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New hope for myeloma: targeted drug combo shows promise in Late-Stage trial

NCT ID NCT04484623

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 study tests whether adding the targeted drug belantamab mafodotin to standard medications (pomalidomide and dexamethasone) works better than another standard combo for people with multiple myeloma that has come back or stopped responding to treatment. About 302 participants will be randomly assigned to one of the two treatment groups. The main goal is to see how long the cancer stays under control.

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, pomalidomide, dexamethasone, bortezomib
What this could lead to
If successful, this combination could offer a more effective treatment option for people with multiple myeloma that has returned or stopped responding to prior therapy.
What could go wrong
This is an advanced phase 3 trial, but the new drug may not prove better than the standard combo, 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

302 people

The number who actually took part.

Started

Oct 2020

Expected to finish

Jun 2029

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: * Capable of giving signed informed consent. * Male or female, 18 years or older. * 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 0 to 2. * Have been previously treated with at least 1 prior line of MM therapy including a lenalidomide-containing regimen and must have documented disease progression during or after their most recent therapy. (Participants treated with lenalidomide ≥10 mg daily for at least 2 consecutive cycles are eligible). * Must have at least 1 aspect of measurable disease defined as one of the following; 1. Urine M-protein excretion greater than or equal to (≥)200 milligrams (mg) per 24-hour, or 2. Serum M-protein concentration ≥0.5 grams/deciliters (g/dL) (≥5.0 g/liter \[L\]), or 3. Serum free light chain (FLC) assay: involved FLC level ≥10 mg/dL (≥100 mg/L) and an abnormal serum free light chain ratio (less than \[\<\]0.26 or greater than \[\>\]1.65) only if participant has no measurable urine or serum M spike. * Have undergone autologous stem cell transplant (ASCT) or are considered transplant ineligible. Participants with a history of ASCT are eligible for study participation provided the following eligibility criteria are met: a. ASCT was \>100 days prior to the first dose of study medication. b. 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 \[NCI-CTCAE\] version 5.0) must be less than or equal to (≤)Grade 1 at the time of enrolment, except for alopecia. * Adequate organ system functions as mentioned in the protocol. * Male and female participants agree to abide by protocol-defined contraceptive requirements. Exclusion Criteria: * Active plasma cell leukemia, symptomatic amyloidosis or active polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma proliferative disorder, and skin changes (POEMS) syndrome at the time of screening. * Prior allogeneic SCT. * Systemic anti-myeloma therapy (including chemotherapy and systemic steroids) within 14 days or five half-lives (whichever is shorter) preceding the first dose of study drug; prior treatment with a monoclonal antibody drug within 30 days of receiving the first dose of study drugs. * Plasmapheresis within 7 days prior to the first dose of study drug. * Received prior treatment with or intolerant to pomalidomide. * Received prior Beta cell maturation antigen (BCMA) targeted therapy. * Intolerant to bortezomib or refractory to bortezomib (for example; participant experienced progressive disease during treatment, or within 60 days of completing treatment, with a bortezomib-containing regimen of 1.3 mg/meter square \[m\^2\] twice weekly). * 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 (AV) 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 (NYHA) functional classification system 4. Uncontrolled hypertension. * Any major surgery within the last 4 weeks. * Previous or concurrent invasive malignancy other than multiple myeloma, except: 1. The disease must be considered medically stable for at least 2 years; or 2. The participant 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. * Evidence of active mucosal or internal bleeding. * Cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice. * Active infection requiring treatment. * Known or active human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C will be excluded unless the protocol-defined criteria are met. * Presence of active renal conditions (such as infection, severe renal impairment requiring dialysis or any other condition that could affect participant's safety). * Ongoing Grade 2 peripheral neuropathy with pain within 14 days prior to randomization or ≥Grade 3 peripheral neuropathy. * Active or history of venous and arterial thromboembolism within the past 3 months. * Contraindications to or unwilling to undergo protocol-required anti-thrombotic prophylaxis. * Current corneal disease except for mild punctate keratopathy. * Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions (including laboratory abnormalities) that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures. * Pregnant or lactating female.

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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

Contacts and locations

Locations

  • GSK Investigational Site

    Tucson, Arizona, 85712, United States

  • GSK Investigational Site

    Fort Myers, Florida, 33901, United States

  • GSK Investigational Site

    Boston, Massachusetts, 02215, United States

  • GSK Investigational Site

    Kansas City, Missouri, 64132, United States

  • GSK Investigational Site

    Nashville, Tennessee, 37203, United States

  • GSK Investigational Site

    Garran, Australian Capital Territory, 2605, Australia

  • GSK Investigational Site

    Darlinghurst, New South Wales, 2010, Australia

  • GSK Investigational Site

    Gosford NSW, New South Wales, 2250, Australia

  • GSK Investigational Site

    Port Macquarie, New South Wales, 2444, Australia

  • GSK Investigational Site

    Benowa, Queensland, 4217, Australia

  • GSK Investigational Site

    South Brisbane, Queensland, 4101, Australia

  • GSK Investigational Site

    Adelaide, South Australia, 5000, Australia

  • GSK Investigational Site

    Fitzroy, Victoria, 3065, Australia

  • GSK Investigational Site

    Heidelberg, Victoria, 3084, Australia

  • GSK Investigational Site

    Malvern, Victoria, 3144, Australia

  • GSK Investigational Site

    Nedlands, Western Australia, 6009, Australia

  • GSK Investigational Site

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

  • GSK Investigational Site

    Curitiba, 01308-050, Brazil

  • GSK Investigational Site

    Joinville, 89201-260, Brazil

  • GSK Investigational Site

    São Paulo, 04537-081, Brazil

  • GSK Investigational Site

    Beijing, 100191, China

  • GSK Investigational Site

    Beijing, China

  • GSK Investigational Site

    Changchun, 130012, China

  • GSK Investigational Site

    Changsha, 410013, China

  • GSK Investigational Site

    Guangzhou, 510060, China

  • GSK Investigational Site

    Hangzhou, 310003, China

  • GSK Investigational Site

    Jiangsu, 221004, China

  • GSK Investigational Site

    Nanchang, 330006, China

  • GSK Investigational Site

    Shenyang, 110004, China

  • GSK Investigational Site

    Shenzhen, 518029, China

  • GSK Investigational Site

    Tianjin, 300020, China

  • GSK Investigational Site

    Wuhan, 430022, China

  • GSK Investigational Site

    Brno, 62500, Czechia

  • GSK Investigational Site

    Hradec Králové, 50333, Czechia

  • GSK Investigational Site

    Prague, 12808, Czechia

  • GSK Investigational Site

    Marseille, 13273, France

  • GSK Investigational Site

    Toulouse, 31059, France

  • GSK Investigational Site

    Vanduvre-lEs-Nancy, 54511, France

  • GSK Investigational Site

    Mainz, 55131, Germany

  • GSK Investigational Site

    Tübingen, 72076, Germany

  • GSK Investigational Site

    Würzburg, 97080, Germany

  • GSK Investigational Site

    Athens, 10676, Greece

  • GSK Investigational Site

    Athens, 115 25, Greece

  • GSK Investigational Site

    Athens, 115 28, Greece

  • GSK Investigational Site

    Ioannina, 45 500, Greece

  • GSK Investigational Site

    Thessaloniki, 57010, Greece

  • GSK Investigational Site

    Haifa, 3109601, Israel

  • GSK Investigational Site

    Jerusalem, 91031, Israel

  • GSK Investigational Site

    Kfar Saba, 4428164, Israel

  • GSK Investigational Site

    Nahariya, 2633737, Israel

  • GSK Investigational Site

    Petah Tikva, 4941492, Israel

  • GSK Investigational Site

    Tel Aviv, 6423906, Israel

  • GSK Investigational Site

    Bologna, 40138, Italy

  • GSK Investigational Site

    Milan, 20122, Italy

  • GSK Investigational Site

    Pavia, 27100, Italy

  • GSK Investigational Site

    Roma, 00161, Italy

  • GSK Investigational Site

    Aichi, 467-8602, Japan

  • GSK Investigational Site

    Chiba, 277-8567, Japan

  • GSK Investigational Site

    Chiba, 296-8602, Japan

  • GSK Investigational Site

    Ehime, 790-8524, Japan

  • GSK Investigational Site

    Fukushima, 960-1295, Japan

  • GSK Investigational Site

    Gunma, 371-8511, Japan

  • GSK Investigational Site

    Gunma, 377-0280, Japan

  • GSK Investigational Site

    Hokkaido, 060-8648, Japan

  • GSK Investigational Site

    Numakunai, 028-3695, Japan

  • GSK Investigational Site

    Okayama, 701-1192, Japan

  • GSK Investigational Site

    Osaka, 565-0871, Japan

  • GSK Investigational Site

    Tottori, 683-8504, Japan

  • GSK Investigational Site

    Yamagata, 990-9585, Japan

  • GSK Investigational Site

    Auckland, 1023, New Zealand

  • GSK Investigational Site

    Auckland, 2025, New Zealand

  • GSK Investigational Site

    Dunedin, 9016, New Zealand

  • GSK Investigational Site

    Hamilton, 3204, New Zealand

  • GSK Investigational Site

    Takapuna Auckland, 622, New Zealand

  • GSK Investigational Site

    Tauranga, 3143, New Zealand

  • GSK Investigational Site

    Bydgoszcz, 85-168, Poland

  • GSK Investigational Site

    Gdansk, 80-214, Poland

  • GSK Investigational Site

    Krakow, 31-501, Poland

  • GSK Investigational Site

    Lodz, 93-513, Poland

  • GSK Investigational Site

    Wroclaw, 50-367, Poland

  • GSK Investigational Site

    Moscow, 125101, Russia

  • GSK Investigational Site

    Moscow, 125284, Russia

  • GSK Investigational Site

    Novosibirsk, 630087, Russia

  • GSK Investigational Site

    Saint Petersburg, 191024, Russia

  • GSK Investigational Site

    Saint Petersburg, 194291, Russia

  • GSK Investigational Site

    Saint Petersburg, 197341, Russia

  • GSK Investigational Site

    Samara, 443099, Russia

  • GSK Investigational Site

    Sochi, 354057, Russia

  • GSK Investigational Site

    Gyeonggi-do, 10408, South Korea

  • GSK Investigational Site

    Hwasun, 58128, South Korea

  • GSK Investigational Site

    Inchon, 21565, South Korea

  • GSK Investigational Site

    Seoul, 03080, South Korea

  • GSK Investigational Site

    Seoul, 03722, South Korea

  • GSK Investigational Site

    Seoul, 06351, South Korea

  • GSK Investigational Site

    Seoul, 06591, South Korea

  • GSK Investigational Site

    Barcelona, 08036, Spain

  • GSK Investigational Site

    Barcelona, 8035, Spain

  • GSK Investigational Site

    Gijón, 33204, Spain

  • GSK Investigational Site

    L'Hospitalet de Llobrega, 08908, Spain

  • GSK Investigational Site

    Madrid, 28006, Spain

  • GSK Investigational Site

    Madrid, 28027, Spain

  • GSK Investigational Site

    MOstoles Madrid, 28933, Spain

  • GSK Investigational Site

    Murcia, 30008, Spain

  • GSK Investigational Site

    Palma de Mallorca, 07120, Spain

  • GSK Investigational Site

    PamplonaNavarra, 31008, Spain

  • GSK Investigational Site

    Pozuelo de AlarcOn Madr, 28223, Spain

  • GSK Investigational Site

    Salamanca, 37007, Spain

  • GSK Investigational Site

    Seville, 41013, Spain

  • GSK Investigational Site

    Valencia, 46026, Spain

  • GSK Investigational Site

    Ankara, 06100, Turkey (Türkiye)

  • GSK Investigational Site

    Ankara, 6340, Turkey (Türkiye)

  • GSK Investigational Site

    Ankara, 6560, Turkey (Türkiye)

  • GSK Investigational Site

    Izmir, 35100, Turkey (Türkiye)

  • GSK Investigational Site

    Izmir, 35330, Turkey (Türkiye)

  • GSK Investigational Site

    Kocaeli, 41400, Turkey (Türkiye)

  • GSK Investigational Site

    Mersin, 33343, Turkey (Türkiye)

  • GSK Investigational Site

    Samsun, 55139, Turkey (Türkiye)

  • GSK Investigational Site

    London, W12 0HS, United Kingdom

  • GSK Investigational Site

    Plymouth, PL6 8D8, United Kingdom

  • GSK Investigational Site

    Southampton, SO16 6YD, United Kingdom

  • GSK Investigational Site

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

  • GSK Investigational Site

    Sutton, SM2 5PT, United Kingdom

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Other studies related to the condition(s) this trial covers.