disease Symptoms
Periodo de tiempo: 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.
|
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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Clinical Sciences & Operations, Sanofi
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
23 de junio de 2022
Finalización primaria (Actual)
6 de noviembre de 2024
Finalización del estudio (Estimado)
22 de octubre de 2027
Fechas de registro del estudio
Enviado por primera vez
31 de mayo de 2022
Primero enviado que cumplió con los criterios de control de calidad
31 de mayo de 2022
Publicado por primera vez (Actual)
6 de junio de 2022
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
2 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
10 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Neoplasias
- Enfermedades del sistema inmunológico
- Neoplasias por tipo histológico
- Enfermedades hematológicas
- Trastornos linfoproliferativos
- Trastornos inmunoproliferativos
- Trastornos hemostáticos
- Paraproteinemias
- Trastornos de proteínas en sangre
- Trastornos hemorrágicos
- Mieloma múltiple
- Neoplasias De Células Plasmáticas
- Químicos orgánicos
- Hidrocarburos
- Hidrocarburos, cíclico
- Hidrocarburos, aromáticos
- Compuestos policíclicos
- Aniluros
- Amidas
- Compuestos anilina
- Amina
- Acetanilidas
- Espierra
- Embarazos
- Esteroides
- Compuestos de anillo fusionado
- Esteroides, fluorado
- Derivados de benceno
- Esparrazadienetrioles
- Etilaminas
- Prednisolona
- Compuestos de benzhydryl
- Dexametasona
- Paracetamol
- Metilprednisolona
- Difenhidramina
- pomalidomida
- isacuximab
- montelukast
Otros números de identificación del estudio
- EFC15951
- 2023 (Subvención/contrato del NIH de EE. UU.: GRAMMY Museum Foundation)
- U1111-1261-5846 (Identificador de registro: ICTRP)
- 2023-508869-32 (Número EudraCT: CTIS)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Los investigadores calificados pueden solicitar acceso a datos a nivel de paciente y documentos de estudio relacionados, incluido el informe de estudio clínico, el protocolo de estudio con cualquier modificación, el formulario de informe de caso en blanco, el plan de análisis estadístico y las especificaciones del conjunto de datos.
Los datos a nivel del paciente se anonimizarán y los documentos del estudio se redactarán para proteger la privacidad de los participantes del ensayo.
Se pueden encontrar más detalles sobre los criterios de intercambio de datos de Sanofi, los estudios elegibles y el proceso para solicitar acceso en: https://vivli.org.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .