SC Versus IV Izatuksymab w połączeniu z Pomalidomidem i Deksametazonem w RRMM (IRAKLIA)
10 sierpnia 2026 zaktualizowane przez: Sanofi
Randomizowane, otwarte badanie fazy 3 oceniające podskórne i dożylne podanie izatuksymabu w skojarzeniu z pomalidomidem i deksametazonem u dorosłych pacjentów z nawrotowym i/lub opornym na leczenie szpiczakiem mnogim (RRMM)
Jest to randomizowane, wieloośrodkowe, otwarte badanie III fazy, oceniające podskórne (SC) i dożylne (IV) podawanie izatuksymabu w skojarzeniu z pomalidomidem i deksametazonem (Pd) u pacjentów z RRMM (uczestnicy badania), którzy otrzymali co najmniej 1 linia terapii obejmująca lenalidomid i inhibitor proteasomu (PI). Kwalifikujący się uczestnicy zostaną losowo przydzieleni w stosunku 1:1 do 1 z 2 ramion badania:
Ramię SC: Izatuksymab SC + Pd
Ramię IV: Izatuksymab IV + Pd
Uczestnicy będą mogli kontynuować terapię do czasu progresji choroby, niedopuszczalnych zdarzeń niepożądanych (AE), prośby uczestnika o przerwanie terapii lub z jakiegokolwiek innego powodu, w zależności od tego, co nastąpi wcześniej.
Przegląd badań
Status
Aktywny, nie rekrutujący
Szczegółowy opis
Dwie grupy badawcze będą leczone w 4-tygodniowych cyklach do czasu progresji choroby, wystąpienia nieakceptowalnych zdarzeń niepożądanych (AE), prośby uczestnika o przerwanie terapii lub jakiegokolwiek innego powodu, w zależności od tego, co nastąpi wcześniej.
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
531
Faza
- Faza 3
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Buenos Aires, Argentyna, 1181
- Investigational Site Number : 0320002
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Buenos Aires, Argentyna, 1180
- Investigational Site Number : 0320008
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Buenos Aires, Argentyna, 1280
- Investigational Site Number : 0320007
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Buenos Aires, Argentyna, 1417
- Investigational Site Number : 0320003
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Buenos Aires, Argentyna, 1426
- Investigational Site Number : 0320004
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Buenos Aires, Argentyna, 1430
- Investigational Site Number : 0320001
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Buenos Aires, Argentyna, 1431
- Investigational Site Number : 0320005
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Córdoba, Argentyna, 5000
- Investigational Site Number : 0320010
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Mendoza, Argentyna, 5501
- Investigational Site Number : 0320009
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Buenos Aires
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La Plata, Buenos Aires, Argentyna, 1900
- Investigational Site Number : 0320006
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New South Wales
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Liverpool, New South Wales, Australia, 2170
- Investigational Site Number : 0360007
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Waratah, New South Wales, Australia, 2298
- Investigational Site Number : 0360004
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Wollongong, New South Wales, Australia, 2500
- Investigational Site Number : 0360003
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South Australia
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Adelaide, South Australia, Australia, 5000
- Investigational Site Number : 0360008
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Victoria
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Melbourne, Victoria, Australia, 3004
- Investigational Site Number : 0360006
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Melbourne, Victoria, Australia, 3065
- Investigational Site Number : 0360009
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Richmond, Victoria, Australia, 3121
- Investigational Site Number : 0360001
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Rio de Janeiro, Brazylia, 22775-001
- Instituto Americas - Ensino, Pesquisa e Inovação - Rio de Janeiro - Avenida Jorge Curi- Site Number : 0760004
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São Paulo, Brazylia, 04537-080
- Clinica São Germano- Site Number : 0760001
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Ceará
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Fortaleza, Ceará, Brazylia, 60115-280
- Núcleo de Oncologia e Hematologia do Ceará- Site Number : 0760006
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Pernambuco
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Recife, Pernambuco, Brazylia, 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, Brazylia, 90880-480
- Hospital Mae de Deus- Site Number : 0760003
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Rio de Janeiro
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Niterói, Rio de Janeiro, Brazylia, 24020-096
- CHN - Complexo Hospitalar de Niterói- Site Number : 0760008
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La Araucanía
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Temuco, La Araucanía, Chile, 4780000
- Investigational Site Number : 1520001
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Reg Metropolitana de Santiago
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Santiago, Reg Metropolitana de Santiago, Chile, 7580206
- Investigational Site Number : 1520002
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Santiago, Reg Metropolitana de Santiago, Chile, 6900941
- Investigational Site Number : 1520003
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Santiago, Reg Metropolitana de Santiago, Chile, 7620001
- Investigational Site Number : 1520006
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Santiago, Reg Metropolitana de Santiago, Chile, 8380455
- Investigational Site Number : 1520004
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Valparaiso
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Viña del Mar, Valparaiso, Chile, 2540364
- Investigational Site Number : 1520005
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Beijing, Chiny, 100191
- Investigational Site Number : 1560022
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Beijing, Chiny, 100034
- Investigational Site Number : 1560001
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Changsha, Chiny, 410013
- Investigational Site Number : 1560010
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Guangzhou, Chiny, 510060
- Investigational Site Number : 1560006
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Hangzhou, Chiny, 310003
- Investigational Site Number : 1560002
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Nanchang, Chiny, 330006
- Investigational Site Number : 1560020
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Nanning, Chiny, 530021
- Investigational Site Number : 1560019
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Qingdao, Chiny, 266011
- Investigational Site Number : 1560011
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Shenyang, Chiny, 110004
- Investigational Site Number : 1560013
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Tianjin, Chiny, 300020
- Investigational Site Number : 1560007
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Tianjin, Chiny, 300060
- Investigational Site Number : 1560018
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Tianjin, Chiny, 300052
- Investigational Site Number : 1560009
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Wuhan, Chiny, 430022
- Investigational Site Number : 1560003
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Wuhan, Chiny, 430030
- Investigational Site Number : 1560008
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Zhengzhou, Chiny, 450008
- Investigational Site Number : 1560004
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Brno, Czechy, 625 00
- Investigational Site Number : 2030005
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Olomouc, Czechy, 779 00
- Investigational Site Number : 2030003
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Ostrava, Czechy, 708 52
- Investigational Site Number : 2030006
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Prague, Czechy, 128 08
- Investigational Site Number : 2030004
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Nantes, Francja, 44093
- Investigational Site Number : 2500002
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Paris, Francja, 75571
- Investigational Site Number : 2500005
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Poitiers, Francja, 86021
- Investigational Site Number : 2500001
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Saint-Priest-en-Jarez, Francja, 42270
- Investigational Site Number : 2500009
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Toulouse, Francja, 31059
- Investigational Site Number : 2500003
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Tours, Francja, 37032
- Investigational Site Number : 2500007
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Athens, Grecja, 106 76
- Investigational Site Number : 3000002
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Athens, Grecja, 115 28
- Investigational Site Number : 3000001
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Pátrai, Grecja, 265 04
- Investigational Site Number : 3000003
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Thessaloniki, Grecja, 570 10
- Investigational Site Number : 3000004
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Madrid, Hiszpania, 28034
- Investigational Site Number : 7240005
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Salamanca, Hiszpania, 37007
- Investigational Site Number : 7240002
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Almería
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Murcia, Almería, Hiszpania, 30120
- Investigational Site Number : 7240006
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Barcelona [Barcelona]
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Badalona, Barcelona [Barcelona], Hiszpania, 08916
- Investigational Site Number : 7240004
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Cantabria
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Santander, Cantabria, Hiszpania, 39008
- Investigational Site Number : 7240003
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Navarre
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Pamplona, Navarre, Hiszpania, 31008
- Investigational Site Number : 7240001
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Kyoto, Japonia, 603-8151
- Investigational Site Number : 3920003
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Osaka, Japonia, 530-8480
- Investigational Site Number : 3920011
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Tokyo, Japonia, 150-8935
- Investigational Site Number : 3920004
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Yamagata, Japonia, 990-9585
- Investigational Site Number : 3920009
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Aichi-ken
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Nagoya, Aichi-ken, Japonia, 467-8602
- Investigational Site Number : 3920001
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Chiba
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Kamogawa, Chiba, Japonia, 296-8602
- Investigational Site Number : 3920007
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Ibaraki
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Higashiibaraki, Ibaraki, Japonia, 311-3117
- Investigational Site Number : 3920005
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Iwate
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Yahaba, Iwate, Japonia, 028-3695
- Investigational Site Number : 3920010
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Kanagawa
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Kamakura, Kanagawa, Japonia, 247-8533
- Investigational Site Number : 3920012
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Okayama-ken
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Okayama, Okayama-ken, Japonia, 701-1192
- Investigational Site Number : 3920002
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Ontario
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Toronto, Ontario, Kanada, M5G 2M9
- Investigational Site Number : 1240001
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Quebec
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Greenfield Park, Quebec, Kanada, J4V 2H1
- Investigational Site Number : 1240004
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Montreal, Quebec, Kanada, H1T 2M4
- Investigational Site Number : 1240003
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Dresden, Niemcy, 01307
- Investigational Site Number : 2760005
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Heidelberg, Niemcy, 69120
- Investigational Site Number : 2760003
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Lübeck, Niemcy, 23562
- Investigational Site Number : 2760006
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Nuremberg, Niemcy, 90419
- Investigational Site Number : 2760007
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Oslo, Norwegia, 0450
- Investigational Site Number : 5780001
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Ålesund, Norwegia, 6017
- Investigational Site Number : 5780002
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Lesser Poland Voivodeship
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Krakow, Lesser Poland Voivodeship, Polska, 31-501
- Investigational Site Number : 6160005
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Lower Silesian Voivodeship
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Wroclaw, Lower Silesian Voivodeship, Polska, 50-088
- Investigational Site Number : 6160004
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Lublin Voivodeship
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Lublin, Lublin Voivodeship, Polska, 20-081
- Investigational Site Number : 6160001
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Colorado
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Aurora, Colorado, Stany Zjednoczone, 80012
- Rocky Mountain Cancer Centers - Aurora- Site Number : 8400021
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Florida
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Jacksonville, Florida, Stany Zjednoczone, 32224
- Mayo Clinic in Florida- Site Number : 8400008
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Plantation, Florida, Stany Zjednoczone, 33322
- Boca Raton Clinical Research Associates- Site Number : 8400030
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Mississippi
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Hattiesburg, Mississippi, Stany Zjednoczone, 39401
- Hattiesburg Clinic- Site Number : 8400006
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New Jersey
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Morristown, New Jersey, Stany Zjednoczone, 07962
- Atlantic Health System- Site Number : 8400005
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New York
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Albany, New York, Stany Zjednoczone, 12206
- New York Oncology Hematology - Albany Cancer Center- Site Number : 8400017
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North Carolina
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Charlotte, North Carolina, Stany Zjednoczone, 28207
- Novant Health Neurology & Sleep- Site Number : 8400014
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Ohio
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Canton, Ohio, Stany Zjednoczone, 44718
- Gabrail Cancer Center- Site Number : 8400027
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Fairfield, Ohio, Stany Zjednoczone, 45014
- Oncology Hematology Care - Fairfield- Site Number : 8400016
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South Carolina
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Spartanburg, South Carolina, Stany Zjednoczone, 29303
- Spartanburg Regional Medical Center- Site Number : 8400002
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Texas
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Dallas, Texas, Stany Zjednoczone, 75390
- University of Texas - Southwestern Medical Center- Site Number : 8400024
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San Antonio, Texas, Stany Zjednoczone, 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, Stany Zjednoczone, 84108
- Veterans Affairs Medical Center - Salt Lake City- Site Number : 8400011
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Borås, Szwecja, 501 82
- Investigational Site Number : 7520001
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Huddinge, Szwecja, 141 57
- Investigational Site Number : 7520003
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Kaohsiung City, Tajwan, 833
- Investigational Site Number : 1580001
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Tainan, Tajwan, 704
- Investigational Site Number : 1580005
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Taipei, Tajwan, 100
- Investigational Site Number : 1580002
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Ankara, Turcja (Türkiye), 06010
- Investigational Site Number : 7920007
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Ankara, Turcja (Türkiye), 06200
- Investigational Site Number : 7920009
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Istanbul, Turcja (Türkiye), 34093
- Investigational Site Number : 7920003
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Istanbul, Turcja (Türkiye), 34098
- Investigational Site Number : 7920005
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Istanbul, Turcja (Türkiye), 34214
- Investigational Site Number : 7920008
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Istanbul, Turcja (Türkiye), 34381
- Investigational Site Number : 7920001
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Izmir, Turcja (Türkiye), 35100
- Investigational Site Number : 7920004
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Budapest, Węgry, 1097
- Investigational Site Number : 3480004
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Budapest, Węgry, 1085
- Investigational Site Number : 3480002
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Kaposvár, Węgry, 7400
- Investigational Site Number : 3480003
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Pécs, Węgry, 7623
- Investigational Site Number : 3480008
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Szombathely, Węgry, 9700
- Investigational Site Number : 3480006
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Székesfehérvár, Węgry, 8000
- Investigational Site Number : 3480005
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Bologna, Włochy, 40138
- Investigational Site Number : 3800002
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Brescia, Włochy, 25123
- Investigational Site Number : 3800005
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Pavia, Włochy, 27100
- Investigational Site Number : 3800003
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Ancona
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Torette, Ancona, Włochy, 60020
- Investigational Site Number : 3800004
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Reggio Emilia
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Meldola, Reggio Emilia, Włochy, 47014
- Investigational Site Number : 3800001
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Roma
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Rome, Roma, Włochy, 00168
- Investigational Site Number : 3800006
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Derbyshire
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Derby, Derbyshire, Zjednoczone Królestwo, DE22 3NE
- Investigational Site Number : 8260003
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England
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Birmingham, England, Zjednoczone Królestwo, B15 2TH
- Investigational Site Number : 8260004
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Leicestershire
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Leicester, Leicestershire, Zjednoczone Królestwo, LE1 5WW
- Investigational Site Number : 8260002
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London, City of
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London, London, City of, Zjednoczone Królestwo, W12 0HS
- Investigational Site Number : 8260005
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Norfolk
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Norwich, Norfolk, Zjednoczone Królestwo, NR4 7UY
- Investigational Site Number : 8260001
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Opis
Kryteria przyjęcia:
- Uczestnicy ze szpiczakiem mnogim, którzy otrzymali wcześniej co najmniej jedną linię leczenia obejmującą lenalidomid i inhibitor proteasomu oraz z mierzalnym stężeniem białka M w surowicy (≥ 0,5 g/dl) i/lub białkiem M w moczu (≥ 200 mg/24 godziny) i/lub test wolnego łańcucha lekkiego (FLC) w surowicy (zaangażowany test FLC ≥10 mg/dl i nieprawidłowy współczynnik FLC w surowicy (1,65))
Kryteria wyłączenia:
- Uczestnicy w wieku poniżej 18 lat, uczestnicy ze statusem sprawności Eastern Cooperative Oncology Group powyżej 2
- Pierwotnie oporni na leczenie uczestnicy szpiczaka mnogiego
- Uczestnicy oporni na anty-CD38 z okresem wypłukiwania krótszym niż 9 miesięcy lub nietolerujący mAb anty-CD38
- Wcześniejsza terapia pomalidomidem
- Uczestnicy z nieodpowiednimi testami biologicznymi.
- Znaczna dysfunkcja serca
- Uczestnicy zdiagnozowani lub leczeni z powodu innego nowotworu w ciągu 3 lat przed randomizacją, z wyjątkiem całkowitej resekcji raka podstawnokomórkowego lub płaskonabłonkowego skóry oraz raka in situ lub raka prostaty niskiego ryzyka po terapii leczniczej
- Współistniejąca białaczka z komórek plazmatycznych
- Aktywna pierwotna amyloidoza lekka (AL).
- Znana choroba związana z zespołem nabytego niedoboru odporności (AIDS) lub znana choroba ludzkiego wirusa upośledzenia odporności (HIV) wymagająca leczenia przeciwwirusowego
- Znaj aktywne zakażenie wirusem zapalenia wątroby typu A. Aktualne aktywne lub przewlekłe zapalenie wątroby typu B (HBV) lub wirusowe zapalenie wątroby typu C (HCV). Dopuszcza się udział uczestników z przewlekłą chorobą HBV lub HCV, która jest kontrolowana w ramach terapii przeciwwirusowej.
- Kobiety w wieku rozrodczym lub uczestnik płci męskiej z kobietami w wieku rozrodczym, które nie zgadzają się na stosowanie wysoce skutecznej metody antykoncepcji
Powyższe informacje nie mają na celu zawierania wszystkich rozważań dotyczących potencjalnego udziału uczestnika w badaniu klinicznym
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Aktywny komparator: Izatuksymab dożylnie (IV)
Dawka izatuksymabu będzie podawana w infuzji dożylnej co tydzień przez 4 tygodnie podczas Cyklu 1 (dni 1, 8, 15 i 22) oraz w dniu 1 i 15 kolejnych cykli.
Każdy cykl będzie trwał 28 dni.
Dawka pomalidomidu będzie przyjmowana doustnie od 1. do 21. dnia każdego cyklu, w najdogodniejszej dla uczestników porze przed lub po podaniu izatuksymabu, najlepiej o tej samej porze każdego dnia.
Deksametazon będzie przyjmowany doustnie w dniach 1, 8, 15 i 22 (powtarzać co 28 dni).
Uczestnicy mogą otrzymać inne leczenie jako leczenie podstawowe i/lub lek doraźny.
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Postać farmaceutyczna: Tabletka; Droga podania: Doustnie
Postać farmaceutyczna: kapsułki twarde; Droga podania: Doustnie
Inne nazwy:
Postać farmaceutyczna: Koncentrat do infuzji dożylnej; Droga podania: Dożylnie
Inne nazwy:
Postać farmaceutyczna: zgodnie z lokalnym produktem handlowym; Droga podania: Doustnie; Pomocniczy produkt leczniczy (AxMP), tj. leczenie podstawowe; Kod ATC: H02AB02
Postać farmaceutyczna: zgodnie z lokalnym produktem handlowym; Droga podania: Doustnie; AxMP tj. leczenie w tle; Kod ATC: R03DC03
Postać farmaceutyczna: zgodnie z lokalnym produktem handlowym; Droga podania: Doustnie; AxMP tj. leczenie w tle; Kod ATC: N02BE01
Postać farmaceutyczna: zgodnie z lokalnym produktem handlowym; Droga podania: Jako premedykacja – doustnie; do leczenia reakcji na wlew – IV (lub odpowiednik doustny); AxMP, czyli leczenie podstawowe i lek doraźny (w przypadku reakcji na wlew); Kod ATC: R06AA02
Postać farmaceutyczna: zgodnie z lokalnym produktem handlowym; Droga podania: Jako premedykacja-IV; do leczenia reakcji na wlew – IV (lub odpowiednik doustny); AxMP, czyli leczenie podstawowe i lek doraźny (w przypadku reakcji na wlew); Kod ATC: H02AB04
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Eksperymentalny: 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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Postać farmaceutyczna: Roztwór do podania podskórnego; Droga podania: podskórnie (sc.)
Inne nazwy:
Postać farmaceutyczna: Tabletka; Droga podania: Doustnie
Postać farmaceutyczna: kapsułki twarde; Droga podania: Doustnie
Inne nazwy:
Postać farmaceutyczna: zgodnie z lokalnym produktem handlowym; Droga podania: Doustnie; Pomocniczy produkt leczniczy (AxMP), tj. leczenie podstawowe; Kod ATC: H02AB02
Postać farmaceutyczna: zgodnie z lokalnym produktem handlowym; Droga podania: Doustnie; AxMP tj. leczenie w tle; Kod ATC: R03DC03
Postać farmaceutyczna: zgodnie z lokalnym produktem handlowym; Droga podania: Doustnie; AxMP tj. leczenie w tle; Kod ATC: N02BE01
Postać farmaceutyczna: zgodnie z lokalnym produktem handlowym; Droga podania: Jako premedykacja – doustnie; do leczenia reakcji na wlew – IV (lub odpowiednik doustny); AxMP, czyli leczenie podstawowe i lek doraźny (w przypadku reakcji na wlew); Kod ATC: R06AA02
Postać farmaceutyczna: zgodnie z lokalnym produktem handlowym; Droga podania: Jako premedykacja-IV; do leczenia reakcji na wlew – IV (lub odpowiednik doustny); AxMP, czyli leczenie podstawowe i lek doraźny (w przypadku reakcji na wlew); Kod ATC: H02AB04
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Ogólny wskaźnik odpowiedzi (ORR)
Ramy czasowe: Od pierwszej dawki leku badawczego (dzień 1) do daty zakończenia obserwacji (06-list-2024), około 28 miesięcy
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ORR według niezależnego komitetu oceniającego (IRC) z wykorzystaniem kryteriów międzynarodowej grupy roboczej szpiczaka (IMWG) z 2016 roku: Odsetek uczestników z całkowitą odpowiedzią (CR), ścisłą całkowitą odpowiedzią (sCR), bardzo dobrą częściową odpowiedzią (VGPR) i częściową odpowiedzią (PR). CR: negatywny wynik immunofiksacji w surowicy i moczu, zanik jakichkolwiek plazmocytom tkanek miękkich (STP), <5% komórek plazmatycznych w aspiratach szpiku kostnego (BM) i prawidłowy stosunek wolnych łańcuchów lekkich (FLC) (0,26-1,65). sCR: CR plus brak komórek klonalnych w biopsji szpiku kostnego. VGPR: białko M w surowicy i moczu wykrywalne w immunofiksacji, nie w elektroforezie; redukcja białka M w surowicy o >=90% plus poziom białka M w moczu <100mg/24 godziny (h); zmniejszenie sumy maksymalnych prostopadłych średnic (SPD) o >=90% w porównaniu z wartością wyjściową w STP; tylko FLC: zmniejszenie różnicy między poziomami FLC zaangażowanymi i niezaangażowanymi o >=90%. PR: redukcja białka M w surowicy o >=50% i redukcja białka M w moczu z 24h o >=90% lub do <200mg/24h. Dodatkowo, jeśli obecne w punkcie wyjściowym, wymagane jest również zmniejszenie rozmiaru SPD STP o >=50%.
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Od pierwszej dawki leku badawczego (dzień 1) do daty zakończenia obserwacji (06-list-2024), około 28 miesięcy
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Zaobserwowane stężenie przed podaniem dawki (Ctrough) izatuksymabu w stanie ustalonym
Ramy czasowe: Przed podaniem dawki w cyklu 6, dzień 1
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Ctrough w stanie stacjonarnym oznaczało obserwowane stężenie w osoczu pobrane przed podaniem dawki w cyklu 6 dniu 1 (równoważne z okresem przed cyklem 6 dniem 1) podania izatuksymabu.
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Przed podaniem dawki w cyklu 6, dzień 1
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Miary wyników drugorzędnych
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Ctrough izatuksymabu w 4. tygodniu (CT4W)
Ramy czasowe: Przed podaniem dawki w cyklu 2, dzień 1 (po 4 tygodniach)
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Obserwowane stężenia osoczowe CT4W zebrano przed podaniem dawki (przeddawkowe) w Dniu 1 Cyklu 2 (co odpowiada okresowi przed Dniem 1 Cyklu 2) podania izatuksymabu.
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Przed podaniem dawki w cyklu 2, dzień 1 (po 4 tygodniach)
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Odsetek uczestników, którzy odpowiedzieli „bardzo zadowolony” i „zadowolony” w kwestionariuszu „Patient Experience and Satisfaction Questionnaire (PESQ-FU)”: Satysfakcja z metody wstrzyknięcia (pozycja 8) w Dniu 15 Cyklu 5
Ramy czasowe: Cykl 5 Dzień 15
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Kwestionariusz PESQ-FU składający się z 9 pozycji został zaprojektowany w celu monitorowania doświadczeń i satysfakcji uczestników dotyczących metody iniekcji (dyskomfort, ból, skutki uboczne, oszczędność czasu i satysfakcja) oraz leku badawczego (skutki uboczne, wartość przyjmowania, satysfakcja i rekomendacja).
Ten kwestionariusz został dostosowany na podstawie jakościowych wywiadów z uczestnikami onkologicznymi.
Odpowiedzi na pytanie dotyczące 'satysfakcji z metody iniekcji' były rejestrowane jako 'bardzo zadowolony, zadowolony, ani zadowolony ani niezadowolony, niezadowolony i bardzo niezadowolony' w określonych punktach czasowych.
Całkowity odsetek uczestników, którzy byli bardzo zadowoleni i zadowoleni z metody iniekcji (pozycja-8) w 5 cyklu, 15 dniu jest tutaj raportowany.
Procenty są zaokrąglone do dziesiątego miejsca po przecinku.
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Cykl 5 Dzień 15
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Ctrough izatuksymabu
Ramy czasowe: Przed podaniem dawki w cyklu 1 w dniach 8, 15 i 22, w cyklach 2-5 w dniach 1 i 15, w cyklach 6, 7, 8, 9, 12, 15, 18, 21, 24 i 27 w dniu 1
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Próbki osocza pobierano w określonych punktach czasowych w celu oceny stężenia Ctrough.
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Przed podaniem dawki w cyklu 1 w dniach 8, 15 i 22, w cyklach 2-5 w dniach 1 i 15, w cyklach 6, 7, 8, 9, 12, 15, 18, 21, 24 i 27 w dniu 1
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Odsetek uczestników z odpowiedzią na 'Kwestionariusz Oczekiwań Pacjenta w punkcie wyjściowym (PEQ-BL)'
Ramy czasowe: Linia wyjściowa (Cykl 1 Dzień 1)
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Zgłoszono odsetek uczestników, którzy na początku badania odpowiedzieli, że zdecydowanie zgadzają się lub zgadzają się z oczekiwaniami dotyczącymi bólu, dyskomfortu i działań niepożądanych związanych z metodą iniekcji, że metoda iniekcji zaoszczędzi czas, że lek badany może powodować działania niepożądane oraz że będzie warto go przyjmować.
Kwestionariusz PEQ-BL składał się z 7 pozycji.
Zgłoszono również odsetek uczestników, którzy kiedykolwiek otrzymywali lek drogą dożylną i/lub podskórną.
Procenty zaokrąglono do pierwszego miejsca po przecinku.
Wartość wyjściową zdefiniowano jako ostatnią niepustą wartość zebraną w dniu rozpoczęcia przyjmowania leku badanego lub przed tym dniem.
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Linia wyjściowa (Cykl 1 Dzień 1)
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Kwestionariusz Wykorzystania Zasobów Zdrowotnych i Wydajności (HRUPQ): Bazowe Wykorzystanie Opieki Zdrowotnej: Liczba Wizyt w Ciągu Ostatnich 6 Miesięcy, w Których Uczestnik Otrzymał Opiekę
Ramy czasowe: Linia początkowa (Cykl 1 Dzień 1)
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Wykorzystanie opieki zdrowotnej w punkcie wyjściowym przed podaniem leku badawczego zostało zebrane za pomocą HRUPQ.
Przedstawiono średnią liczbę wizyt w ciągu ostatnich 6 miesięcy, w których uczestnik otrzymał opiekę w przychodni lub szpitalnym oddziale ratunkowym z powodu jakiegokolwiek problemu zdrowotnego, w tym MM lub z powodu MM, oraz opiekę domową świadczoną przez pielęgniarkę lub innego pracownika służby zdrowia z powodu jakiegokolwiek problemu zdrowotnego, w tym MM lub z powodu MM.
Wartość wyjściowa została zdefiniowana jako ostatnia niebrakująca wartość zebrana w dniu lub przed datą rozpoczęcia podawania leku badawczego.
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Linia początkowa (Cykl 1 Dzień 1)
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HRUPQ: Bazowe Wykorzystanie Opieki Zdrowotnej: Liczba Nocy Spędzonych w Szpitalu przez Uczestnika w Ciągu Ostatnich 6 Miesięcy
Ramy czasowe: Linia bazowa (Cykl 1 Dzień 1)
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Wykorzystanie opieki zdrowotnej w punkcie wyjściowym przed podaniem leku w badaniu było zbierane za pomocą HRUPQ.
Przedstawiono średnią liczbę nocy w ciągu ostatnich 6 miesięcy, które uczestnik spędził w szpitalu z powodu jakiegokolwiek problemu zdrowotnego, w tym MM lub z powodu MM, oraz liczbę nocy spędzonych na oddziale intensywnej terapii (ICU) z powodu jakiegokolwiek problemu zdrowotnego, w tym MM lub z powodu MM.
Wartość wyjściową zdefiniowano jako ostatnią niebrakującą wartość zebraną w dniu rozpoczęcia podawania leku w badaniu lub przed tą datą.
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Linia bazowa (Cykl 1 Dzień 1)
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HRUPQ: Wykorzystanie Opieki Zdrowotnej w Punkcie Wyjściowym: Liczba Konsultacji z Pracownikiem Służby Zdrowia (HCP) przez Uczestnika w Ciągu Ostatnich 6 Miesięcy
Ramy czasowe: Linia wyjściowa (Cykl 1 Dzień 1)
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Wykorzystanie opieki zdrowotnej w punkcie wyjściowym przed podaniem leku badawczego zostało zebrane za pomocą HRUPQ.
Przedstawiono średnią liczbę wizyt u następujących specjalistów opieki zdrowotnej, z jakiej skorzystał uczestnik w ciągu ostatnich 6 miesięcy: lekarz rodzinny lub lekarz podstawowej opieki zdrowotnej (PCC) leczący różne schorzenia z dowolnego powodu zdrowotnego, w tym MM lub związanych z MM, fizjoterapeuta lub terapeuta zajęciowy z dowolnego powodu zdrowotnego, w tym MM lub związanych z MM, specjalista zdrowia psychicznego (np. psychiatra, psycholog, pielęgniarka psychiatryczna) z dowolnego powodu zdrowotnego, w tym MM lub związanych z MM, lekarz medycyny lub klinicysta specjalizujący się w konkretnej chorobie lub problemie medycznym (specjalista) z dowolnego powodu zdrowotnego, w tym MM lub związanych z MM.
Wartość wyjściowa została zdefiniowana jako ostatnia niepusta wartość zebrana w dniu lub przed datą rozpoczęcia podawania leku badawczego.
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Linia wyjściowa (Cykl 1 Dzień 1)
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Odsetek uczestników, którzy kiedykolwiek przeszli na emeryturę w trakcie badania na podstawie HRUPQ
Ramy czasowe: Od pierwszej dawki leku badawczego (dzień 1) do PCD (06-list-2024), około 28 miesięcy
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Status zatrudnienia został oceniony za pomocą kwestionariusza HRUPQ.
Wskaźnik procentowy uczestników, którzy przeszli na emeryturę w trakcie badania, został przedstawiony.
Procenty zaokrąglono do jednego miejsca po przecinku.
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Od pierwszej dawki leku badawczego (dzień 1) do PCD (06-list-2024), około 28 miesięcy
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Odsetek uczestników, którzy wcześnie zakończyli udział z powodu MM w oparciu o HRUPQ
Ramy czasowe: Od pierwszej dawki leku w badaniu (dzień 1) do PCD (06-list-2024), około 28 miesięcy
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Status zatrudnienia został oceniony za pomocą kwestionariusza HRUPQ.
Zgłoszono odsetek uczestników, którzy przeszli na wcześniejszą emeryturę z powodu MM.
Procenty są zaokrąglone do dziesiątego miejsca po przecinku.
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Od pierwszej dawki leku w badaniu (dzień 1) do PCD (06-list-2024), około 28 miesięcy
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Very Good Partial Response or Better Rate
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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'
Ramy czasowe: 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'
Ramy czasowe: 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'
Ramy czasowe: 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'
Ramy czasowe: 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'
Ramy czasowe: 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'
Ramy czasowe: 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'
Ramy czasowe: 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'
Ramy czasowe: 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'
Ramy czasowe: 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)'
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For functional scales: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score and a positive change from baseline represents a better level of emotional functioning.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
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Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-C30: Cognitive Functioning
Ramy czasowe: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For functional scales: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score and a positive change from baseline represents a better level of cognitive functioning.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
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Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-C30: Social Functioning
Ramy czasowe: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For functional scales: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score and a positive change from baseline represents a better level of social functioning.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
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Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-C30: Fatigue
Ramy czasowe: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For symptom scales: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score for symptoms and a positive change from baseline represents a higher level of symptomatology.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
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Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-C30: Nausea and Vomiting
Ramy czasowe: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For symptom scales: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score for symptoms and a positive change from baseline represents a higher level of symptomatology.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
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Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-C30: Pain
Ramy czasowe: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For symptom scales: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score for symptoms and a positive change from baseline represents a higher level of symptomatology.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
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Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-C30: Dyspnea
Ramy czasowe: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score for symptom items and a positive change from baseline represents a higher level of symptomatology.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
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Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-C30: Insomnia
Ramy czasowe: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score for symptom items and a positive change from baseline represents a higher level of symptomatology.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
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Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-C30: Appetite Loss
Ramy czasowe: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score for symptom items and a positive change from baseline represents a higher level of symptomatology.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
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Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-C30: Constipation
Ramy czasowe: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score for symptom items and a positive change from baseline represents a higher level of symptomatology.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
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Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-C30: Diarrhea
Ramy czasowe: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score for symptom items and a positive change from baseline represents a higher level of symptomatology.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
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Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-C30: Financial Difficulties
Ramy czasowe: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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EORTC QLQ-C30 is a cancer specific 30-item instrument that provides a comprehensive assessment of the principal health related QoL dimensions: GHS/QoL (2 items), functional scales (physical [5 items], role [2 items], emotional [4 items], cognitive [2 items], social [2 items]), symptom scales (fatigue [3 items], nausea & vomiting [2 items], pain [2 items]) and symptom items- 1 item each (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties).
For symptom items: questions were rated on a 4-point scale (1: not at all to 4: very much).
All of the scales and single-item measures range in score from 0 to 100; mean is presented here.
A higher score for symptom items and a positive change from baseline represents a higher level of financial difficulties.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
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Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-Myeloma Module (MY20): Disease Symptoms
Ramy czasowe: 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
Ramy czasowe: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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The EORTC QLQ-MY20 was used in conjunction with the EORTC QLQ-C30 to assess symptoms and side effects due to the treatment or the disease which impacts health related QoL in participants with MM.
It contains 20 items, 4 independent subscales covering 2 functional domains: symptom scales which include disease symptoms (6 items) and side-effects of treatment (10 items) and function scale which include future perspective (3 items) and body image (1 item).
Scores for each subscale are based on the 4-point Likert scale ranging from (1: not at all to 4: very much) and transformed from raw scores to linear scales ranging from 0 to 100; mean is presented here.
A higher score for side effects of treatment and a positive change from baseline represents more side effects, worse QoL.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
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Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 30 Day 15 and EOT visit (up to DCO date: 29-Aug-2025) (30 days after last drug administration or before further anti myeloma therapy initiation,whichever occurred first,up to approximately 38 months)
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Change From Baseline in EORTC QLQ-MY20: Future Perspective
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Dyrektor Studium: Clinical Sciences & Operations, Sanofi
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Przydatne linki
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
23 czerwca 2022
Zakończenie podstawowe (Rzeczywisty)
6 listopada 2024
Ukończenie studiów (Szacowany)
22 października 2027
Daty rejestracji na studia
Pierwszy przesłany
31 maja 2022
Pierwszy przesłany, który spełnia kryteria kontroli jakości
31 maja 2022
Pierwszy wysłany (Rzeczywisty)
6 czerwca 2022
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
2 września 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
10 sierpnia 2026
Ostatnia weryfikacja
1 sierpnia 2026
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
- Choroby naczyniowe
- Choroby układu krążenia
- Nowotwory
- Choroby układu odpornościowego
- Nowotwory według typu histologicznego
- Choroby hematologiczne
- Zaburzenia limfoproliferacyjne
- Zaburzenia immunoproliferacyjne
- Zaburzenia hemostatyczne
- Paraproteinemie
- Zaburzenia białek krwi
- Zaburzenia krwotoczne
- Szpiczak mnogi
- Nowotwory, komórki plazmatyczne
- Organiczne chemikalia
- Węglowodory
- Węglowodory, cykliczne
- Węglowodory, aromatyczne
- Związki policykliczne
- Anilidy
- Amides
- Związki aniliny
- Aminy
- Acetanilidy
- Ciąży
- Ciężarne
- Steroidy
- Związki sterownika
- Sterydy, fluorowane
- Pochodne benzenu
- Ciąży
- Etyloamin
- Prednizolon
- Związki benzhydrylu
- Deksametazon
- Paracetamol
- Metyloprednizolon
- Difenhydramina
- pomalidomid
- isatuximab
- Montellukast
Inne numery identyfikacyjne badania
- EFC15951
- 2023 (Grant/umowa NIH USA: GRAMMY Museum Foundation)
- U1111-1261-5846 (Identyfikator rejestru: ICTRP)
- 2023-508869-32 (Numer EudraCT: CTIS)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
TAK
Opis planu IPD
Wykwalifikowani badacze mogą poprosić o dostęp do danych na poziomie pacjenta i powiązanych dokumentów badawczych, w tym raportu z badania klinicznego, protokołu badania z wszelkimi poprawkami, czystego formularza opisu przypadku, planu analizy statystycznej i specyfikacji zbioru danych.
Dane na poziomie pacjenta zostaną zanonimizowane, a dokumenty badawcze zostaną zredagowane w celu ochrony prywatności uczestników badania.
Więcej informacji na temat kryteriów udostępniania danych przez firmę Sanofi, kwalifikujących się badań i procesu ubiegania się o dostęp można znaleźć na stronie: https://vivli.org.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Tak
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .