SC versus IV isatuximab v kombinaci s pomalidomidem a dexamethasonem u RRMM (IRAKLIA)
10. srpna 2026 aktualizováno: Sanofi
Randomizovaná otevřená studie fáze 3 hodnotící subkutánní versus intravenózní podávání isatuximabu v kombinaci s pomalidomidem a dexamethasonem u dospělých pacientů s relapsem a/nebo refrakterním mnohočetným myelomem (RRMM)
Toto je randomizovaná, multicentrická, otevřená studie fáze 3 hodnotící subkutánní (SC) vs. intravenózní (IV) podávání isatuximabu v kombinaci s pomalidomidem a dexamethasonem (Pd) u pacientů s RRMM (účastníků studie), kteří dostali alespoň 1 předchozí linie terapie zahrnující lenalidomid a inhibitor proteazomu (PI). Způsobilí účastníci budou randomizováni 1:1 do 1 ze 2 studijních větví:
Ram SC: Isatuximab SC + Pd
Rameno IV: Isatuximab IV + Pd
Účastníci budou moci pokračovat v léčbě až do progrese onemocnění, nepřijatelných nežádoucích příhod (AE), požadavku účastníka na přerušení léčby nebo z jakéhokoli jiného důvodu, podle toho, co nastane dříve.
Přehled studie
Postavení
Postavení
Aktivní, ne nábor
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Detailní popis
Dvě ramena studie budou léčena ve 4týdenních cyklech až do progrese onemocnění, nepřijatelných nežádoucích příhod (AE), požadavku účastníka na přerušení léčby nebo z jakéhokoli jiného důvodu, podle toho, co nastane dříve.
Typ studie
Typ studie
Intervenční
Zápis (Aktuální)
Zápis
531
Fáze
Fáze
- Fáze 3
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
Studijní kontakt
- Jméno: Trial Transparency email recommended (Toll free for US & Canada)
- Telefonní číslo: option 6 800-633-1610
- E-mail: contact-us@sanofi.com
Studijní místa
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Buenos Aires, Argentina, 1181
- Investigational Site Number : 0320002
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Buenos Aires, Argentina, 1180
- Investigational Site Number : 0320008
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Buenos Aires, Argentina, 1280
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Buenos Aires, Argentina, 1417
- Investigational Site Number : 0320003
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Buenos Aires, Argentina, 1426
- Investigational Site Number : 0320004
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Buenos Aires, Argentina, 1430
- Investigational Site Number : 0320001
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Buenos Aires, Argentina, 1431
- Investigational Site Number : 0320005
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Córdoba, Argentina, 5000
- Investigational Site Number : 0320010
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Mendoza, Argentina, 5501
- Investigational Site Number : 0320009
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Buenos Aires
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La Plata, Buenos Aires, Argentina, 1900
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New South Wales
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Liverpool, New South Wales, Austrálie, 2170
- Investigational Site Number : 0360007
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Waratah, New South Wales, Austrálie, 2298
- Investigational Site Number : 0360004
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Wollongong, New South Wales, Austrálie, 2500
- Investigational Site Number : 0360003
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South Australia
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Adelaide, South Australia, Austrálie, 5000
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Victoria
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Melbourne, Victoria, Austrálie, 3004
- Investigational Site Number : 0360006
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Melbourne, Victoria, Austrálie, 3065
- Investigational Site Number : 0360009
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Richmond, Victoria, Austrálie, 3121
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Rio de Janeiro, Brazílie, 22775-001
- Instituto Americas - Ensino, Pesquisa e Inovação - Rio de Janeiro - Avenida Jorge Curi- Site Number : 0760004
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São Paulo, Brazílie, 04537-080
- Clinica São Germano- Site Number : 0760001
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Ceará
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Fortaleza, Ceará, Brazílie, 60115-280
- Núcleo de Oncologia e Hematologia do Ceará- Site Number : 0760006
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Pernambuco
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Recife, Pernambuco, Brazílie, 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, Brazílie, 90880-480
- Hospital Mae de Deus- Site Number : 0760003
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Rio de Janeiro
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Niterói, Rio de Janeiro, Brazílie, 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
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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
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Santiago, Reg Metropolitana de Santiago, Chile, 8380455
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Valparaiso
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Viña del Mar, Valparaiso, Chile, 2540364
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Nantes, Francie, 44093
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Paris, Francie, 75571
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Poitiers, Francie, 86021
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Saint-Priest-en-Jarez, Francie, 42270
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Toulouse, Francie, 31059
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Tours, Francie, 37032
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Bologna, Itálie, 40138
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Brescia, Itálie, 25123
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Pavia, Itálie, 27100
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Ancona
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Torette, Ancona, Itálie, 60020
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Reggio Emilia
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Meldola, Reggio Emilia, Itálie, 47014
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Roma
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Rome, Roma, Itálie, 00168
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Kyoto, Japonsko, 603-8151
- Investigational Site Number : 3920003
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Osaka, Japonsko, 530-8480
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Tokyo, Japonsko, 150-8935
- Investigational Site Number : 3920004
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Yamagata, Japonsko, 990-9585
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Aichi-ken
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Nagoya, Aichi-ken, Japonsko, 467-8602
- Investigational Site Number : 3920001
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Chiba
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Kamogawa, Chiba, Japonsko, 296-8602
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Ibaraki
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Higashiibaraki, Ibaraki, Japonsko, 311-3117
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Iwate
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Yahaba, Iwate, Japonsko, 028-3695
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Kanagawa
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Kamakura, Kanagawa, Japonsko, 247-8533
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Okayama-ken
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Okayama, Okayama-ken, Japonsko, 701-1192
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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
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Budapest, Maďarsko, 1097
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Budapest, Maďarsko, 1085
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Kaposvár, Maďarsko, 7400
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Pécs, Maďarsko, 7623
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Szombathely, Maďarsko, 9700
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Székesfehérvár, Maďarsko, 8000
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Oslo, Norsko, 0450
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Ålesund, Norsko, 6017
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Dresden, Německo, 01307
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Heidelberg, Německo, 69120
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Lübeck, Německo, 23562
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Nuremberg, Německo, 90419
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Lesser Poland Voivodeship
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Krakow, Lesser Poland Voivodeship, Polsko, 31-501
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Lower Silesian Voivodeship
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Wroclaw, Lower Silesian Voivodeship, Polsko, 50-088
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Lublin Voivodeship
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Lublin, Lublin Voivodeship, Polsko, 20-081
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Derbyshire
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Derby, Derbyshire, Spojené království, DE22 3NE
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England
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Birmingham, England, Spojené království, B15 2TH
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Leicestershire
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Leicester, Leicestershire, Spojené království, LE1 5WW
- Investigational Site Number : 8260002
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London, City of
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London, London, City of, Spojené království, W12 0HS
- Investigational Site Number : 8260005
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Norfolk
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Norwich, Norfolk, Spojené království, NR4 7UY
- Investigational Site Number : 8260001
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Colorado
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Aurora, Colorado, Spojené státy, 80012
- Rocky Mountain Cancer Centers - Aurora- Site Number : 8400021
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Florida
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Jacksonville, Florida, Spojené státy, 32224
- Mayo Clinic in Florida- Site Number : 8400008
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Plantation, Florida, Spojené státy, 33322
- Boca Raton Clinical Research Associates- Site Number : 8400030
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Mississippi
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Hattiesburg, Mississippi, Spojené státy, 39401
- Hattiesburg Clinic- Site Number : 8400006
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New Jersey
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Morristown, New Jersey, Spojené státy, 07962
- Atlantic Health System- Site Number : 8400005
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New York
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Albany, New York, Spojené státy, 12206
- New York Oncology Hematology - Albany Cancer Center- Site Number : 8400017
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North Carolina
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Charlotte, North Carolina, Spojené státy, 28207
- Novant Health Neurology & Sleep- Site Number : 8400014
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Ohio
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Canton, Ohio, Spojené státy, 44718
- Gabrail Cancer Center- Site Number : 8400027
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Fairfield, Ohio, Spojené státy, 45014
- Oncology Hematology Care - Fairfield- Site Number : 8400016
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South Carolina
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Spartanburg, South Carolina, Spojené státy, 29303
- Spartanburg Regional Medical Center- Site Number : 8400002
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Texas
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Dallas, Texas, Spojené státy, 75390
- University of Texas - Southwestern Medical Center- Site Number : 8400024
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San Antonio, Texas, Spojené státy, 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, Spojené státy, 84108
- Veterans Affairs Medical Center - Salt Lake City- Site Number : 8400011
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Kaohsiung City, Tchaj-wan, 833
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Tainan, Tchaj-wan, 704
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Taipei, Tchaj-wan, 100
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Ankara, Turecko (Türkiye), 06010
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Ankara, Turecko (Türkiye), 06200
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Istanbul, Turecko (Türkiye), 34093
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Istanbul, Turecko (Türkiye), 34098
- Investigational Site Number : 7920005
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Istanbul, Turecko (Türkiye), 34214
- Investigational Site Number : 7920008
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Istanbul, Turecko (Türkiye), 34381
- Investigational Site Number : 7920001
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Izmir, Turecko (Türkiye), 35100
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Brno, Česko, 625 00
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Olomouc, Česko, 779 00
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Ostrava, Česko, 708 52
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Prague, Česko, 128 08
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Beijing, Čína, 100191
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Beijing, Čína, 100034
- Investigational Site Number : 1560001
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Changsha, Čína, 410013
- Investigational Site Number : 1560010
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Guangzhou, Čína, 510060
- Investigational Site Number : 1560006
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Hangzhou, Čína, 310003
- Investigational Site Number : 1560002
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Nanchang, Čína, 330006
- Investigational Site Number : 1560020
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Nanning, Čína, 530021
- Investigational Site Number : 1560019
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Qingdao, Čína, 266011
- Investigational Site Number : 1560011
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Shenyang, Čína, 110004
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Tianjin, Čína, 300020
- Investigational Site Number : 1560007
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Tianjin, Čína, 300060
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Tianjin, Čína, 300052
- Investigational Site Number : 1560009
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Wuhan, Čína, 430022
- Investigational Site Number : 1560003
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Wuhan, Čína, 430030
- Investigational Site Number : 1560008
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Zhengzhou, Čína, 450008
- Investigational Site Number : 1560004
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Athens, Řecko, 106 76
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Athens, Řecko, 115 28
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Pátrai, Řecko, 265 04
- Investigational Site Number : 3000003
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Thessaloniki, Řecko, 570 10
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Madrid, Španělsko, 28034
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Salamanca, Španělsko, 37007
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Almería
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Murcia, Almería, Španělsko, 30120
- Investigational Site Number : 7240006
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Barcelona [Barcelona]
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Badalona, Barcelona [Barcelona], Španělsko, 08916
- Investigational Site Number : 7240004
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Cantabria
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Santander, Cantabria, Španělsko, 39008
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Navarre
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Pamplona, Navarre, Španělsko, 31008
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Borås, Švédsko, 501 82
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Huddinge, Švédsko, 141 57
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Popis
Kritéria pro zařazení:
- Účastníci s mnohočetným myelomem, kteří podstoupili alespoň jednu předchozí linii terapie zahrnující lenalidomid a inhibitor proteazomu a s měřitelným sérovým M-proteinem (≥ 0,5 g/dl) a/nebo M-proteinem v moči (≥ 200 mg/24 hodin) a/nebo test volného lehkého řetězce (FLC) v séru (zapojený test FLC ≥10 mg/dl a abnormální poměr FLC v séru (1,65))
Kritéria vyloučení:
- Účastníci mladší 18 let, účastníci s výkonnostním statusem Eastern Cooperative Oncology Group více než 2
- Účastníci primárního refrakterního mnohočetného myelomu
- Účastníci refrakterní na anti-CD38 s vymývacím obdobím kratším než 9 měsíců nebo netolerantní k anti-CD38 mAb
- Předchozí léčba pomalidomidem
- Účastníci s neadekvátními biologickými testy.
- Významná srdeční dysfunkce
- Účastníci, u kterých byla diagnostikována nebo léčena jiná rakovina během 3 let před randomizací, s výjimkou kompletní resekce bazocelulárního karcinomu nebo spinocelulárního karcinomu kůže a in situ malignity nebo nízkorizikového karcinomu prostaty po kurativní terapii
- Souběžná plazmatická leukémie
- Aktivní primární amyloid-light (AL) amyloidóza
- Známé onemocnění související se syndromem získané imunodeficience (AIDS) nebo známé onemocnění virem lidské imunodeficience (HIV) vyžadující antivirovou léčbu
- Poznejte aktivní infekci hepatitidy A. Současná aktivní nebo chronická infekce hepatitidy B (HBV) nebo hepatitidy C (HCV). Účastníci s chronickým onemocněním HBV nebo HCV, které je kontrolováno antivirovou terapií, jsou povoleni.
- Ženy ve fertilním věku nebo mužský účastník se ženami ve fertilním věku, které nesouhlasí s používáním vysoce účinné metody antikoncepce
Výše uvedené informace nejsou určeny k tomu, aby obsahovaly všechny úvahy relevantní pro potenciální účast účastníka v klinickém hodnocení
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Počet zbraní
2
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
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Aktivní komparátor: Isatuximab intravenózně (IV)
Dávka isatuximabu bude podávána formou IV infuze týdně po dobu 4 týdnů během 1. cyklu (1., 8., 15. a 22. den) a 1. a 15. dne následujících cyklů.
Každý cyklus bude 28 dní.
Dávka pomalidomidu bude podávána perorálně v den 1 až den 21 každého cyklu v době, která je pro účastníky nejvhodnější, před nebo po podání isatuximabu, nejlépe každý den ve stejnou dobu.
Dexamethason se bude užívat perorálně 1., 8., 15. a 22. den (opakuje se každých 28 dní).
Účastníci mohou získat další léčbu jako základní léčbu a/nebo záchrannou medikaci.
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Léková forma: Tableta; Způsob podání: Orální
Léková forma: tvrdé tobolky; Způsob podání: Orální
Ostatní jména:
Léková forma: Koncentrovaný roztok pro IV infuzi; Způsob podání: Intravenózní
Ostatní jména:
Léková forma: Podle místního komerčního produktu; Způsob podání: Orální; Auxiliary Medicinal Product (AxMP), tj. základní léčba; ATC kód: H02AB02
Léková forma: Podle místního komerčního produktu; Způsob podání: Orální; AxMP, tj. léčba na pozadí; ATC kód: R03DC03
Léková forma: Podle místního komerčního produktu; Způsob podání: Orální; AxMP, tj. léčba na pozadí; ATC kód: N02BE01
Léková forma: Podle místního komerčního produktu; Způsob podání: Jako premedikace- orální; pro řízení infuzních reakcí-IV (nebo perorální ekvivalent); AxMP, tj. základní léčba a záchranná medikace (v případě reakcí na infuzi); ATC kód: R06AA02
Léková forma: Podle místního komerčního produktu; Způsob podání: Jako premedikace-IV; pro řízení infuzních reakcí - IV (nebo perorální ekvivalent); AxMP, tj. základní léčba a záchranná medikace (v případě reakcí na infuzi); ATC kód: H02AB04
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Experimentální: 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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Léková forma: Roztok pro subkutánní podání; Cesta podání: Subkutánní (SC)
Ostatní jména:
Léková forma: Tableta; Způsob podání: Orální
Léková forma: tvrdé tobolky; Způsob podání: Orální
Ostatní jména:
Léková forma: Podle místního komerčního produktu; Způsob podání: Orální; Auxiliary Medicinal Product (AxMP), tj. základní léčba; ATC kód: H02AB02
Léková forma: Podle místního komerčního produktu; Způsob podání: Orální; AxMP, tj. léčba na pozadí; ATC kód: R03DC03
Léková forma: Podle místního komerčního produktu; Způsob podání: Orální; AxMP, tj. léčba na pozadí; ATC kód: N02BE01
Léková forma: Podle místního komerčního produktu; Způsob podání: Jako premedikace- orální; pro řízení infuzních reakcí-IV (nebo perorální ekvivalent); AxMP, tj. základní léčba a záchranná medikace (v případě reakcí na infuzi); ATC kód: R06AA02
Léková forma: Podle místního komerčního produktu; Způsob podání: Jako premedikace-IV; pro řízení infuzních reakcí - IV (nebo perorální ekvivalent); AxMP, tj. základní léčba a záchranná medikace (v případě reakcí na infuzi); ATC kód: H02AB04
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Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Celková míra odpovědi (ORR)
Časové okno: Od první dávky studijního léku (den 1) do PCD (06.11.2024), přibližně 28 měsíců
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ORR podle nezávislého hodnotícího výboru (IRC) pomocí kritérií mezinárodní myelomové pracovní skupiny (IMWG) z roku 2016: Procento účastníků s úplnou odpovědí (CR), přísnou CR (sCR), velmi dobrou parciální odpovědí (VGPR) a parciální odpovědí (PR). CR: negativní imuno fixace v séru a moči, vymizení jakýchkoli plazmocytomů měkkých tkání (STP), <5 % plazmatických buněk v aspirátech kostní dřeně (BM) a normální poměr volných lehkých řetězců (FLC) (0,26–1,65). sCR: CR plus žádné klonální buňky v biopsii BM. VGPR: sérový a močový M-protein detekovatelný imuno fixací, nikoli elektroforézou; >=90 % redukce sérového M-protein plus hladina močového M-proteinu <100 mg/24 hodin (h); >=90 % snížení součtu maximálních kolmých průměrů (SPD) ve srovnání s výchozím stavem u STP; pouze FLC: >=90 % snížení rozdílu mezi hladinami zapojeného a nezapojeného FLC. PR: >=50 % redukce sérového M-protein a snížení 24hodinového močového M-protein o >=90 % nebo na <200 mg/24 h. Kromě výše uvedeného, pokud byly přítomny při výchozím stavu, je také vyžadováno >=50 % snížení velikosti SPD u STP.
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Od první dávky studijního léku (den 1) do PCD (06.11.2024), přibližně 28 měsíců
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Pozorovaná koncentrace před dávkováním (Ctrough) přípravku Isatuximab v ustáleném stavu
Časové okno: Před podáním dávky v 6. cyklu, 1. den
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Ctrough v ustáleném stavu byla pozorovaná plazmatická koncentrace naměřená před podáním dávky na Cyklu 6 Den 1 (ekvivalentně před Cyklem 6 Den 1) podání dávky isatuximabu.
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Před podáním dávky v 6. cyklu, 1. den
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Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Ctrough isatuximabu ve 4 týdnech (CT4W)
Časové okno: Před podáním dávky v cyklu 2, den 1 (po 4 týdnech)
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Koncentrace CT4W byly pozorované plazmatické koncentrace odebrané před dávkou v Cyklu 2 Den 1 (ekvivalentní před Cyklem 2 Den 1) podání dávky isatuximabu.
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Před podáním dávky v cyklu 2, den 1 (po 4 týdnech)
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Procento účastníků, kteří odpověděli 'velmi spokojen/a' a 'spokojen/a' v 'Dotazníku pacientovy zkušenosti a spokojenosti (PESQ-FU)': Spokojenost s metodou injekční aplikace (položka 8) v cyklu 5, den 15
Časové okno: Cyklus 5 Den 15
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Dotazník PESQ-FU sestávající z 9 položek byl navržen pro sledování zkušeností a spokojenosti účastníků týkajících se způsobu aplikace injekce (nepohodlí, bolest, vedlejší účinky, úspora času a spokojenost) a studijního léčiva (vedlejší účinky, užitečnost užívání, spokojenost a doporučení).
Tento dotazník byl upraven na základě kvalitativních rozhovorů s onkologickými pacienty.
Odpovědi na 'spokojenost se způsobem aplikace injekce' byly zaznamenány jako 'velmi spokojen(a), spokojen(a), ani spokojen(a) ani nespokojen(a), nespokojen(a) a velmi nespokojen(a)' ve stanovených časových bodech.
Celkové procento účastníků, kteří byli velmi spokojeni a spokojeni se způsobem aplikace injekce (položka-8) v 5. cyklu 15. den, je uvedeno zde.
Procenta jsou zaokrouhlena na jedno desetinné místo.
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Cyklus 5 Den 15
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Ctrough isatuximabu
Časové okno: Před podáním dávky v cyklu 1 ve dnech 8, 15 a 22, v cyklech 2 až 5 ve dnech 1 a 15, v cyklech 6, 7, 8, 9, 12, 15, 18, 21, 24 a 27 v den 1
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Vzorky plazmy byly odebírány ve stanovených časových bodech pro stanovení Ctrough.
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Před podáním dávky v cyklu 1 ve dnech 8, 15 a 22, v cyklech 2 až 5 ve dnech 1 a 15, v cyklech 6, 7, 8, 9, 12, 15, 18, 21, 24 a 27 v den 1
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Procento účastníků s odpovědí na 'Dotazník očekávání pacienta při vstupu do studie (PEQ-BL)'
Časové okno: Základní hodnoty (cyklus 1 den 1)
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Hlášeno je procento účastníků, kteří na začátku studie vyjádřili silný souhlas nebo souhlas s očekáváními bolesti, nepohodlí a vedlejších účinků způsobu injekce, že způsob injekce ušetří čas, že studijní léčivo může mít vedlejší účinky a že by stálo za to jej užívat.
Dotazník PEQ-BL se skládal ze 7 položek.
Rovněž je hlášeno procento účastníků, kteří kdy dostávali léčivo intravenózně a/nebo subkutánně.
Procenta jsou zaokrouhlena na jedno desetinné místo.
Základní hodnota byla definována jako poslední nezaznamenaná hodnota získaná v den zahájení podávání studijního léčiva nebo před ním.
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Základní hodnoty (cyklus 1 den 1)
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Dotazník o využívání zdravotních zdrojů a produktivity (HRUPQ): Využívání zdravotní péče na začátku studie: Počet případů, kdy účastník vyhledal péči za posledních 6 měsíců
Časové okno: Výchozí hodnota (Cyklus 1 Den 1)
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Využívání zdravotní péče výchozí hodnoty před podáním studijního léku bylo shromážděno prostřednictvím HRUPQ.
Uvádí se průměrný počet případů za posledních 6 měsíců, kdy účastník obdržel péči na klinice nebo na pohotovosti z jakéhokoli zdravotního důvodu včetně MM nebo z důvodu MM a péči v domácím prostředí od sestry nebo jiného zdravotnického pracovníka z jakéhokoli zdravotního důvodu včetně MM nebo z důvodu MM.
Výchozí hodnota byla definována jako poslední nechybějící hodnota shromážděná k datu zahájení podávání studijního léku nebo před ním.
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Výchozí hodnota (Cyklus 1 Den 1)
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HRUPQ: Základní využívání zdravotní péče: Počet nocí, které účastník strávil v nemocnici za posledních 6 měsíců
Časové okno: Základní hodnota (Cyklus 1 Den 1)
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Využívání zdravotní péče před zahájením podávání studijního léku bylo zjišťováno pomocí HRUPQ.
Uvádí se průměrný počet nocí za posledních 6 měsíců, které účastník strávil v nemocnici z jakéhokoli zdravotního důvodu včetně MM nebo kvůli MM, a strávil na jednotce intenzivní péče (JIP) z jakéhokoli zdravotního důvodu včetně MM nebo kvůli MM.
Základní hodnota byla definována jako poslední nechybějící hodnota zjištěná v den nebo před datem zahájení podávání studijního léku.
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Základní hodnota (Cyklus 1 Den 1)
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HRUPQ: Výchozí využívání zdravotní péče: Počet konzultací účastníka se zdravotnickým pracovníkem za posledních 6 měsíců
Časové okno: Výchozí hodnota (cyklus 1 den 1)
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Využívání zdravotní péče v základním stavu před podáním studijního léku bylo zjišťováno pomocí HRUPQ.
Uvádí se průměrný počet konzultací (setkání nebo rozhovorů) účastníka v uplynulých 6 měsících s následujícími zdravotnickými pracovníky: praktický lékař nebo primární zdravotnický pracovník (PCC), který léčí různé onemocnění pro jakýkoli zdravotní problém včetně MM nebo souvisejícího s MM, fyzioterapeut nebo ergoterapeut pro jakýkoli zdravotní problém včetně MM nebo souvisejícího s MM, odborník na duševní zdraví (např. psychiatr, psycholog, psychiatrická sestra) pro jakýkoli zdravotní problém včetně MM nebo souvisejícího s MM, lékař nebo zdravotnický pracovník specializující se na konkrétní onemocnění nebo problém (specialista) pro jakýkoli zdravotní problém včetně MM nebo souvisejícího s MM.
Základní hodnota byla definována jako poslední nechybějící hodnota zaznamenaná v den nebo před datem zahájení podávání studijního léku.
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Výchozí hodnota (cyklus 1 den 1)
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Procento účastníků, kteří během studie odešli do důchodu, na základě HRUPQ
Časové okno: Od první dávky podání studijního léčiva (den 1) do PCD (06.11.2024), přibližně 28 měsíců
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Stav zaměstnání byl hodnocen pomocí HRUPQ.
Jsou uvedena procenta účastníků, kteří během studie odešli do důchodu.
Procenta jsou zaokrouhlena na desetinné místo.
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Od první dávky podání studijního léčiva (den 1) do PCD (06.11.2024), přibližně 28 měsíců
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Procento účastníků, kteří předčasně ukončili studii z důvodu MM na základě HRUPQ
Časové okno: Od první dávky podání studijního léku (Den 1) až do PCD (06.11.2024), přibližně 28 měsíců
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Zaměstnanecký status byl hodnocen pomocí HRUPQ.
Je uvedeno procento účastníků, kteří předčasně odešli do důchodu z důvodu MM.
Procenta jsou zaokrouhlena na desetinné místo.
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Od první dávky podání studijního léku (Den 1) až do PCD (06.11.2024), přibližně 28 měsíců
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Very Good Partial Response or Better Rate
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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'
Časové okno: 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'
Časové okno: 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'
Časové okno: 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'
Časové okno: 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'
Časové okno: 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'
Časové okno: 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'
Časové okno: 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'
Časové okno: 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'
Časové okno: 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)'
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For functional scales: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score and a positive change from baseline represents a better level of physical functioning.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
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Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-C30: Role Functioning
Časové okno: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For functional scales: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score and a positive change from baseline represents a better level of role functioning.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
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Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-C30: Emotional Functioning
Časové okno: 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.
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Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-C30: Cognitive Functioning
Časové okno: 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
Časové okno: 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
Časové okno: 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.
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Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-C30: Nausea and Vomiting
Časové okno: 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.
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Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-C30: Pain
Časové okno: 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.
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Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-C30: Dyspnea
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score for symptom items and a positive change from baseline represents a higher level of symptomatology.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
|
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
Časové okno: 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
Časové okno: 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
Časové okno: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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The EORTC QLQ-MY20 was used in conjunction with the EORTC QLQ-C30 to assess symptoms and side effects due to the treatment or the disease which impacts health related QoL in participants with MM.
It contains 20 items, 4 independent subscales covering 2 functional domains: symptom scales which include disease symptoms (6 items) and side-effects of treatment (10 items) and function scale which include future perspective (3 items) and body image (1 item).
Scores for each subscale are based on the 4-point Likert scale ranging from (1: not at all to 4: very much) and transformed from raw scores to linear scales ranging from 0 to 100; mean is presented here.
A higher score for side effects of treatment and a positive change from baseline represents more side effects, worse QoL.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
|
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
Časové okno: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
|
The EORTC QLQ-MY20 was used in conjunction with the EORTC QLQ-C30 to assess symptoms and side effects due to the treatment or the disease which impacts health related QoL in participants with MM.
It contains 20 items, 4 independent subscales covering 2 functional domains: symptom scales which include disease symptoms (6 items) and side-effects of treatment (10 items) and function scale which include future perspective (3 items) and body image (1 item).
Scores for each subscale are based on the 4-point Likert scale ranging from (1: not at all to 4: very much) and transformed from raw scores to linear scales ranging from 0 to 100; mean is presented here.
A higher score for future perspectives and a positive change from baseline represents better outcomes, better QoL.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
|
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
|
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Change From Baseline in EORTC QLQ-MY20: Body Image
Časové okno: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
|
The EORTC QLQ-MY20 was used in conjunction with the EORTC QLQ-C30 to assess symptoms and side effects due to the treatment or the disease which impacts health related QoL in participants with MM.
It contains 20 items, 4 independent subscales covering 2 functional domains: symptom scales which include disease symptoms (6 items) and side-effects of treatment (10 items) and function scale which include future perspective (3 items) and body image (1 item).
Scores for each subscale are based on the 4-point Likert scale ranging from (1: not at all to 4: very much) and transformed from raw scores to linear scales ranging from 0 to 100; mean is presented here.
A higher score for body image and a positive change from baseline represents better outcomes, better QoL.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
|
Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in European Quality of Life Group Measure With 5 Dimensions and 5 Levels Per Dimension (EQ-5D-5L): Visual Analogue Scale (VAS)
Časové okno: 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.
|
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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Sponzor
Vyšetřovatelé
Vyšetřovatelé
- Ředitel studie: Clinical Sciences & Operations, Sanofi
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Užitečné odkazy
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
Začátek studia
23. června 2022
Primární dokončení (Aktuální)
Primární dokončení
6. listopadu 2024
Dokončení studie (Odhadovaný)
Dokončení studie
22. října 2027
Termíny zápisu do studia
První předloženo
První předloženo
31. května 2022
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
31. května 2022
První zveřejněno (Aktuální)
První zveřejněno
6. června 2022
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
2. září 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
10. srpna 2026
Naposledy ověřeno
Naposledy ověřeno
1. srpna 2026
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Cévní onemocnění
- Kardiovaskulární choroby
- Novotvary
- Onemocnění imunitního systému
- Novotvary podle histologického typu
- Hematologická onemocnění
- Lymfoproliferativní poruchy
- Imunoproliferativní poruchy
- Hemostatické poruchy
- Paraproteinémie
- Poruchy krevních bílkovin
- Hemoragické poruchy
- Mnohočetný myelom
- Novotvary, plazmatické buňky
- Organické chemikálie
- Uhlovodíky
- Uhlovodíky, cyklické
- Uhlovodíky, aromatické
- Polycyklické sloučeniny
- Anilides
- Amidy
- Anilinové sloučeniny
- Aminy
- Acetanilidy
- Těhotenství
- Těhotenství
- Steroidy
- Sloučeniny roztaveného kruhu
- Steroidy, fluorované
- Deriváty benzenu
- Těhotenství
- Ethylaminy
- Prednisolone
- Benzhydrylové sloučeniny
- Dexamethason
- Acetaminofen
- Methylprednisolon
- Difenhydramin
- Pomalidomid
- Isatuximab
- Montelukast
Další identifikační čísla studie
Další identifikační čísla studie
- EFC15951
- 2023 (Grant/smlouva NIH USA: GRAMMY Museum Foundation)
- U1111-1261-5846 (Identifikátor registru: ICTRP)
- 2023-508869-32 (Číslo EudraCT: CTIS)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
ANO
Popis plánu IPD
Kvalifikovaní výzkumní pracovníci mohou požádat o přístup k údajům na úrovni pacientů a souvisejícím dokumentům studie, včetně zprávy o klinické studii, protokolu studie s případnými dodatky, prázdného formuláře zprávy o případu, plánu statistické analýzy a specifikací datové sady.
Údaje na úrovni pacientů budou anonymizovány a studijní dokumenty budou redigovány, aby bylo chráněno soukromí účastníků studie.
Další podrobnosti o kritériích sdílení dat společnosti Sanofi, způsobilých studiích a procesu žádosti o přístup lze nalézt na: https://vivli.org.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ano
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .