RecruitingPhase 3NCT06679101

A Study of Belantamab Mafodotin Administered in Combination With Lenalidomide and Dexamethasone (BRd) Versus Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma (NDMM) Who Are Ineligible for Autologous Stem Cell Transplantation (TI-NDMM)

A Phase 3, Randomized, Open-label Study of Belantamab Mafodotin Administered in Combination With Lenalidomide and Dexamethasone (BRd) Versus Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma Who Are Ineligible for Autologous Stem Cell Transplantation (TI-NDMM)

Sponsor

GlaxoSmithKline

Enrollment

520 participants

Start Date

Dec 16, 2024

Study Type

INTERVENTIONAL

Conditions

Multiple Myeloma Newly Diagnosed Multiple Myeloma

Summary

The purpose of this Phase 3 study is to evaluate if BRd prolongs progression free survival (PFS) and/or improves minimal residual disease (MRD) negative status compared with DRd in participants with TI-NDMM.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two treatment combinations for newly diagnosed multiple myeloma (a blood cancer) in patients who are not eligible for a stem cell transplant. It compares belantamab mafodotin + lenalidomide + dexamethasone (BRd) versus daratumumab + lenalidomide + dexamethasone (DRd) to see which works better and is safer. **You may be eligible if...** - You are 18 or older with newly diagnosed multiple myeloma - You are not eligible for autologous stem cell transplant (due to age or health conditions) - You have not received prior treatment for myeloma - Your kidney, heart, and other organ function meet the requirements **You may NOT be eligible if...** - You have received any prior myeloma treatment - You have previously had eye problems caused by belantamab mafodotin - You have significant heart, lung, or liver conditions - You have active serious infections - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBelantamab mafodotin

Belantamab mafodotin will be administered.

DRUGLenalidomide

Lenalidomide will be administered.

DRUGDexamethasone

Dexamethasone will be administered.

DRUGDaratumumab

Daratumumab will be administered.

Locations(181)

GSK Investigational Site

Mobile, Alabama, United States

GSK Investigational Site

Phoenix, Arizona, United States

GSK Investigational Site

Beverly Hills, California, United States

GSK Investigational Site

Pasadena, California, United States

GSK Investigational Site

Aurora, Colorado, United States

GSK Investigational Site

Washington D.C., District of Columbia, United States

GSK Investigational Site

Englewood, Florida, United States

GSK Investigational Site

Lady Lake, Florida, United States

GSK Investigational Site

Pembroke Pines, Florida, United States

GSK Investigational Site

Saint Augustine, Florida, United States

GSK Investigational Site

Atlanta, Georgia, United States

GSK Investigational Site

Portland, Maine, United States

GSK Investigational Site

Worcester, Massachusetts, United States

GSK Investigational Site

Ann Arbor, Michigan, United States

GSK Investigational Site

Detroit, Michigan, United States

GSK Investigational Site

Billings, Montana, United States

GSK Investigational Site

Hackensack, New Jersey, United States

GSK Investigational Site

New York, New York, United States

GSK Investigational Site

Stony Brook, New York, United States

GSK Investigational Site

Charlotte, North Carolina, United States

GSK Investigational Site

Winston-Salem, North Carolina, United States

GSK Investigational Site

Columbus, Ohio, United States

GSK Investigational Site

Providence, Rhode Island, United States

GSK Investigational Site

Austin, Texas, United States

GSK Investigational Site

Austin, Texas, United States

GSK Investigational Site

Kingwood, Texas, United States

GSK Investigational Site

San Antonio, Texas, United States

GSK Investigational Site

Tyler, Texas, United States

GSK Investigational Site

Fairfax, Virginia, United States

GSK Investigational Site

Puyallup, Washington, United States

GSK Investigational Site

Capital Federal, Argentina

GSK Investigational Site

Ciudad Autonoma de Buenos Aire, Argentina

GSK Investigational Site

Córdoba, Argentina

GSK Investigational Site

Rosario, Argentina

GSK Investigational Site

Viedma, Argentina

GSK Investigational Site

Gosford NSW, New South Wales, Australia

GSK Investigational Site

Box Hill, Victoria, Australia

GSK Investigational Site

Melbourne, Victoria, Australia

GSK Investigational Site

Fitzroy, Australia

GSK Investigational Site

Herston, Australia

GSK Investigational Site

St Leonards, Australia

GSK Investigational Site

Bruges, Belgium

GSK Investigational Site

Brussels, Belgium

GSK Investigational Site

Ghent, Belgium

GSK Investigational Site

Hornu, Belgium

GSK Investigational Site

Roeselare, Belgium

GSK Investigational Site

Salvador, Estado de Bahia, Brazil

GSK Investigational Site

Porto Alegre, Rio Grande do Sul, Brazil

GSK Investigational Site

Barretos, Brazil

GSK Investigational Site

Joinville, Brazil

GSK Investigational Site

Porto Alegre, Brazil

GSK Investigational Site

São Paulo, Brazil

GSK Investigational Site

São Paulo, Brazil

GSK Investigational Site

São Paulo, Brazil

GSK Investigational Site

São Paulo, Brazil

GSK Investigational Site

Teresina, Brazil

GSK Investigational Site

Vitória, Brazil

GSK Investigational Site

Saint John, New Brunswick, Canada

GSK Investigational Site

Beijing, China

GSK Investigational Site

Chengdu, China

GSK Investigational Site

Chongqing, China

GSK Investigational Site

Guangzhou, China

GSK Investigational Site

Guangzhou, China

GSK Investigational Site

Hangzhou, China

GSK Investigational Site

Nanchang, China

GSK Investigational Site

Nanchang, China

GSK Investigational Site

Nanjing, China

GSK Investigational Site

Shanghai, China

GSK Investigational Site

Shanghia, China

GSK Investigational Site

Shenzhen, China

GSK Investigational Site

Shenzhen, China

GSK Investigational Site

Tianjin, China

GSK Investigational Site

Wenzhou, China

GSK Investigational Site

Xi'an, China

GSK Investigational Site

Ostrava, Czechia

GSK Investigational Site

Prague, Czechia

GSK Investigational Site

Bobigny, France

GSK Investigational Site

Nantes, France

GSK Investigational Site

Villejuif, France

GSK Investigational Site

Jena, Europe, Germany

GSK Investigational Site

Lübeck, Schleswig-Holstein, Germany

GSK Investigational Site

Chemnitz, Germany

GSK Investigational Site

Cologne, Germany

GSK Investigational Site

Dresden, Germany

GSK Investigational Site

Hamburg, Germany

GSK Investigational Site

Hanover, Germany

GSK Investigational Site

Mainz, Germany

GSK Investigational Site

Würzburg, Germany

GSK Investigational Site

Alexandroupoli, Greece

GSK Investigational Site

Athens, Greece

GSK Investigational Site

Athens, Greece

GSK Investigational Site

Athens, Greece

GSK Investigational Site

Pátrai, Greece

GSK Investigational Site

Thessaloniki, Greece

GSK Investigational Site

Ahmedabad, India

GSK Investigational Site

Bangalore, India

GSK Investigational Site

Hyderabad, India

GSK Investigational Site

Kolkata, India

GSK Investigational Site

Kolkata, India

GSK Investigational Site

Pune, India

GSK Investigational Site

Sushrut Hospital and Research, India

GSK Investigational Site

Dublin, Ireland

GSK Investigational Site

Galway, Ireland

GSK Investigational Site

Waterford, Ireland

GSK Investigational Site

Beersheba, Israel

GSK Investigational Site

Jerusalem, Israel

GSK Investigational Site

Koranit, Israel

GSK Investigational Site

Petah Tikva, Israel

GSK Investigational Site

Tel Aviv, Israel

GSK Investigational Site

Ancona, Italy

GSK Investigational Site

Catania, Italy

GSK Investigational Site

Meldola FC, Italy

GSK Investigational Site

Palermo, Italy

GSK Investigational Site

Pavia, Italy

GSK Investigational Site

Pisa, Italy

GSK Investigational Site

Roma, Italy

GSK Investigational Site

Shibuya-Ku, Tokyo, Japan

GSK Investigational Site

Aichi, Japan

GSK Investigational Site

Ehime, Japan

GSK Investigational Site

Ehime, Japan

GSK Investigational Site

Fukuoka, Japan

GSK Investigational Site

Fukushima, Japan

GSK Investigational Site

Gunma, Japan

GSK Investigational Site

Hyōgo, Japan

GSK Investigational Site

Hyōgo, Japan

GSK Investigational Site

Ibaraki, Japan

GSK Investigational Site

Ishikawa, Japan

GSK Investigational Site

Kanagawa, Japan

GSK Investigational Site

Miyagi, Japan

GSK Investigational Site

Nara, Japan

GSK Investigational Site

Numakunai, Japan

GSK Investigational Site

Osaka, Japan

GSK Investigational Site

Sapporo, Japan

GSK Investigational Site

Suita, Japan

GSK Investigational Site

Tokyo, Japan

GSK Investigational Site

Yamagata, Japan

GSK Investigational Site

Bergen, Norway

GSK Investigational Site

Lrenskog, Norway

GSK Investigational Site

Oslo, Norway

GSK Investigational Site

Lodz, Poland

GSK Investigational Site

Lublin, Poland

GSK Investigational Site

Lublin, Poland

GSK Investigational Site

Warsaw, Poland

GSK Investigational Site

Wałbrzych, Poland

GSK Investigational Site

Kuils River, South Africa

GSK Investigational Site

Pretoria, South Africa

GSK Investigational Site

Hwasun, South Korea

GSK Investigational Site

Jeonju, 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

Seoul, South Korea

GSK Investigational Site

Ulsan, South Korea

GSK Investigational Site

Badalona, Spain

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

Gijón, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Málaga, Spain

GSK Investigational Site

Murcia, Spain

GSK Investigational Site

Salamanca, Spain

GSK Investigational Site

Santander, Spain

GSK Investigational Site

Valladolid, Spain

GSK Investigational Site

Kaohsiung City, Taiwan

GSK Investigational Site

Taichung, Taiwan

GSK Investigational Site

Tainan, Taiwan

GSK Investigational Site

Taipei, Taiwan

GSK Investigational Site

Taoyuan, Taiwan

GSK Investigational Site

Samsun, Atakum, Turkey (Türkiye)

GSK Investigational Site

Kocaeli, İzmit, Turkey (Türkiye)

GSK Investigational Site

Ankara, Yenimahalle, Turkey (Türkiye)

GSK Investigational Site

Adana, Turkey (Türkiye)

GSK Investigational Site

Ankara, Turkey (Türkiye)

GSK Investigational Site

Sisli - Istanbul, Turkey (Türkiye)

GSK Investigational Site

Leicester, United Kingdom

GSK Investigational Site

Middlesbrough, United Kingdom

GSK Investigational Site

Oxford, United Kingdom

GSK Investigational Site

Plymouth, United Kingdom

GSK Investigational Site

Wolverhampton, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06679101

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