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ACTIVE NOT RECRUITING
NCT04162210
PHASE3

Study of Single Agent Belantamab Mafodotin Versus Pomalidomide Plus Low-dose Dexamethasone (Pom/Dex) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

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

Interventions

DRUG

Belantamab mafodotin

Belantamab mafodotin will be administered.

DRUG

Pom/dex (Pomalidomide plus low dose Dexamethasone)

Pomalidomide and Dexamethasone will be administered.

Locations (102)

GSK Investigational Site

Tucson, Arizona, United States

GSK Investigational Site

Pueblo, Colorado, United States

GSK Investigational Site

Detroit, Michigan, United States

GSK Investigational Site

Omaha, Nebraska, United States

GSK Investigational Site

Clifton Park, New York, United States

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Cincinnati, Ohio, United States

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Corvallis, Oregon, United States

GSK Investigational Site

Eugene, Oregon, United States

GSK Investigational Site

Tyler, Texas, United States

GSK Investigational Site

Milwaukee, Wisconsin, United States

GSK Investigational Site

St Leonards, New South Wales, Australia

GSK Investigational Site

Hobart, Tasmania, Australia

GSK Investigational Site

Fitzroy, Victoria, Australia

GSK Investigational Site

Geelong, Victoria, Australia

GSK Investigational Site

Nedlands, Western Australia, Australia

GSK Investigational Site

Bruges, Belgium

GSK Investigational Site

Brussels, Belgium

GSK Investigational Site

Brussels, Belgium

GSK Investigational Site

Edegem, Belgium

GSK Investigational Site

Kortrijk, Belgium

GSK Investigational Site

Yvoir, Belgium

GSK Investigational Site

Porto Alegre, Rio Grande do Sul, Brazil

GSK Investigational Site

Curitiba, Brazil

GSK Investigational Site

Fortaleza, Brazil

GSK Investigational Site

Porto Alegre, Brazil

GSK Investigational Site

Rio de Janeiro, Brazil

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São Paulo, Brazil

GSK Investigational Site

São Paulo, Brazil

GSK Investigational Site

São Paulo, Brazil

GSK Investigational Site

São Paulo, Brazil

GSK Investigational Site

Sofia, Bulgaria

GSK Investigational Site

Edmonton, Alberta, Canada

GSK Investigational Site

Beijing, China

GSK Investigational Site

Beijing, China

GSK Investigational Site

Beijing, China

GSK Investigational Site

Chengdu, China

GSK Investigational Site

Hangzhou, China

GSK Investigational Site

Nanchang, China

GSK Investigational Site

Shenzhen, China

GSK Investigational Site

Tianjin, China

GSK Investigational Site

Tianjin, China

GSK Investigational Site

Xuzhou, China

GSK Investigational Site

Zhengzhou, China

GSK Investigational Site

Le Mans, France

GSK Investigational Site

Montpellier, France

GSK Investigational Site

Poitiers, France

GSK Investigational Site

Berlin, Germany

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Tübingen, Germany

GSK Investigational Site

Athens, Greece

GSK Investigational Site

Athens, Greece

GSK Investigational Site

Haidari - Athens, Greece

GSK Investigational Site

Larissa, Greece

GSK Investigational Site

Pátrai, Greece

GSK Investigational Site

Thessaloniki, Greece

GSK Investigational Site

Thessaloniki, Greece

GSK Investigational Site

Budapest, Hungary

GSK Investigational Site

Budapest, Hungary

GSK Investigational Site

Budapest, Hungary

GSK Investigational Site

Debrecen, Hungary

GSK Investigational Site

Kaposvár, Hungary

GSK Investigational Site

Nyíregyháza, Hungary

GSK Investigational Site

Brescia, Italy

GSK Investigational Site

Catanzaro, Italy

GSK Investigational Site

Milan, Italy

GSK Investigational Site

Milan, Italy

GSK Investigational Site

Pavia, Italy

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Perugia, Italy

GSK Investigational Site

Ravenna, Italy

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Roma, Italy

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San Giovanni Rotondo FG, Italy

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Siena, Italy

GSK Investigational Site

Shibuya-Ku, Tokyo, Japan

GSK Investigational Site

Aichi, Japan

GSK Investigational Site

Chiba, Japan

GSK Investigational Site

Ehime, Japan

GSK Investigational Site

Fukushima, Japan

GSK Investigational Site

Gifu, Japan

GSK Investigational Site

Gunma, Japan

GSK Investigational Site

Hokkaido, Japan

GSK Investigational Site

Kyoto, Japan

GSK Investigational Site

Kyoto, Japan

GSK Investigational Site

Osaka, Japan

GSK Investigational Site

Tokyo, Japan

GSK Investigational Site

Amersfoort, Netherlands

GSK Investigational Site

Gdansk, Poland

GSK Investigational Site

Kaluga, Russia

GSK Investigational Site

Gyeonggi-do, South Korea

GSK Investigational Site

Hwasun, South Korea

GSK Investigational Site

Incheon, 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

Seoul, South Korea

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

L'Hospitalet de Llobrega, Spain

GSK Investigational Site

Málaga, Spain

GSK Investigational Site

PamplonaNavarra, Spain

GSK Investigational Site

Pozuelo de AlarcOn Madr, Spain

GSK Investigational Site

Santiago de Compostela, Spain

GSK Investigational Site

Dundee, United Kingdom

GSK Investigational Site

London, United Kingdom