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New hope for myeloma patients: drug combo trial launches

NCT ID NCT06679101

Disease control Sponsor: GlaxoSmithKline Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tests whether a new combination of drugs—belantamab mafodotin, lenalidomide, and dexamethasone—can help people with newly diagnosed multiple myeloma who cannot have a stem cell transplant. The study will compare this new combo to the current standard treatment (daratumumab, lenalidomide, and dexamethasone) in 520 participants. The goal is to see if the new combo delays cancer progression or leads to deeper remission.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
belantamab mafodotin, lenalidomide, and dexamethasone
What this could lead to
If successful, this combination could offer a new, more effective first-line treatment option for people with newly diagnosed multiple myeloma who cannot have a stem cell transplant.
What could go wrong
This is an early-stage Phase 3 trial, so results are not guaranteed. The new combination may not be better than the current standard, and side effects like eye problems or low blood counts are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 520 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Apr 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple myeloma Newly diagnosed multiple myeloma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    181 sites in 24 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • GSK Investigational Site

    RECRUITING

    Mobile, Alabama, 36607, United States

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    Phoenix, Arizona, 85054, United States

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    Beverly Hills, California, 90211, United States

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    Pasadena, California, 91105, United States

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    Aurora, Colorado, 80012, United States

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    Washington D.C., District of Columbia, 20007, United States

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    Englewood, Florida, 34223, United States

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    Lady Lake, Florida, 32159, United States

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    Pembroke Pines, Florida, 33024, United States

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    Saint Augustine, Florida, 32256, United States

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    Atlanta, Georgia, 30322, United States

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    Portland, Maine, 04074, United States

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    Worcester, Massachusetts, 01655, United States

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    Ann Arbor, Michigan, 48103, United States

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    Detroit, Michigan, 48201, United States

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    Billings, Montana, 59102, United States

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    Hackensack, New Jersey, 07601, United States

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    New York, New York, 10065, United States

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    Stony Brook, New York, 11790, United States

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    Charlotte, North Carolina, 28204, United States

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    Winston-Salem, North Carolina, 27103, United States

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    Columbus, Ohio, 43214, United States

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    Providence, Rhode Island, 02903, United States

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    Austin, Texas, 78705, United States

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    Austin, Texas, 78712, United States

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    Kingwood, Texas, 77339, United States

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    San Antonio, Texas, 78240, United States

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    Tyler, Texas, 75702, United States

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    Fairfax, Virginia, 22031, United States

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    Puyallup, Washington, 98373, United States

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    Capital Federal, C1426ANZ, Argentina

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    Ciudad Autonoma de Buenos Aire, 1414, Argentina

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    Córdoba, Argentina

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    Rosario, S2002, Argentina

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    Viedma, R8500ACE, Argentina

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    Gosford NSW, New South Wales, 2250, Australia

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    Box Hill, Victoria, 3128, Australia

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    Melbourne, Victoria, 3004, Australia

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    Fitzroy, Australia

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    Herston, Australia

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    St Leonards, Australia

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    Bruges, 8000, Belgium

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    Brussels, 1200, Belgium

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    Ghent, 9000, Belgium

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    Hornu, 7301, Belgium

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    Roeselare, 8800, Belgium

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    Salvador, Estado de Bahia, Brazil

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    Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

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    Barretos, 14784-400, Brazil

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    Joinville, 89201-260, Brazil

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    Porto Alegre, Brazil

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    São Paulo, 01509-010, Brazil

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    São Paulo, 04537-080, Brazil

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    São Paulo, 05403-000, Brazil

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    São Paulo, Brazil

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    Teresina, 64049-200, Brazil

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    Vitória, 29043-260, Brazil

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    Saint John, New Brunswick, E2L 4L2, Canada

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    Beijing, 100191, China

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    Chengdu, 610072, China

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    Chongqing, 400016, China

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    Guangzhou, 510060, China

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    Guangzhou, 510515, China

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    Hangzhou, 310003, China

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    Nanchang, 330000, China

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    Nanchang, China

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    Nanjing, 210008, China

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    Shanghai, 200032, China

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    Shanghia, 200080, China

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    Shenzhen, 430022, China

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    Shenzhen, 518039, China

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    Tianjin, 300020, China

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    Wenzhou, 325000, China

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    Xi'an, 710004, China

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    Ostrava, 708 52, Czechia

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    Prague, 100 34, Czechia

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    Bobigny, 93009, France

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    Nantes, 44202, France

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    Villejuif, 94805, France

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    Jena, Europe, 7747, Germany

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    Lübeck, Schleswig-Holstein, 23538, Germany

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    Chemnitz, 9116, Germany

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    Cologne, 50937, Germany

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    Dresden, 01307, Germany

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    Hamburg, 20246, Germany

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    Hanover, 30625, Germany

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    Mainz, 55131, Germany

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    Würzburg, 97080, Germany

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    Alexandroupoli, 68 100, Greece

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    Athens, 106 76, Greece

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    Athens, 115 28, Greece

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    Athens, Greece

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    Pátrai, 26504, Greece

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    Thessaloniki, 54007, Greece

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    Ahmedabad, 380009, India

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    Bangalore, 560054, India

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    Hyderabad, 500033, India

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    Kolkata, 700014, India

  • GSK Investigational Site

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    Kolkata, 700156, India

  • GSK Investigational Site

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    Pune, 411001, India

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    Sushrut Hospital and Research, 400071, India

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    Dublin, D09V2N0, Ireland

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    Galway, Ireland

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    Waterford, Ireland

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    Beersheba, 84101, Israel

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    Jerusalem, 91120, Israel

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    Koranit, 2018100, Israel

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    Petah Tikva, 49100, Israel

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    Tel Aviv, 64239, Israel

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    Ancona, Italy

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    Catania, Italy

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    Meldola FC, 47014, Italy

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    Palermo, 90127, Italy

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    Pavia, 27100, Italy

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    Pisa, Italy

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    Roma, 00161, Italy

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    Shibuya-Ku, Tokyo, 150-8935, Japan

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    Aichi, 467-8602, Japan

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    Ehime, 790-0024, Japan

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    Ehime, 790-8524, Japan

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    Fukuoka, 815-8555, Japan

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    Fukushima, 960-1295, Japan

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    Gunma, 371-8511, Japan

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    Hyōgo, 660-8550, Japan

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    Hyōgo, 670-8540, Japan

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    Ibaraki, 300-0028, Japan

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    Ishikawa, 920-8641, Japan

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    Kanagawa, 211-8510, Japan

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    Miyagi, 983-8520, Japan

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    Nara, 632-8552, Japan

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    Numakunai, 028-3695, Japan

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    Osaka, 589-8511, Japan

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    Sapporo, 003-0006, Japan

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    Suita, 565-0871, Japan

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    Tokyo, 105-8471, Japan

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    Yamagata, 990-9585, Japan

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    Bergen, 5021, Norway

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    Lrenskog, 1470, Norway

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    Oslo, Norway

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    Lodz, 93-513, Poland

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    Lublin, 20-954, Poland

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    Lublin, Poland

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    Warsaw, 02-781, Poland

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    Wałbrzych, 58-309, Poland

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    Kuils River, 7580, South Africa

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    Pretoria, 0181, South Africa

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    Hwasun, 519-763, South Korea

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    Jeonju, 561-712, South Korea

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    Seoul, 03080, South Korea

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    Seoul, 03722, South Korea

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    Seoul, 06351, South Korea

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    Seoul, 06591, South Korea

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    Seoul, 138-736, South Korea

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    Ulsan, 44033, South Korea

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    Badalona, Spain

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    Barcelona, 08035, Spain

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    Gijón, 33394, Spain

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    Madrid, 28007, Spain

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    Madrid, 28041, Spain

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    Madrid, Spain

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    Málaga, 29010, Spain

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    Murcia, 30120, Spain

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    Salamanca, Spain

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    Santander, 39011, Spain

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    Valladolid, 47003, Spain

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    Kaohsiung City, 807, Taiwan

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    Taichung, 407219, Taiwan

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    Tainan, 704, Taiwan

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    Taipei, 10002, Taiwan

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    Taoyuan, 33305, Taiwan

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    Samsun, Atakum, 55200, Turkey (Türkiye)

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    Kocaeli, İzmit, 41001, Turkey (Türkiye)

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    Ankara, Yenimahalle, 06170, Turkey (Türkiye)

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    Adana, 01330, Turkey (Türkiye)

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    Ankara, 06680, Turkey (Türkiye)

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    Sisli - Istanbul, 34381, Turkey (Türkiye)

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    Leicester, LE1 5WW, United Kingdom

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    Middlesbrough, TS4 3BW, United Kingdom

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    Oxford, OX3 7LE, United Kingdom

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    Plymouth, PL6 8DH, United Kingdom

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    Wolverhampton, WV10 0QP, United Kingdom

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