SC versus IV Isatuximab in Kombination mit Pomalidomid und Dexamethason bei RRMM (IRAKLIA)
10. August 2026 aktualisiert von: Sanofi
Eine randomisierte, offene Phase-3-Studie zur Bewertung der subkutanen vs. intravenösen Verabreichung von Isatuximab in Kombination mit Pomalidomid und Dexamethason bei erwachsenen Patienten mit rezidiviertem und/oder refraktärem multiplem Myelom (RRMM)
Dies ist eine randomisierte, multizentrische, offene Phase-3-Studie zur Bewertung der subkutanen (SC) vs. intravenösen (IV) Verabreichung von Isatuximab in Kombination mit Pomalidomid und Dexamethason (Pd) bei RRMM-Patienten (Studienteilnehmer), die mindestens 1 zuvor erhalten haben Therapielinie, die Lenalidomid und einen Proteasom-Inhibitor (PI) umfasst. Geeignete Teilnehmer werden 1:1 in 1 von 2 Studienarmen randomisiert:
Arm SC: Isatuximab SC + Pd
Arm IV: Isatuximab IV + Pd
Die Teilnehmer dürfen die Therapie bis zum Fortschreiten der Krankheit, inakzeptablen unerwünschten Ereignissen (AEs), dem Wunsch des Teilnehmers, die Therapie abzubrechen, oder einem anderen Grund fortsetzen, je nachdem, was zuerst eintritt.
Studienübersicht
Status
Aktiv, nicht rekrutierend
Bedingungen
Detaillierte Beschreibung
Zwei Studienarme werden in 4-wöchigen Zyklen bis zum Fortschreiten der Krankheit, inakzeptablen unerwünschten Ereignissen (AEs), dem Wunsch des Teilnehmers, die Therapie abzubrechen, oder einem anderen Grund behandelt, je nachdem, was zuerst eintritt.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
531
Phase
- Phase 3
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Buenos Aires, Argentinien, 1181
- Investigational Site Number : 0320002
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Buenos Aires, Argentinien, 1180
- Investigational Site Number : 0320008
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Buenos Aires, Argentinien, 1280
- Investigational Site Number : 0320007
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Buenos Aires, Argentinien, 1417
- Investigational Site Number : 0320003
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Buenos Aires, Argentinien, 1426
- Investigational Site Number : 0320004
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Buenos Aires, Argentinien, 1430
- Investigational Site Number : 0320001
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Buenos Aires, Argentinien, 1431
- Investigational Site Number : 0320005
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Córdoba, Argentinien, 5000
- Investigational Site Number : 0320010
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Mendoza, Argentinien, 5501
- Investigational Site Number : 0320009
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Buenos Aires
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La Plata, Buenos Aires, Argentinien, 1900
- Investigational Site Number : 0320006
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New South Wales
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Liverpool, New South Wales, Australien, 2170
- Investigational Site Number : 0360007
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Waratah, New South Wales, Australien, 2298
- Investigational Site Number : 0360004
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Wollongong, New South Wales, Australien, 2500
- Investigational Site Number : 0360003
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South Australia
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Adelaide, South Australia, Australien, 5000
- Investigational Site Number : 0360008
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Victoria
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Melbourne, Victoria, Australien, 3004
- Investigational Site Number : 0360006
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Melbourne, Victoria, Australien, 3065
- Investigational Site Number : 0360009
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Richmond, Victoria, Australien, 3121
- Investigational Site Number : 0360001
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Rio de Janeiro, Brasilien, 22775-001
- Instituto Americas - Ensino, Pesquisa e Inovação - Rio de Janeiro - Avenida Jorge Curi- Site Number : 0760004
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São Paulo, Brasilien, 04537-080
- Clinica São Germano- Site Number : 0760001
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Ceará
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Fortaleza, Ceará, Brasilien, 60115-280
- Núcleo de Oncologia e Hematologia do Ceará- Site Number : 0760006
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Pernambuco
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Recife, Pernambuco, Brasilien, 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, Brasilien, 90880-480
- Hospital Mae de Deus- Site Number : 0760003
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Rio de Janeiro
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Niterói, Rio de Janeiro, Brasilien, 24020-096
- CHN - Complexo Hospitalar de Niterói- Site Number : 0760008
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La Araucanía
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Temuco, La Araucanía, Chile, 4780000
- Investigational Site Number : 1520001
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Reg Metropolitana de Santiago
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Santiago, Reg Metropolitana de Santiago, Chile, 7580206
- Investigational Site Number : 1520002
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Santiago, Reg Metropolitana de Santiago, Chile, 6900941
- Investigational Site Number : 1520003
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Santiago, Reg Metropolitana de Santiago, Chile, 7620001
- Investigational Site Number : 1520006
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Santiago, Reg Metropolitana de Santiago, Chile, 8380455
- Investigational Site Number : 1520004
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Valparaiso
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Viña del Mar, Valparaiso, Chile, 2540364
- Investigational Site Number : 1520005
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Beijing, China, 100191
- Investigational Site Number : 1560022
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Beijing, China, 100034
- Investigational Site Number : 1560001
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Changsha, China, 410013
- Investigational Site Number : 1560010
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Guangzhou, China, 510060
- Investigational Site Number : 1560006
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Hangzhou, China, 310003
- Investigational Site Number : 1560002
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Nanchang, China, 330006
- Investigational Site Number : 1560020
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Nanning, China, 530021
- Investigational Site Number : 1560019
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Qingdao, China, 266011
- Investigational Site Number : 1560011
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Shenyang, China, 110004
- Investigational Site Number : 1560013
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Tianjin, China, 300020
- Investigational Site Number : 1560007
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Tianjin, China, 300060
- Investigational Site Number : 1560018
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Tianjin, China, 300052
- Investigational Site Number : 1560009
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Wuhan, China, 430022
- Investigational Site Number : 1560003
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Wuhan, China, 430030
- Investigational Site Number : 1560008
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Zhengzhou, China, 450008
- Investigational Site Number : 1560004
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Dresden, Deutschland, 01307
- Investigational Site Number : 2760005
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Heidelberg, Deutschland, 69120
- Investigational Site Number : 2760003
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Lübeck, Deutschland, 23562
- Investigational Site Number : 2760006
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Nuremberg, Deutschland, 90419
- Investigational Site Number : 2760007
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Nantes, Frankreich, 44093
- Investigational Site Number : 2500002
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Paris, Frankreich, 75571
- Investigational Site Number : 2500005
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Poitiers, Frankreich, 86021
- Investigational Site Number : 2500001
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Saint-Priest-en-Jarez, Frankreich, 42270
- Investigational Site Number : 2500009
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Toulouse, Frankreich, 31059
- Investigational Site Number : 2500003
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Tours, Frankreich, 37032
- Investigational Site Number : 2500007
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Athens, Griechenland, 106 76
- Investigational Site Number : 3000002
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Athens, Griechenland, 115 28
- Investigational Site Number : 3000001
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Pátrai, Griechenland, 265 04
- Investigational Site Number : 3000003
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Thessaloniki, Griechenland, 570 10
- Investigational Site Number : 3000004
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Bologna, Italien, 40138
- Investigational Site Number : 3800002
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Brescia, Italien, 25123
- Investigational Site Number : 3800005
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Pavia, Italien, 27100
- Investigational Site Number : 3800003
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Ancona
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Torette, Ancona, Italien, 60020
- Investigational Site Number : 3800004
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Reggio Emilia
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Meldola, Reggio Emilia, Italien, 47014
- Investigational Site Number : 3800001
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Roma
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Rome, Roma, Italien, 00168
- Investigational Site Number : 3800006
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Kyoto, Japan, 603-8151
- Investigational Site Number : 3920003
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Osaka, Japan, 530-8480
- Investigational Site Number : 3920011
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Tokyo, Japan, 150-8935
- Investigational Site Number : 3920004
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Yamagata, Japan, 990-9585
- Investigational Site Number : 3920009
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Aichi-ken
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Nagoya, Aichi-ken, Japan, 467-8602
- Investigational Site Number : 3920001
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Chiba
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Kamogawa, Chiba, Japan, 296-8602
- Investigational Site Number : 3920007
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Ibaraki
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Higashiibaraki, Ibaraki, Japan, 311-3117
- Investigational Site Number : 3920005
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Iwate
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Yahaba, Iwate, Japan, 028-3695
- Investigational Site Number : 3920010
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Kanagawa
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Kamakura, Kanagawa, Japan, 247-8533
- Investigational Site Number : 3920012
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Okayama-ken
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Okayama, Okayama-ken, Japan, 701-1192
- Investigational Site Number : 3920002
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Ontario
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Toronto, Ontario, Kanada, M5G 2M9
- Investigational Site Number : 1240001
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Quebec
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Greenfield Park, Quebec, Kanada, J4V 2H1
- Investigational Site Number : 1240004
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Montreal, Quebec, Kanada, H1T 2M4
- Investigational Site Number : 1240003
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Oslo, Norwegen, 0450
- Investigational Site Number : 5780001
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Ålesund, Norwegen, 6017
- Investigational Site Number : 5780002
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Lesser Poland Voivodeship
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Krakow, Lesser Poland Voivodeship, Polen, 31-501
- Investigational Site Number : 6160005
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Lower Silesian Voivodeship
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Wroclaw, Lower Silesian Voivodeship, Polen, 50-088
- Investigational Site Number : 6160004
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Lublin Voivodeship
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Lublin, Lublin Voivodeship, Polen, 20-081
- Investigational Site Number : 6160001
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Borås, Schweden, 501 82
- Investigational Site Number : 7520001
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Huddinge, Schweden, 141 57
- Investigational Site Number : 7520003
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Madrid, Spanien, 28034
- Investigational Site Number : 7240005
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Salamanca, Spanien, 37007
- Investigational Site Number : 7240002
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Almería
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Murcia, Almería, Spanien, 30120
- Investigational Site Number : 7240006
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Barcelona [Barcelona]
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Badalona, Barcelona [Barcelona], Spanien, 08916
- Investigational Site Number : 7240004
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Cantabria
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Santander, Cantabria, Spanien, 39008
- Investigational Site Number : 7240003
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Navarre
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Pamplona, Navarre, Spanien, 31008
- Investigational Site Number : 7240001
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Kaohsiung City, Taiwan, 833
- Investigational Site Number : 1580001
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Tainan, Taiwan, 704
- Investigational Site Number : 1580005
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Taipei, Taiwan, 100
- Investigational Site Number : 1580002
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Brno, Tschechien, 625 00
- Investigational Site Number : 2030005
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Olomouc, Tschechien, 779 00
- Investigational Site Number : 2030003
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Ostrava, Tschechien, 708 52
- Investigational Site Number : 2030006
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Prague, Tschechien, 128 08
- Investigational Site Number : 2030004
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Ankara, Türkei (türkiye), 06010
- Investigational Site Number : 7920007
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Ankara, Türkei (türkiye), 06200
- Investigational Site Number : 7920009
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Istanbul, Türkei (türkiye), 34093
- Investigational Site Number : 7920003
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Istanbul, Türkei (türkiye), 34098
- Investigational Site Number : 7920005
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Istanbul, Türkei (türkiye), 34214
- Investigational Site Number : 7920008
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Istanbul, Türkei (türkiye), 34381
- Investigational Site Number : 7920001
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Izmir, Türkei (türkiye), 35100
- Investigational Site Number : 7920004
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Budapest, Ungarn, 1097
- Investigational Site Number : 3480004
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Budapest, Ungarn, 1085
- Investigational Site Number : 3480002
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Kaposvár, Ungarn, 7400
- Investigational Site Number : 3480003
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Pécs, Ungarn, 7623
- Investigational Site Number : 3480008
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Szombathely, Ungarn, 9700
- Investigational Site Number : 3480006
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Székesfehérvár, Ungarn, 8000
- Investigational Site Number : 3480005
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Colorado
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Aurora, Colorado, Vereinigte Staaten, 80012
- Rocky Mountain Cancer Centers - Aurora- Site Number : 8400021
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Florida
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Jacksonville, Florida, Vereinigte Staaten, 32224
- Mayo Clinic in Florida- Site Number : 8400008
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Plantation, Florida, Vereinigte Staaten, 33322
- Boca Raton Clinical Research Associates- Site Number : 8400030
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Mississippi
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Hattiesburg, Mississippi, Vereinigte Staaten, 39401
- Hattiesburg Clinic- Site Number : 8400006
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New Jersey
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Morristown, New Jersey, Vereinigte Staaten, 07962
- Atlantic Health System- Site Number : 8400005
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New York
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Albany, New York, Vereinigte Staaten, 12206
- New York Oncology Hematology - Albany Cancer Center- Site Number : 8400017
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North Carolina
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Charlotte, North Carolina, Vereinigte Staaten, 28207
- Novant Health Neurology & Sleep- Site Number : 8400014
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Ohio
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Canton, Ohio, Vereinigte Staaten, 44718
- Gabrail Cancer Center- Site Number : 8400027
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Fairfield, Ohio, Vereinigte Staaten, 45014
- Oncology Hematology Care - Fairfield- Site Number : 8400016
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South Carolina
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Spartanburg, South Carolina, Vereinigte Staaten, 29303
- Spartanburg Regional Medical Center- Site Number : 8400002
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Texas
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Dallas, Texas, Vereinigte Staaten, 75390
- University of Texas - Southwestern Medical Center- Site Number : 8400024
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San Antonio, Texas, Vereinigte Staaten, 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, Vereinigte Staaten, 84108
- Veterans Affairs Medical Center - Salt Lake City- Site Number : 8400011
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Derbyshire
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Derby, Derbyshire, Vereinigtes Königreich, DE22 3NE
- Investigational Site Number : 8260003
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England
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Birmingham, England, Vereinigtes Königreich, B15 2TH
- Investigational Site Number : 8260004
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Leicestershire
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Leicester, Leicestershire, Vereinigtes Königreich, LE1 5WW
- Investigational Site Number : 8260002
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London, City of
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London, London, City of, Vereinigtes Königreich, W12 0HS
- Investigational Site Number : 8260005
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Norfolk
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Norwich, Norfolk, Vereinigtes Königreich, NR4 7UY
- Investigational Site Number : 8260001
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
Einschlusskriterien:
- Teilnehmer mit multiplem Myelom, die mindestens eine vorherige Therapielinie erhalten haben, einschließlich Lenalidomid und eines Proteasom-Inhibitors, und mit messbarem Serum-M-Protein (≥ 0,5 g/dl) und/oder Urin-M-Protein (≥ 200 mg/24 Stunden) und/oder Assay für freie Leichtketten (FLC) im Serum (beteiligter FLC-Assay ≥10 mg/dL und anormales Serum-FLC-Verhältnis (1,65))
Ausschlusskriterien:
- Teilnehmer unter 18 Jahren, Teilnehmer mit einem Leistungsstatus der Eastern Cooperative Oncology Group von mehr als 2
- Teilnehmer des primär refraktären multiplen Myeloms
- Teilnehmer, die gegenüber Anti-CD38 refraktär sind und eine Auswaschphase von weniger als 9 Monaten aufweisen oder gegenüber Anti-CD38-mAb-Mitteln intolerant sind
- Vortherapie mit Pomalidomid
- Teilnehmer mit unzureichenden biologischen Tests.
- Erhebliche Herzfunktionsstörung
- Teilnehmer, bei denen innerhalb von 3 Jahren vor der Randomisierung ein anderer Krebs diagnostiziert oder behandelt wurde, mit Ausnahme der vollständigen Resektion von Basalzellkarzinom oder Plattenepithelkarzinom der Haut und In-situ-Malignität oder Prostatakrebs mit geringem Risiko nach kurativer Therapie
- Begleitende Plasmazellleukämie
- Aktive primäre Amyloid-Light (AL)-Amyloidose
- Bekannte Erkrankung im Zusammenhang mit dem erworbenen Immunschwächesyndrom (AIDS) oder bekannte Erkrankung mit dem humanen Immunschwächevirus (HIV), die eine antivirale Behandlung erfordert
- Kennen Sie eine aktive Hepatitis-A-Infektion. Aktuelle aktive oder chronische Hepatitis B (HBV)- oder Hepatitis C (HCV)-Infektion. Teilnehmer mit chronischer HBV- oder HCV-Erkrankung, die unter antiviraler Therapie kontrolliert wird, sind zugelassen.
- Frauen im gebärfähigen Alter oder männliche Teilnehmer mit Frauen im gebärfähigen Alter, die einer hochwirksamen Methode der Empfängnisverhütung nicht zustimmen
Die vorstehenden Informationen sollen nicht alle Überlegungen enthalten, die für die potenzielle Teilnahme eines Teilnehmers an einer klinischen Studie relevant sind
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Aktiver Komparator: Isatuximab intravenös (IV)
Die Isatuximab-Dosis wird 4 Wochen lang wöchentlich während Zyklus 1 (Tage 1, 8, 15 und 22) und Tag 1 und 15 der nachfolgenden Zyklen als intravenöse Infusion verabreicht.
Jeder Zyklus dauert 28 Tage.
Die Pomalidomid-Dosis wird an Tag 1 bis Tag 21 jedes Zyklus zu dem für die Teilnehmer günstigsten Zeitpunkt vor oder nach der Isatuximab-Verabreichung oral eingenommen, vorzugsweise jeden Tag zur gleichen Zeit.
Dexamethason wird am 1., 8., 15. und 22. Tag oral eingenommen (alle 28 Tage zu wiederholen).
Teilnehmer können weitere Behandlungen als Hintergrundbehandlung und/oder Notfallmedikation erhalten.
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Darreichungsform: Tablette; Verabreichungsweg: Oral
Darreichungsform: Hartkapseln; Verabreichungsweg: Oral
Andere Namen:
Darreichungsform: Konzentratlösung zur IV-Infusion; Verabreichungsweg: Intravenös
Andere Namen:
Darreichungsform: Gemäß lokalem Handelsprodukt; Verabreichungsweg: Oral; Hilfsmedikament (AxMP), d. h. Hintergrundbehandlung; ATC-Code: H02AB02
Darreichungsform: Gemäß lokalem Handelsprodukt; Verabreichungsweg: Oral; AxMP, d. h. Hintergrundbehandlung; ATC-Code: R03DC03
Darreichungsform: Gemäß lokalem Handelsprodukt; Verabreichungsweg: Oral; AxMP, d. h. Hintergrundbehandlung; ATC-Code: N02BE01
Darreichungsform: Gemäß lokalem Handelsprodukt; Verabreichungsweg: Als Prämedikation – oral; zur Behandlung von Infusionsreaktionen-IV (oder orales Äquivalent); AxMP, d. h. Hintergrundbehandlung und Notfallmedikation (bei Infusionsreaktionen); ATC-Code: R06AA02
Darreichungsform: Gemäß lokalem Handelsprodukt; Verabreichungsweg: Als Prämedikation-IV; zur Behandlung von Infusionsreaktionen – intravenös (oder orales Äquivalent); AxMP, d. h. Hintergrundbehandlung und Notfallmedikation (bei Infusionsreaktionen); ATC-Code: H02AB04
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Experimental: Isatuximab Subcutaneous (SC)
Isatuximab dose will administered SC weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and Day 1 and 15 of subsequent cycles.
Each cycle will be 28 days in duration.
Pomalidomide dose will be taken orally on Day 1 to Day 21 of each cycle at the time that is the most convenient for the participants prior to or after isatuximab administration, preferably at the same time every day.
Dexamethasone will be taken orally on Day 1, 8, 15 and 22 (to be repeated every 28 days).
Participants may receive other treatments as background treatment and/or rescue medication.
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Darreichungsform: Lösung zur subkutanen Verabreichung; Verabreichungsweg: Subkutan (SC)
Andere Namen:
Darreichungsform: Tablette; Verabreichungsweg: Oral
Darreichungsform: Hartkapseln; Verabreichungsweg: Oral
Andere Namen:
Darreichungsform: Gemäß lokalem Handelsprodukt; Verabreichungsweg: Oral; Hilfsmedikament (AxMP), d. h. Hintergrundbehandlung; ATC-Code: H02AB02
Darreichungsform: Gemäß lokalem Handelsprodukt; Verabreichungsweg: Oral; AxMP, d. h. Hintergrundbehandlung; ATC-Code: R03DC03
Darreichungsform: Gemäß lokalem Handelsprodukt; Verabreichungsweg: Oral; AxMP, d. h. Hintergrundbehandlung; ATC-Code: N02BE01
Darreichungsform: Gemäß lokalem Handelsprodukt; Verabreichungsweg: Als Prämedikation – oral; zur Behandlung von Infusionsreaktionen-IV (oder orales Äquivalent); AxMP, d. h. Hintergrundbehandlung und Notfallmedikation (bei Infusionsreaktionen); ATC-Code: R06AA02
Darreichungsform: Gemäß lokalem Handelsprodukt; Verabreichungsweg: Als Prämedikation-IV; zur Behandlung von Infusionsreaktionen – intravenös (oder orales Äquivalent); AxMP, d. h. Hintergrundbehandlung und Notfallmedikation (bei Infusionsreaktionen); ATC-Code: H02AB04
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Gesamtansprechrate (ORR)
Zeitfenster: Von der ersten Dosis der Studienmedikamentenverabreichung (Tag 1) bis zum PCD (06.11.2024), ungefähr 28 Monate
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ORR durch unabhängiges Prüfgremium (IRC) unter Verwendung der 2016-Kriterien der International Myeloma Working Group (IMWG): Prozentsatz der Teilnehmer mit kompletter Remission (CR), strenger kompletter Remission (sCR), sehr guter partieller Remission (VGPR) und partieller Remission (PR). CR: negatives Immunfixation in Serum und Urin, Verschwinden jeglicher Weichteil-Plasmazytome (STP), <5% Plasmazellen in Knochenmark (BM)-Aspiraten und ein normales freies Leichtketten (FLC)-Verhältnis (0,26-1,65). sCR: CR plus keine klonalen Zellen in der BM-Biopsie. VGPR: Serum- und Urin-M-Protein durch Immunfixation nachweisbar, nicht durch Elektrophorese; ≥90% Reduktion des Serum-M-Proteins plus Urin-M-Proteinspiegel <100 mg/24 Stunden (h); ≥90% Abnahme der Summe der maximalen senkrechten Durchmesser (SPD) im Vergleich zum Ausgangswert bei STP; Nur FLC: ≥90% Abnahme der Differenz zwischen betroffenen und nicht betroffenen FLC-Spiegeln. PR: ≥50% Reduktion des Serum-M-Proteins und Reduktion des 24-h-Urin-M-Proteins um ≥90% oder auf <200 mg/24 h. Zusätzlich zu den oben genannten Punkten, falls bei Ausgangswert vorhanden, ist auch eine ≥50% Reduktion der Größe SPD von STPs erforderlich.
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Von der ersten Dosis der Studienmedikamentenverabreichung (Tag 1) bis zum PCD (06.11.2024), ungefähr 28 Monate
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Beobachtete Konzentration vor der Dosisgabe (Ctrough) von Isatuximab im Steady-State
Zeitfenster: Prä-Dosis an Zyklus 6 Tag 1
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Ctrough im stationären Zustand war die beobachtete Plasmakonzentration, die vor der Dosis am Zyklus 6 Tag 1 (entsprechend vor Zyklus 6 Tag 1) der Isatuximab-Verabreichungsdosis gesammelt wurde.
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Prä-Dosis an Zyklus 6 Tag 1
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Ctrough von Isatuximab nach 4 Wochen (CT4W)
Zeitfenster: Prä-Dosis bei Zyklus 2 Tag 1 (nach 4 Wochen)
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Die CT4W waren die beobachteten Plasmakonzentrationen, die vor der Gabe der Isatuximab-Dosis am Zyklus 2 Tag 1 (entsprechend vor Zyklus 2 Tag 1) gesammelt wurden.
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Prä-Dosis bei Zyklus 2 Tag 1 (nach 4 Wochen)
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Prozentsatz der Teilnehmer, die mit der Frage „Patientenerfahrungs- und Zufriedenheitsfragebogen (PESQ-FU): Zufriedenheit mit der Injektionsmethode“ (Item-8) am Zyklus 5 Tag 15 „sehr zufrieden“ und „zufrieden“ geantwortet haben
Zeitfenster: Zyklus 5 Tag 15
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Der PESQ-FU-Fragebogen mit 9 Items wurde entwickelt, um die Erfahrungen und die Zufriedenheit der Teilnehmer hinsichtlich der Injektionsmethode (Unbehagen, Schmerzen, Nebenwirkungen, Zeitersparnis und Zufriedenheit) und der Studienmedikation (Nebenwirkungen, Nutzen, Zufriedenheit und Empfehlung) zu verfolgen.
Dieser Fragebogen wurde auf der Grundlage qualitativer Interviews mit onkologischen Studienteilnehmern angepasst.
Die Antworten zur 'Zufriedenheit mit der Injektionsmethode' wurden zu festgelegten Zeitpunkten als 'sehr zufrieden, zufrieden, weder zufrieden noch unzufrieden, unzufrieden und sehr unzufrieden' erfasst.
Der Gesamtprozentsatz der Teilnehmer, die mit der Injektionsmethode (Item-8) am Zyklus 5 Tag 15 sehr zufrieden und zufrieden waren, wird hier berichtet.
Prozentsätze werden auf die erste Dezimalstelle gerundet.
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Zyklus 5 Tag 15
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Ctrough von Isatuximab
Zeitfenster: Prä-Dosis an Zyklus 1 Tag 8, 15 und 22, Zyklen 2 bis 5 Tag 1 und 15, Zyklen 6, 7, 8, 9, 12, 15, 18, 21, 24 und 27 Tag 1
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Plasmaproben wurden zu festgelegten Zeitpunkten für die Bewertung von Ctrough entnommen.
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Prä-Dosis an Zyklus 1 Tag 8, 15 und 22, Zyklen 2 bis 5 Tag 1 und 15, Zyklen 6, 7, 8, 9, 12, 15, 18, 21, 24 und 27 Tag 1
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Prozentsatz der Teilnehmer mit Antwort auf den 'Patientenerwartungsfragebogen bei Studienbeginn (PEQ-BL)'
Zeitfenster: Baseline (Zyklus 1 Tag 1)
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Prozentsatz der Teilnehmer, die bei Studienbeginn angaben, dass sie stark zustimmen oder zustimmen mit den Erwartungen an Schmerzen, Unbehagen und Nebenwirkungen durch die Injektionsmethode, dass die Injektionsmethode Zeit sparen würde, dass das Studienmedikament Nebenwirkungen verursachen könnte und dass es sich lohnen würde, es einzunehmen, wird berichtet.
PEQ-BL bestand aus 7 Punkten.
Prozentsatz der Teilnehmer, die jemals Medikamente über IV- und/oder SC-Verabreichung erhalten haben, wird ebenfalls berichtet.
Prozentsätze sind auf die erste Dezimalstelle gerundet.
Der Basiswert wurde als letzter vorhandener Wert definiert, der am oder vor dem Startdatum der Studienmedikation erhoben wurde.
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Baseline (Zyklus 1 Tag 1)
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Health Resource Utilization and Productivity Questionnaire (HRUPQ): Baseline Healthcare Utilization: Number of Times in the Past 6 Months a Participant Received Care
Zeitfenster: Baseline (Zyklus 1 Tag 1)
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Die Inanspruchnahme von Gesundheitsleistungen vor Studienbeginn vor der Verabreichung der Studienmedikation wurde mittels HRUPQ erfasst.
Die durchschnittliche Anzahl der Besuche in den letzten 6 Monaten, bei denen ein Teilnehmer in einer Klinik oder Notaufnahme wegen eines Gesundheitsproblems einschließlich MM oder aufgrund von MM behandelt wurde, sowie die durchschnittliche Anzahl der Besuche von Pflegepersonal oder anderen medizinischen Fachkräften zu Hause wegen eines Gesundheitsproblems einschließlich MM oder aufgrund von MM, wird dargestellt.
Der Basiswert wurde als der letzte nicht fehlende Wert definiert, der am oder vor dem Startdatum der Studienmedikation erfasst wurde.
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Baseline (Zyklus 1 Tag 1)
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HRUPQ: Basisgesundheitsnutzung: Anzahl der Nächte in den letzten 6 Monaten, die ein Teilnehmer im Krankenhaus verbracht hat
Zeitfenster: Baseline (Zyklus 1 Tag 1)
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Die Inanspruchnahme von Gesundheitsleistungen vor Studienbeginn vor der Verabreichung der Studienmedikation wurde über den HRUPQ erfasst.
Die durchschnittliche Anzahl der Nächte in den letzten 6 Monaten, die ein Teilnehmer aufgrund jeglicher Gesundheitsprobleme einschließlich MM oder aufgrund von MM im Krankenhaus verbrachte, und die Anzahl der Nächte, die ein Teilnehmer auf der Intensivstation (ICU) aufgrund jeglicher Gesundheitsprobleme einschließlich MM oder aufgrund von MM verbrachte, wird dargestellt.
Der Basiswert wurde als der letzte nicht fehlende Wert definiert, der am oder vor dem Startdatum der Studienmedikation erhoben wurde.
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Baseline (Zyklus 1 Tag 1)
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HRUPQ: Baseline Healthcare Utilization: Anzahl der Konsultationen eines medizinischen Fachpersonals (HCP) durch einen Teilnehmer in den letzten 6 Monaten
Zeitfenster: Baseline (Zyklus 1 Tag 1)
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Die Inanspruchnahme von Gesundheitsleistungen vor Studienbeginn vor der Verabreichung der Studienmedikation wurde mittels HRUPQ erfasst.
Die durchschnittliche Anzahl der Konsultationen (persönlich oder telefonisch) der folgenden medizinischen Fachkräfte durch Teilnehmer in den letzten 6 Monaten wird dargestellt: Allgemeinarzt oder primärer medizinischer Betreuer (PCC) zur Behandlung verschiedener Erkrankungen bei jeglichen Gesundheitsproblemen einschließlich MM oder MM-bezogen, Physio- oder Ergotherapeut bei jeglichen Gesundheitsproblemen einschließlich MM oder MM-bezogen, psychosoziale Fachkraft (z.B. Psychiater, Psychologe, psychiatrische Pflegekraft) bei jeglichen Gesundheitsproblemen einschließlich MM oder MM-bezogen, Facharzt oder medizinischer Betreuer mit Spezialisierung auf bestimmte Erkrankungen (Spezialist) bei jeglichen Gesundheitsproblemen einschließlich MM oder MM-bezogen.
Der Basiswert wurde als letzter vorhandener Wert definiert, der am oder vor dem Startdatum der Studienmedikation erhoben wurde.
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Baseline (Zyklus 1 Tag 1)
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Prozentsatz der Teilnehmer, die während der Studie basierend auf HRUPQ in den Ruhestand getreten sind
Zeitfenster: Von der ersten Dosis der Studienmedikamentenverabreichung (Tag 1) bis zum PCD (06.11.2024), etwa 28 Monate
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Der Beschäftigungsstatus wurde über HRUPQ erfasst.
Der Prozentsatz der Teilnehmer, die während der Studie in den Ruhestand getreten sind, wird angegeben.
Die Prozentsätze sind auf die erste Dezimalstelle gerundet.
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Von der ersten Dosis der Studienmedikamentenverabreichung (Tag 1) bis zum PCD (06.11.2024), etwa 28 Monate
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Prozentsatz der Teilnehmer, die aufgrund von MM basierend auf HRUPQ vorzeitig ausgeschieden sind
Zeitfenster: Von der ersten Dosis der Studienmedikamentenverabreichung (Tag 1) bis zum PCD (06.11.2024), ungefähr 28 Monate
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Der Beschäftigungsstatus wurde über HRUPQ ermittelt.
Der Prozentsatz der Teilnehmer, die aufgrund von MM vorzeitig in den Ruhestand gegangen sind, wird angegeben.
Die Prozentsätze sind auf die erste Dezimalstelle gerundet.
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Von der ersten Dosis der Studienmedikamentenverabreichung (Tag 1) bis zum PCD (06.11.2024), ungefähr 28 Monate
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Very Good Partial Response or Better Rate
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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'
Zeitfenster: 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'
Zeitfenster: 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'
Zeitfenster: 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'
Zeitfenster: 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'
Zeitfenster: 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'
Zeitfenster: 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'
Zeitfenster: 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'
Zeitfenster: 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'
Zeitfenster: 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)'
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
|
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For functional scales: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score and a positive change from baseline represents a better level of physical functioning.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
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Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-C30: Role Functioning
Zeitfenster: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
|
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For functional scales: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score and a positive change from baseline represents a better level of role functioning.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
|
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-C30: Emotional Functioning
Zeitfenster: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
|
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For functional scales: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score and a positive change from baseline represents a better level of emotional functioning.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
|
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-C30: Cognitive Functioning
Zeitfenster: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
|
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For functional scales: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score and a positive change from baseline represents a better level of cognitive functioning.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
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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
Zeitfenster: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
|
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For functional scales: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score and a positive change from baseline represents a better level of social functioning.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
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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
Zeitfenster: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
|
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For symptom scales: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score for symptoms and a positive change from baseline represents a higher level of symptomatology.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
|
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-C30: Nausea and Vomiting
Zeitfenster: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
|
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For symptom scales: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score for symptoms and a positive change from baseline represents a higher level of symptomatology.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
|
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-C30: Pain
Zeitfenster: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
|
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For symptom scales: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score for symptoms and a positive change from baseline represents a higher level of symptomatology.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
|
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-C30: Dyspnea
Zeitfenster: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
|
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score for symptom items and a positive change from baseline represents a higher level of symptomatology.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
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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
Zeitfenster: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
|
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score for symptom items and a positive change from baseline represents a higher level of symptomatology.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
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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
Zeitfenster: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
|
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score for symptom items and a positive change from baseline represents a higher level of symptomatology.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
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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
Zeitfenster: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
|
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score for symptom items and a positive change from baseline represents a higher level of symptomatology.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
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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
Zeitfenster: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
|
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score for symptom items and a positive change from baseline represents a higher level of symptomatology.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
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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
Zeitfenster: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
|
EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score for symptom items and a positive change from baseline represents a higher level of financial difficulties.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
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Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-Myeloma Module (MY20): Disease Symptoms
Zeitfenster: 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
Zeitfenster: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
|
The EORTC QLQ-MY20 was used in conjunction with the EORTC QLQ-C30 to assess symptoms and side effects due to the treatment or the disease which impacts health related QoL in participants with MM.
It contains 20 items, 4 independent subscales covering 2 functional domains: symptom scales which include disease symptoms (6 items) and side-effects of treatment (10 items) and function scale which include future perspective (3 items) and body image (1 item).
Scores for each subscale are based on the 4-point Likert scale ranging from (1: not at all to 4: very much) and transformed from raw scores to linear scales ranging from 0 to 100; mean is presented here.
A higher score for side effects of treatment and a positive change from baseline represents more side effects, worse QoL.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
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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
Zeitfenster: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
|
The EORTC QLQ-MY20 was used in conjunction with the EORTC QLQ-C30 to assess symptoms and side effects due to the treatment or the disease which impacts health related QoL in participants with MM.
It contains 20 items, 4 independent subscales covering 2 functional domains: symptom scales which include disease symptoms (6 items) and side-effects of treatment (10 items) and function scale which include future perspective (3 items) and body image (1 item).
Scores for each subscale are based on the 4-point Likert scale ranging from (1: not at all to 4: very much) and transformed from raw scores to linear scales ranging from 0 to 100; mean is presented here.
A higher score for future perspectives and a positive change from baseline represents better outcomes, better QoL.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
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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
Zeitfenster: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
|
The EORTC QLQ-MY20 was used in conjunction with the EORTC QLQ-C30 to assess symptoms and side effects due to the treatment or the disease which impacts health related QoL in participants with MM.
It contains 20 items, 4 independent subscales covering 2 functional domains: symptom scales which include disease symptoms (6 items) and side-effects of treatment (10 items) and function scale which include future perspective (3 items) and body image (1 item).
Scores for each subscale are based on the 4-point Likert scale ranging from (1: not at all to 4: very much) and transformed from raw scores to linear scales ranging from 0 to 100; mean is presented here.
A higher score for body image and a positive change from baseline represents better outcomes, better QoL.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
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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)
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Studienleiter: Clinical Sciences & Operations, Sanofi
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Nützliche Links
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
23. Juni 2022
Primärer Abschluss (Tatsächlich)
6. November 2024
Studienabschluss (Geschätzt)
22. Oktober 2027
Studienanmeldedaten
Zuerst eingereicht
31. Mai 2022
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
31. Mai 2022
Zuerst gepostet (Tatsächlich)
6. Juni 2022
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
2. September 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
10. August 2026
Zuletzt verifiziert
1. August 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Gefäßerkrankungen
- Herz-Kreislauf-Erkrankungen
- Neubildungen
- Erkrankungen des Immunsystems
- Neubildungen nach histologischem Typ
- Hämatologische Erkrankungen
- Lymphoproliferative Erkrankungen
- Immunproliferative Erkrankungen
- Hämostasestörungen
- Paraproteinämien
- Bluteiweißstörungen
- Hämorrhagische Störungen
- Multiples Myelom
- Neubildungen, Plasmazelle
- Organische Chemikalien
- Kohlenwasserstoffe
- Kohlenwasserstoffe, zyklisch
- Kohlenwasserstoffe, aromatisch
- Polycyclische Verbindungen
- Anilides
- Amides
- Anilinverbindungen
- Amine
- Acetanilide
- Schwangerschaft
- Schwangerschaft
- Steroide
- Fusions-Ring-Verbindungen
- Steroide, fluoriert
- Benzolderivate
- Schwangerschaften
- Ethylamine
- Prednisolon
- Benzhydrylverbindungen
- Dexamethason
- Acetaminophen
- Methylprednisolon
- Diphenhydramin
- Pomalidomid
- Isatuximab
- Montelukast
Andere Studien-ID-Nummern
- EFC15951
- 2023 (US NIH Stipendium/Vertrag: GRAMMY Museum Foundation)
- U1111-1261-5846 (Registrierungskennung: ICTRP)
- 2023-508869-32 (EudraCT-Nummer: CTIS)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
JA
Beschreibung des IPD-Plans
Qualifizierte Forscher können Zugang zu Daten auf Patientenebene und zugehörigen Studiendokumenten anfordern, einschließlich des klinischen Studienberichts, des Studienprotokolls mit allen Änderungen, des Blanko-Fallberichtsformulars, des statistischen Analyseplans und der Datensatzspezifikationen.
Daten auf Patientenebene werden anonymisiert und Studiendokumente werden geschwärzt, um die Privatsphäre der Studienteilnehmer zu schützen.
Weitere Einzelheiten zu den Datenfreigabekriterien von Sanofi, geeigneten Studien und dem Verfahren zur Beantragung des Zugangs finden Sie unter: https://vivli.org.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Ja
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .