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ACTIVE NOT RECRUITING
NCT04484623
PHASE3

Belantamab Mafodotin Plus Pomalidomide and Dexamethasone (Pd) Versus Bortezomib Plus Pd in Relapsed/Refractory Multiple Myeloma

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

Summary

This study will evaluate the efficacy and safety of belantamab mafodotin in combination with pomalidomide and dexamethasone (Arm A) compared with that of combination of pomalidomide, bortezomib and dexamethasone (Arm B) in participants with relapsed/refractory multiple myeloma (RRMM).

Official title: A Phase III, Multicenter, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Pomalidomide and Dexamethasone (B-Pd) Versus Pomalidomide Plus Bortezomib and Dexamethasone (PVd) in Participants With Relapsed/Refractory Multiple Myeloma (DREAMM 8)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

302

Start Date

2020-10-01

Completion Date

2029-10-25

Last Updated

2025-03-18

Healthy Volunteers

No

Interventions

DRUG

Belantamab mafodotin

Humanized anti-B-cell maturation antigen (BCMA) antibody/drug conjugate will be administered.

DRUG

Pomalidomide

Immunomodulatory drug (IMiD) will be administered.

DRUG

Dexamethasone

Synthetic glucocorticoid with anti-tumor activity will be administered.

DRUG

Bortezomib

Proteasome Inhibitor will be administered.

Locations (119)

GSK Investigational Site

Tucson, Arizona, United States

GSK Investigational Site

Fort Myers, Florida, United States

GSK Investigational Site

Boston, Massachusetts, United States

GSK Investigational Site

Kansas City, Missouri, United States

GSK Investigational Site

Nashville, Tennessee, United States

GSK Investigational Site

Garran, Australian Capital Territory, Australia

GSK Investigational Site

Darlinghurst, New South Wales, Australia

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Gosford NSW, New South Wales, Australia

GSK Investigational Site

Port Macquarie, New South Wales, Australia

GSK Investigational Site

Benowa, Queensland, Australia

GSK Investigational Site

South Brisbane, Queensland, Australia

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Adelaide, South Australia, Australia

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Fitzroy, Victoria, Australia

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Heidelberg, Victoria, Australia

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Malvern, Victoria, Australia

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Nedlands, Western Australia, Australia

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Curitiba, Brazil

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Joinville, Brazil

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Porto Alegre, Brazil

GSK Investigational Site

São Paulo, Brazil

GSK Investigational Site

Beijing, China

GSK Investigational Site

Beijing, China

GSK Investigational Site

Changchun, China

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Changsha, China

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Hangzhou, China

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Jiangsu, China

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Nanchang, China

GSK Investigational Site

Shenyang, China

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Tianjin, China

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Brno, Czechia

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Hradec Králové, Czechia

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Prague, Czechia

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Marseille, France

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Toulouse, France

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Vanduvre-lEs-Nancy, France

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Mainz, Germany

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Tübingen, Germany

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Würzburg, Germany

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Athens, Greece

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Athens, Greece

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Athens, Greece

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Ioannina, Greece

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Thessaloniki, Greece

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Haifa, Israel

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Jerusalem, Israel

GSK Investigational Site

Kfar Saba, Israel

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Nahariya, Israel

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Petah Tikva, Israel

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Tel Aviv, Israel

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Bologna, Italy

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Milan, Italy

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Pavia, Italy

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Roma, Italy

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Aichi, Japan

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Chiba, Japan

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Chiba, Japan

GSK Investigational Site

Ehime, Japan

GSK Investigational Site

Fukushima, Japan

GSK Investigational Site

Gunma, Japan

GSK Investigational Site

Gunma, Japan

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Hokkaido, Japan

GSK Investigational Site

Numakunai, Japan

GSK Investigational Site

Okayama, Japan

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Osaka, Japan

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Tottori, Japan

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Yamagata, Japan

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Auckland, New Zealand

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Dunedin, New Zealand

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Grafton, New Zealand

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Hamilton, New Zealand

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Takapuna Auckland, New Zealand

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Tauranga, New Zealand

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Bydgoszcz, Poland

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Gdansk, Poland

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Krakow, Poland

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Lodz, Poland

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Wroclaw, Poland

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Moscow, Russia

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Moscow, Russia

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Novosibirsk, Russia

GSK Investigational Site

Saint Petersburg, Russia

GSK Investigational Site

Saint Petersburg, Russia

GSK Investigational Site

Saint Petersburg, Russia

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Samara, Russia

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Sochi, Russia

GSK Investigational Site

Gyeonggi-do, South Korea

GSK Investigational Site

Hwasun, South Korea

GSK Investigational Site

Inchon, South Korea

GSK Investigational Site

Seoul, South Korea

GSK Investigational Site

Seoul, South Korea

GSK Investigational Site

Seoul, South Korea

GSK Investigational Site

Seoul, South Korea

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

Barcelona, Spain

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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

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Murcia, Spain

GSK Investigational Site

Palma de Mallorca, Spain

GSK Investigational Site

PamplonaNavarra, Spain

GSK Investigational Site

Pozuelo de AlarcOn Madr, Spain

GSK Investigational Site

Salamanca, Spain

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Seville, Spain

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Valencia, Spain

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Ankara, Turkey (Türkiye)

GSK Investigational Site

Ankara, Turkey (Türkiye)

GSK Investigational Site

Ankara, Turkey (Türkiye)

GSK Investigational Site

Izmir, Turkey (Türkiye)

GSK Investigational Site

Izmir, Turkey (Türkiye)

GSK Investigational Site

Kocaeli, Turkey (Türkiye)

GSK Investigational Site

Mersin, Turkey (Türkiye)

GSK Investigational Site

Samsun, Turkey (Türkiye)

GSK Investigational Site

London, United Kingdom

GSK Investigational Site

Plymouth, United Kingdom

GSK Investigational Site

Southampton, United Kingdom

GSK Investigational Site

Stoke-on-Trent, United Kingdom

GSK Investigational Site

Sutton, United Kingdom