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Liver function study for myeloma drug cancelled before it began

NCT ID NCT04398680

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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 was a Phase 1 study designed to see how the drug belantamab mafodotin behaves in people with multiple myeloma who also have liver impairment. The goal was to check safety and drug levels in the blood. However, the study was withdrawn before any participants were enrolled, so no results are available.

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 could go wrong
The study was withdrawn before any participants were enrolled, so no data was collected. It is unclear if this treatment will be safe or effective for patients with liver problems.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Started

Apr 2021

Expected to finish

Nov 2025

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 capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed Consent Form. * Male and/or female must be 18 years of age or older, at the time of signing the informed consent. * Eastern Cooperative Oncology Group performance status 0-2. * Participants with histologically or cytologically confirmed diagnosis of multiple myeloma, as defined in International Myeloma Working Group criteria: Has failed at least 1 prior line of anti-myeloma * Participants has measurable disease with at least one of the following: Serum M-protein greater than or equal to (\>=)0.5 grams per deciliter (g/dL) \>=5 grams per liter \[g/L\]); Urine M-protein \>=200 milligram per 24 hours (mg/24 hr); and Serum free light chain assay: Involved free light chain level \>=10 milligrams per deciliter (mg/dL) (\>=100 milligrams per liter \[mg/L\]); abnormal serum free light chain ratio (\<0.26 or \>1.65); participants with plasmacytoma and otherwise non-measurable disease * Participants with a history of autologous SCT are eligible for study participation provided the following eligibility criteria are met: 1. Transplant was \>100 days prior to study enrollment, 2. No active infection(s), and 3. Participant meets the remainder of the eligibility criteria outlined in this protocol. * Participants with adequate organ system functions as defined below: Absolute neutrophil count \>=1.0 times 10\^9/liter (L); Hemoglobin \>=8.0 g/dL (or 4.9 millimoles per liter); Platelets \>= 75 times 10\^9/L; Serum bilirubin and aspartate aminotransferase: Group 1 (normal) serum bilirubin and aspartate aminotransferase \<=upper limit of normal (ULN); Group 2 (moderate) serum bilirubin \>1.5-3 times ULN and any aspartate aminotransferase; alanine aminotransferase \<=5 ULN; Estimated glomerular filtration rate \>=30 milliliter per minute per 1.73 meter square (mL/min/m\^2); Urine dipstick for protein or Albumin/creatinine ratio (from spot urine) negative/trace (if \>=1+ only eligible if confirmed \<=500 mg/g (56 mg/mmol) by albumin/creatinine ratio (spot urine from first void; and left ventricular ejection fraction by echocardiograms \>=45 percent (%). * Main additional inclusion criteria in Group 1 (matched control participants): Matched to at least one moderate hepatic impaired participant by Baseline albumin levels (+/-10%) and Baseline weight (+/-20%). * 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 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). * 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 from the time of first dose of study until 6 months after the last dose of study treatment. * Participants with a history of Hepatitis B virus and/or Hepatitis C virus and HIV exposure are eligible under specific conditions. Exclusion Criteria: * Active plasma cell leukemia at the time of screening. symptomatic amyloidosis, active polyneuropathy, organomegaly, endocrinopathy, myeloma protein and skin changes, Waldenstroem macroglobulinemia. * Participants had a prior allogeneic SCT. * Prior belantamab mafodotin therapy if given within the last 90 days. * Systemic active infection requiring treatment * Any unresolved toxicity \>=Grade 2 from previous treatment except for alopecia, or peripheral neuropathy up to Grade 2. * Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions (including lab abnormalities except hepatic impairment) 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 sudden onset of, or clinically relevant changes in: ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, in the last 14 days prior to the first dose. * Participants with Hepatitis B will be excluded unless the following criteria can be met: If the participant is hepatitis B core antibody (HbcAb) positive or hepatitis B surface antigen (HbsAg) negative, then hepatitis B virus (HBV) deoxyribonucleic acid (DNA) should be undetectable at the time of screening; If HbsAg+ at screening or \<=3 months prior to first dose of study treatment, then HBV DNA should be undetectable, highly effective antiviral treatment should be started ≥4 weeks prior to first dose of study treatment. Participants with cirrhosis are excluded. * Positive hepatitis C antibody test result or positive hepatitis C ribonucleic acid test result at Screening or within 3 months prior to first dose of study treatment unless the participant can meet the following criteria: RNA test negative and/or Successful anti-viral treatment (usually 8 weeks duration) is required, followed by a negative HCV RNA test after a washout period of at least 4 weeks prior to first dose. * Participants with Gilbert's syndrome. * -Participants with previous or concurrent invasive malignancies other than MM are excluded, unless the prior malignancy has been considered medically stable for at least 1 year. The participant must not be receiving active therapy, other than hormonal therapy for this disease. * Evidence of cardiovascular risk including any of the following: Evidence of current clinically significant untreated arrhythmias, including clinically significant electrocardiogram abnormalities including second degree (Mobitz Type II) or third degree atrioventricular block; History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within 3 months of Screening; Class III or IV heart failure as defined by the New York Heart Association functional classification system; and Uncontrolled hypertension. * Known human immunodeficiency virus infection, unless the participant can meet all of the following criteria: Established anti-retroviral therapy (ART) for at least 4 weeks and HIV viral load \<400 copies/mL prior to first dose; CD4+ T-cell (CD4+) counts ≥350 cells/ L and no history of AIDS-defining opportunistic infections within the last 12 months. * Current corneal epithelial disease except for mild punctuate keratopathy. * Participant is a woman who is pregnant or breastfeeding.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • GSK Investigational Site

    Tucson, Arizona, 85724, United States

  • GSK Investigational Site

    Beverly Hills, California, 90211, United States

  • GSK Investigational Site

    Plantation, Florida, 33322, United States

  • GSK Investigational Site

    Wichita, Kansas, 67214, United States

  • GSK Investigational Site

    Baltimore, Maryland, 21201-1595, United States

  • GSK Investigational Site

    Monroeville, Pennsylvania, 15146, United States

  • GSK Investigational Site

    The Woodlands, Texas, 77380, United States

  • GSK Investigational Site

    Milwaukee, Wisconsin, 53233, United States

  • GSK Investigational Site

    Athens, 10676, Greece

  • GSK Investigational Site

    Daegu, 41944, South Korea

  • GSK Investigational Site

    Hwasun, 58128, South Korea

  • GSK Investigational Site

    Incheon, 405-760, South Korea

  • GSK Investigational Site

    Jeonju, 561-172, 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

    Seoul, 120-752, South Korea

  • GSK Investigational Site

    Suwon Kyunggi-do, 16499, South Korea

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