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New hope for Hard-to-Treat myeloma: targeted drug shows promise

NCT ID NCT03525678

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This phase 2 trial tested a drug called belantamab mafodotin in 221 people with multiple myeloma that had not responded to at least three prior treatments. The drug is an antibody-drug conjugate that delivers a toxin directly to cancer cells. Participants received one of two doses intravenously every three weeks. The main goal was to see how many patients had their cancer shrink or disappear.

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 provide a new treatment option for patients with multiple myeloma who have run out of effective therapies.
What could go wrong
This is a phase 2 trial with a relatively small number of participants, so results may not confirm broader effectiveness. The drug can cause side effects like eye problems and low blood counts.

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

221 people

The number who actually took part.

Started

Jun 2018

Finished

Sep 2024

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 who provided signed written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. * Male or female, 18 years or older. * Participants with Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. * Participants with histologically or cytologically confirmed diagnosis of MM as defined in IMWG, 2014 criteria, and participant has undergone stem cell transplant or is considered transplant ineligible and has failed at least 3 prior lines of anti-myeloma treatments, including an anti-CD38 antibody (example \[e.g.\], daratumumab) alone or in combination, and is refractory to an Immunomodulatory drug (IMiD) (that is \[i.e.\], lenalidomide or pomalidomide), and to a proteasome inhibitor (e.g., bortezomib, ixazomib or carfilzomib). * The participant has measurable disease with at least one of the following: Serum M-protein \>=0.5 grams per deciliter (g/dL) (\>=5 grams per Liter \[g/L\]); Urine M-protein \>=200 milligram per 24 hours (mg/24h); Serum Free light chain (FLC) assay: Involved FLC level \>=10 mg/dL (\>=100 mg/Liter) and an abnormal serum FLC ratio (\<0.26 or \>1.65). * Participants with a history of autologous stem cell transplant are eligible for study participation provided the following eligibility criteria are met: transplant was \>100 days prior to study enrollment; no active infection(s); participants meet the remainder of the eligibility criteria outlined in the protocol. * Participants with adequate organ system functions as defined follows: Absolute neutrophil count (ANC) \>=1.0 X 10\^9/L; Hemoglobin \>=8.0 g/dL; Platelets\>= 50 X 10\^9/L; Total bilirubin \<=1.5X Upper limit of normal (ULN). Isolated bilirubin \>=1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35 percent); Alanine aminotransferase (ALT) \<=2.5X ULN; Estimated glomerular filtration rate (eGFR) \>=30 milliliter per minute per 1.73 meter square (mL/min/m\^2); Spot urine (albumin/creatinine ratios \[spot urine\]) \<500 milligram per gram (mg/g) (56 mg per millimoles \[mg/mmol\]); Left ventricular ejection fraction (LVEF) (Echocardiogram)\>=45 percent. * Female participants: Contraceptive use by men or 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 not a woman of childbearing potential (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 intervention period and for at least 80 days 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 a negative highly sensitive serum pregnancy test (as required by local regulations) within 72 hours before the first dose of study intervention. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. * Male participants: Contraceptive use by men or women 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 intervention period and for at least 140 days: Refrain from donating sperm; 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 Agree to use a male condom and female partner to use an additional highly effective contraceptive method with a failure rate of \<1% per year as when having sexual intercourse with a WOCBP who is not currently pregnant. * All prior treatment-related toxicities (defined by National Cancer Institute- Common Toxicity Criteria for Adverse Events \[NCI-CTCAE\]), version 4.03, must be \<=Grade 1 at the time of enrollment except for alopecia and Grade 2 peripheral neuropathy. * For France only: A participant will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category. Exclusion Criteria: * Systemic anti-myeloma therapy within \<=14 days, or 5 half-lives, whichever is shorter, or plasmapheresis within 7 days prior to the first dose of study drug. * Systemic treatment with high dose steroids (equivalent to \>=60 mg prednisone daily for \>=4 days) within the past 14 days if administered to treat MM or non-MM disease. * Symptomatic amyloidosis, active 'polyneuropathy, organomegaly, endocrinopathy, myeloma protein, and skin changes' (POEMS) syndrome, active plasma cell leukemia at the time of screening. * Prior allogeneic stem cell transplant. * Current corneal epithelial disease except mild punctate keratopathy. * Use of an investigational drug within 14 days or five half-lives, whichever is shorter, preceding the first dose of study drug. Prior treatment with a monoclonal antibody within 30 days of receiving the first dose of study drugs. Prior B-cell maturation antigen (BCMA) targeted therapy. * Evidence of active mucosal or internal bleeding. * Any major surgery within the last four weeks. * Presence of active renal condition (infection, requirement for dialysis or any other condition that could affect participant's safety). Participants with isolated proteinuria resulting from MM are eligible. * 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 to the study procedures. * Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. * Malignancies other than disease under study are excluded, except for any other malignancy from which the participant has been disease-free for more than 2 years and, in the opinion of the principal investigators and GlaxoSmithKline Medical Monitor, will not affect the evaluation of the effects of this clinical trial treatment on the currently targeted malignancy (MM). Participants with curatively treated non-melanoma skin cancer may be enrolled. * Evidence of cardiovascular risk including any of the following: Corrected QT interval Fridericia (QTcF) interval \>480 milliseconds (msec); Evidence of current clinically significant uncontrolled arrhythmias, including clinically significant electrocardiogram abnormalities such as 2nd degree (Type II) or 3rd degree atrioventricular (AV) block; History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within six months of Screening; Class III or IV heart failure as defined by the New York Heart Association functional classification system (NYHA); Uncontrolled hypertension. * Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to belantamab mafodotin, or any of the components of the study treatment. * Pregnant or lactating female. * Active infection requiring antibiotic, antiviral, or antifungal treatment. * Known Human Immunodeficiency Virus (HIV) infection. * Presence of hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb at screening or within 3 months prior to first dose of study treatment. * 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 treatment.

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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

    New Haven, Connecticut, 06510, United States

  • GSK Investigational Site

    Atlanta, Georgia, 30322, United States

  • GSK Investigational Site

    Atlanta, Georgia, 30342, United States

  • GSK Investigational Site

    Chicago, Illinois, 60612, United States

  • GSK Investigational Site

    Chicago, Illinois, 60637, United States

  • GSK Investigational Site

    Indianapolis, Indiana, 46202, United States

  • GSK Investigational Site

    Fairway, Kansas, 66205, United States

  • GSK Investigational Site

    Baton Rouge, Louisiana, 70121, United States

  • GSK Investigational Site

    Baltimore, Maryland, 21201, United States

  • GSK Investigational Site

    Boston, Massachusetts, 02215, United States

  • GSK Investigational Site

    Rochester, Minnesota, 55905, United States

  • GSK Investigational Site

    New York, New York, 10029, United States

  • GSK Investigational Site

    New York, New York, 10065, United States

  • GSK Investigational Site

    Charlotte, North Carolina, 28204, United States

  • GSK Investigational Site

    Columbus, Ohio, 43210, United States

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19104, United States

  • GSK Investigational Site

    Nashville, Tennessee, 37232, United States

  • GSK Investigational Site

    Houston, Texas, 77030, United States

  • GSK Investigational Site

    Salt Lake City, Utah, 84112, United States

  • GSK Investigational Site

    Seattle, Washington, 98109, United States

  • GSK Investigational Site

    Madison, Wisconsin, 53792, United States

  • GSK Investigational Site

    Woodville, South Australia, 5011, Australia

  • GSK Investigational Site

    Fitzroy, Victoria, 3065, Australia

  • GSK Investigational Site

    Melbourne, Victoria, 3004, Australia

  • GSK Investigational Site

    Calgary, Alberta, T2N 4N2, Canada

  • GSK Investigational Site

    Winnipeg, Manitoba, R3E 0V9, Canada

  • GSK Investigational Site

    Toronto, Ontario, M5G 2M9, Canada

  • GSK Investigational Site

    Lille, 59037, France

  • GSK Investigational Site

    Nantes, 44093, France

  • GSK Investigational Site

    Paris, 75010, France

  • GSK Investigational Site

    Pessac, 33600, France

  • GSK Investigational Site

    Pierre-Bénite, 69495, France

  • GSK Investigational Site

    Toulouse, 31059, France

  • GSK Investigational Site

    Dresden, 01307, Germany

  • GSK Investigational Site

    Hanover, 30625, Germany

  • GSK Investigational Site

    Koblenz, 56068, Germany

  • GSK Investigational Site

    Schwerin, 19049, Germany

  • GSK Investigational Site

    Tübingen, 72076, Germany

  • GSK Investigational Site

    Würzburg, 97080, Germany

  • GSK Investigational Site

    Aviano PN, 33081, Italy

  • GSK Investigational Site

    Parma, 43126, Italy

  • GSK Investigational Site

    Rionero in Vulture PZ, 85028, Italy

  • GSK Investigational Site

    Torino, 10126, Italy

  • GSK Investigational Site

    Badalona, 08916, Spain

  • GSK Investigational Site

    Barcelona, 08036, Spain

  • GSK Investigational Site

    Granada, 18014, Spain

  • GSK Investigational Site

    Madrid, 28041, Spain

  • GSK Investigational Site

    Madrid, 28223, Spain

  • GSK Investigational Site

    Murcia, 30008, Spain

  • GSK Investigational Site

    PamplonaNavarra, 31008, Spain

  • GSK Investigational Site

    Salamanca, 37007, Spain

  • GSK Investigational Site

    Valencia, 46017, Spain

  • GSK Investigational Site

    Birmingham, B9 5SS, United Kingdom

  • GSK Investigational Site

    Bournemouth, BH7 7DW, United Kingdom

  • GSK Investigational Site

    London, NW1 2BU, United Kingdom

  • GSK Investigational Site

    Nottingham, NG5 1PB, United Kingdom

  • GSK Investigational Site

    Oxford, OX3 7LE, United Kingdom

  • GSK Investigational Site

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

  • GSK Investigational Site

    Sutton, SM2 5PT, United Kingdom

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