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Study of Single Agent Belantamab Mafodotin Versus Pomalidomide Plus Low-dose Dexamethasone (Pom/Dex) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)
Sponsor: GlaxoSmithKline
Summary
This open-label, randomized study for evaluating the efficacy and safety of single agent belantamab mafodotin when compared to pom/dex in participants with RRMM. Participants will be randomized in a 2:1 ratio to receive either single agent belantamab mafodotin or pom/dex. Belantamab mafodotin will be administered on Day 1 (D1) at every 3 weeks (Q3W) schedule. Pomalidomide will be administered daily on Days 1 to 21 of each 28-day cycle, with dexamethasone administered once weekly (Days 1, 8, 15, and 22). Participants in both arms will be treated until disease progression, death, unacceptable toxicity, withdrawal of consent, and lost to follow-up or end of study, whichever comes first.
Official title: A Phase III, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Single Agent Belantamab Mafodotin Compared to Pomalidomide Plus Lowdose Dexamethasone (Pom/Dex) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) (DREAMM 3)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
325
Start Date
2020-04-02
Completion Date
2027-03-11
Last Updated
2026-03-31
Healthy Volunteers
No
Conditions
Interventions
Belantamab mafodotin
Belantamab mafodotin will be administered.
Pom/dex (Pomalidomide plus low dose Dexamethasone)
Pomalidomide and Dexamethasone will be administered.
Locations (102)
GSK Investigational Site
Tucson, Arizona, United States
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Pueblo, Colorado, United States
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Detroit, Michigan, United States
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Omaha, Nebraska, United States
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Clifton Park, New York, United States
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Cincinnati, Ohio, United States
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Corvallis, Oregon, United States
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Eugene, Oregon, United States
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Tyler, Texas, United States
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Milwaukee, Wisconsin, United States
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St Leonards, New South Wales, Australia
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Hobart, Tasmania, Australia
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Fitzroy, Victoria, Australia
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Geelong, Victoria, Australia
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Nedlands, Western Australia, Australia
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Bruges, Belgium
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Brussels, Belgium
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Brussels, Belgium
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Edegem, Belgium
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Kortrijk, Belgium
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Yvoir, Belgium
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Porto Alegre, Rio Grande do Sul, Brazil
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Curitiba, Brazil
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Fortaleza, Brazil
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Porto Alegre, Brazil
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Rio de Janeiro, Brazil
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São Paulo, Brazil
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São Paulo, Brazil
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São Paulo, Brazil
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São Paulo, Brazil
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Sofia, Bulgaria
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Edmonton, Alberta, Canada
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Beijing, China
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Beijing, China
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Beijing, China
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Chengdu, China
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Hangzhou, China
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Nanchang, China
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Shenzhen, China
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Tianjin, China
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Tianjin, China
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Xuzhou, China
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Zhengzhou, China
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Le Mans, France
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Montpellier, France
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Poitiers, France
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Berlin, Germany
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Tübingen, Germany
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Athens, Greece
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Athens, Greece
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Haidari - Athens, Greece
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Larissa, Greece
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Pátrai, Greece
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Thessaloniki, Greece
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Thessaloniki, Greece
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Budapest, Hungary
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Budapest, Hungary
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Budapest, Hungary
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Debrecen, Hungary
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Kaposvár, Hungary
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Nyíregyháza, Hungary
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Brescia, Italy
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Catanzaro, Italy
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Milan, Italy
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Milan, Italy
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Pavia, Italy
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Perugia, Italy
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Ravenna, Italy
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Roma, Italy
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San Giovanni Rotondo FG, Italy
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Siena, Italy
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Shibuya-Ku, Tokyo, Japan
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Aichi, Japan
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Chiba, Japan
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Ehime, Japan
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Fukushima, Japan
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Gifu, Japan
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Gunma, Japan
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Hokkaido, Japan
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Kyoto, Japan
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Kyoto, Japan
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Osaka, Japan
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Tokyo, Japan
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Amersfoort, Netherlands
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Gdansk, Poland
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Kaluga, Russia
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Gyeonggi-do, South Korea
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Hwasun, South Korea
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Incheon, South Korea
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Seongnam-si Gyeonggi-do, South Korea
GSK Investigational Site
Seoul, South Korea
GSK Investigational Site
Seoul, South Korea
GSK Investigational Site
Seoul, South Korea
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Barcelona, Spain
GSK Investigational Site
Barcelona, Spain
GSK Investigational Site
L'Hospitalet de Llobrega, Spain
GSK Investigational Site
Málaga, Spain
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PamplonaNavarra, Spain
GSK Investigational Site
Pozuelo de AlarcOn Madr, Spain
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Santiago de Compostela, Spain
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Dundee, United Kingdom
GSK Investigational Site
London, United Kingdom