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RECRUITING

NCT06679101

PHASE3

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)

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

520

Start Date

2024-12-16

Completion Date

2031-03-31

Last Updated

2026-01-08

Healthy Volunteers

Conditions

Multiple Myeloma Newly Diagnosed Multiple Myeloma

Interventions

DRUG

Belantamab mafodotin

Belantamab mafodotin will be administered.

DRUG

Lenalidomide

Lenalidomide will be administered.

DRUG

Dexamethasone

Dexamethasone will be administered.

DRUG

Daratumumab

Daratumumab will be administered.

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. ≥70 years of age, OR 2. Age 18 to 69 years with presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT, (or for whom national guidelines do not permit transplant due to a cut-off age below 70 years), OR 3. Who refuse high-dose chemotherapy with ASCT as an initial treatment. 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.

Locations (174)

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

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

Billings, Montana, 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

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

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

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

Salvador, 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

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 District, 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

Clinical Research Directory

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)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (174)