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New dosing strategy aims to tame eye side effects in myeloma drug

NCT ID NCT05064358

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested different dosing schedules of the drug belantamab mafodotin in 177 adults with multiple myeloma that had returned or stopped responding to at least three prior treatments. The goal was to see if changing the dose or how often it is given could reduce serious eye problems while still controlling the cancer. The trial has been completed, and results will help determine if a safer dosing option is possible.

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
What this could lead to
If successful, this could lead to a safer dosing schedule for belantamab mafodotin, offering a treatment option for patients with multiple myeloma who have run out of other therapies.
What could go wrong
This is a phase 2 trial with only 177 participants, so results may not apply to all patients. The drug can cause serious eye side effects, and it is not a cure—patients may still need ongoing treatment.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

177 people

The number who actually took part.

Started

Mar 2022

Finished

Feb 2026

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: * Participant must be 18 years of age inclusive at the time of signing the informed consent form (ICF). * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. * Histologically or cytologically confirmed diagnosis of MM and a. Has undergone stem cell transplant or is considered transplant ineligible, and b. Has failed at least 3 prior lines of anti-myeloma therapies, including an anti-cluster of differentiation (CD)38 antibody (e.g., daratumumab) alone or in combination and is refractory to an immunomodulatory agent (e.g., lenalidomide, pomalidomide) and a proteasome inhibitor (e.g., bortezomib, ixazomib, carfilzomib). * France specific: participants have failed at least 4 prior lines of anti-myeloma therapies * Participant has measurable disease per modified IMWG criteria. * Life expectancy of at least 6 months, in the opinion of the investigator. * Male and female participants agree to abide by protocol-defined contraceptive requirements. * Participant is capable of giving signed informed consent. * Participant meets country-specific inclusion criteria described in the protocol. Exclusion Criteria: * Symptomatic amyloidosis, active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, myeloma protein, and skin changes), or active plasma cell leukemia at the time of screening. * Current corneal epithelial disease, except nonconfluent superficial punctate keratitis (SPK). * Evidence of active mucosal or internal bleeding. * Presence of an active renal condition. * Any serious and/or unstable pre-existing medical condition, psychiatric disorder, or other conditions that could interfere with the participant's safety, obtaining informed consent, or compliance with the study procedures. * Malignancies other than the disease under study, except for any other malignancy from which the participant has been disease free for \>2 years and, will not affect the evaluation of the effects of the study treatment on the currently targeted malignancy (MM). Participants with curatively treated non-melanoma skin cancer may be enrolled without a 2-year restriction. * Evidence of cardiovascular risk as per the protocol criteria. * Pregnant or lactating female. * Active infection requiring antibiotic, antiviral, or antifungal treatment. * Known human immunodeficiency virus (HIV) infection, unless the criteria in protocol can be met. * Hepatitis B and C will be excluded unless the criteria in protocol can be met. * Cirrhosis or current unstable liver or biliary disease. * Alanine aminotransferase (ALT) \>2.5× upper limit of normal (ULN). * Total Bilirubin \>1.5×ULN. * Systemic anti-MM therapy within \<=14 days or 5 half-lives, whichever is shorter. * Systemic therapy with high dose steroids within \<=14 days before the first dose of study treatment. * Prior allogenic stem cell transplant. * Prior treatment with a monoclonal antibody \<=30 days before the first dose of study treatment. Use of monoclonal antibodies for serious conditions unrelated to multiple myeloma, such as COVID, may be permitted. * Prior treatment with an anti-B cell maturation antigen (BCMA) targeted therapy or hypersensitivity reactions to any components of the study treatment. * Treatment with an antibody-drug conjugate. * Participant has received any major surgery \<=4 weeks before the first dose of study treatment. An exception may be allowed for bone stabilizing surgery. * Inadequate bone marrow reserve or organ functions as demonstrated by any of the following: a. Absolute neutrophil count \<1.0×10\^9/L, b. Hemoglobin \<8 gram/deciliter (g/dL), c. Platelet count \<50×10\^9/L, d. Spot urine (albumin/creatinine ratio) \>500 milligram/gram (mg/g), e. Estimated glomerular filtration rate (eGFR) \<30 milliliter per minute per 1.73 meter square (mL/min/1.73m\^2). * UK specific: a. Absolute neutrophil count \<1.5×10\^9/L, c. Platelet count \<75×10\^9/L

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma Recurrence

As listed by the trial registrant

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

Multiple myeloma

Contacts and locations

Locations

  • GSK Investigational Site

    West Palm Beach, Florida, 33401, United States

  • GSK Investigational Site

    Kansas City, Missouri, 64114, United States

  • GSK Investigational Site

    New York, New York, 10065, United States

  • GSK Investigational Site

    Chattanooga, Tennessee, 37404, United States

  • GSK Investigational Site

    Nashville, Tennessee, 37203, United States

  • GSK Investigational Site

    Houston, Texas, 77090, United States

  • GSK Investigational Site

    Buenos Aires, C1181ACH, Argentina

  • GSK Investigational Site

    Capital Federal, C1426ANZ, Argentina

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aire, 1414, Argentina

  • GSK Investigational Site

    Pilar, B1629AHJ, Argentina

  • GSK Investigational Site

    Rosario, S2002, Argentina

  • GSK Investigational Site

    Liverpool, New South Wales, 2170, Australia

  • GSK Investigational Site

    Newcastle, New South Wales, 2298, Australia

  • GSK Investigational Site

    Woodville, South Australia, 5011, Australia

  • GSK Investigational Site

    East Melbourne, Victoria, 3002, Australia

  • GSK Investigational Site

    Joinville, 89201-260, Brazil

  • GSK Investigational Site

    Porto Alegre, 90850-170, Brazil

  • GSK Investigational Site

    Rio de Janeiro, 22271-110, Brazil

  • GSK Investigational Site

    Salvador, 41253-190, Brazil

  • GSK Investigational Site

    São Paulo, 01236-030, Brazil

  • GSK Investigational Site

    São Paulo, 04537-080, Brazil

  • GSK Investigational Site

    Montreal, Quebec, H4J 1C5, Canada

  • GSK Investigational Site

    Avignon, 84902, France

  • GSK Investigational Site

    Nice, 06189, France

  • GSK Investigational Site

    Orléans, 45100, France

  • GSK Investigational Site

    Cottbus, 03048, Germany

  • GSK Investigational Site

    Dresden, 01307, Germany

  • GSK Investigational Site

    Greifswald, 17475, Germany

  • GSK Investigational Site

    Hamburg, 22763, Germany

  • GSK Investigational Site

    Athens, 106 76, Greece

  • GSK Investigational Site

    Athens, 11528, Greece

  • GSK Investigational Site

    Athens, 12462, Greece

  • GSK Investigational Site

    Rio Patras, 26504, Greece

  • GSK Investigational Site

    Dublin, 8, Ireland

  • GSK Investigational Site

    Dublin, D09 V2N0, Ireland

  • GSK Investigational Site

    Alessandria, 15121, Italy

  • GSK Investigational Site

    Ascoli Piceno, 63100, Italy

  • GSK Investigational Site

    Ferrara, 44124, Italy

  • GSK Investigational Site

    Genova, 16132, Italy

  • GSK Investigational Site

    Meldola FC, 47014, Italy

  • GSK Investigational Site

    Reggio Emilia, 42123, Italy

  • GSK Investigational Site

    Rimini, 47900, Italy

  • GSK Investigational Site

    Mexico City, 03100, Mexico

  • GSK Investigational Site

    Mexico City, 03720, Mexico

  • GSK Investigational Site

    Bydgoszcz, 85-168, Poland

  • GSK Investigational Site

    Gdansk, 80-214, Poland

  • GSK Investigational Site

    Katowice, 40-519, Poland

  • GSK Investigational Site

    Lublin, 20-081, Poland

  • GSK Investigational Site

    Poznan, 60-569, Poland

  • GSK Investigational Site

    Torun, 87-100, Poland

  • GSK Investigational Site

    Warsaw, 02-781, Poland

  • GSK Investigational Site

    Wałbrzych, 58-309, Poland

  • GSK Investigational Site

    Wroclaw, 50-367, Poland

  • GSK Investigational Site

    Hwasun, 58128, South Korea

  • GSK Investigational Site

    Pusan, 49241, South Korea

  • GSK Investigational Site

    Seoul, 03080, South Korea

  • GSK Investigational Site

    Seoul, 06591, South Korea

  • GSK Investigational Site

    Albacete, 02006, Spain

  • GSK Investigational Site

    Barcelona, 08026, Spain

  • GSK Investigational Site

    Córdoba, 140044, Spain

  • GSK Investigational Site

    Girona, 17007, Spain

  • GSK Investigational Site

    Oviedo, 33011, Spain

  • GSK Investigational Site

    Terrassa - Barcelona, 08221, Spain

  • GSK Investigational Site

    Valencia, 46010, Spain

  • GSK Investigational Site

    Bern, 3010, Switzerland

  • GSK Investigational Site

    Taichung, 404, Taiwan

  • GSK Investigational Site

    Taichung, 40705, Taiwan

  • GSK Investigational Site

    Tainan, 704, Taiwan

  • GSK Investigational Site

    Taipei, 100, Taiwan

  • GSK Investigational Site

    Taipei, 112, Taiwan

  • GSK Investigational Site

    Bangkok, 10210, Thailand

  • GSK Investigational Site

    Bangkok, 10330, Thailand

  • GSK Investigational Site

    Chiang Mai, 50200, Thailand

  • GSK Investigational Site

    Khon Kaen, 40002, Thailand

  • GSK Investigational Site

    Leicester, LE1 5WW, United Kingdom

  • GSK Investigational Site

    London, W12 0HS, United Kingdom

  • GSK Investigational Site

    Stoke-on-Trent, ST4 6QG, United Kingdom

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