Studie av enkeltmiddel Belantamab Mafodotin versus Pomalidomid Plus Lavdose deksametason (Pom/Dex) hos deltakere med residiverende/refraktært myelomatose (RRMM) (DREAMM-3)
5. juni 2026 oppdatert av: GlaxoSmithKline
En fase III, åpen, randomisert studie for å evaluere effektiviteten og sikkerheten til enkeltmiddel Belantamab Mafodotin sammenlignet med Pomalidomid Plus lavdose deksametason (Pom/Dex) hos deltakere med residiverende/refraktært myelomatose (RRMM) (DREAMM 3)
Denne åpne, randomiserte studien for å evaluere effektiviteten og sikkerheten til enkeltmiddel belantamab mafodotin sammenlignet med pom/dex hos deltakere med RRMM.
Deltakerne vil bli randomisert i et 2:1-forhold for å motta enten enkeltmiddel belantamab mafodotin eller pom/dex.
Belantamab mafodotin vil bli administrert på dag 1 (D1) hver 3. uke (Q3W).
Pomalidomid vil bli administrert daglig på dag 1 til 21 i hver 28-dagers syklus, med deksametason administrert én gang i uken (dag 1, 8, 15 og 22).
Deltakere i begge armer vil bli behandlet inntil sykdomsprogresjon, død, uakseptabel toksisitet, tilbaketrekking av samtykke og tapt til oppfølging eller slutten av studien, avhengig av hva som kommer først.
Studieoversikt
Status
Aktiv, ikke rekrutterende
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
325
Fase
- Fase 3
Utvidet tilgang
Tilgjengelig utenfor den kliniske utprøvingen.
Se utvidet tilgangspost.
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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St Albans, Australia, 03021
- GSK Investigational Site
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New South Wales
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Gosford NSW, New South Wales, Australia, 2250
- GSK Investigational Site
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Liverpool, New South Wales, Australia, 2170
- GSK Investigational Site
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St Leonards, New South Wales, Australia, 2065
- GSK Investigational Site
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South Australia
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Woodville, South Australia, Australia, 5011
- GSK Investigational Site
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Tasmania
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Hobart, Tasmania, Australia, 7000
- GSK Investigational Site
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Victoria
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Clayton, Victoria, Australia, 3168
- GSK Investigational Site
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Fitzroy, Victoria, Australia, 3065
- GSK Investigational Site
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Geelong, Victoria, Australia, 3220
- GSK Investigational Site
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Western Australia
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Nedlands, Western Australia, Australia, 6009
- GSK Investigational Site
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Bruges, Belgia, 8000
- GSK Investigational Site
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Brussels, Belgia, 1200
- GSK Investigational Site
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Brussels, Belgia, 1090
- GSK Investigational Site
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Edegem, Belgia, 2650
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Kortrijk, Belgia, 8500
- GSK Investigational Site
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Yvoir, Belgia, 5530
- GSK Investigational Site
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Curitiba, Brasil, 80530-010
- GSK Investigational Site
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Fortaleza, Brasil, 60115-281
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Porto Alegre, Brasil, 90110-270
- GSK Investigational Site
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Rio de Janeiro, Brasil, 22793-080
- GSK Investigational Site
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São Paulo, Brasil, 04537-080
- GSK Investigational Site
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São Paulo, Brasil, 01321001
- GSK Investigational Site
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São Paulo, Brasil, 01509-900
- GSK Investigational Site
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São Paulo, Brasil, 05651-901
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brasil, 90035-903
- GSK Investigational Site
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Pleven, Bulgaria, 5800
- GSK Investigational Site
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Plovdiv, Bulgaria, 4000
- GSK Investigational Site
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Sofia, Bulgaria, 1606
- GSK Investigational Site
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Sofia, Bulgaria, 1407
- GSK Investigational Site
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Sofia, Bulgaria, 1000
- GSK Investigational Site
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Sofia, Bulgaria, 01431
- GSK Investigational Site
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Alberta
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Edmonton, Alberta, Canada, T6G 1Z2
- GSK Investigational Site
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Arizona
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Tucson, Arizona, Forente stater, 85715
- GSK Investigational Site
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Colorado
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Pueblo, Colorado, Forente stater, 81008
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Michigan
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Detroit, Michigan, Forente stater, 48202
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Nebraska
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Omaha, Nebraska, Forente stater, 68130
- GSK Investigational Site
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New York
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Clifton Park, New York, Forente stater, 12065
- GSK Investigational Site
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Ohio
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Cincinnati, Ohio, Forente stater, 45236
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Oregon
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Corvallis, Oregon, Forente stater, 97330
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Eugene, Oregon, Forente stater, 97401
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Texas
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Tyler, Texas, Forente stater, 75702
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Wisconsin
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Milwaukee, Wisconsin, Forente stater, 53226
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Le Mans, Frankrike, 72015
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Montpellier, Frankrike, 34295
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Poitiers, Frankrike, 86021
- GSK Investigational Site
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Athens, Hellas, 10676
- GSK Investigational Site
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Athens, Hellas, 115 28
- GSK Investigational Site
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Haidari - Athens, Hellas, 12462
- GSK Investigational Site
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Larissa, Hellas, 41 110
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Pátrai, Hellas, 26500
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Thessaloniki, Hellas, 57010
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Thessaloniki, Hellas, 54007
- GSK Investigational Site
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Bologna, Italia, 40138
- GSK Investigational Site
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Brescia, Italia, 25123
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Catanzaro, Italia, 88100
- GSK Investigational Site
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Milan, Italia, 20122
- GSK Investigational Site
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Milan, Italia, 20141
- GSK Investigational Site
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Pavia, Italia, 27100
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Perugia, Italia, 05100
- GSK Investigational Site
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Ravenna, Italia, 48123
- GSK Investigational Site
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Roma, Italia, 00161
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San Giovanni Rotondo FG, Italia, 71013
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Siena, Italia, 53100
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Aichi, Japan, 467-8602
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Chiba, Japan, 277-8567
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Ehime, Japan, 790-8524
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Fukushima, Japan, 960-1295
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Gifu, Japan, 503-8502
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Gunma, Japan, 377-0280
- GSK Investigational Site
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Hokkaido, Japan, 060-8648
- GSK Investigational Site
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Kyoto, Japan, 602-8566
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Kyoto, Japan, 603-8151
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Osaka, Japan, 565-0871
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Tokyo, Japan, 108-8639
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Tokyo
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Shibuya-Ku, Tokyo, Japan, 150-8935
- GSK Investigational Site
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Beijing, Kina, 100050
- GSK Investigational Site
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Beijing, Kina, 100191
- GSK Investigational Site
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Beijing, Kina, 100730
- GSK Investigational Site
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Beijing, Kina, 100000
- GSK Investigational Site
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Changsha, Kina, 130012
- GSK Investigational Site
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Chengdu, Kina, 610041
- GSK Investigational Site
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Guangzhou, Kina, 510080
- GSK Investigational Site
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Hangzhou, Kina, 310009
- GSK Investigational Site
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Nanchang, Kina, 330006
- GSK Investigational Site
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Shenzhen, Kina, 518029
- GSK Investigational Site
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Tianjin, Kina, 300020
- GSK Investigational Site
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Tianjin, Kina, 300060
- GSK Investigational Site
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Xuzhou, Kina, 221006
- GSK Investigational Site
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Zhengzhou, Kina, 450052
- GSK Investigational Site
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Amersfoort, Nederland, 3813 TZ
- GSK Investigational Site
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Gdansk, Polen, 80-214
- GSK Investigational Site
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Krakow, Polen, 30510
- GSK Investigational Site
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Torun, Polen, 87-100
- GSK Investigational Site
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Kaluga, Russland, 248007
- GSK Investigational Site
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Kirov, Russland, 610027
- GSK Investigational Site
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Krasnoyarsk, Russland, 660022
- GSK Investigational Site
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Nizhny Novgorod, Russland, 603137
- GSK Investigational Site
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Novosibirsk, Russland, 630087
- GSK Investigational Site
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Saint Petersburg, Russland, 191024
- GSK Investigational Site
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Saint Petersburg, Russland, 197341
- GSK Investigational Site
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Samara, Russland, 443099
- GSK Investigational Site
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Sochi, Russland, 354057
- GSK Investigational Site
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Syktyvkar, Russland, 167904
- GSK Investigational Site
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Tula, Russland, 300053
- GSK Investigational Site
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Yekaterinburg, Russland, 620102
- GSK Investigational Site
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Barcelona, Spania, 08036
- GSK Investigational Site
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Barcelona, Spania, 08916
- GSK Investigational Site
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L'Hospitalet de Llobrega, Spania, 08908
- GSK Investigational Site
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Málaga, Spania, 29004
- GSK Investigational Site
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PamplonaNavarra, Spania, 31008
- GSK Investigational Site
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Pozuelo de AlarcOn Madr, Spania, 28223
- GSK Investigational Site
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Santiago de Compostela, Spania, 15706
- GSK Investigational Site
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Airdrie, Storbritannia, ML6 0JS
- GSK Investigational Site
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Dundee, Storbritannia, DD1 9SY
- GSK Investigational Site
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Edinburgh, Storbritannia, EH4 2XU
- GSK Investigational Site
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London, Storbritannia, W12 0NN
- GSK Investigational Site
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London, Storbritannia, EC1 7ED
- GSK Investigational Site
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Nottingham, Storbritannia, NG5 1PB
- GSK Investigational Site
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Oxford, Storbritannia, OX3 7LJ
- GSK Investigational Site
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Plymouth, Storbritannia, PL6 8D8
- GSK Investigational Site
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Stoke-on-Trent, Storbritannia, ST4 6QG
- GSK Investigational Site
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Gyeonggi-do, Sør -Korea, 10408
- GSK Investigational Site
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Hwasun, Sør -Korea, 58128
- GSK Investigational Site
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Incheon, Sør -Korea, 21565
- GSK Investigational Site
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Seongnam-si Gyeonggi-do, Sør -Korea, 13620
- GSK Investigational Site
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Seoul, Sør -Korea, 03080
- GSK Investigational Site
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Seoul, Sør -Korea, 06591
- GSK Investigational Site
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Seoul, Sør -Korea, 05505
- GSK Investigational Site
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Berlin, Tyskland, 13125
- GSK Investigational Site
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Tübingen, Tyskland, 72076
- GSK Investigational Site
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Budapest, Ungarn, 1083
- GSK Investigational Site
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Budapest, Ungarn, 1097
- GSK Investigational Site
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Budapest, Ungarn, 1088
- GSK Investigational Site
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Debrecen, Ungarn, 4012
- GSK Investigational Site
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Kaposvár, Ungarn, 7400
- GSK Investigational Site
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Nyíregyháza, Ungarn, 4400
- GSK Investigational Site
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
14 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Beskrivelse
Inklusjonskriterier:
- I stand til å gi signert informert samtykke.
- Deltakere må være 18 år eller eldre på tidspunktet for signering av det informerte samtykket. I Republikken Korea må deltakerne være over 19 år inkludert, på tidspunktet for undertegning av informert samtykke.
- Eastern Cooperative Oncology Group (ECOG) ytelsesstatus på 0 til 2.
- Histologisk eller cytologisk bekreftet diagnose av multippelt myelom (MM) som definert i henhold til IMWG, og: Har gjennomgått autolog stamcelletransplantasjon (SCT), eller anses som ikke kvalifisert for transplantasjon; Har mottatt minst 2 tidligere linjer med myelombehandlinger, inkludert minst 2 påfølgende sykluser av både lenalidomid og en proteasomhemmer (gitt separat eller i kombinasjon), og må ha dokumentert sykdomsprogresjon ved eller innen 60 dager etter fullføring av siste behandling eller må være ikke-responsiv under siste behandling, der ikke-responsiv er definert som å ikke oppnå minst minimal respons (MR) etter 2 komplette behandlingssykluser. I slike tilfeller må manglende oppnåelse av minst MR fastslås tidligst minst 4 uker etter siste behandling.
- Har målbar sykdom med minst ett av følgende: Serum M-protein >=0,5 gram per desiliter (g/dL) (>=5 gram per liter); Urin M-protein >=200 mg/24 timer; Serumfri lett kjede (FLC)-analyse: Involvert FLC-nivå >=10 milligram per desiliter (mg/dL) (>=100 mg/L) og et unormalt serum-FLC-forhold (1,65).
- Deltakere med en historie med autolog SCT er kvalifisert for studiedeltakelse forutsatt at følgende kvalifikasjonskriterier er oppfylt: Transplantasjon var >100 dager før initiering av studiebehandling; Ingen aktiv(e) infeksjon(er).
- Tilstrekkelig organsystemfunksjoner som definert: Absolutt nøytrofiltall (ANC) >=1,0*10^9/L; Hemoglobin >= 8,0 g/dL; Blodplater >= 50x10^9/L; Total bilirubin 1,5*ULN er akseptabelt hvis bilirubin er fraksjonert og direkte bilirubin
- Prevensjonsbruk av menn eller kvinner bør være i samsvar med lokale forskrifter angående prevensjonsmetoder for de som deltar i kliniske studier. Mannlige deltakere er kvalifisert til å delta hvis de samtykker i følgende i løpet av intervensjonsperioden og inntil 6 måneder etter siste dose av studieintervensjon for å tillate fjerning av endret sæd: Avstå fra å donere sæd PLUS, enten: Vær avholdende fra heteroseksuelle samleie som deres foretrukne og vanlige livsstil (avholdende på langsiktig og vedvarende basis) og godtar å forbli avholdende ELLER Må godta å bruke prevensjon/barriere som beskrevet nedenfor avhengig av om de er randomisert til arm 1 (belantamab mafodotin) eller arm 2 (pom/ dex), selv om de har gjennomgått en vellykket vasektomi: Godta å bruke en mannlig kondom gjennom hele studiebehandlingen inkludert 6 måneders oppfølgingsperiode selv om de har gjennomgått en vellykket vasektomi og en kvinnelig partner å bruke en ekstra svært effektiv prevensjonsmetode med en feilprosent på
- En kvinnelig deltaker er kvalifisert til å delta hvis hun ikke er gravid eller ammer, og minst ett av følgende forhold gjelder: Er ikke en kvinne i fertil alder (WOCBP) ELLER er en WOCBP og godtar å overholde følgende: Arm 1 ( belantamab mafodotin): Bruk en prevensjonsmetode som er svært effektiv (med en feilrate på
- Alle tidligere behandlingsrelaterte toksisiteter (definert av National Cancer Institute- Common Toxicity Criteria for Adverse Events [NCI-CTCAE], versjon 5.0, 2017) må være
Ekskluderingskriterier:
- Symptomatisk amyloidose, aktivt POEMS-syndrom (polynevropati, organomegali, endokrinopati, myelomprotein og hudforandringer); aktiv plasmacelleleukemi på tidspunktet for screening.
- Systemisk anti-myelombehandling eller bruk av et undersøkelsesmiddel innen
- Tidligere behandling med et anti-MM monoklonalt antistoff innen 30 dager før første dose av studieintervensjon.
- Tidligere B-cellemodningsantigen (BCMA)-målrettet terapi eller tidligere pomalidomidbehandling.
- Plasmaferese innen 7 dager før første dose av studieintervensjon.
- Tidligere allogen stamcelletransplantasjon. (Deltakere som har gjennomgått en syngenisk transplantasjon vil bare bli tillatt dersom ingen historie med, eller for tiden aktiv, graft-versus-host-sykdom [GvHD]).
- Enhver større operasjon i løpet av de siste 4 ukene.
- Tilstedeværelse av aktiv nyretilstand (infeksjon, behov for dialyse eller enhver annen tilstand som kan påvirke deltakerens sikkerhet). Deltakere med isolert proteinuri som følge av MM er kvalifisert, forutsatt at de oppfyller kriteriene som beskrevet i inklusjonskriteriene.
- Enhver alvorlig og/eller ustabil eksisterende medisinsk, psykiatrisk lidelse eller andre tilstander (inkludert laboratorieavvik) som kan forstyrre deltakerens sikkerhet, innhenting av informert samtykke eller overholdelse av studieprosedyrer.
- Anamnese med (ikke-smittsom) lungebetennelse som krevde steroider, eller nåværende pneumonitt.
- Bevis på aktiv slimhinneblødning eller indre blødning.
- Gjeldende ustabil lever- eller gallesykdom per etterforskers vurdering definert av tilstedeværelsen av ascites, encefalopati, koagulopati, hypoalbuminemi, esophageal eller gastrisk varicer, vedvarende gulsott eller skrumplever. (Stabil kronisk leversykdom [inkludert Gilberts syndrom eller asymptomatiske gallestein] eller hepatobiliær involvering av malignitet er akseptabelt hvis deltakeren ellers oppfyller opptakskriteriene)
- Deltakere med tidligere eller samtidige maligniteter andre enn myelomatose er ekskludert, med mindre den andre maligniteten har blitt ansett som medisinsk stabil i minst 2 år. Deltakeren må ikke motta aktiv terapi, annet enn hormonbehandling for denne sykdommen. (Deltakere med kurativt behandlet ikke-melanom hudkreft er tillatt uten 2-års begrensning).
- Bevis på kardiovaskulær risiko inkludert noen av følgende: Bevis på aktuelle klinisk signifikante ukontrollerte arytmier inkludert klinisk signifikante elektrokardiogram (EKG) abnormiteter inkludert 2. grad (Mobitz Type II) eller 3. grads atrioventrikulær blokkering; Anamnese med hjerteinfarkt, akutte koronare syndromer (inkludert ustabil angina), koronar angioplastikk eller stenting eller bypass-transplantasjon innen 3 måneder etter screening; Klasse III eller IV hjertesvikt som definert av New York Heart Association (NYHA) funksjonelle klassifiseringssystem; Ukontrollert hypertensjon.
- Kjent umiddelbar eller forsinket overfølsomhetsreaksjon eller idiosynkrasi til legemidler som er kjemisk relatert til belantamab mafodotin, pomalidomid, deksametason eller noen av komponentene i studieintervensjonen.
- Gravid eller ammende kvinne.
- Aktiv infeksjon som krever behandling.
- Kjent humant immunsviktvirus (HIV), med mindre deltakeren kan oppfylle alle følgende kriterier: Etablert antiretroviral terapi (ART) i minst 4 uker og HIV viral belastning
- Deltakere med hepatitt B vil bli ekskludert med mindre følgende kriterier kan oppfylles: Hvis deltakeren er hepatitt B kjerneantistoff (HbcAb) positiv eller hepatitt B overflateantigen (HbsAg) negativ, bør hepatitt B virus (HBV) deoksyribonukleinsyre (DNA) være uoppdagelig på tidspunktet for screening; Hvis HbsAg+ ved screening eller
- Positivt testresultat for hepatitt C-antistoff eller positivt resultat av hepatitt C-ribonukleinsyre (RNA) ved screening eller innen 3 måneder før første dose av studiebehandlingen med mindre deltakeren kan oppfylle følgende kriterier: Hepatitt C RNA-test negativ ved screening og vellykket anti- viral behandling (vanligvis 8 ukers varighet) er nødvendig, etterfulgt av en negativ HCV RNA-test etter en utvaskingsperiode på minst 4 uker (hepatitt RNA er valgfritt og deltakere med negativ hepatitt C antistofftest er ikke pålagt å også gjennomgå hepatitt C RNA-testing ).
- Deltakere som ikke kan tolerere tromboembolisk profylakse.
- Nåværende hornhinneepitelsykdom bortsett fra mild punktert keratopati.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Deltakere som får Belantamab mafodotin
Deltakerne vil motta belantamab mafodotin enkeltmiddeldose på dag 1 av Q3W
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Belantamab mafodotin vil bli administrert.
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Aktiv komparator: Deltakere som mottar pom/dex
Deltakerne vil motta pomalidomid daglig på dag 1 til 21 av hver 28-dagers syklus, med deksametason en gang i uken på dag 1, 8, 15 og 22.
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Pomalidomid og deksametason vil bli administrert.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Progression-Free Survival (PFS) Based on Investigator-Assessed Response as Per International Myeloma Working Group (IMWG)
Tidsramme: Up to 27 months
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PFS is time from randomization until earliest date of progressive disease (PD), or death due to any cause per investigator-assessed response per IMWG.
PD is ≥25% increase from nadir in any of following: serum M-protein (absolute increase ≥0.5 gram per deciliter [g/dL]),urine M-protein(absolute increase ≥200 mg/24hr),difference between involved/uninvolved FLC levels (absolute increase >10 mg/dL) in patients without measurable serum and urine M-protein levels, or bone marrow plasma-cell percentage irrespective of baseline status (absolute increase ≥10%) in patients without measurable serum and urine M-protein levels and without measurable involved FLC levels; appearance of new lesion,≥50% increase in longest diameter of a lesion previously measured >1cm in short axis, or ≥50% increase from nadir in sum of products of two longest perpendicular diameters of more than 1 lesion; ≥50% increase in circulating plasma cells (minimum of 200 cells/microliter) if this is only measure of disease.
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Up to 27 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Overall Survival (OS)
Tidsramme: Up to approximately 263 weeks
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OS is defined as the time from randomization until death due to any cause.
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Up to approximately 263 weeks
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Overall Response Rate (ORR)
Tidsramme: Up to approximately 263 weeks
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Overall Response Rate is defined as the percentage of participants with a confirmed partial response (PR) or better (i.e., PR, very good partial response [VGPR], complete response [CR] and stringent complete response [sCR]), according to the International Myeloma Working Group (IMWG) Response Criteria.
PR: ≥50% reduction of serum M-protein and reduction in 24-hour (h) urinary M-protein by ≥90% or to <200 mg/24-h; VGPR: serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component <100 mg/24-h; CR:negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND <5% plasmacytomas in the bone marrow; sCR:stringent complete response, CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.
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Up to approximately 263 weeks
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Clinical Benefit Rate (CBR)
Tidsramme: Up to approximately 263 weeks
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Clinical benefit rate is defined as the percentage of participants with a confirmed minimal response (MR) or better according to the IMWG Response Criteria.
MR is >= 25% but < 49% reduction of serum M-protein and reduction in 24-hour urinary M-protein by 50-89%.
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Up to approximately 263 weeks
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Duration of Response (DoR)
Tidsramme: Up to approximately 263 weeks
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Duration of response is defined as the time from first documented evidence of PR or better, to the time when disease progression (PD) is documented per IMWG response criteria; or death due to PD occurs among participants who achieve an overall response, i.e. confirmed PR or better.
PD= Increase of 25% from lowest confirmed response value in 1 or more of the following criteria: Serum M-protein with absolute increase of >= 0.5 g/dL; Serum M-protein increase >= 1 g/dL if the lowest M-component was >=5 g/dL; Urinary M-protein (absolute increase must be >= 200 mg per 24 h).
PR = ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥ 90% or to <200 mg/24 h.
|
Up to approximately 263 weeks
|
|
Time to Response (TTR)
Tidsramme: Up to approximately 263 weeks
|
TTR is defined as the time between the date of randomization and the first documented evidence of response (PR or better) among participants who achieve confirmed PR or better.
PR: >=50% reduction of serum M-protein & reduction in 24h urinary M-protein by >=90%/<200mg/24 h.
|
Up to approximately 263 weeks
|
|
Time to Progression (TTP)
Tidsramme: Up to approximately 263 weeks
|
TTP is defined as the time from the date of randomization until the earliest date of documented PD (per IMWG Response Criteria) or death due to PD. PD: increase of >=25% from lowest confirmed value in any 1 of following criteria: serum M-protein (absolute increase must be >=0.5 g/dL), serum M-protein increase >=1g/dL if lowest M component was >=5g/dL; urine M-component (absolute increase must be >=200mg/24 hour),appearance of new lesion(s), >=50% increase from nadir in Sum of the Products of the maximal perpendicular Diameters of measured lesions (SPD) of >1 lesion, or >=50% increase in the longest diameter of previous lesion >1 cm in short axis.
|
Up to approximately 263 weeks
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Tidsramme: Up to approximately 263 weeks
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment.
TEAE is an event that emerged during treatment having been absent pre-treatment or worsened relative to the pre-treatment state.
AEs were to be coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.
|
Up to approximately 263 weeks
|
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Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-baseline Relative to Baseline
Tidsramme: Baseline (Day 1) and up to approximately 263 weeks
|
Blood samples were collected for evaluation of hematology parameters.
The summaries of worst-case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0.
The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values have been presented.
Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
[Basophils (Baso), Mean Corpuscular Hemoglobin Concentration (MCHC), Mean Corpuscular Hemoglobin (MCH), Mean Corpuscular Volume (MCV), Erythrocytes (Ery), Hematocrit (Hct), Monocytes (Mono), Reticulocytes (Ret), Leukocytes (Leu), Eosinophils (Eosi), Lymphocytes (Lym), Neutrophils (Neu)]
|
Baseline (Day 1) and up to approximately 263 weeks
|
|
Number of Participants With Maximum Grade Increase Post-Baseline Relative to Baseline in Hematology
Tidsramme: Baseline (Day 1) and up to approximately 263 weeks
|
Blood samples were collected for evaluation of hematology parameters.
The summaries of maximum grade increase from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE version 5.0.
Grade 1 (G1): mild; Grade 2 (G2): moderate; Grade 3 (G3): severe; Grade 4 (G4) life-threatening or disabling.
Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade.
Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
[White Blood Cells (WBC)]
|
Baseline (Day 1) and up to approximately 263 weeks
|
|
Number of Participants With Worst Case Clinical Chemistry Results Relative to Normal Range Post-baseline Relative to Baseline
Tidsramme: Baseline (Day 1) and up to approximately 263 weeks
|
Blood samples were collected for evaluation of clinical chemistry parameters.
The summaries of worst-case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0.
The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values have been presented.
Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
[Kappa Light (K Lt), Lambda (λ),Monoclonal (Mc), Protein (P), Change (Cge), Alpha (α), Beta (β), Creatine Kinase (CK), Gamma (γ) ,Immunoglobulin (I-Globulin), Indirect (In.)]
|
Baseline (Day 1) and up to approximately 263 weeks
|
|
Number of Participants With Maximum Grade Increase Post-Baseline Relative to Baseline in Clinical Chemistry
Tidsramme: Baseline (Day 1) and Up to approximately 263 weeks
|
Blood samples were collected for evaluation of clinical chemistry parameters.
The summaries of maximum grade increase from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.Grade 1 (G1): mild; Grade 2 (G2): moderate; Grade 3 (G3): severe; Grade 4 (G4) life-threatening or disabling.
Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade.
Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
[Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Aspartate Aminotransferase (AST), Creatine Kinase (CPK), Gamma Glutamyl Transferase (GGT)]
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Baseline (Day 1) and Up to approximately 263 weeks
|
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Number of Participants With Shift in Urine Albumin Creatinine Ratio From Baseline to Worst Post-Baseline
Tidsramme: Baseline (Day 1) and Up to approximately 263 weeks
|
Urine samples were analyzed for spot urine albumin/creatinine ratio (UACR)[milligrams/grams (mg/g)].
Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
The "worst post-baseline value" is defined as the highest UACR measurement recorded for a participant after the baseline assessment and up to the end of the study observation period.
The "shift" will be calculated as the difference between this worst post-baseline UACR value and the baseline UACR value (Worst Post-Baseline UACR - Baseline UACR).
Each category is reported as "Baseline category, Worst post-baseline category."
Ranges are inclusive and expressed as [lower-upper].
|
Baseline (Day 1) and Up to approximately 263 weeks
|
|
Number of Participants With Maximum Worst-case Change From Baseline in Best Corrected Visual Acuity Test (BCVA) Scores
Tidsramme: Baseline (Day 1) and up to approximately 263 weeks
|
BCVA score was assessed individually for each eye.
BCVA score was calculated based on the Logarithm of the Minimum Angle of Resolution (logMAR score).
Any worst-case change from baseline categories are presented for right and left eyes.
BCVA test scores were categorized as no change/improved vision, possible worsened vision and definite worsened vision.
No change/improved vision was defined as a change from baseline <0.12 logMAR score; a possible worsened vision was defined as a change from baseline >=0.12 to <0.3 logMAR score; a definite worsened vision was defined as a change from baseline >=0.3 logMAR score.
Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits.
Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
|
Baseline (Day 1) and up to approximately 263 weeks
|
|
Observed Plasma Concentrations of Belantamab Mafodotin- Antibody-drug Conjugate (ADC)
Tidsramme: Pre-dose on Day (D)1 of Cycles(C)1,2,3,4,6,9,12,18,24,30,36,42; End of Infusion (EOI) on D1 of C1,2,3,4&6; Start of infusion (SOI) + 2 hours(h) on D1,SOI + 24 h on D1; D4,D8-15,D22 of C1&C3; D1 of C2,3,4&6; C3D2; & End of Treatment(EOT) (~242 weeks)
|
Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin
|
Pre-dose on Day (D)1 of Cycles(C)1,2,3,4,6,9,12,18,24,30,36,42; End of Infusion (EOI) on D1 of C1,2,3,4&6; Start of infusion (SOI) + 2 hours(h) on D1,SOI + 24 h on D1; D4,D8-15,D22 of C1&C3; D1 of C2,3,4&6; C3D2; & End of Treatment(EOT) (~242 weeks)
|
|
Observed Plasma Concentrations of Belantamab Mafodotin- Total Monoclonal Antibody (mAb)
Tidsramme: Pre-dose on Day (D)1 of Cycles (C)1,2,3,4,6,9,12,18,24,30,36,42; EOI on D1 of C1,2,3, 4 & 6; SOI + 24h on D1&2 of C1&3; D4, D8-15, D22 of C1&3; D1of C2,3,4 & 6; D2 of C3; and EOT (~242 weeks)
|
Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin
|
Pre-dose on Day (D)1 of Cycles (C)1,2,3,4,6,9,12,18,24,30,36,42; EOI on D1 of C1,2,3, 4 & 6; SOI + 24h on D1&2 of C1&3; D4, D8-15, D22 of C1&3; D1of C2,3,4 & 6; D2 of C3; and EOT (~242 weeks)
|
|
Observed Plasma Concentrations of Belantamab Mafodotin-Cys-mc Microtubular Inhibitor Monomethyl Auristatin-F (MMAF)
Tidsramme: Pre-dose on Day (D)1 of Cycles (C)1,2,3,4,6,9,12,18,24,30,36,42; EOI on D1 of C1,2,3, 4 & 6; D1 SOI + 2 h of C1&3; D2 SOI + 24h of C1&3; D4, D8-15, D22 of C1&3; D1 of C2,3,4,6,9,12,18,24 & 30; D2 of C3; and EOT (~242 weeks)
|
Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin
|
Pre-dose on Day (D)1 of Cycles (C)1,2,3,4,6,9,12,18,24,30,36,42; EOI on D1 of C1,2,3, 4 & 6; D1 SOI + 2 h of C1&3; D2 SOI + 24h of C1&3; D4, D8-15, D22 of C1&3; D1 of C2,3,4,6,9,12,18,24 & 30; D2 of C3; and EOT (~242 weeks)
|
|
Number of Participants With Post-baseline Positive Anti-Drug Antibody (ADAs) Against Belantamab Mafodotin
Tidsramme: Upto approximately 263 weeks
|
Serum samples collected for the analysis of the presence of ADAs using validated immunoassays.
All samples were tested in screening assay, and positive samples were further characterized for antibody titers.
|
Upto approximately 263 weeks
|
|
Titers of ADAs Against Belantamab Mafodotin
Tidsramme: Up to approximately 263 weeks
|
Serum samples were collected and tested for the presence of antibodies against belantamab mafodotin .
Confirmed positive ADA samples were further analyzed to obtain the titer of the antibodies.
Titers of anti-drug antibodies against belantamab mafodotin is presented.
|
Up to approximately 263 weeks
|
|
Number of Participants With Symptomatic Adverse Effects as Measured by the Patient Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Tidsramme: Up to approximately 263 weeks
|
PRO-CTCAE is a patient-reported outcome measure developed to evaluate symptomatic toxicity in participants on cancer clinical trials.
The PRO-CTCAE includes an item library of 124 items representing 78 symptomatic toxicities drawn from the CTCAE.
It includes symptomatic toxicities drawn from the CTCAE like blurred vision, chills, constipation, decreased appetite, fatigue, general pain, mouth/throat sores, nausea, nosebleed, shortness of breath, vomiting, watery eyes, cough, itchy, loose/watery stools, Numb/Tingling Hands/Feet (N/T H/F), Pain/Burning (P/B) and Problems Tasting Food/Drink (Prob Tasting F/D) .
Items are scored individually on a 0 to 4 scale for severity, frequency and interference.
A score of 0 indicates no symptom or interference, while higher score of 4 signify increasing severity, frequency, and interference with daily activities.
|
Up to approximately 263 weeks
|
|
Change From Baseline (CFB) in Ocular Surface Disease Index (OSDI) Total Score
Tidsramme: Baseline (Day 1) and Up to approximately 263 weeks
|
OSDI is 12-item patient-reported outcomes questionnaire designed to provide rapid assessment of range of ocular surface symptoms, including symptoms related to chronic dry eye, severity, and impact on patient's ability to function.
In addition to an overall score, there are three subscales of OSDI: ocular symptoms, vision-related function, and environmental triggers.
OSDI items are scored on a 0 to 4 Likert-type scale, where 0 = None of the time and 4 = All of the time.
Total OSDI score = ([sum of scores for all questions answered×100]/[total number of questions answered×4]).
Subscale scores are computed similarly with only questions from each subscale used to generate its own score.
Any subscales analyzed separately would also have a maximum possible score of 100.
A score of 100=to complete disability, while a score of 0=to no disability.
Decrease in score from baseline means improvement
|
Baseline (Day 1) and Up to approximately 263 weeks
|
|
Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) Score.
Tidsramme: Baseline (Day 1), every three weeks(Q3W) starting from week 4 until week 238, End of Treatment (~242 weeks) and Follow up (~ 263 weeks)
|
The EORTC QLQ-C30 includes 30-items with single and multi-item scales.
These included five functional scales (physical functioning [PF], role functioning [RF], emotional functioning [EF] cognitive functioning [CF] and social functioning [SF]), three symptom scales (fatigue, nausea/vomiting [N/V] and pain), a global health status (GHS)/ Quality-of-Life (QoL) scale, and six single items (dyspnea, insomnia, appetite loss [AL], constipation, diarrhea and financial difficulties [FD]).
Response options are 1 to 4. Scores were averaged and transformed to 0 to 100, a high score for functional scales/ GHS/QoL represent better functioning ability or health-related quality-of-life (HRQoL), whereas a high score for symptom scales/ single items represent significant symptomatology.
Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
|
Baseline (Day 1), every three weeks(Q3W) starting from week 4 until week 238, End of Treatment (~242 weeks) and Follow up (~ 263 weeks)
|
|
Change From Baseline (CFB) in EORTC QLQ 20-item Multiple Myeloma Module (MY20) Score
Tidsramme: Baseline (Day 1), every three weeks(Q3W) starting from week 4 until week 238, End of Treatment (~242 weeks) and Follow up (~263 weeks)
|
The EORTC QLQ-MY20 is a supplement to the QLQ-C30 instrument used in participants with multiple myeloma.
The module comprised of 20 questions that addressed four myeloma-specific HRQoL domains: disease symptoms (DS), side effects of treatment (SET), future perspective (FP) and body image (BI).
Responses are 1 to 4. Scores were averaged and scales were transformed to 0 to 100 scale.
A high score for disease symptoms and side effects of treatment represented a high level of symptomatology or problems, whereas a high score for future perspective and body image represented better outcomes.
Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
|
Baseline (Day 1), every three weeks(Q3W) starting from week 4 until week 238, End of Treatment (~242 weeks) and Follow up (~263 weeks)
|
|
Change From Baseline (CFB) in EORTC IL52 Score
Tidsramme: Baseline (Day 1), every three weeks(Q3W) starting from week 4 until week 238
|
European Organization for Research and Treatment of Cancer Item Library 52 (EORTC-QLQ-IL52) is disease symptoms domain from EORTC Quality of Life Questionnaire 20-item Multiple Myeloma module) (EORTC QLQ-MY20).
Disease symptoms domain of IL52 contain 6 items covering following concepts: bone aches or pain, back pain, hip pain, arm or shoulder pain, chest pain, and pain increasing with activity.
IL52 items are scored on 1 to 4 Likert-type scale, where 1 = Not at all, 2 = A little, 3 = Quite a bit, and 4 = Very much.
A raw score is then calculated as mean of completed item responses across 6 disease symptom items.
For symptom scales, this raw score is linearly transformed to a 0 to 100 scale using the formula: [(raw score - 1) / 3] × 100.
Under this approach, a score of 0 indicates no symptoms across items, while a score of 100 indicates the highest level of symptom burden.
Accordingly, higher scores indicate greater symptom burden or worse disease symptoms
|
Baseline (Day 1), every three weeks(Q3W) starting from week 4 until week 238
|
|
Number of Participants With Minimal Residual Disease (MRD) Negativity Rate
Tidsramme: Up to approximately 263 weeks
|
MRD negativity rate is defined as the percentage of participants who are MRD negative by Next generation sequencing (NGS) method.
The number of participants with MRD negativity has been presented
|
Up to approximately 263 weeks
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: GSK Clinical Trials, GlaxoSmithKline
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
2. april 2020
Primær fullføring (Faktiske)
12. september 2022
Studiet fullført (Antatt)
11. mars 2027
Datoer for studieregistrering
Først innsendt
11. november 2019
Først innsendt som oppfylte QC-kriteriene
11. november 2019
Først lagt ut (Faktiske)
14. november 2019
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
1. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
5. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Vaskulære sykdommer
- Kardiovaskulære sykdommer
- Neoplasmer
- Sykdommer i immunsystemet
- Neoplasmer etter histologisk type
- Hematologiske sykdommer
- Lymfoproliferative lidelser
- Immunproliferative lidelser
- Neoplasmer, plasmacelle
- Hemostatiske lidelser
- Paraproteinemier
- Blodproteinforstyrrelser
- Hemoragiske lidelser
- Hemic og lymfatiske sykdommer
- Multippelt myelom
- Polysykliske forbindelser
- Gravadienes
- Gravaner
- Steroider
- Smeltede ringforbindelser
- Steroider, fluorert
- Gravadienetrioler
- Deksametason
- pomalidomid
- Belantamab mafodotin
Andre studie-ID-numre
- 207495
- 2018-004252-38 (EudraCT-nummer)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
IPD for denne studien vil bli gjort tilgjengelig via nettstedet for forespørsel om kliniske studier.
IPD-delingstidsramme
IPD vil bli gjort tilgjengelig innen 6 måneder etter publisering av resultatene av de primære endepunktene, viktige sekundære endepunkter og sikkerhetsdata for studien.
Tilgangskriterier for IPD-deling
Tilgang gis etter at et forskningsforslag er sendt inn og har mottatt godkjenning fra det uavhengige granskingspanelet og etter at en datadelingsavtale er på plass.
Tilgang gis for en innledende periode på 12 måneder, men en forlengelse kan gis, når det er berettiget, i inntil ytterligere 12 måneder.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .