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Looking for participantsPhase3

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

NCT ID: NCT06679101

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Belantamab mafodotin (drug), Lenalidomide (drug), Dexamethasone (drug), Daratumumab (drug)
How long the study runs
Study runs about 76 months (dates as stated)
About the drug or intervention
Belantamab mafodotin — drug: Belantamab mafodotin will be administered. · Lenalidomide — drug: Lenalidomide will be administered. · Dexamethasone — drug: Dexamethasone will be administered. · Daratumumab — drug: Daratumumab will be administered.
Patient visit burden
Not specified by the sponsor

In plain English

This study looks at two treatment combinations for people newly diagnosed with multiple myeloma, a cancer of the blood, who cannot have a stem cell transplant using their own cells. One group will receive belantamab mafodotin with lenalidomide and dexamethasone, while the other group will receive daratumumab with lenalidomide and dexamethasone. The study is funded by GlaxoSmithKline.

Who can take part

  • Adults aged 18 or over (or the legal age of consent where the study takes place) who can give informed consent.
  • Newly diagnosed multiple myeloma that needs treatment, with at least one sign of measurable disease found in blood or urine tests.
  • Not able to have high-dose chemotherapy with a stem cell transplant using their own cells, either because of age limits where they live or because of other health problems.
  • Able to carry out day-to-day activities at least some of the time (performance status score of 0 to 2).
  • Good enough organ function based on blood tests.
  • Men must follow rules about using contraception and not donating sperm during treatment and for at least 6 months after the last dose.
  • Women must not be pregnant or breastfeeding, and women who could become pregnant must use highly effective contraception during treatment and for 4 months after the last dose, and not donate eggs.

Who may not be able to

  • Certain related conditions, such as systemic AL amyloidosis, Waldenstrom's disease, POEMS syndrome, or primary plasma cell leukaemia.
  • Any previous whole-body treatment for multiple myeloma or smouldering multiple myeloma.
  • Signs that the myeloma has spread to the brain or spinal cord coverings.
  • Major surgery in the 2 weeks before the first dose, or not fully recovered from surgery.
  • Serious or unstable medical or mental health problems that could affect safety or taking part.
  • Current liver or bile disease (with some exceptions, such as Gilbert's syndrome or symptom-free gallstones).
  • Other cancers, unless stable for at least 2 years and agreed with the study's medical monitor.
  • Certain heart problems, such as untreated abnormal heart rhythms, a recent heart attack or heart procedure (within 3 months), or severe heart failure.
  • HIV infection, unless strict conditions are met.
  • Hepatitis B or C, unless strict conditions are met.
  • Current disease of the surface of the eye (the cornea), apart from a mild form.
  • Cannot tolerate medicines used to prevent viral infections or blood clots.
  • Allergy or bad reaction to belantamab mafodotin or similar drugs.
  • Plasma exchange treatment within 7 days before the first dose.
  • Live or live-attenuated vaccines within 30 days before the first dose of belantamab mafodotin.

What taking part involves

  • • Taking one of two drug combinations: either belantamab mafodotin with lenalidomide and dexamethasone, or daratumumab with lenalidomide and dexamethasone. Not stated — ask the trial team for details on how each drug is given.
  • • Not stated — ask the trial team for details about tests, scans and other procedures.

Time commitment: Not stated — ask the trial team about how long the study lasts, how often visits happen, and what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
520
Started
2024-12-16
Last checked
2026-04

Plain English Summary

What is this study?

  • • Testing a new treatment for multiple myeloma
  • • Phase3 - 520 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with multiple myeloma

Where?

  • • Leicester - GSK Investigational Site
  • • Middlesbrough - GSK Investigational Site
  • • Oxford - GSK Investigational Site
  • • Plymouth - GSK Investigational Site
  • • +1 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Multiple MyelomaNewly Diagnosed Multiple Myeloma

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

have a negativehave 2 negativeCD4result or positivetest negativeby a negativemet

Treatment history

Treatments you must have had:

  • ✓ 2 negative highly sensitive serum pregnancy tests

Treatments you must NOT have had:

  • ✗ or concurrent malignancies other than multiple myeloma
  • ✗ a live or live-attenuated vaccine

What the study is looking for

  • ✓Is at least 18 or the legal age of consent in the jurisdiction in which the study is taking place, at the time of...
  • ✓Capable of giving signed agreement to take part, which includes compliance with the requirements and restrictions listed...
  • ✓NDMM with a requirement for treatment as documented per IMWG criteria.
  • ✓Must have at least 1 aspect of cancer that can be measured on scans, as assessed by the central laboratory, defined as 1 of the following:
  • ✓Urine M-protein excretion ≥200 mg/24 hours (≥0.2 g/24 hours) And/or

Who cannot take part

  • ✗Prior treatment that goes through your whole body for multiple myeloma, or smoldering multiple myeloma.
  • ✗Signs of meningeal or central nervous system involvement with multiple myeloma.
  • ✗Major surgery within 2 weeks prior to the first dose of study drugs or has not recovered fully from surgery....
  • ✗Current active liver or biliary disease (except for Gilbert's syndrome or not causing symptoms gallstones, or otherwise...
  • ✗Evidence of cardiovascular risk including any of the following:
See the full criteria
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.

Where Is This Study? (5 UK sites)

GSK Investigational Site

Leicester LE1 5WW, United Kingdom

Recruiting
Site contact (verified)
Mamta GargPrincipal Investigator
US GSK Clinical Trials Call Center877-379-3718GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

GSK Investigational Site

Middlesbrough TS4 3BW, United Kingdom

Recruiting
Site contact (verified)
Matthew HoranPrincipal Investigator
US GSK Clinical Trials Call Center877-379-3718GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

GSK Investigational Site

Oxford OX3 7LE, United Kingdom

Recruiting
Site contact (verified)
Karthik RamasamyPrincipal Investigator
US GSK Clinical Trials Call Center877-379-3718GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

GSK Investigational Site

Plymouth PL6 8DH, United Kingdom

Recruiting
Site contact (verified)
Hannah HunterPrincipal Investigator
US GSK Clinical Trials Call Center877-379-3718GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

GSK Investigational Site

Wolverhampton WV10 0QP, United Kingdom

Recruiting
Site contact (verified)
Supratik BasuPrincipal Investigator
US GSK Clinical Trials Call Center877-379-3718GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

How to Get in Touch

US GSK Clinical Trials Call Center

Sponsor contact

CONTACT

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

Sponsor contact

CONTACT

+44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-04