SC Versus IV Isatuximab in combinazione con pomalidomide e desametasone in RRMM (IRAKLIA)
10 agosto 2026 aggiornato da: Sanofi
Uno studio randomizzato, di fase 3, in aperto che valuta la somministrazione sottocutanea rispetto a quella endovenosa di isatuximab in combinazione con pomalidomide e desametasone in pazienti adulti con mieloma multiplo recidivato e/o refrattario (RRMM)
Si tratta di uno studio randomizzato, multicentrico, di fase 3, in aperto, che valuta la somministrazione sottocutanea (SC) vs. linea di terapia comprendente lenalidomide e un inibitore del proteasoma (PI). I partecipanti idonei saranno randomizzati 1:1 in 1 dei 2 bracci dello studio:
Braccio SC: Isatuximab SC + Pd
Braccio IV: Isatuximab IV + Pd
I partecipanti potranno continuare la terapia fino alla progressione della malattia, eventi avversi inaccettabili (EA), richiesta del partecipante di interrompere la terapia o qualsiasi altro motivo, a seconda di quale evento si verifichi per primo.
Panoramica dello studio
Stato
Attivo, non reclutante
Condizioni
Descrizione dettagliata
Due bracci dello studio saranno trattati in cicli di 4 settimane fino alla progressione della malattia, eventi avversi inaccettabili (EA), richiesta dei partecipanti di interrompere la terapia o qualsiasi altro motivo, a seconda di quale evento si verifichi per primo.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
531
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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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, Brasile, 22775-001
- Instituto Americas - Ensino, Pesquisa e Inovação - Rio de Janeiro - Avenida Jorge Curi- Site Number : 0760004
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São Paulo, Brasile, 04537-080
- Clinica São Germano- Site Number : 0760001
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Ceará
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Fortaleza, Ceará, Brasile, 60115-280
- Núcleo de Oncologia e Hematologia do Ceará- Site Number : 0760006
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Pernambuco
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Recife, Pernambuco, Brasile, 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, Brasile, 90880-480
- Hospital Mae de Deus- Site Number : 0760003
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Rio de Janeiro
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Niterói, Rio de Janeiro, Brasile, 24020-096
- CHN - Complexo Hospitalar de Niterói- Site Number : 0760008
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Ontario
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Toronto, Ontario, Canada, M5G 2M9
- Investigational Site Number : 1240001
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Quebec
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Greenfield Park, Quebec, Canada, J4V 2H1
- Investigational Site Number : 1240004
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Montreal, Quebec, Canada, H1T 2M4
- Investigational Site Number : 1240003
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Brno, Cechia, 625 00
- Investigational Site Number : 2030005
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Olomouc, Cechia, 779 00
- Investigational Site Number : 2030003
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Ostrava, Cechia, 708 52
- Investigational Site Number : 2030006
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Prague, Cechia, 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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Beijing, Cina, 100191
- Investigational Site Number : 1560022
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Beijing, Cina, 100034
- Investigational Site Number : 1560001
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Changsha, Cina, 410013
- Investigational Site Number : 1560010
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Guangzhou, Cina, 510060
- Investigational Site Number : 1560006
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Hangzhou, Cina, 310003
- Investigational Site Number : 1560002
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Nanchang, Cina, 330006
- Investigational Site Number : 1560020
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Nanning, Cina, 530021
- Investigational Site Number : 1560019
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Qingdao, Cina, 266011
- Investigational Site Number : 1560011
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Shenyang, Cina, 110004
- Investigational Site Number : 1560013
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Tianjin, Cina, 300020
- Investigational Site Number : 1560007
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Tianjin, Cina, 300060
- Investigational Site Number : 1560018
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Tianjin, Cina, 300052
- Investigational Site Number : 1560009
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Wuhan, Cina, 430022
- Investigational Site Number : 1560003
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Wuhan, Cina, 430030
- Investigational Site Number : 1560008
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Zhengzhou, Cina, 450008
- Investigational Site Number : 1560004
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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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Dresden, Germania, 01307
- Investigational Site Number : 2760005
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Heidelberg, Germania, 69120
- Investigational Site Number : 2760003
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Lübeck, Germania, 23562
- Investigational Site Number : 2760006
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Nuremberg, Germania, 90419
- Investigational Site Number : 2760007
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Kyoto, Giappone, 603-8151
- Investigational Site Number : 3920003
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Osaka, Giappone, 530-8480
- Investigational Site Number : 3920011
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Tokyo, Giappone, 150-8935
- Investigational Site Number : 3920004
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Yamagata, Giappone, 990-9585
- Investigational Site Number : 3920009
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Aichi-ken
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Nagoya, Aichi-ken, Giappone, 467-8602
- Investigational Site Number : 3920001
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Chiba
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Kamogawa, Chiba, Giappone, 296-8602
- Investigational Site Number : 3920007
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Ibaraki
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Higashiibaraki, Ibaraki, Giappone, 311-3117
- Investigational Site Number : 3920005
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Iwate
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Yahaba, Iwate, Giappone, 028-3695
- Investigational Site Number : 3920010
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Kanagawa
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Kamakura, Kanagawa, Giappone, 247-8533
- Investigational Site Number : 3920012
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Okayama-ken
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Okayama, Okayama-ken, Giappone, 701-1192
- Investigational Site Number : 3920002
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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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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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Oslo, Norvegia, 0450
- Investigational Site Number : 5780001
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Ålesund, Norvegia, 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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Derbyshire
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Derby, Derbyshire, Regno Unito, DE22 3NE
- Investigational Site Number : 8260003
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England
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Birmingham, England, Regno Unito, B15 2TH
- Investigational Site Number : 8260004
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Leicestershire
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Leicester, Leicestershire, Regno Unito, LE1 5WW
- Investigational Site Number : 8260002
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London, City of
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London, London, City of, Regno Unito, W12 0HS
- Investigational Site Number : 8260005
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Norfolk
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Norwich, Norfolk, Regno Unito, NR4 7UY
- Investigational Site Number : 8260001
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Madrid, Spagna, 28034
- Investigational Site Number : 7240005
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Salamanca, Spagna, 37007
- Investigational Site Number : 7240002
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Almería
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Murcia, Almería, Spagna, 30120
- Investigational Site Number : 7240006
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Barcelona [Barcelona]
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Badalona, Barcelona [Barcelona], Spagna, 08916
- Investigational Site Number : 7240004
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Cantabria
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Santander, Cantabria, Spagna, 39008
- Investigational Site Number : 7240003
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Navarre
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Pamplona, Navarre, Spagna, 31008
- Investigational Site Number : 7240001
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Colorado
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Aurora, Colorado, Stati Uniti, 80012
- Rocky Mountain Cancer Centers - Aurora- Site Number : 8400021
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Florida
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Jacksonville, Florida, Stati Uniti, 32224
- Mayo Clinic in Florida- Site Number : 8400008
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Plantation, Florida, Stati Uniti, 33322
- Boca Raton Clinical Research Associates- Site Number : 8400030
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Mississippi
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Hattiesburg, Mississippi, Stati Uniti, 39401
- Hattiesburg Clinic- Site Number : 8400006
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New Jersey
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Morristown, New Jersey, Stati Uniti, 07962
- Atlantic Health System- Site Number : 8400005
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New York
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Albany, New York, Stati Uniti, 12206
- New York Oncology Hematology - Albany Cancer Center- Site Number : 8400017
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North Carolina
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Charlotte, North Carolina, Stati Uniti, 28207
- Novant Health Neurology & Sleep- Site Number : 8400014
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Ohio
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Canton, Ohio, Stati Uniti, 44718
- Gabrail Cancer Center- Site Number : 8400027
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Fairfield, Ohio, Stati Uniti, 45014
- Oncology Hematology Care - Fairfield- Site Number : 8400016
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South Carolina
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Spartanburg, South Carolina, Stati Uniti, 29303
- Spartanburg Regional Medical Center- Site Number : 8400002
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Texas
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Dallas, Texas, Stati Uniti, 75390
- University of Texas - Southwestern Medical Center- Site Number : 8400024
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San Antonio, Texas, Stati Uniti, 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, Stati Uniti, 84108
- Veterans Affairs Medical Center - Salt Lake City- Site Number : 8400011
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Borås, Svezia, 501 82
- Investigational Site Number : 7520001
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Huddinge, Svezia, 141 57
- Investigational Site Number : 7520003
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Kaohsiung City, Taiwan, 833
- Investigational Site Number : 1580001
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Tainan, Taiwan, 704
- Investigational Site Number : 1580005
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Taipei, Taiwan, 100
- Investigational Site Number : 1580002
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Ankara, Turchia (Türkiye), 06010
- Investigational Site Number : 7920007
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Ankara, Turchia (Türkiye), 06200
- Investigational Site Number : 7920009
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Istanbul, Turchia (Türkiye), 34093
- Investigational Site Number : 7920003
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Istanbul, Turchia (Türkiye), 34098
- Investigational Site Number : 7920005
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Istanbul, Turchia (Türkiye), 34214
- Investigational Site Number : 7920008
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Istanbul, Turchia (Türkiye), 34381
- Investigational Site Number : 7920001
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Izmir, Turchia (Türkiye), 35100
- Investigational Site Number : 7920004
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Budapest, Ungheria, 1097
- Investigational Site Number : 3480004
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Budapest, Ungheria, 1085
- Investigational Site Number : 3480002
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Kaposvár, Ungheria, 7400
- Investigational Site Number : 3480003
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Pécs, Ungheria, 7623
- Investigational Site Number : 3480008
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Szombathely, Ungheria, 9700
- Investigational Site Number : 3480006
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Székesfehérvár, Ungheria, 8000
- Investigational Site Number : 3480005
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Descrizione
Criterio di inclusione:
- - Partecipanti con mieloma multiplo che hanno ricevuto almeno una precedente linea di terapia tra cui lenalidomide e un inibitore del proteasoma e con proteina M sierica misurabile (≥ 0,5 g/dL) e/o proteina M urinaria (≥ 200 mg/24 ore) e/o analisi delle catene leggere libere (FLC) sieriche (saggio FLC coinvolto ≥10 mg/dL e rapporto FLC sierico anomalo (1,65))
Criteri di esclusione:
- Partecipanti di età inferiore a 18 anni, partecipanti con performance status dell'Eastern Cooperative Oncology Group superiore a 2
- Partecipanti al mieloma multiplo refrattario primario
- Partecipanti refrattari all'anti-CD38 con un periodo di wash-out inferiore a 9 mesi o intolleranti agli agenti mAb anti-CD38
- Precedente terapia con pomalidomide
- Partecipanti con test biologici inadeguati.
- Disfunzione cardiaca significativa
- - Partecipanti diagnosticati o trattati per un altro tumore entro 3 anni prima della randomizzazione, ad eccezione della resezione completa del carcinoma a cellule basali o del carcinoma a cellule squamose della pelle e della neoplasia maligna in situ o del carcinoma prostatico a basso rischio dopo terapia curativa
- Concomitante leucemia plasmacellulare
- Amiloidosi primaria amiloide-leggera (AL) attiva
- Malattia nota correlata alla sindrome da immunodeficienza acquisita (AIDS) o malattia nota da virus dell'immunodeficienza umana (HIV) che richiede un trattamento antivirale
- Conoscere l'infezione da epatite A attiva. Infezione da epatite B (HBV) o epatite C (HCV) attiva o cronica in corso. Sono ammessi i partecipanti con malattia cronica da HBV o HCV controllata con terapia antivirale.
- Donne in età fertile o partecipanti di sesso maschile con donne in età fertile che non accettano di utilizzare un metodo di controllo delle nascite altamente efficace
Le informazioni di cui sopra non intendono contenere tutte le considerazioni relative alla potenziale partecipazione di un partecipante a una sperimentazione clinica
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Comparatore attivo: Isatuximab endovenoso (IV)
La dose di isatuximab verrà somministrata tramite infusione endovenosa settimanalmente per 4 settimane durante il Ciclo 1 (giorni 1, 8, 15 e 22) e i giorni 1 e 15 dei cicli successivi.
Ogni ciclo durerà 28 giorni.
La dose di pomalidomide sarà assunta per via orale dal Giorno 1 al Giorno 21 di ciascun ciclo nel momento più conveniente per i partecipanti prima o dopo la somministrazione di isatuximab, preferibilmente alla stessa ora ogni giorno.
Il desametasone verrà assunto per via orale nei giorni 1, 8, 15 e 22 (da ripetere ogni 28 giorni).
I partecipanti possono ricevere altri trattamenti come trattamento di base e/o farmaci di salvataggio.
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Forma farmaceutica: Compressa; Via di somministrazione: Orale
Forma farmaceutica: capsule rigide; Via di somministrazione: Orale
Altri nomi:
Forma farmaceutica: soluzione concentrata per infusione endovenosa; Via di somministrazione: endovenosa
Altri nomi:
Forma farmaceutica: Come da prodotto commerciale locale; Via di somministrazione: orale; Prodotto medicinale ausiliario (AxMP), ovvero trattamento di base; Codice ATC: H02AB02
Forma farmaceutica: Come da prodotto commerciale locale; Via di somministrazione: orale; AxMP ovvero trattamento di fondo; Codice ATC: R03DC03
Forma farmaceutica: Come da prodotto commerciale locale; Via di somministrazione: orale; AxMP ovvero trattamento di fondo; Codice ATC: N02BE01
Forma farmaceutica: Come da prodotto commerciale locale; Via di somministrazione: come premedicazione orale; per la gestione delle reazioni all'infusione IV (o equivalente orale); AxMP, ovvero trattamento di base e farmaci di salvataggio (in caso di reazioni all'infusione); Codice ATC: R06AA02
Forma farmaceutica: Come da prodotto commerciale locale; Via di somministrazione: come premedicazione IV; per la gestione delle reazioni all'infusione - IV (o equivalente orale); AxMP, ovvero trattamento di base e farmaci di salvataggio (in caso di reazioni all'infusione); Codice ATC: H02AB04
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Sperimentale: 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 farmaceutica: Soluzione per somministrazione sottocutanea; Via di somministrazione: Sottocutanea (SC)
Altri nomi:
Forma farmaceutica: Compressa; Via di somministrazione: Orale
Forma farmaceutica: capsule rigide; Via di somministrazione: Orale
Altri nomi:
Forma farmaceutica: Come da prodotto commerciale locale; Via di somministrazione: orale; Prodotto medicinale ausiliario (AxMP), ovvero trattamento di base; Codice ATC: H02AB02
Forma farmaceutica: Come da prodotto commerciale locale; Via di somministrazione: orale; AxMP ovvero trattamento di fondo; Codice ATC: R03DC03
Forma farmaceutica: Come da prodotto commerciale locale; Via di somministrazione: orale; AxMP ovvero trattamento di fondo; Codice ATC: N02BE01
Forma farmaceutica: Come da prodotto commerciale locale; Via di somministrazione: come premedicazione orale; per la gestione delle reazioni all'infusione IV (o equivalente orale); AxMP, ovvero trattamento di base e farmaci di salvataggio (in caso di reazioni all'infusione); Codice ATC: R06AA02
Forma farmaceutica: Come da prodotto commerciale locale; Via di somministrazione: come premedicazione IV; per la gestione delle reazioni all'infusione - IV (o equivalente orale); AxMP, ovvero trattamento di base e farmaci di salvataggio (in caso di reazioni all'infusione); Codice ATC: H02AB04
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Tasso di Risposta Complessivo (ORR)
Lasso di tempo: Dal primo dosaggio di somministrazione del farmaco dello studio (Giorno 1) fino al PCD (06-nov-2024), approssimativamente 28 mesi
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Tasso di risposta obiettiva (ORR) valutato dal comitato di revisione indipendente (IRC) secondo i criteri del 2016 dell'International Myeloma Working Group (IMWG):Percentuale di partecipanti con risposta completa (CR), risposta completa stringente (sCR), risposta parziale molto buona (VGPR) e risposta parziale (PR).CR:immunofissazione negativa su siero e urina, scomparsa di qualsiasi plasmocitoma dei tessuti molli (STP), <5% di plasmacellule negli aspirati midollari (BM) e un rapporto catene leggere libere (FLC) normale (0,26-1,65).sCR:CR
più assenza di cellule clonali nella biopsia midollare.
VGPR:proteina M sierica e urinaria rilevabile mediante immunofissazione, non mediante elettroforesi; riduzione >=90% della proteina M sierica più livello di proteina M urinaria <100mg/24ore(h); diminuzione >=90% della somma dei diametri perpendicolari massimi (SPD) rispetto al basale negli STP; solo FLC: diminuzione >=90% della differenza tra i livelli di FLC coinvolto e non coinvolto.PR:riduzione >=50% della proteina M sierica e riduzione della proteina M urinaria nelle 24h di >=90% o a <200mg/24h.Oltre a quanto sopra, se presente al basale, è richiesta anche una riduzione >=50% delle dimensioni SPD degli STP.
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Dal primo dosaggio di somministrazione del farmaco dello studio (Giorno 1) fino al PCD (06-nov-2024), approssimativamente 28 mesi
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Concentrazione Osservata Prima della Somministrazione (Ctrough) di Isatuximab allo Stato Stazionario
Lasso di tempo: Pre-dose al Ciclo 6 Giorno 1
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La Ctrough allo stato stazionario era la concentrazione plasmatica osservata raccolta pre-dose al Ciclo 6 Giorno 1 (equivalente a prima del Ciclo 6 Giorno 1) della dose di somministrazione di isatuximab.
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Pre-dose al Ciclo 6 Giorno 1
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Ctrough di Isatuximab a 4 settimane (CT4W)
Lasso di tempo: Pre-dose al Ciclo 2 Giorno 1 (a 4 settimane)
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Le concentrazioni plasmatiche osservate del CT4W sono state raccolte in pre-dose al Giorno 1 del Ciclo 2 (equivalente a prima del Giorno 1 del Ciclo 2) della dose di somministrazione di isatuximab.
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Pre-dose al Ciclo 2 Giorno 1 (a 4 settimane)
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Percentuale di partecipanti che hanno risposto 'Molto soddisfatto' e 'Soddisfatto' al questionario 'Esperienza e soddisfazione del paziente (PESQ-FU)': Soddisfazione per il metodo di iniezione (Item-8) al Ciclo 5 Giorno 15
Lasso di tempo: Ciclo 5 Giorno 15
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Il PESQ-FU, composto da 9 elementi, è stato progettato per seguire l'esperienza e la soddisfazione dei partecipanti riguardo al metodo di iniezione (disagio, dolore, effetti collaterali, risparmio di tempo e soddisfazione) e al farmaco in studio (effetti collaterali, utilità dell'assunzione, soddisfazione e raccomandazione).
Questo questionario è stato adattato sulla base di interviste qualitative con partecipanti oncologici.
Le risposte alla 'soddisfazione per il metodo di iniezione' sono state registrate come 'molto soddisfatto, soddisfatto, né soddisfatto né insoddisfatto, insoddisfatto e molto insoddisfatto' in momenti specifici.
La percentuale totale dei partecipanti che erano molto soddisfatti e soddisfatti del metodo di iniezione (elemento-8) al Ciclo 5 Giorno 15 è riportata qui.
Le percentuali sono arrotondate alla decima cifra decimale.
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Ciclo 5 Giorno 15
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Cmin di Isatuximab
Lasso di tempo: Pre-dose nei giorni 8, 15 e 22 del Ciclo 1, nei giorni 1 e 15 dei Cicli 2-5, e nei giorni 1 dei Cicli 6, 7, 8, 9, 12, 15, 18, 21, 24 e 27
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I campioni di plasma sono stati raccolti in momenti specifici per la valutazione di Ctrough.
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Pre-dose nei giorni 8, 15 e 22 del Ciclo 1, nei giorni 1 e 15 dei Cicli 2-5, e nei giorni 1 dei Cicli 6, 7, 8, 9, 12, 15, 18, 21, 24 e 27
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Percentuale di Partecipanti con Risposta al 'Questionario sulle Aspettative del Paziente al Basale (PEQ-BL)'
Lasso di tempo: Baseline (Ciclo 1 Giorno 1)
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Viene riportata la percentuale di partecipanti che hanno risposto di essere fortemente d'accordo o d'accordo al basale con le aspettative di dolore, disagio ed effetti collaterali derivanti dal metodo di iniezione, che il metodo di iniezione farebbe risparmiare tempo, che il farmaco in studio potrebbe comportare effetti collaterali e che varrebbe la pena prenderlo.
Il PEQ-BL era composto da 7 item.
Viene riportata anche la percentuale di partecipanti che hanno mai ricevuto farmaci per via endovenosa e/o sottocutanea.
Le percentuali sono arrotondate alla decima cifra decimale.
Il valore basale è stato definito come l'ultimo valore non mancante raccolto in data pari o antecedente alla data di inizio del farmaco in studio.
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Baseline (Ciclo 1 Giorno 1)
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Questionario sull'Utilizzo delle Risorse Sanitarie e sulla Produttività (HRUPQ): Utilizzo Sanitario di Base: Numero di Volte negli Ultimi 6 Mesi in cui un Partecipante ha Ricevuto Cure
Lasso di tempo: Baseline (Ciclo 1 Giorno 1)
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L'utilizzo dei servizi sanitari al basale prima della somministrazione del farmaco dello studio è stato raccolto tramite HRUPQ.
Viene presentato il numero medio di volte negli ultimi 6 mesi in cui un partecipante ha ricevuto assistenza in una clinica o nel pronto soccorso ospedaliero per qualsiasi problema di salute inclusa la MM o dovuto alla MM e l'assistenza domiciliare da un infermiere o altro professionista sanitario per qualsiasi problema di salute inclusa la MM o dovuto alla MM.
Il valore basale è stato definito come l'ultimo valore non mancante raccolto in o prima della data di inizio del farmaco dello studio.
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Baseline (Ciclo 1 Giorno 1)
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HRUPQ: Utilizzo Sanitario di Base: Numero di Notti negli Ultimi 6 Mesi in cui un Partecipante ha Soggiornato in Ospedale
Lasso di tempo: Baseline (Ciclo 1 Giorno 1)
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L'utilizzo dell'assistenza sanitaria al basale prima della somministrazione del farmaco dello studio è stato raccolto tramite HRUPQ.
Viene presentato il numero medio di notti negli ultimi 6 mesi in cui un partecipante è rimasto in ospedale per qualsiasi problema di salute inclusi MM o a causa di MM e il numero di notti trascorse in unità di terapia intensiva (ICU) per qualsiasi problema di salute inclusi MM o a causa di MM.
Il valore basale è stato definito come l'ultimo valore non mancante raccolto in o prima della data di inizio del farmaco dello studio.
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Baseline (Ciclo 1 Giorno 1)
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HRUPQ: Utilizzo Sanitario Basale: Numero di Volte negli Ultimi 6 Mesi in cui un Partecipante ha Consultato un Professionista Sanitario (HCP)
Lasso di tempo: Baseline (Ciclo 1 Giorno 1)
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L'utilizzo dell'assistenza sanitaria al basale prima della somministrazione del farmaco dello studio è stato raccolto tramite HRUPQ.
Viene presentato il numero medio di volte negli ultimi 6 mesi in cui un partecipante ha consultato (ha visto o parlato con) i seguenti professionisti sanitari: medico generico o clinico di cure primarie (PCC) che tratta una varietà di malattie per qualsiasi problema di salute inclusa MM o correlata a MM, fisioterapista o terapista occupazionale per qualsiasi problema di salute inclusa MM o correlata a MM, professionista della salute mentale (ad esempio psichiatra, psicologo, infermiere psichiatrico) per qualsiasi problema di salute inclusa MM o correlata a MM, medico o clinico specializzato in una particolare malattia medica o problema (specialista) per qualsiasi problema di salute inclusa MM o correlata a MM.
Il valore basale è stato definito come l'ultimo valore non mancante raccolto in o prima della data di inizio del farmaco dello studio.
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Baseline (Ciclo 1 Giorno 1)
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Percentuale di partecipanti che si sono ritirati durante lo studio basata su HRUPQ
Lasso di tempo: Dal primo dosaggio della somministrazione del farmaco dello studio (Giorno 1) fino al PCD (06-nov-2024), approssimativamente 28 mesi
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Lo stato occupazionale è stato valutato tramite HRUPQ.
Viene riportata la percentuale di partecipanti che si sono ritirati durante lo studio.
Le percentuali sono arrotondate al decimo di punto decimale.
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Dal primo dosaggio della somministrazione del farmaco dello studio (Giorno 1) fino al PCD (06-nov-2024), approssimativamente 28 mesi
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Percentuale di partecipanti che si sono ritirati anticipatamente a causa di MM basato su HRUPQ
Lasso di tempo: Dal primo dosaggio di somministrazione del farmaco dello studio (Giorno 1) fino al PCD (06-nov-2024), circa 28 mesi
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Lo stato occupazionale è stato valutato tramite HRUPQ.
Viene riportata la percentuale di partecipanti che sono andati in pensione anticipatamente a causa del MM.
Le percentuali sono arrotondate alla prima cifra decimale.
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Dal primo dosaggio di somministrazione del farmaco dello studio (Giorno 1) fino al PCD (06-nov-2024), circa 28 mesi
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Very Good Partial Response or Better Rate
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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'
Lasso di tempo: 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'
Lasso di tempo: 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'
Lasso di tempo: 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'
Lasso di tempo: 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'
Lasso di tempo: 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'
Lasso di tempo: 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'
Lasso di tempo: 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'
Lasso di tempo: 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'
Lasso di tempo: 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)'
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For functional scales: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score and a positive change from baseline represents a better level of physical functioning.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
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Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-C30: Role Functioning
Lasso di tempo: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For functional scales: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score and a positive change from baseline represents a better level of role functioning.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
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Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-C30: Emotional Functioning
Lasso di tempo: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For functional scales: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score and a positive change from baseline represents a better level of emotional functioning.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
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Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-C30: Cognitive Functioning
Lasso di tempo: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For functional scales: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score and a positive change from baseline represents a better level of cognitive functioning.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
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Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-C30: Social Functioning
Lasso di tempo: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For functional scales: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score and a positive change from baseline represents a better level of social functioning.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
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Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-C30: Fatigue
Lasso di tempo: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For symptom scales: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score for symptoms and a positive change from baseline represents a higher level of symptomatology.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
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Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-C30: Nausea and Vomiting
Lasso di tempo: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For symptom scales: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score for symptoms and a positive change from baseline represents a higher level of symptomatology.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
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Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-C30: Pain
Lasso di tempo: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For symptom scales: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score for symptoms and a positive change from baseline represents a higher level of symptomatology.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
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Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-C30: Dyspnea
Lasso di tempo: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score for symptom items and a positive change from baseline represents a higher level of symptomatology.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
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Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-C30: Insomnia
Lasso di tempo: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score for symptom items and a positive change from baseline represents a higher level of symptomatology.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
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Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-C30: Appetite Loss
Lasso di tempo: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score for symptom items and a positive change from baseline represents a higher level of symptomatology.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
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Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-C30: Constipation
Lasso di tempo: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score for symptom items and a positive change from baseline represents a higher level of symptomatology.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
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Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-C30: Diarrhea
Lasso di tempo: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score for symptom items and a positive change from baseline represents a higher level of symptomatology.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
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Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-C30: Financial Difficulties
Lasso di tempo: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score for symptom items and a positive change from baseline represents a higher level of financial difficulties.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
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Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-Myeloma Module (MY20): Disease Symptoms
Lasso di tempo: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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The EORTC QLQ-MY20 was used in conjunction with the EORTC QLQ-C30 to assess symptoms and side effects due to the treatment or the disease which impacts health related QoL in participants with MM.
It contains 20 items, 4 independent subscales covering 2 functional domains: symptom scales which include disease symptoms (6 items) and side-effects of treatment (10 items) and function scale which include future perspective (3 items) and body image (1 item).
Scores for each subscale are based on the 4-point Likert scale ranging from (1: not at all to 4: very much) and transformed from raw scores to linear scales ranging from 0 to 100; mean is presented here.
A higher score for disease symptoms and a positive change from baseline represents more symptoms, worse QoL.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
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Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-MY20: Side Effects of Treatment
Lasso di tempo: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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The EORTC QLQ-MY20 was used in conjunction with the EORTC QLQ-C30 to assess symptoms and side effects due to the treatment or the disease which impacts health related QoL in participants with MM.
It contains 20 items, 4 independent subscales covering 2 functional domains: symptom scales which include disease symptoms (6 items) and side-effects of treatment (10 items) and function scale which include future perspective (3 items) and body image (1 item).
Scores for each subscale are based on the 4-point Likert scale ranging from (1: not at all to 4: very much) and transformed from raw scores to linear scales ranging from 0 to 100; mean is presented here.
A higher score for side effects of treatment and a positive change from baseline represents more side effects, worse QoL.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
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Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-MY20: Future Perspective
Lasso di tempo: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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The EORTC QLQ-MY20 was used in conjunction with the EORTC QLQ-C30 to assess symptoms and side effects due to the treatment or the disease which impacts health related QoL in participants with MM.
It contains 20 items, 4 independent subscales covering 2 functional domains: symptom scales which include disease symptoms (6 items) and side-effects of treatment (10 items) and function scale which include future perspective (3 items) and body image (1 item).
Scores for each subscale are based on the 4-point Likert scale ranging from (1: not at all to 4: very much) and transformed from raw scores to linear scales ranging from 0 to 100; mean is presented here.
A higher score for future perspectives and a positive change from baseline represents better outcomes, better QoL.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
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Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-MY20: Body Image
Lasso di tempo: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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The EORTC QLQ-MY20 was used in conjunction with the EORTC QLQ-C30 to assess symptoms and side effects due to the treatment or the disease which impacts health related QoL in participants with MM.
It contains 20 items, 4 independent subscales covering 2 functional domains: symptom scales which include disease symptoms (6 items) and side-effects of treatment (10 items) and function scale which include future perspective (3 items) and body image (1 item).
Scores for each subscale are based on the 4-point Likert scale ranging from (1: not at all to 4: very much) and transformed from raw scores to linear scales ranging from 0 to 100; mean is presented here.
A higher score for body image and a positive change from baseline represents better outcomes, better QoL.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
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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 European Quality of Life Group Measure With 5 Dimensions and 5 Levels Per Dimension (EQ-5D-5L): Visual Analogue Scale (VAS)
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Direttore dello studio: Clinical Sciences & Operations, Sanofi
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Collegamenti utili
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
23 giugno 2022
Completamento primario (Effettivo)
6 novembre 2024
Completamento dello studio (Stimato)
22 ottobre 2027
Date di iscrizione allo studio
Primo inviato
31 maggio 2022
Primo inviato che soddisfa i criteri di controllo qualità
31 maggio 2022
Primo Inserito (Effettivo)
6 giugno 2022
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
2 settembre 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
10 agosto 2026
Ultimo verificato
1 agosto 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie vascolari
- Malattia cardiovascolare
- Neoplasie
- Malattie del sistema immunitario
- Neoplasie per tipo istologico
- Malattie ematologiche
- Malattie linfoproliferative
- Disturbi immunoproliferativi
- Disturbi emostatici
- Paraproteinemie
- Disturbi delle proteine del sangue
- Disturbi emorragici
- Mieloma multiplo
- Neoplasie, plasmacellule
- Prodotti chimici organici
- Idrocarburi
- Idrocarburi, ciclici
- Idrocarburi, aromatici
- Composti policiclici
- Anilides
- Amides
- Composti di anilina
- Ammine
- Acetanilides
- Incinta
- In gravidanza
- Steroidi
- Composti anelli fusi
- Steroidi, fluorurati
- Derivati di benzene
- Incintadienetrioli
- Etilammine
- Prednisolone
- Composti benzidrilici
- Desametasone
- Acetaminofene
- Metilprednisolone
- Difenidramina
- pomalidomide
- Isatuximab
- Montelukast
Altri numeri di identificazione dello studio
- EFC15951
- 2023 (Sovvenzione/contratto NIH degli Stati Uniti: GRAMMY Museum Foundation)
- U1111-1261-5846 (Identificatore di registro: ICTRP)
- 2023-508869-32 (Numero EudraCT: CTIS)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano IPD
I ricercatori qualificati possono richiedere l'accesso ai dati a livello di paziente e ai relativi documenti di studio, tra cui il rapporto dello studio clinico, il protocollo dello studio con eventuali modifiche, il modulo di segnalazione del caso in bianco, il piano di analisi statistica e le specifiche del set di dati.
I dati a livello di paziente saranno resi anonimi e i documenti dello studio saranno redatti per proteggere la privacy dei partecipanti allo studio.
Ulteriori dettagli sui criteri di condivisione dei dati di Sanofi, sugli studi ammissibili e sulla procedura per richiedere l'accesso sono disponibili all'indirizzo: https://vivli.org.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Sì
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .