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Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
Sponsor: GlaxoSmithKline
Summary
This is a Phase 3, randomized, open-label study designed to evaluate safety and efficacy of belantamab mafodotin in combination with bortezomib/dexamethasone (Arm A) versus daratumumab in combination with bortezomib/dexamethasone (Arm B) in the participants with relapsed recurrent multiple myeloma.
Official title: DREAMM 7: A Multicenter, Open-Label, Randomized Phase III Study to Evaluate the Efficacy and Safety of the Combination of Belantamab Mafodotin, Bortezomib, and Dexamethasone (B-Vd) Compared With the Combination of Daratumumab, Bortezomib and Dexamethasone (D-Vd) in Participants With Relapsed/Refractory Multiple Myeloma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
494
Start Date
2020-05-07
Completion Date
2026-06-19
Last Updated
2024-10-24
Healthy Volunteers
No
Conditions
Interventions
Belantamab mafodotin
Humanized anti-B-cell maturation antigen (BCMA) antibody/drug conjugate
Daratumumab
Anti-cluster of differentiation 38 \[CD-38\] monoclonal antibody
Bortezomib
Proteasome Inhibitor
Dexamethasone
Synthetic glucocorticoid with anti-tumor activity
Locations (144)
GSK Investigational Site
Yuma, Arizona, United States
GSK Investigational Site
Denver, Colorado, United States
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Fairfield, Connecticut, United States
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Kansas City, Kansas, United States
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Tyler, Texas, United States
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Roanoke, Virginia, United States
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Camperdown, New South Wales, Australia
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Liverpool, New South Wales, Australia
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St Leonards, New South Wales, Australia
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Waratah, New South Wales, Australia
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Wollongong, New South Wales, Australia
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Benowa, Queensland, Australia
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Herston, Queensland, Australia
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Ashford, South Australia, Australia
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Box Hill, Victoria, Australia
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Heidelberg, Victoria, Australia
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Melbourne, Victoria, Australia
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Murdoch, Western Australia, Australia
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Nedlands, Western Australia, Australia
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Brussels, Belgium
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Brussels, Belgium
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Ghent, Belgium
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Roeselare, Belgium
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Florianópolis, Brazil
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Joinville, Brazil
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Natal, 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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Edmonton, Alberta, Canada
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London, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Beijing, China
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Beijing, China
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Changchun, China
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Guangzhou, China
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Guangzhou, China
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Hangzhou, China
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Jinan, China
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Nanjing, China
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Shenyang, China
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Suzhou, China
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Tianjin, China
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Zhengzhou, China
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Brno, Czechia
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Hradec Králové, Czechia
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Ostrava, Czechia
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Prague, Czechia
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Amiens, France
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Caen, France
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Nice, France
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Paris, France
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Rennes, France
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Cologne, Germany
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Düsseldorf, Germany
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Jena, Germany
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München, Germany
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Ulm, Germany
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Würzburg, Germany
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Alexandroupoli, Greece
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Athens, Greece
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Thessaloniki, Greece
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Jerusalem, Israel
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Kfar Saba, Israel
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Tel Aviv, Israel
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Tel Litwinsky, Israel
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Bergamo, Italy
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Bologna, Italy
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Brescia, Italy
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Catania, Italy
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Meldola FC, Italy
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Milan, Italy
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Ravenna, Italy
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Roma, Italy
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Siena, Italy
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Torino, Italy
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Aichi, Japan
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Aichi, Japan
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Aomori, Japan
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Ehime, Japan
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Fukuoka, Japan
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Fukuoka, Japan
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Fukuoka, Japan
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Fukuoka, Japan
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Gifu, Japan
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Gunma, Japan
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Hyōgo, Japan
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Kanagawa, Japan
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Kanagawa, Japan
GSK Investigational Site
Kochi, Japan
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Nagano, Japan
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Okayama, Japan
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Osaka, Japan
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Osaka, Japan
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Shizuoka, Japan
GSK Investigational Site
Dordrecht, Netherlands
GSK Investigational Site
Groningen, Netherlands
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Christchurch, New Zealand
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Dunedin, New Zealand
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Takapuna Auckland, New Zealand
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Wellington, New Zealand
GSK Investigational Site
Chorzów, Poland
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Krakow, Poland
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Lodz, Poland
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Lublin, Poland
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Lublin, Poland
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Nowy Sącz, Poland
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Poznan, Poland
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Warsaw, Poland
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Moscow, Russia
GSK Investigational Site
Nizhny Novgorod, Russia
GSK Investigational Site
Novosibirsk, Russia
GSK Investigational Site
Saint Petersburg, Russia
GSK Investigational Site
Saint Petersburg, Russia
GSK Investigational Site
Samara, Russia
GSK Investigational Site
Saratov, Russia
GSK Investigational Site
Ufa, Russia
GSK Investigational Site
Pusan, South Korea
GSK Investigational Site
Seongnam-si Gyeonggi-do, South Korea
GSK Investigational Site
Seoul, South Korea
GSK Investigational Site
Seoul, South Korea
GSK Investigational Site
Ulsan, South Korea
GSK Investigational Site
Barcelona, Spain
GSK Investigational Site
Barcelona, Spain
GSK Investigational Site
Cáceres, Spain
GSK Investigational Site
Gijón, Spain
GSK Investigational Site
L'Hospitalet de Llobrega, Spain
GSK Investigational Site
Madrid, Spain
GSK Investigational Site
Madrid, Spain
GSK Investigational Site
MOstoles Madrid, Spain
GSK Investigational Site
Murcia, Spain
GSK Investigational Site
PamplonaNavarra, Spain
GSK Investigational Site
Pozuelo de AlarcOn Madr, Spain
GSK Investigational Site
Salamanca, Spain
GSK Investigational Site
Bournemouth, United Kingdom
GSK Investigational Site
Cardiff, United Kingdom
GSK Investigational Site
Dundee, United Kingdom
GSK Investigational Site
Leicester, United Kingdom
GSK Investigational Site
London, United Kingdom
GSK Investigational Site
Stoke-on-Trent, United Kingdom
GSK Investigational Site
Sutton, United Kingdom