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)

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified March 2026 by GlaxoSmithKline
Sponsor
GlaxoSmithKline
Information Provided by (Responsible Party)
GlaxoSmithKline
Clinicaltrials.gov Identifier
NCT06679101
Other Study ID Numbers:
214828
First Submitted
November 5, 2024
First Posted
November 6, 2024
Last Update Posted
April 21, 2026
Last Verified
March 2026

ClinicalTrials.gov processed this data on April 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Multiple MyelomaNewly Diagnosed Multiple Myeloma
Drug: Belantamab mafodotinDrug: Lenalidomide

Study Design

Study TypeInterventional
Actual Enrollment520 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleA 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)
Study Start DateDecember 15, 2024
Actual Primary Completion Date4yrs 11mos from now
Actual Study Completion Date4yrs 11mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Arm A: Belantamab Mafodotin + Lenalidomide + Dexamethasone
Belantamab mafodotin, lenalidomide, and dexamethasone will be administered. Treatment will continue in both arms until progressive disease (PD), death, unacceptable toxicity, withdrawal of consent, or end of study, whichever occurs first.
Drug: Belantamab mafodotin
Belantamab mafodotin will be administered.
Arm B: Daratumumab + Lenalidomide + Dexamethasone
Daratumumab, lenalidomide, and dexamethasone will be administered. Treatment will continue in both arms until PD, death, unacceptable toxicity, withdrawal of consent, or end of study, whichever occurs first.
Drug: Lenalidomide
Lenalidomide will be administered.

Outcome Measures

Primary Outcome Measures
  1. PFS
    Defined as the time from the date of randomization to the date of first documented PD per International Myeloma Working Group (IMWG) criteria by Independent Review Committee (IRC) or death from any cause in the absence of progression, whichever occurs first.
  2. Number of Participants Achieving MRD Negative Status
    Defined as achieving MRD negativity at 10\^-5 sensitivity threshold (1 nucleated tumor cell in 100,000 normal cells) assessed by next-generation sequencing (NGS) at least once during the time of confirmed complete response (CR) or better response per IMWG criteria by IRC.
Secondary Outcome Measures
  1. Overall Survival (OS)
  2. PFS2
    Defined as the time from the date of randomization to the date of documented PD following the first subsequent anti-myeloma therapy or death from any cause, whichever is earlier.
  3. Number of Participants Achieving CR or Better (CR+)
  4. Number of Participants Achieving Very Good Partial Response (VGPR) or Better
  5. Number of Participants Achieving Sustained MRD Negative Status
    Defined as achieving MRD negative status at 10\^-5 sensitivity threshold (1 nucleated tumor cell in 100,000 normal cells) assessed by NGS at least twice, a minimum of 1 year apart and with no MRD positive result in between, during the time of confirmed CR+ response per IMWG criteria by IRC.
  6. Duration of Response (DoR)
  7. Time to Second Next Line Therapy (TTST)
  8. Number of Participants With Adverse Events (AEs)
  9. Number of Participants With Ocular Findings on Ophthalmic Exam
  10. Maximum Post-baseline Patient-Reported Outcomes Version of the Common Term Criteria for Adverse Events (PRO-CTCAE) Score
  11. Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30
  12. Change From Baseline in EORTC QLQ-MY20
  13. Plasma Concentrations of Belantamab Mafodotin
  14. Plasma Concentrations of Cysteine Maleimidocaproyl Monomethyl Auristatin F (cys-mcMMAF)

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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 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.

Contacts and Locations

Sponsors and CollaboratorsGlaxoSmithKline
Locations
GSK Investigational Site | Mobile Alabama, United States, 36607GSK Investigational Site | Phoenix Arizona, United States, 85054GSK Investigational Site | Beverly Hills California, United States, 90211GSK Investigational Site | Pasadena California, United States, 91105GSK Investigational Site | Aurora Colorado, United States, 80012GSK Investigational Site | Washington D.C. District of Columbia, United States, 20007GSK Investigational Site | Englewood Florida, United States, 34223GSK Investigational Site | Lady Lake Florida, United States, 32159GSK Investigational Site | Pembroke Pines Florida, United States, 33024GSK Investigational Site | Saint Augustine Florida, United States, 32256GSK Investigational Site | Atlanta Georgia, United States, 30322GSK Investigational Site | Portland Maine, United States, 04074GSK Investigational Site | Worcester Massachusetts, United States, 01655GSK Investigational Site | Ann Arbor Michigan, United States, 48103GSK Investigational Site | Detroit Michigan, United States, 48201GSK Investigational Site | Billings Montana, United States, 59102GSK Investigational Site | Hackensack New Jersey, United States, 07601GSK Investigational Site | New York New York, United States, 10065GSK Investigational Site | Stony Brook New York, United States, 11790GSK Investigational Site | Charlotte North Carolina, United States, 28204GSK Investigational Site | Winston-Salem North Carolina, United States, 27103GSK Investigational Site | Columbus Ohio, United States, 43214GSK Investigational Site | Providence Rhode Island, United States, 02903GSK Investigational Site | Austin Texas, United States, 78705GSK Investigational Site | Austin Texas, United States, 78712GSK Investigational Site | Kingwood Texas, United States, 77339GSK Investigational Site | San Antonio Texas, United States, 78240GSK Investigational Site | Tyler Texas, United States, 75702GSK Investigational Site | Fairfax Virginia, United States, 22031GSK Investigational Site | Puyallup Washington, United States, 98373GSK Investigational Site | Capital Federal , Argentina, C1426ANZGSK Investigational Site | Ciudad Autonoma de Buenos Aire , Argentina, 1414GSK Investigational Site | Córdoba , Argentina, GSK Investigational Site | Rosario , Argentina, S2002GSK Investigational Site | Viedma , Argentina, R8500ACEGSK Investigational Site | Gosford NSW New South Wales, Australia, 2250GSK Investigational Site | Box Hill Victoria, Australia, 3128GSK Investigational Site | Melbourne Victoria, Australia, 3004GSK Investigational Site | Fitzroy , Australia, GSK Investigational Site | Herston , Australia, GSK Investigational Site | St Leonards , Australia, GSK Investigational Site | Bruges , Belgium, 8000GSK Investigational Site | Brussels , Belgium, 1200GSK Investigational Site | Ghent , Belgium, 9000GSK Investigational Site | Hornu , Belgium, 7301GSK Investigational Site | Roeselare , Belgium, 8800GSK Investigational Site | Salvador Estado de Bahia, Brazil, GSK Investigational Site | Porto Alegre Rio Grande do Sul, Brazil, 90035-903GSK Investigational Site | Barretos , Brazil, 14784-400GSK Investigational Site | Joinville , Brazil, 89201-260GSK Investigational Site | Porto Alegre , Brazil, GSK Investigational Site | São Paulo , Brazil, 01509-010GSK Investigational Site | São Paulo , Brazil, 04537-080GSK Investigational Site | São Paulo , Brazil, 05403-000GSK Investigational Site | São Paulo , Brazil, GSK Investigational Site | Teresina , Brazil, 64049-200GSK Investigational Site | Vitória , Brazil, 29043-260GSK Investigational Site | Saint John New Brunswick, Canada, E2L 4L2GSK Investigational Site | Beijing , China, 100191GSK Investigational Site | Chengdu , China, 610072GSK Investigational Site | Chongqing , China, 400016GSK Investigational Site | Guangzhou , China, 510060GSK Investigational Site | Guangzhou , China, 510515GSK Investigational Site | Hangzhou , China, 310003GSK Investigational Site | Nanchang , China, 330000GSK Investigational Site | Nanchang , China, GSK Investigational Site | Nanjing , China, 210008GSK Investigational Site | Shanghai , China, 200032GSK Investigational Site | Shanghia , China, 200080GSK Investigational Site | Shenzhen , China, 430022GSK Investigational Site | Shenzhen , China, 518039GSK Investigational Site | Tianjin , China, 300020GSK Investigational Site | Wenzhou , China, 325000GSK Investigational Site | Xi'an , China, 710004GSK Investigational Site | Ostrava , Czechia, 708 52GSK Investigational Site | Prague , Czechia, 100 34GSK Investigational Site | Bobigny , France, 93009GSK Investigational Site | Nantes , France, 44202GSK Investigational Site | Villejuif , France, 94805GSK Investigational Site | Jena Europe, Germany, 7747GSK Investigational Site | Lübeck Schleswig-Holstein, Germany, 23538GSK Investigational Site | Chemnitz , Germany, 9116GSK Investigational Site | Cologne , Germany, 50937GSK Investigational Site | Dresden , Germany, 01307GSK Investigational Site | Hamburg , Germany, 20246GSK Investigational Site | Hanover , Germany, 30625GSK Investigational Site | Mainz , Germany, 55131GSK Investigational Site | Würzburg , Germany, 97080GSK Investigational Site | Alexandroupoli , Greece, 68 100GSK Investigational Site | Athens , Greece, 106 76GSK Investigational Site | Athens , Greece, 115 28GSK Investigational Site | Athens , Greece, GSK Investigational Site | Pátrai , Greece, 26504GSK Investigational Site | Thessaloniki , Greece, 54007GSK Investigational Site | Ahmedabad , India, 380009GSK Investigational Site | Bangalore , India, 560054GSK Investigational Site | Hyderabad , India, 500033GSK Investigational Site | Kolkata , India, 700014GSK Investigational Site | Kolkata , India, 700156GSK Investigational Site | Pune , India, 411001GSK Investigational Site | Sushrut Hospital and Research , India, 400071GSK Investigational Site | Dublin , Ireland, D09V2N0GSK Investigational Site | Galway , Ireland, GSK Investigational Site | Waterford , Ireland, GSK Investigational Site | Beersheba , Israel, 84101GSK Investigational Site | Jerusalem , Israel, 91120GSK Investigational Site | Koranit , Israel, 2018100GSK Investigational Site | Petah Tikva , Israel, 49100GSK Investigational Site | Tel Aviv , Israel, 64239GSK Investigational Site | Ancona , Italy, GSK Investigational Site | Catania , Italy, GSK Investigational Site | Meldola FC , Italy, 47014GSK Investigational Site | Palermo , Italy, 90127GSK Investigational Site | Pavia , Italy, 27100GSK Investigational Site | Pisa , Italy, GSK Investigational Site | Roma , Italy, 00161GSK Investigational Site | Shibuya-Ku Tokyo, Japan, 150-8935GSK Investigational Site | Aichi , Japan, 467-8602GSK Investigational Site | Ehime , Japan, 790-0024GSK Investigational Site | Ehime , Japan, 790-8524GSK Investigational Site | Fukuoka , Japan, 815-8555GSK Investigational Site | Fukushima , Japan, 960-1295GSK Investigational Site | Gunma , Japan, 371-8511GSK Investigational Site | Hyōgo , Japan, 660-8550GSK Investigational Site | Hyōgo , Japan, 670-8540GSK Investigational Site | Ibaraki , Japan, 300-0028GSK Investigational Site | Ishikawa , Japan, 920-8641GSK Investigational Site | Kanagawa , Japan, 211-8510GSK Investigational Site | Miyagi , Japan, 983-8520GSK Investigational Site | Nara , Japan, 632-8552GSK Investigational Site | Numakunai , Japan, 028-3695GSK Investigational Site | Osaka , Japan, 589-8511GSK Investigational Site | Sapporo , Japan, 003-0006GSK Investigational Site | Suita , Japan, 565-0871GSK Investigational Site | Tokyo , Japan, 105-8471GSK Investigational Site | Yamagata , Japan, 990-9585GSK Investigational Site | Bergen , Norway, 5021GSK Investigational Site | Lrenskog , Norway, 1470GSK Investigational Site | Oslo , Norway, GSK Investigational Site | Lodz , Poland, 93-513GSK Investigational Site | Lublin , Poland, 20-954GSK Investigational Site | Lublin , Poland, GSK Investigational Site | Warsaw , Poland, 02-781GSK Investigational Site | Wałbrzych , Poland, 58-309GSK Investigational Site | Kuils River , South Africa, 7580GSK Investigational Site | Pretoria , South Africa, 0181GSK Investigational Site | Hwasun , South Korea, 519-763GSK Investigational Site | Jeonju , South Korea, 561-712GSK Investigational Site | Seoul , South Korea, 03080GSK Investigational Site | Seoul , South Korea, 03722GSK Investigational Site | Seoul , South Korea, 06351GSK Investigational Site | Seoul , South Korea, 06591GSK Investigational Site | Seoul , South Korea, 138-736GSK Investigational Site | Ulsan , South Korea, 44033GSK Investigational Site | Badalona , Spain, GSK Investigational Site | Barcelona , Spain, 08035GSK Investigational Site | Gijón , Spain, 33394GSK Investigational Site | Madrid , Spain, 28007GSK Investigational Site | Madrid , Spain, 28041GSK Investigational Site | Madrid , Spain, GSK Investigational Site | Málaga , Spain, 29010GSK Investigational Site | Murcia , Spain, 30120GSK Investigational Site | Salamanca , Spain, GSK Investigational Site | Santander , Spain, 39011GSK Investigational Site | Valladolid , Spain, 47003GSK Investigational Site | Kaohsiung City , Taiwan, 807GSK Investigational Site | Taichung , Taiwan, 407219GSK Investigational Site | Tainan , Taiwan, 704GSK Investigational Site | Taipei , Taiwan, 10002GSK Investigational Site | Taoyuan , Taiwan, 33305GSK Investigational Site | Samsun Atakum, Turkey (Türkiye), 55200GSK Investigational Site | Kocaeli İzmit, Turkey (Türkiye), 41001GSK Investigational Site | Ankara Yenimahalle, Turkey (Türkiye), 06170GSK Investigational Site | Adana , Turkey (Türkiye), 01330GSK Investigational Site | Ankara , Turkey (Türkiye), 06680GSK Investigational Site | Sisli - Istanbul , Turkey (Türkiye), 34381GSK Investigational Site | Leicester , United Kingdom, LE1 5WWGSK Investigational Site | Middlesbrough , United Kingdom, TS4 3BWGSK Investigational Site | Oxford , United Kingdom, OX3 7LEGSK Investigational Site | Plymouth , United Kingdom, PL6 8DHGSK Investigational Site | Wolverhampton , United Kingdom, WV10 0QP