SC Versus IV Isatuximab pomalidomiddal és dexametazonnal kombinációban RRMM-ben (IRAKLIA)
2026. augusztus 10. frissítette: Sanofi
Véletlenszerű, 3. fázisú, nyílt vizsgálat, amely az izatuximab pomalidomiddal és dexametazonnal kombinált szubkután és intravénás alkalmazását értékeli relapszusban és/vagy refrakter myeloma multiplexben (RRMM) szenvedő felnőtt betegeknél
Ez egy randomizált, többközpontú, 3. fázisú, nyílt elrendezésű vizsgálat, amely az izatuximab pomalidomiddal és dexametazonnal (Pd) kombinált szubkután (SC) és intravénás (IV) adagolását értékeli olyan RRMM-betegeknél (a vizsgálat résztvevőinél), akik korábban legalább 1 kezelést kaptak. a lenalidomidot és a proteaszóma inhibitort (PI) is beleértve. A jogosult résztvevőket 1:1 arányban véletlenszerűen osztják a 2 vizsgálati kar közül 1-be:
Kar SC: Isatuximab SC + Pd
IV kar: Isatuximab IV + Pd
A résztvevők folytathatják a terápiát a betegség progressziójáig, az elfogadhatatlan nemkívánatos eseményekig (AE), a résztvevők a terápia leállítására irányuló kérelméig vagy bármely más okig, attól függően, hogy melyik következik be előbb.
A tanulmány áttekintése
Állapot
Aktív, nem toborzó
Körülmények
Részletes leírás
Két vizsgálati ágat 4 hetes ciklusokban kezelnek a betegség progressziójáig, elfogadhatatlan nemkívánatos eseményekig (AE), a résztvevők a terápia leállítására vonatkozó kérelméig vagy bármely más okig, attól függően, hogy melyik következik be előbb.
Tanulmány típusa
Beavatkozó
Beiratkozás (Tényleges)
531
Fázis
- 3. fázis
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi helyek
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Buenos Aires, Argentína, 1181
- Investigational Site Number : 0320002
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Buenos Aires, Argentína, 1180
- Investigational Site Number : 0320008
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Buenos Aires, Argentína, 1280
- Investigational Site Number : 0320007
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Buenos Aires, Argentína, 1417
- Investigational Site Number : 0320003
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Buenos Aires, Argentína, 1426
- Investigational Site Number : 0320004
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Buenos Aires, Argentína, 1430
- Investigational Site Number : 0320001
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Buenos Aires, Argentína, 1431
- Investigational Site Number : 0320005
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Córdoba, Argentína, 5000
- Investigational Site Number : 0320010
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Mendoza, Argentína, 5501
- Investigational Site Number : 0320009
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Buenos Aires
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La Plata, Buenos Aires, Argentína, 1900
- Investigational Site Number : 0320006
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New South Wales
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Liverpool, New South Wales, Ausztrália, 2170
- Investigational Site Number : 0360007
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Waratah, New South Wales, Ausztrália, 2298
- Investigational Site Number : 0360004
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Wollongong, New South Wales, Ausztrália, 2500
- Investigational Site Number : 0360003
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South Australia
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Adelaide, South Australia, Ausztrália, 5000
- Investigational Site Number : 0360008
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Victoria
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Melbourne, Victoria, Ausztrália, 3004
- Investigational Site Number : 0360006
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Melbourne, Victoria, Ausztrália, 3065
- Investigational Site Number : 0360009
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Richmond, Victoria, Ausztrália, 3121
- Investigational Site Number : 0360001
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Rio de Janeiro, Brazília, 22775-001
- Instituto Americas - Ensino, Pesquisa e Inovação - Rio de Janeiro - Avenida Jorge Curi- Site Number : 0760004
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São Paulo, Brazília, 04537-080
- Clinica São Germano- Site Number : 0760001
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Ceará
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Fortaleza, Ceará, Brazília, 60115-280
- Núcleo de Oncologia e Hematologia do Ceará- Site Number : 0760006
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Pernambuco
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Recife, Pernambuco, Brazília, 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, Brazília, 90880-480
- Hospital Mae de Deus- Site Number : 0760003
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Rio de Janeiro
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Niterói, Rio de Janeiro, Brazília, 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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Brno, Csehország, 625 00
- Investigational Site Number : 2030005
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Olomouc, Csehország, 779 00
- Investigational Site Number : 2030003
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Ostrava, Csehország, 708 52
- Investigational Site Number : 2030006
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Prague, Csehország, 128 08
- Investigational Site Number : 2030004
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Derbyshire
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Derby, Derbyshire, Egyesült Királyság, DE22 3NE
- Investigational Site Number : 8260003
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England
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Birmingham, England, Egyesült Királyság, B15 2TH
- Investigational Site Number : 8260004
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Leicestershire
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Leicester, Leicestershire, Egyesült Királyság, LE1 5WW
- Investigational Site Number : 8260002
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London, City of
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London, London, City of, Egyesült Királyság, W12 0HS
- Investigational Site Number : 8260005
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Norfolk
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Norwich, Norfolk, Egyesült Királyság, NR4 7UY
- Investigational Site Number : 8260001
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Colorado
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Aurora, Colorado, Egyesült Államok, 80012
- Rocky Mountain Cancer Centers - Aurora- Site Number : 8400021
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Florida
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Jacksonville, Florida, Egyesült Államok, 32224
- Mayo Clinic in Florida- Site Number : 8400008
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Plantation, Florida, Egyesült Államok, 33322
- Boca Raton Clinical Research Associates- Site Number : 8400030
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Mississippi
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Hattiesburg, Mississippi, Egyesült Államok, 39401
- Hattiesburg Clinic- Site Number : 8400006
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New Jersey
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Morristown, New Jersey, Egyesült Államok, 07962
- Atlantic Health System- Site Number : 8400005
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New York
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Albany, New York, Egyesült Államok, 12206
- New York Oncology Hematology - Albany Cancer Center- Site Number : 8400017
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North Carolina
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Charlotte, North Carolina, Egyesült Államok, 28207
- Novant Health Neurology & Sleep- Site Number : 8400014
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Ohio
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Canton, Ohio, Egyesült Államok, 44718
- Gabrail Cancer Center- Site Number : 8400027
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Fairfield, Ohio, Egyesült Államok, 45014
- Oncology Hematology Care - Fairfield- Site Number : 8400016
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South Carolina
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Spartanburg, South Carolina, Egyesült Államok, 29303
- Spartanburg Regional Medical Center- Site Number : 8400002
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Texas
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Dallas, Texas, Egyesült Államok, 75390
- University of Texas - Southwestern Medical Center- Site Number : 8400024
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San Antonio, Texas, Egyesült Államok, 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, Egyesült Államok, 84108
- Veterans Affairs Medical Center - Salt Lake City- Site Number : 8400011
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Nantes, Franciaország, 44093
- Investigational Site Number : 2500002
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Paris, Franciaország, 75571
- Investigational Site Number : 2500005
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Poitiers, Franciaország, 86021
- Investigational Site Number : 2500001
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Saint-Priest-en-Jarez, Franciaország, 42270
- Investigational Site Number : 2500009
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Toulouse, Franciaország, 31059
- Investigational Site Number : 2500003
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Tours, Franciaország, 37032
- Investigational Site Number : 2500007
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Athens, Görögország, 106 76
- Investigational Site Number : 3000002
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Athens, Görögország, 115 28
- Investigational Site Number : 3000001
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Pátrai, Görögország, 265 04
- Investigational Site Number : 3000003
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Thessaloniki, Görögország, 570 10
- Investigational Site Number : 3000004
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Kyoto, Japán, 603-8151
- Investigational Site Number : 3920003
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Osaka, Japán, 530-8480
- Investigational Site Number : 3920011
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Tokyo, Japán, 150-8935
- Investigational Site Number : 3920004
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Yamagata, Japán, 990-9585
- Investigational Site Number : 3920009
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Aichi-ken
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Nagoya, Aichi-ken, Japán, 467-8602
- Investigational Site Number : 3920001
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Chiba
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Kamogawa, Chiba, Japán, 296-8602
- Investigational Site Number : 3920007
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Ibaraki
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Higashiibaraki, Ibaraki, Japán, 311-3117
- Investigational Site Number : 3920005
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Iwate
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Yahaba, Iwate, Japán, 028-3695
- Investigational Site Number : 3920010
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Kanagawa
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Kamakura, Kanagawa, Japán, 247-8533
- Investigational Site Number : 3920012
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Okayama-ken
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Okayama, Okayama-ken, Japán, 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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Beijing, Kína, 100191
- Investigational Site Number : 1560022
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Beijing, Kína, 100034
- Investigational Site Number : 1560001
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Changsha, Kína, 410013
- Investigational Site Number : 1560010
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Guangzhou, Kína, 510060
- Investigational Site Number : 1560006
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Hangzhou, Kína, 310003
- Investigational Site Number : 1560002
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Nanchang, Kína, 330006
- Investigational Site Number : 1560020
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Nanning, Kína, 530021
- Investigational Site Number : 1560019
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Qingdao, Kína, 266011
- Investigational Site Number : 1560011
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Shenyang, Kína, 110004
- Investigational Site Number : 1560013
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Tianjin, Kína, 300020
- Investigational Site Number : 1560007
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Tianjin, Kína, 300060
- Investigational Site Number : 1560018
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Tianjin, Kína, 300052
- Investigational Site Number : 1560009
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Wuhan, Kína, 430022
- Investigational Site Number : 1560003
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Wuhan, Kína, 430030
- Investigational Site Number : 1560008
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Zhengzhou, Kína, 450008
- Investigational Site Number : 1560004
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Lesser Poland Voivodeship
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Krakow, Lesser Poland Voivodeship, Lengyelország, 31-501
- Investigational Site Number : 6160005
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Lower Silesian Voivodeship
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Wroclaw, Lower Silesian Voivodeship, Lengyelország, 50-088
- Investigational Site Number : 6160004
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Lublin Voivodeship
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Lublin, Lublin Voivodeship, Lengyelország, 20-081
- Investigational Site Number : 6160001
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Budapest, Magyarország, 1097
- Investigational Site Number : 3480004
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Budapest, Magyarország, 1085
- Investigational Site Number : 3480002
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Kaposvár, Magyarország, 7400
- Investigational Site Number : 3480003
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Pécs, Magyarország, 7623
- Investigational Site Number : 3480008
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Szombathely, Magyarország, 9700
- Investigational Site Number : 3480006
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Székesfehérvár, Magyarország, 8000
- Investigational Site Number : 3480005
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Oslo, Norvégia, 0450
- Investigational Site Number : 5780001
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Ålesund, Norvégia, 6017
- Investigational Site Number : 5780002
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Dresden, Németország, 01307
- Investigational Site Number : 2760005
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Heidelberg, Németország, 69120
- Investigational Site Number : 2760003
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Lübeck, Németország, 23562
- Investigational Site Number : 2760006
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Nuremberg, Németország, 90419
- Investigational Site Number : 2760007
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Bologna, Olaszország, 40138
- Investigational Site Number : 3800002
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Brescia, Olaszország, 25123
- Investigational Site Number : 3800005
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Pavia, Olaszország, 27100
- Investigational Site Number : 3800003
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Ancona
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Torette, Ancona, Olaszország, 60020
- Investigational Site Number : 3800004
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Reggio Emilia
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Meldola, Reggio Emilia, Olaszország, 47014
- Investigational Site Number : 3800001
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Roma
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Rome, Roma, Olaszország, 00168
- Investigational Site Number : 3800006
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Madrid, Spanyolország, 28034
- Investigational Site Number : 7240005
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Salamanca, Spanyolország, 37007
- Investigational Site Number : 7240002
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Almería
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Murcia, Almería, Spanyolország, 30120
- Investigational Site Number : 7240006
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Barcelona [Barcelona]
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Badalona, Barcelona [Barcelona], Spanyolország, 08916
- Investigational Site Number : 7240004
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Cantabria
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Santander, Cantabria, Spanyolország, 39008
- Investigational Site Number : 7240003
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Navarre
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Pamplona, Navarre, Spanyolország, 31008
- Investigational Site Number : 7240001
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Borås, Svédország, 501 82
- Investigational Site Number : 7520001
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Huddinge, Svédország, 141 57
- Investigational Site Number : 7520003
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Kaohsiung City, Tajvan, 833
- Investigational Site Number : 1580001
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Tainan, Tajvan, 704
- Investigational Site Number : 1580005
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Taipei, Tajvan, 100
- Investigational Site Number : 1580002
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Ankara, Törökország (Türkiye), 06010
- Investigational Site Number : 7920007
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Ankara, Törökország (Türkiye), 06200
- Investigational Site Number : 7920009
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Istanbul, Törökország (Türkiye), 34093
- Investigational Site Number : 7920003
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Istanbul, Törökország (Türkiye), 34098
- Investigational Site Number : 7920005
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Istanbul, Törökország (Türkiye), 34214
- Investigational Site Number : 7920008
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Istanbul, Törökország (Türkiye), 34381
- Investigational Site Number : 7920001
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Izmir, Törökország (Türkiye), 35100
- Investigational Site Number : 7920004
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Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
18 év és régebbi (Felnőtt, Idősebb felnőtt)
Egészséges önkénteseket fogad
Nem
Leírás
Bevételi kritériumok:
- Myeloma multiplexben szenvedő résztvevők, akik legalább egy korábbi terápiát kaptak, beleértve lenalidomidot és proteaszóma-gátlót, és mérhető szérum M-proteint (≥ 0,5 g/dl) és/vagy vizelet M-proteint (≥ 200 mg/24 óra) tartalmaznak és/vagy szérummentes könnyű lánc (FLC) vizsgálat (Involved FLC assay ≥10 mg/dL és abnormális szérum FLC arány (1,65))
Kizárási kritériumok:
- 18 évnél fiatalabb résztvevők, 2-nél idősebb Keleti Kooperatív Onkológiai Csoport teljesítménystátuszú résztvevők
- Primer refrakter myeloma multiplex résztvevők
- Az anti-CD38-ra rezisztens résztvevők 9 hónapnál rövidebb kimosási periódussal, vagy nem tolerálják az anti-CD38 mAb szereket
- Előzetes pomalidomid terápia
- Nem megfelelő biológiai tesztekkel rendelkező résztvevők.
- Jelentős szívműködési zavar
- Azok a résztvevők, akiknél a randomizálást megelőző 3 éven belül más daganatos betegséget diagnosztizáltak vagy kezeltek, kivéve a bőr bazálissejtes karcinóma vagy laphámsejtes karcinóma teljes reszekcióját, valamint in situ rosszindulatú daganatot vagy alacsony kockázatú prosztatarákot gyógyító terápia után
- Egyidejű plazmasejtes leukémia
- Aktív primer amiloid-light (AL) amiloidózis
- Ismert szerzett immunhiányos szindrómával (AIDS) összefüggő betegség vagy ismert humán immunhiány vírus (HIV) betegség, amely vírusellenes kezelést igényel
- Ismerje meg az aktív hepatitis A fertőzést. Aktív vagy krónikus hepatitis B (HBV) vagy hepatitis C (HCV) fertőzés. A krónikus HBV-vel vagy vírusellenes kezeléssel kontrollált HCV-betegségben szenvedő résztvevők engedélyezettek.
- Fogamzóképes korú nők vagy férfi résztvevő fogamzóképes korú nőkkel, akik nem járulnak hozzá a rendkívül hatékony fogamzásgátlási módszer alkalmazásához
A fenti információk nem tartalmaznak minden olyan megfontolást, amely a résztvevő potenciális klinikai vizsgálatban való részvételével kapcsolatos
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
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Aktív összehasonlító: Izatuximab intravénás (IV)
Az izatuximab adagját intravénás infúzióval kell beadni hetente 4 héten keresztül az 1. ciklusban (1., 8., 15. és 22. nap), valamint a következő ciklusok 1. és 15. napján.
Minden ciklus 28 napos lesz.
A pomalidomid adagot orálisan kell bevenni minden ciklus 1. és 21. napján, abban az időpontban, amely a résztvevők számára a legkényelmesebb az izatuximab beadása előtt vagy után, lehetőleg minden nap ugyanabban az időben.
A dexametazont szájon át kell bevenni az 1., 8., 15. és 22. napon (28 naponként meg kell ismételni).
A résztvevők háttérkezelésként és/vagy mentőgyógyszerként egyéb kezelésekben is részesülhetnek.
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Gyógyszerforma: Tabletta; Az alkalmazás módja: Orális
Gyógyszerforma: kemény kapszula; Az alkalmazás módja: Orális
Más nevek:
Gyógyszerforma: oldatos koncentrátum intravénás infúzióhoz; Az alkalmazás módja: Intravénás
Más nevek:
Gyógyszerforma: A helyi kereskedelmi termék szerint; Az alkalmazás módja: Orális; Kiegészítő gyógyszerkészítmény (AxMP), azaz háttérkezelés; ATC kód: H02AB02
Gyógyszerforma: A helyi kereskedelmi termék szerint; Az alkalmazás módja: Orális; AxMP azaz háttérkezelés; ATC kód: R03DC03
Gyógyszerforma: A helyi kereskedelmi termék szerint; Az alkalmazás módja: Orális; AxMP azaz háttérkezelés; ATC kód: N02BE01
Gyógyszerforma: A helyi kereskedelmi termék szerint; Az alkalmazás módja: premedikációként - orálisan; infúziós reakciók kezelésére-IV (vagy orális ekvivalens); AxMP azaz háttérkezelés és mentőgyógyszer (infúziós reakciók esetén); ATC kód: R06AA02
Gyógyszerforma: A helyi kereskedelmi termék szerint; Az alkalmazás módja: Premedikációként-IV; infúziós reakciók kezelésére - IV (vagy orális ekvivalens); AxMP azaz háttérkezelés és mentőgyógyszer (infúziós reakciók esetén); ATC kód: H02AB04
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Kísérleti: 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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Gyógyszerforma: Oldat szubkután beadásra; Beadási mód: Subcutan (SC)
Más nevek:
Gyógyszerforma: Tabletta; Az alkalmazás módja: Orális
Gyógyszerforma: kemény kapszula; Az alkalmazás módja: Orális
Más nevek:
Gyógyszerforma: A helyi kereskedelmi termék szerint; Az alkalmazás módja: Orális; Kiegészítő gyógyszerkészítmény (AxMP), azaz háttérkezelés; ATC kód: H02AB02
Gyógyszerforma: A helyi kereskedelmi termék szerint; Az alkalmazás módja: Orális; AxMP azaz háttérkezelés; ATC kód: R03DC03
Gyógyszerforma: A helyi kereskedelmi termék szerint; Az alkalmazás módja: Orális; AxMP azaz háttérkezelés; ATC kód: N02BE01
Gyógyszerforma: A helyi kereskedelmi termék szerint; Az alkalmazás módja: premedikációként - orálisan; infúziós reakciók kezelésére-IV (vagy orális ekvivalens); AxMP azaz háttérkezelés és mentőgyógyszer (infúziós reakciók esetén); ATC kód: R06AA02
Gyógyszerforma: A helyi kereskedelmi termék szerint; Az alkalmazás módja: Premedikációként-IV; infúziós reakciók kezelésére - IV (vagy orális ekvivalens); AxMP azaz háttérkezelés és mentőgyógyszer (infúziós reakciók esetén); ATC kód: H02AB04
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
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Általános Válaszarány (ORR)
Időkeret: A vizsgálati gyógyszer első adásától (1. nap) a PCD-ig (2024. november 6.), körülbelül 28 hónapig
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ORR független felülvizsgálati bizottság (IRC) által a 2016-os nemzetközi myeloma munkacsoport (IMWG) kritériumai alapján: A résztvevők százalékos aránya teljes válasszal (CR), szigorú CR-vel (sCR), nagyon jó parciális válasszal (VGPR) és parciális válasszal (PR). CR: negatív immunfixáció a szérumban és a vizeletben, bármilyen lágy szöveti plazmocitóma (STP) eltűnése, <5% plazmasejt a csontvelő (BM) aspirátumban és normális szabad könnyű lánc (FLC) arány (0,26-1,65). sCR: CR plusz nincsenek klonális sejtek a BM biopsziában. VGPR: szérum és vizelet M-fehérje immunfixációval kimutatható, nem elektroforézissel; >=90%-os csökkenés a szérum M-fehérjében plusz vizelet M-fehérje szint <100mg/24óra; >=90%-os csökkenés a maximális merőleges átmérők összegében (SPD) az alapvonthoz képest STP-ben; Csak FLC: >=90%-os csökkenés az érintett és nem érintett FLC szintek közötti különbségben. PR: >=50%-os csökkenés a szérum M-fehérjében és >=90%-os csökkenés a 24 órás vizelet M-fehérjében vagy <200mg/24h-ra. A fentieken kívül, ha jelen volt az alapvonalképen, >=50%-os csökkenés szükséges az STP-k SPD méretében is.
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A vizsgálati gyógyszer első adásától (1. nap) a PCD-ig (2024. november 6.), körülbelül 28 hónapig
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A stabil állapotban mért Isatuximab koncentráció adagolás előtt (Ctrough)
Időkeret: Ciklus 6, 1. nap, dózis előtt
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A Ctrough egyensúlyi állapotban az isatuximab adagolás 6. ciklus 1. napján (ami a 6. ciklus 1. napja előtti időpontnak felel meg) adagolás előtt gyűjtött megfigyelt plazmakoncentráció volt.
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Ciklus 6, 1. nap, dózis előtt
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
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Az Isatuximab Ctrough szintje 4 hét után (CT4W)
Időkeret: Pre-adagolás a 2. ciklus 1. napján (4 hét után)
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A CT4W az izatuximab adagolása előtt a 2. ciklus 1. napján (amely megegyezik a 2. ciklus 1. napja előttivel) gyűjtött megfigyelt plazmakoncentrációkat jelentette.
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Pre-adagolás a 2. ciklus 1. napján (4 hét után)
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A 'Betegegyüttműködési és Elégedettségi Kérdőív (PESQ-FU)': Elégedettség az Injekciós Módszerrel (8. tétel) című kérdőív Nagyon Elégedett és Elégedett válaszát adó résztvevők százalékos aránya az 5. ciklus 15. napján
Időkeret: 5. ciklus 15. napja
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A 9 tételből álló PESQ-FU kérdőív a résztvevők injekciós módszerrel kapcsolatos tapasztalatainak és elégedettségének (kellemetlenség, fájdalom, mellékhatások, időmegtakarítás és elégedettség) valamint a vizsgálati gyógyszerrel kapcsolatos tapasztalataiknak (mellékhatások, érdemes volt szedni, elégedettség és ajánlás) a nyomon követésére készült.
Ez a kérdőív onkológiai résztvevőkkel folytatott kvalitatív interjúk alapján lett módosítva.
Az 'injekciós módszerrel való elégedettség' válaszait 'nagyon elégedett, elégedett, sem elégedett sem nem elégedett, elégedetlen és nagyon elégedetlen' kategóriákban rögzítették meghatározott időpontokban.
Azon résztvevők teljes százalékos aránya, akik nagyon elégedettek és elégedettek voltak az injekciós módszerrel (8. tétel) az 5. ciklus 15. napján, itt kerül jelentésre.
A százalékos arányokat a tizedes helyre kerekítették.
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5. ciklus 15. napja
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Isatuximab Ctrough értéke
Időkeret: Pre-administráció a 1. ciklus 8., 15. és 22. napján, a 2-5. ciklusok 1. és 15. napján, a 6., 7., 8., 9., 12., 15., 18., 21., 24. és 27. ciklusok 1. napján
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A plazma mintákat meghatározott időpontokban gyűjtötték össze a Ctrough értékelésére.
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Pre-administráció a 1. ciklus 8., 15. és 22. napján, a 2-5. ciklusok 1. és 15. napján, a 6., 7., 8., 9., 12., 15., 18., 21., 24. és 27. ciklusok 1. napján
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A résztvevők százalékos aránya, akik válaszoltak a 'Betegek elvárásainak kérdőíve a kiindulási időpontban (PEQ-BL)' kérdőívre
Időkeret: Alapvonal (1. ciklus 1. nap)
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Jelentésre került azon résztvevők százalékos aránya, akik az alapvonalon erősen egyetértettek vagy egyetértettek a fájdalommal, kellemetlenséggel és mellékhatásokkal kapcsolatos elvárásokkal kapcsolatban az injekciós módszerrel, hogy az injekciós módszer időt takarít meg, hogy a vizsgálati gyógyszer mellékhatásokat okozhat, és hogy érdemes lenne bevenni.
A PEQ-BL 7 tényezőből állt.
Szintén jelentésre került azon résztvevők százalékos aránya, akik valaha intravenás és/vagy subcután adagolással kaptak gyógyszert.
A százalékos arányok a tizedik tizedesjegyre kerekítve vannak.
Az alapvonal értéke a vizsgálati gyógyszer kezdési dátumán vagy az azt megelőzően gyűjtött utolsó nem hiányzó értékként volt meghatározva.
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Alapvonal (1. ciklus 1. nap)
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Egészségügyi Erőforrás-felhasználás és Termelékenység Kérdőív (HRUPQ): Alapvonal Egészségügyi Igénybevétel: A Részvevő Ápolásban Részesülésének Alkalmainak Száma az Elmúlt 6 Hónapban
Időkeret: Alapvizsgálat (1. ciklus 1. nap)
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A vizsgálati gyógyszer beadása előtti alapvonalon történő egészségügyi ellátás igénybevételét a HRUPQ-n keresztül gyűjtötték.
Bemutatjuk az elmúlt 6 hónapban a résztvevők átlagos számú alkalmát, amikor klinikán vagy kórházi sürgősségi osztályon ellátásban részesültek bármilyen egészségügyi probléma, beleértve az MM-t vagy az MM miatt, valamint ápolói vagy más egészségügyi szakember által nyújtott otthoni ellátásban bármilyen egészségügyi probléma, beleértve az MM-t vagy az MM miatt.
Az alapvonal értéke a vizsgálati gyógyszer kezdési dátumán vagy az azt megelőzően gyűjtött utolsó nem hiányzó értékként lett meghatározva.
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Alapvizsgálat (1. ciklus 1. nap)
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HRUPQ: Alapvető egészségügyi igénybevétel: A résztvevő kórházban töltött éjszakáinak száma az elmúlt 6 hónapban
Időkeret: Alapvonal (1. ciklus 1. nap)
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Az alapvonalon történő egészségügyi ellátás igénybevétele a vizsgálati gyógyszer beadása előtt a HRUPQ-n keresztül gyűjtött adatok alapján történt.
Bemutatjuk az elmúlt 6 hónapban azon éjszakák átlagos számát, amikor a résztvevő bármilyen egészségügyi probléma, beleértve az MM-t vagy az MM miatt, kórházban, valamint intenzív osztályon (ICU) töltött.
Az alapvonal értéke a vizsgálati gyógyszer kezdési dátumán vagy az azt megelőzően gyűjtött utolsó nem hiányzó értékként lett meghatározva.
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Alapvonal (1. ciklus 1. nap)
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HRUPQ: Alapvonalas Egészségügyi Kihasználtság: A Részvevők Alkalmainak Száma, Amikor Egészségügyi Szakembert (HCP) Kerestek Fel az Elmúlt 6 Hónapban
Időkeret: Alapvonal (1. ciklus 1. nap)
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Az egészségügyi ellátás igénybevétele a tanulmányi gyógyszer beadása előtti alapvonalon a HRUPQ segítségével gyűjtötték.
Az elmúlt 6 hónapban a résztvevők átlagos alkalmak száma, amikor megkérdeztek (látogatták vagy beszéltek) a következő egészségügyi szakembereket: általános orvos vagy elsődleges ellátási klinikus (PCC), aki különféle betegségeket kezel bármilyen egészségügyi probléma esetén, beleértve az MM-t vagy az MM-hez kapcsolódóan, fizikai vagy munkaterápiás szakember bármilyen egészségügyi probléma esetén, beleértve az MM-t vagy az MM-hez kapcsolódóan, mentálhigiénés szakember (pl. pszichiáter, pszichológus, pszichiátriai ápoló) bármilyen egészségügyi probléma esetén, beleértve az MM-t vagy az MM-hez kapcsolódóan, orvos vagy klinikus, aki egy adott orvosi betegségre vagy problémára szakosodott (szakorvos) bármilyen egészségügyi probléma esetén, beleértve az MM-t vagy az MM-hez kapcsolódóan, bemutatásra kerül.
Az alapvonal értéket a tanulmányi gyógyszer kezdési dátumán vagy azt megelőzően gyűjtött utolsó nem hiányzó értékként határozták meg.
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Alapvonal (1. ciklus 1. nap)
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A vizsgálat során HRUPQ alapján nyugdíjba vonult résztvevők százalékos aránya
Időkeret: Az első dózis beadásától kezdve (1. nap) a PCD-ig (2024. november 6.), kb. 28 hónapig
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A foglalkoztatási állapotot a HRUPQ segítségével értékelték.
A tanulmány során valaha is nyugdíjba vonult résztvevők százalékos arányát közöljük.
A százalékos arányokat a tizedes helyre kerekítjük.
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Az első dózis beadásától kezdve (1. nap) a PCD-ig (2024. november 6.), kb. 28 hónapig
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Az MM miatt korán abbahagyó résztvevők százalékos aránya a HRUPQ alapján
Időkeret: A vizsgálati gyógyszer első adásától (1. nap) a PCD-ig (2024. november 6.), körülbelül 28 hónapig
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A foglalkoztatási állapotot a HRUPQ segítségével értékelték.
A résztvevők azon százalékos arányát jelentik, akik korán nyugdíjba vonultak MM miatt.
A százalékos arányokat a tizedes helyre kerekítették.
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A vizsgálati gyógyszer első adásától (1. nap) a PCD-ig (2024. november 6.), körülbelül 28 hónapig
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Very Good Partial Response or Better Rate
Időkeret: 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
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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
Időkeret: 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
Időkeret: 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'
Időkeret: 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'
Időkeret: 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'
Időkeret: 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'
Időkeret: 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'
Időkeret: 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'
Időkeret: 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'
Időkeret: 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'
Időkeret: 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'
Időkeret: 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)'
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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)
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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)
Időkeret: Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (up to PCD: 06-Nov-2024) (30 days after last drug administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)
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The EQ-5D-5L is a standardized measure of health status that provides a simple, generic measure of health utility, and consists of 2 sections: descriptive and a VAS.
The descriptive system consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems.
The VAS records the respondent's self-rated health on a 20-cm vertical scale ranging from 0: the worst health you can imagine to 100: the best health you can imagine.
Change from baseline in VAS is reported here.
A higher score in VAS and positive change from baseline represents a better level of QoL.
The baseline value was defined as the last non-missing value collected on or before the start date of study medication.
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Baseline (Cycle 1 Day 1) and Cycle 2 Day 1, Cycles 3 to 21 Day 15 and EOT visit (up to PCD: 06-Nov-2024) (30 days after last drug administration or before further anti myeloma therapy initiation, whichever occurred first, up to approximately 28 months)
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ORR Based on at Least 1 Chromosomal Abnormality
Időkeret: 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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Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Szponzor
Nyomozók
- Tanulmányi igazgató: Clinical Sciences & Operations, Sanofi
Publikációk és hasznos linkek
A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.
Hasznos linkek
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
2022. június 23.
Elsődleges befejezés (Tényleges)
2024. november 6.
A tanulmány befejezése (Becsült)
2027. október 22.
Tanulmányi regisztráció dátumai
Először benyújtva
2022. május 31.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2022. május 31.
Első közzététel (Tényleges)
2022. június 6.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
2026. szeptember 2.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2026. augusztus 10.
Utolsó ellenőrzés
2026. augusztus 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
- Érrendszeri betegségek
- Szív-és érrendszeri betegségek
- Neoplazmák
- Immunrendszeri betegségek
- Neoplazmák szövettani típus szerint
- Hematológiai betegségek
- Limfoproliferatív rendellenességek
- Immunproliferatív rendellenességek
- Hemostatikus rendellenességek
- Paraproteinémiák
- Vérfehérje rendellenességek
- Hemorrhagiás rendellenességek
- Myeloma multiplex
- Neoplazmák, plazmasejt
- Szerves vegyi anyagok
- Szénhidrogének
- Szénhidrogének, ciklikus
- Szénhidrogének, aromás
- Policiklusos vegyületek
- Anilidok
- Kialakulás
- Anilinvegyületek
- Aminok
- Acetanilidek
- Terhesség
- Terhesség
- Szteroidok
- Olvasztott gyűrűs vegyületek
- Szteroidok, fluortartalmú
- Benzolszármazékok
- Remoklóriumok
- Etil -aminok
- Prednizolon
- Benzhidrilvegyületek
- Dexametazon
- Acetaminofen
- Metilprednizolon
- Difenhidramin
- pomalidomid
- izatuximab
- montelukaszt
Egyéb vizsgálati azonosító számok
- EFC15951
- 2023 (Az Egyesült Államok NIH támogatása/szerződése: GRAMMY Museum Foundation)
- U1111-1261-5846 (Registry Identifier: ICTRP)
- 2023-508869-32 (EudraCT szám: CTIS)
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IGEN
IPD terv leírása
A minősített kutatók hozzáférést kérhetnek a betegszintű adatokhoz és a kapcsolódó vizsgálati dokumentumokhoz, beleértve a klinikai vizsgálati jelentést, a vizsgálati protokollt az esetleges módosításokkal, az üres esetjelentési űrlapot, a statisztikai elemzési tervet és az adatkészlet specifikációit.
A betegszintű adatokat anonimizáljuk, a vizsgálati dokumentumokat pedig töröljük a vizsgálatban résztvevők magánéletének védelme érdekében.
A Sanofi adatmegosztási kritériumairól, a jogosult tanulmányokról és a hozzáférés kérésének folyamatáról további részletek a következő címen találhatók: https://vivli.org.
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Igen
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
Nem
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