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NCT06679101PHASE3Recruiting

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)

GlaxoSmithKline

Start Date

12/16/2024

Completion Date

4/28/2031

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 Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: 1. Is at least 18 or the legal age of consent in the jurisdiction in which the study is taking place, at the time of signing the informed consent. 2. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in the protocol. 3. NDMM with a requirement for treatment as documented per IMWG criteria. 4. Must have at least 1 aspect of measurable disease, as assessed by the central laboratory, defined as 1 of the following: 1. Urine M-protein excretion ≥200 mg/24 hours (≥0.2 g/24 hours) And/or 2. Serum M-protein concentration ≥0.5 g/dL (≥5.0 g/L) And/or 3. Serum free light-chain (FLC) assay: involved FLC level ≥10 mg/dL (≥100 mg/L) and an abnormal serum FLC ratio (\<0.26 or \>1.65). 5. Newly diagnosed and not considered candidate for high-dose chemotherapy with autologous stem cell transplant (ASCT) due to any of the following: 1. Exclusion from treatment with ASCT due to country- or site-specific age restriction. 2. Presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 7. Adequate organ system function as defined by the laboratory assessments. 8. Male participants: * Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. * Male participants are eligible to participate if they agree to the following during the Treatment Period and for at least 6 months after the last dose of study intervention to allow for clearance of any altered sperm: * Refrain from donating fresh unwashed semen PLUS either: * Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent. OR * Must agree to use contraception/barrier as detailed below * Agree to use a male condom, even if they have undergone a successful vasectomy, and female partner to use an additional highly effective contraceptive method with a failure rate of \<1% per year when having sexual intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant. Male participants should also use a condom when having sexual intercourse with pregnant females. 9. Female participants * Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. * A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies: * Is not a WOCBP OR * Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \<1% per year), preferably with low user dependency during the Treatment Period and for 4 months after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention. * A WOCBP must have 2 negative highly sensitive serum pregnancy tests before starting treatment, the first may be performed within 14 days from C1D1, the second within 24 hours before the first dose of study intervention. * Should pregnancy occur in a female on treatment or the female partner of a male on treatment, treatment must be stopped, and it is advised to seek advice from a physician specialized or experienced in teratology. Exclusion Criteria: 1. Diagnosis of systemic amyloid light chain amyloidosis, Waldenstrom's disease, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma proliferative disorder, skin changes) or Primary Plasma Cell Leukemia (defined as circulating plasma cells \>5%). 2. Prior systemic therapy for multiple myeloma, or smoldering multiple myeloma. 3. Signs of meningeal or central nervous system involvement with multiple myeloma. 4. Major surgery within 2 weeks prior to the first dose of study drugs or has not recovered fully from surgery. Kyphoplasty is not considered major surgery. 5. Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions (including lab abnormalities) that could interfere with participant's safety, obtaining informed consent, or compliance with study procedures. 6. Current active liver or biliary disease (except for Gilbert's syndrome or asymptomatic gallstones, or otherwise stable chronic liver disease as per the investigator's assessment). 7. Participants with previous or concurrent malignancies other than multiple myeloma are excluded. Exceptions are any other malignancy that has been considered medically stable for at least 2 years, after discussion with the GSK Medical Monitor. The participant must not be receiving active therapy, other than hormonal therapy for this disease. 8. Evidence of cardiovascular risk including any of the following: 1. Evidence of current clinically significant untreated arrhythmias, including clinically significant electrocardiogram abnormalities including second-degree (Mobitz Type II) or third-degree atrioventricular block. 2. Recent history (within 3 months of screening) of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty or stenting, or bypass grafting. 3. Class III or IV heart failure as defined by the New York Heart Association functional classification system. 9. Known human immunodeficiency virus (HIV) infection, unless the participant can meet all of the following criteria: 1. Established antiretroviral therapy for at least 4 weeks and HIV viral load \<400 copies/mL within Screening Period. 2. CD4+ T-cell (CD4+) counts ≥350 cells/μL. 3. No history of acquired immune deficiency syndrome-defining opportunistic infections within the last 12 months. 10. Positive hepatitis C antibody test result or positive hepatitis C ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study intervention unless the participant can meet the following criteria: 1. RNA test negative. 2. Successful antiviral treatment (usually 8 weeks duration) is required, followed by a negative hepatitis C viral load RNA test after a washout period of at least 4 weeks. 11. Participants with hepatitis B will be excluded unless the defined criteria can be met. 12. Current corneal epithelial disease except for mild punctate keratopathy. 13. Intolerance or contraindications to antiviral prophylaxis. 14. Unable to tolerate antithrombotic prophylaxis. 15. Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to drugs chemically related to belantamab mafodotin, or any of the components of the study intervention. 16. Plasmapheresis within 7 days prior to the first dose of study intervention. 17. Participants must not have received a live or live-attenuated vaccine within 30 days prior to first dose of belantamab mafodotin.

Interventions

DRUG

Belantamab mafodotin

DRUG

Lenalidomide

DRUG

Dexamethasone

DRUG

Daratumumab

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Conditions

Multiple MyelomaNewly Diagnosed Multiple Myeloma

Locations

GSK Investigational Site

Mobile, Alabama 36607

United States

GSK Investigational Site

Phoenix, Arizona 85054

United States

GSK Investigational Site

Beverly Hills, California 90211

United States

GSK Investigational Site

Pasadena, California 91105

United States

GSK Investigational Site

Aurora, Colorado 80012

United States

GSK Investigational Site

Washington D.C., District of Columbia 20007

United States

GSK Investigational Site

Englewood, Florida 34223

United States

GSK Investigational Site

Lady Lake, Florida 32159

United States

GSK Investigational Site

Pembroke Pines, Florida 33024

United States

GSK Investigational Site

Saint Augustine, Florida 32256

United States

GSK Investigational Site

Atlanta, Georgia 30322

United States

GSK Investigational Site

Portland, Maine 04074

United States

GSK Investigational Site

Worcester, Massachusetts 01655

United States

GSK Investigational Site

Ann Arbor, Michigan 48103

United States

GSK Investigational Site

Detroit, Michigan 48201

United States

GSK Investigational Site

Billings, Montana 59102

United States

GSK Investigational Site

Hackensack, New Jersey 07601

United States

GSK Investigational Site

New York, New York 10065

United States

GSK Investigational Site

Stony Brook, New York 11790

United States

GSK Investigational Site

Charlotte, North Carolina 28204

United States

GSK Investigational Site

Winston-Salem, North Carolina 27103

United States

GSK Investigational Site

Columbus, Ohio 43214

United States

GSK Investigational Site

Providence, Rhode Island 02903

United States

GSK Investigational Site

Austin, Texas 78705

United States

GSK Investigational Site

Austin, Texas 78712

United States

GSK Investigational Site

Kingwood, Texas 77339

United States

GSK Investigational Site

San Antonio, Texas 78240

United States

GSK Investigational Site

Tyler, Texas 75702

United States

GSK Investigational Site

Fairfax, Virginia 22031

United States

GSK Investigational Site

Puyallup, Washington 98373

United States

GSK Investigational Site

Capital Federal, C1426ANZ

Argentina

GSK Investigational Site

Ciudad Autonoma de Buenos Aire, 1414

Argentina

GSK Investigational Site

Córdoba,

Argentina

GSK Investigational Site

Rosario, S2002

Argentina

GSK Investigational Site

Viedma, R8500ACE

Argentina

GSK Investigational Site

Gosford NSW, New South Wales 2250

Australia

GSK Investigational Site

Box Hill, Victoria 3128

Australia

GSK Investigational Site

Melbourne, Victoria 3004

Australia

GSK Investigational Site

Fitzroy,

Australia

GSK Investigational Site

Herston,

Australia

GSK Investigational Site

St Leonards,

Australia

GSK Investigational Site

Bruges, 8000

Belgium

GSK Investigational Site

Brussels, 1200

Belgium

GSK Investigational Site

Ghent, 9000

Belgium

GSK Investigational Site

Hornu, 7301

Belgium

GSK Investigational Site

Roeselare, 8800

Belgium

GSK Investigational Site

Salvador, Estado de Bahia

Brazil

GSK Investigational Site

Porto Alegre, Rio Grande do Sul 90035-903

Brazil

GSK Investigational Site

Barretos, 14784-400

Brazil

GSK Investigational Site

Joinville, 89201-260

Brazil

GSK Investigational Site

Porto Alegre,

Brazil

GSK Investigational Site

São Paulo, 01509-010

Brazil

GSK Investigational Site

São Paulo, 04537-080

Brazil

GSK Investigational Site

São Paulo, 05403-000

Brazil

GSK Investigational Site

São Paulo,

Brazil

GSK Investigational Site

Teresina, 64049-200

Brazil

GSK Investigational Site

Vitória, 29043-260

Brazil

GSK Investigational Site

Saint John, New Brunswick E2L 4L2

Canada

GSK Investigational Site

Beijing, 100191

China

GSK Investigational Site

Chengdu, 610072

China

GSK Investigational Site

Chongqing, 400016

China

GSK Investigational Site

Guangzhou, 510060

China

GSK Investigational Site

Guangzhou, 510515

China

GSK Investigational Site

Hangzhou, 310003

China

GSK Investigational Site

Nanchang, 330000

China

GSK Investigational Site

Nanchang,

China

GSK Investigational Site

Nanjing, 210008

China

GSK Investigational Site

Shanghai, 200032

China

GSK Investigational Site

Shanghia, 200080

China

GSK Investigational Site

Shenzhen, 430022

China

GSK Investigational Site

Shenzhen, 518039

China

GSK Investigational Site

Tianjin, 300020

China

GSK Investigational Site

Wenzhou, 325000

China

GSK Investigational Site

Xi'an, 710004

China

GSK Investigational Site

Ostrava, 708 52

Czechia

GSK Investigational Site

Prague, 100 34

Czechia

GSK Investigational Site

Bobigny, 93009

France

GSK Investigational Site

Nantes, 44202

France

GSK Investigational Site

Villejuif, 94805

France

GSK Investigational Site

Jena, Europe 7747

Germany

GSK Investigational Site

Lübeck, Schleswig-Holstein 23538

Germany

GSK Investigational Site

Chemnitz, 9116

Germany

GSK Investigational Site

Cologne, 50937

Germany

GSK Investigational Site

Dresden, 01307

Germany

GSK Investigational Site

Hamburg, 20246

Germany

GSK Investigational Site

Hanover, 30625

Germany

GSK Investigational Site

Mainz, 55131

Germany

GSK Investigational Site

Würzburg, 97080

Germany

GSK Investigational Site

Alexandroupoli, 68 100

Greece

GSK Investigational Site

Athens, 106 76

Greece

GSK Investigational Site

Athens, 115 28

Greece

GSK Investigational Site

Athens,

Greece

GSK Investigational Site

Pátrai, 26504

Greece

GSK Investigational Site

Thessaloniki, 54007

Greece

GSK Investigational Site

Ahmedabad, 380009

India

GSK Investigational Site

Bangalore, 560054

India

GSK Investigational Site

Hyderabad, 500033

India

GSK Investigational Site

Kolkata, 700014

India

GSK Investigational Site

Kolkata, 700156

India

GSK Investigational Site

Pune, 411001

India

GSK Investigational Site

Sushrut Hospital and Research, 400071

India

GSK Investigational Site

Dublin, D09V2N0

Ireland

GSK Investigational Site

Galway,

Ireland

GSK Investigational Site

Waterford,

Ireland

GSK Investigational Site

Beersheba, 84101

Israel

GSK Investigational Site

Jerusalem, 91120

Israel

GSK Investigational Site

Koranit, 2018100

Israel

GSK Investigational Site

Petah Tikva, 49100

Israel

GSK Investigational Site

Tel Aviv, 64239

Israel

GSK Investigational Site

Ancona,

Italy

GSK Investigational Site

Catania,

Italy

GSK Investigational Site

Meldola FC, 47014

Italy

GSK Investigational Site

Palermo, 90127

Italy

GSK Investigational Site

Pavia, 27100

Italy

GSK Investigational Site

Pisa,

Italy

GSK Investigational Site

Roma, 00161

Italy

GSK Investigational Site

Shibuya-Ku, Tokyo 150-8935

Japan

GSK Investigational Site

Aichi, 467-8602

Japan

GSK Investigational Site

Ehime, 790-0024

Japan

GSK Investigational Site

Ehime, 790-8524

Japan

GSK Investigational Site

Fukuoka, 815-8555

Japan

GSK Investigational Site

Fukushima, 960-1295

Japan

GSK Investigational Site

Gunma, 371-8511

Japan

GSK Investigational Site

Hyōgo, 660-8550

Japan

GSK Investigational Site

Hyōgo, 670-8540

Japan

GSK Investigational Site

Ibaraki, 300-0028

Japan

GSK Investigational Site

Ishikawa, 920-8641

Japan

GSK Investigational Site

Kanagawa, 211-8510

Japan

GSK Investigational Site

Miyagi, 983-8520

Japan

GSK Investigational Site

Nara, 632-8552

Japan

GSK Investigational Site

Numakunai, 028-3695

Japan

GSK Investigational Site

Osaka, 589-8511

Japan

GSK Investigational Site

Sapporo, 003-0006

Japan

GSK Investigational Site

Suita, 565-0871

Japan

GSK Investigational Site

Tokyo, 105-8471

Japan

GSK Investigational Site

Yamagata, 990-9585

Japan

GSK Investigational Site

Bergen, 5021

Norway

GSK Investigational Site

Lrenskog, 1470

Norway

GSK Investigational Site

Oslo,

Norway

GSK Investigational Site

Lodz, 93-513

Poland

GSK Investigational Site

Lublin, 20-954

Poland

GSK Investigational Site

Lublin,

Poland

GSK Investigational Site

Warsaw, 02-781

Poland

GSK Investigational Site

Wałbrzych, 58-309

Poland

GSK Investigational Site

Kuils River, 7580

South Africa

GSK Investigational Site

Pretoria, 0181

South Africa

GSK Investigational Site

Hwasun, 519-763

South Korea

GSK Investigational Site

Jeonju, 561-712

South Korea

GSK Investigational Site

Seoul, 03080

South Korea

GSK Investigational Site

Seoul, 03722

South Korea

GSK Investigational Site

Seoul, 06351

South Korea

GSK Investigational Site

Seoul, 06591

South Korea

GSK Investigational Site

Seoul, 138-736

South Korea

GSK Investigational Site

Ulsan, 44033

South Korea

GSK Investigational Site

Badalona,

Spain

GSK Investigational Site

Barcelona, 08035

Spain

GSK Investigational Site

Gijón, 33394

Spain

GSK Investigational Site

Madrid, 28007

Spain

GSK Investigational Site

Madrid, 28041

Spain

GSK Investigational Site

Madrid,

Spain

GSK Investigational Site

Málaga, 29010

Spain

GSK Investigational Site

Murcia, 30120

Spain

GSK Investigational Site

Salamanca,

Spain

GSK Investigational Site

Santander, 39011

Spain

GSK Investigational Site

Valladolid, 47003

Spain

GSK Investigational Site

Kaohsiung City, 807

Taiwan

GSK Investigational Site

Taichung, 407219

Taiwan

GSK Investigational Site

Tainan, 704

Taiwan

GSK Investigational Site

Taipei, 10002

Taiwan

GSK Investigational Site

Taoyuan, 33305

Taiwan

GSK Investigational Site

Samsun, Atakum 55200

Turkey (Türkiye)

GSK Investigational Site

Kocaeli, İzmit 41001

Turkey (Türkiye)

GSK Investigational Site

Ankara, Yenimahalle 06170

Turkey (Türkiye)

GSK Investigational Site

Adana, 01330

Turkey (Türkiye)

GSK Investigational Site

Ankara, 06680

Turkey (Türkiye)

GSK Investigational Site

Sisli - Istanbul, 34381

Turkey (Türkiye)

GSK Investigational Site

Leicester, LE1 5WW

United Kingdom

GSK Investigational Site

Middlesbrough, TS4 3BW

United Kingdom

GSK Investigational Site

Oxford, OX3 7LE

United Kingdom

GSK Investigational Site

Plymouth, PL6 8DH

United Kingdom

GSK Investigational Site

Wolverhampton, WV10 0QP

United Kingdom