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New hope for myeloma: extended dosing may cut side effects

NCT ID NCT07227311

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 26, 2026 · Updated 3 times

Summary

This study tests whether giving the drug belantamab mafodotin less often, combined with other standard cancer medicines, can still control multiple myeloma while reducing side effects like eye problems. About 200 adults whose cancer has returned or stopped responding to prior treatment will take part. The goal is to find a safer, effective way to manage this blood cancer long-term.

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

About 200 people

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

Started

Apr 2026

Expected to finish

Aug 2030

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: • Participants are eligible to be included in the study only if all of the following criteria apply: Applicable to All Arms - BPd, BVd, BKd: * Male or female, 18 years or older (at the time consent is obtained). * Have a confirmed diagnosis of Multiple Myeloma (MM) as defined by the International Myeloma Working Group (IMWG) criteria. * Eastern Cooperative Oncology Group (ECOG) performance status of zero to 2. * Have been previously treated with at least 1, but no more than 2, prior lines of MM therapy and must have documented disease progression during or after their most recent therapy. * Must have at least 1 aspect of measurable disease, defined as one the following: 1. Urine M-protein excretion ≥200 mg/24 h, or 2. Serum M-protein concentration ≥0.5 g/dL (≥5.0 g/L), or 3. Free Light Chain (FLC) assay: involved FLC level ≥10 mg/dL (≥100 mg/L) and an abnormal serum free light chain ratio (\<0.26 or \>1.65) only if patient has no measurable urine or serum M spike. * Patients with a history of Autologous Stem Cell Transplant (ASCT) are eligible for study participation provided the following eligibility criteria are met: 1. ASCT was \>100 days prior to the first dose of study medication, 2. No active bacterial, viral, or fungal infection(s) present. * All prior treatment-related toxicities (defined by National Cancer Institute-Common Terminology Criteria for Adverse Events \[NCI-CTCAE\] v5.0) must be ≤Grade 1 at the time of enrollment, except for alopecia. * Adequate organ system functions as defined by the laboratory assessments. * Contraceptive requirements for men and women per local regulations; strict pregnancy prevention for women of childbearing potential (WOCBP), including negative pregnancy tests and use of highly effective contraception. * Male participants must refrain from sperm donation and must use a condom plus an additional highly effective method of contraception if sexually active with a woman of childbearing potential. Specific Inclusion Criteria for BPd arm: • Prior treatment must include a lenalidomide-containing regimen, with lenalidomide administered for at least 2 consecutive cycles. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: Applicable for all (BPd, BVd, BKd): * Active plasma cell leukemia at Screening. * Symptomatic amyloidosis, including active Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal plasma proliferative disorder, and Skin changes (POEMS). * Previous or concurrent invasive malignancy other than MM, except: 1. The disease must be considered medically stable for at least 2 years; or 2. The patient must not be receiving active therapy, other than hormonal therapy for this disease. * Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to belantamab mafodotin or drugs chemically related to belantamab mafodotin, or any of the components of the study treatment. * Plasmapheresis within 7 days prior to the first dose of study intervention. * Patients after prior allogeneic stem cell transplant * Any major surgery within 4 weeks prior to start of treatment, except for bone stabilizing surgery. * Evidence of active mucosal or internal bleeding. * Intolerance or contraindications to anti-viral prophylaxis. * Current corneal epithelial disease except for mild punctate keratopathy. * Systemic anti-myeloma therapy (including chemotherapy and systemic steroids); prior treatment with an anti-MM monoclonal antibody drug within 30 days of receiving the first dose of study intervention. * Presence of active renal condition (infection, requirement for dialysis, or any other condition that could affect participant's safety). Patients with isolated proteinuria resulting from MM are eligible, provided they fulfill certain criteria * Received prior B-cell maturation antigen (BCMA)-targeted therapy. * Contact lenses are prohibited while receiving belantamab mafodotin treatment. Use may be restarted after a qualified eye care specialist confirms there are no other contraindications. Bandage contact lenses are permitted during study treatment as directed by the treating eye care specialist. * HIV infection unless well-controlled, no recent AIDS-defining infections, and adequate CD4+ count. * Significant liver dysfunction (ALT \>2.5x ULN, bilirubin \>1.5x ULN, cirrhosis, unstable liver/biliary disease). * Positive hepatitis B or C markers unless criteria for resolved infection are met. * Evidence of cardiovascular risk including any of the following: untreated arrhythmias, recent MI/ACS/angioplasty/bypass, NYHA III/IV heart failure, uncontrolled hypertension, QTc prolongation. Specific Exclusion Criteria for BPd Arm: * Received prior treatment with or intolerant to pomalidomide. * Active or history of venous and arterial thromboembolism within the past 3 months. Specific Exclusion Criteria for BVd Arm: * Intolerant to bortezomib or refractory to bortezomib (defined as progressive disease during treatment with a bortezomib-containing regimen of 1.3 mg/m² twice weekly or within 60 days of completing that treatment). * Ongoing Grade 2 or higher peripheral neuropathy or neuropathic pain. Specific Exclusion Criteria for BKd Arm: * Intolerant to carfilzomib or refractory to carfilzomib (defined as progressive disease during treatment with a carfilzomib-containing regimen or within 60 days of completing that treatment). * Known history of allergy to captisol (i.e., cyclodextrin derivatives) used to solubilize carfilzomib. * Left ventricular ejection fraction \<40% as assessed by transthoracic echocardiogram. * Pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to enrolment. * Intolerance to hydration due to pre-existing pulmonary or cardiac impairment. * Known pulmonary hypertension.

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma refractory plasma cell neoplasm

As listed by the trial registrant

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

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

    59 sites in 8 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

    Los Alamitos, California, 90720, United States

  • GSK Investigational Site

    RECRUITING

    Torrance, California, 90505, United States

  • GSK Investigational Site

    RECRUITING

    Whittier, California, 90602, United States

  • GSK Investigational Site

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    Norwich, Connecticut, 06360, United States

  • GSK Investigational Site

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    Fort Myers, Florida, 33912, United States

  • GSK Investigational Site

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    Macon, Georgia, 31210, United States

  • GSK Investigational Site

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    Baton Rouge, Louisiana, 70809, United States

  • GSK Investigational Site

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    Bethesda, Maryland, 20817, United States

  • GSK Investigational Site

    RECRUITING

    Bridgeton, Missouri, 63044, United States

  • GSK Investigational Site

    RECRUITING

    Springfield, Missouri, 65807, United States

  • GSK Investigational Site

    RECRUITING

    Farmington, New Mexico, 87401, United States

  • GSK Investigational Site

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • GSK Investigational Site

    RECRUITING

    Dunkirk, Nord, 59240, France

  • GSK Investigational Site

    RECRUITING

    Nantes, 44093, France

  • GSK Investigational Site

    RECRUITING

    Paris, 75012, France

  • GSK Investigational Site

    RECRUITING

    Paris, 75475, France

  • GSK Investigational Site

    RECRUITING

    Paris, 75651, France

  • GSK Investigational Site

    RECRUITING

    Saint-Etienne, France

  • GSK Investigational Site

    RECRUITING

    Frankfurt, 60389, Germany

  • GSK Investigational Site

    RECRUITING

    Hamburg, 22763, Germany

  • GSK Investigational Site

    RECRUITING

    Karlsruhe, 76133, Germany

  • GSK Investigational Site

    RECRUITING

    Koblenz, 56068, Germany

  • GSK Investigational Site

    RECRUITING

    München, 80634, Germany

  • GSK Investigational Site

    RECRUITING

    Thessaloniki, Central Macedonia, 570 10, Greece

  • GSK Investigational Site

    RECRUITING

    Athens, 106 76, Greece

  • GSK Investigational Site

    RECRUITING

    Athens, 11528, Greece

  • GSK Investigational Site

    RECRUITING

    Periohi Dragana Alexand, 68100, Greece

  • GSK Investigational Site

    RECRUITING

    Thessaloniki, 54007, Greece

  • GSK Investigational Site

    RECRUITING

    Aichi, 467-8602, Japan

  • GSK Investigational Site

    RECRUITING

    Chiba, 277-8567, Japan

  • GSK Investigational Site

    RECRUITING

    Ehime, 790-8524, Japan

  • GSK Investigational Site

    RECRUITING

    Fukushima, 960-1295, Japan

  • GSK Investigational Site

    RECRUITING

    Gunma, 371-8511, Japan

  • GSK Investigational Site

    RECRUITING

    Hokkaido, 060-8543, Japan

  • GSK Investigational Site

    RECRUITING

    Ishikawa, 920-8641, Japan

  • GSK Investigational Site

    RECRUITING

    Numakunai, 028-3695, Japan

  • GSK Investigational Site

    RECRUITING

    Okayama, 701-1192, Japan

  • GSK Investigational Site

    RECRUITING

    Osaka, 590-0197, Japan

  • GSK Investigational Site

    RECRUITING

    Sendai, 983-8520, Japan

  • GSK Investigational Site

    RECRUITING

    Tokyo, 105-8471, Japan

  • GSK Investigational Site

    RECRUITING

    Yamanashi, 409-3898, Japan

  • GSK Investigational Site

    RECRUITING

    Amersfoort, 3813 TZ, Netherlands

  • GSK Investigational Site

    RECRUITING

    Hoofddorp, 2130 AT, Netherlands

  • GSK Investigational Site

    RECRUITING

    The Hague, 2545 AA, Netherlands

  • GSK Investigational Site

    RECRUITING

    Seoul, Seoul Teugbyeolsi, 06351, South Korea

  • GSK Investigational Site

    RECRUITING

    Seoul, 03722, South Korea

  • GSK Investigational Site

    RECRUITING

    Seoul, 110-774, South Korea

  • GSK Investigational Site

    RECRUITING

    Seoul, 137701, South Korea

  • GSK Investigational Site

    RECRUITING

    Seoul, 138-736, South Korea

  • GSK Investigational Site

    RECRUITING

    Ulsan, 44033, South Korea

  • GSK Investigational Site

    RECRUITING

    Jerez de la Frontera, Andalusia, 11407, Spain

  • GSK Investigational Site

    RECRUITING

    Badalona, 08916, Spain

  • GSK Investigational Site

    RECRUITING

    Córdoba, 14004, Spain

  • GSK Investigational Site

    RECRUITING

    Gijón, 33394, Spain

  • GSK Investigational Site

    RECRUITING

    Madrid, 28006, Spain

  • GSK Investigational Site

    RECRUITING

    Madrid, 28041, Spain

  • GSK Investigational Site

    RECRUITING

    Málaga, 29010, Spain

  • GSK Investigational Site

    RECRUITING

    Salamanca, 37007, Spain

  • GSK Investigational Site

    RECRUITING

    Vitoria-Gasteiz, 01009, Spain

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