Phase 2 Myeloma Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults aged 18 or older
• People whose general health and ability to carry out daily activities falls within an acceptable range, as measured by a standard oncology scale (ECOG score of 0, 1, or 2)
• People with a confirmed diagnosis of multiple myeloma, based on tissue or cell testing, according to internationally recognised criteria
• People whose multiple myeloma has come back or stopped responding after at least 3 previous treatment regimens, which must have included at least one drug from each of these three groups: a proteasome inhibitor (such as bortezomib, carfilzomib, or ixazomib), an immunomodulatory drug (such as thalidomide, lenalidomide, or pomalidomide), and an anti-CD38 antibody treatment (such as daratumumab or isatuximab)
• People who have previously received certain other BCMA-targeted therapies (such as CAR-T cell therapy or bispecific antibodies targeting BCMA) — but not belantamab mafodotin specifically — may still be considered
• People who have had a stem cell transplant, provided it was completed more than 100 days before enrolling in the study
• People whose myeloma shows measurable signs of disease activity through blood or urine tests, or a specific protein ratio in the blood (people with non-secretory disease may also be considered — confirm with trial site)
• People with blood counts and organ function results within the ranges required by the trial, based on tests done within 28 days before registration — including white blood cell counts, haemoglobin, platelets, liver enzyme levels, kidney function, and urine protein levels — without having needed certain blood-boosting treatments in the 14 days before those tests (excluding erythropoietin)
• People who test negative for pregnancy within 7 days before registration (for those who could become pregnant), and who agree to follow the study's instructions regarding pregnancy prevention
• People willing to provide written consent to participate, provide blood samples for research purposes, and return to the enrolling site for follow-up visits

Who may not be able to join:

• People who currently have active plasma cell leukaemia, symptomatic amyloidosis, active POEMS syndrome, or Waldenström macroglobulinaemia
• People who have previously been treated with belantamab mafodotin specifically
• People who currently have an active infection that requires treatment
• People who still have unresolved side effects rated grade 2 or higher from previous treatments, with the exception of hair loss or nerve-related symptoms up to grade 2
• People who have had major surgery within 4 weeks before registration
• People with serious unstable medical or psychiatric conditions that could affect their safety, ability to consent, or ability to follow the study requirements
• People with signs of active bleeding in the mouth, gut, or internally
• People with currently unstable liver or bile duct disease, such as fluid build-up in the abdomen, confusion related to liver problems, blood clotting issues, very low protein levels, swollen veins in the oesophagus or stomach, persistent yellowing of the skin, or cirrhosis (stable chronic liver conditions or liver involvement from the myeloma itself may be acceptable — confirm with trial site)
• People who have had another cancer besides multiple myeloma, unless that cancer has been considered medically stable for more than 2 years and no active treatment (other than hormonal therapy) is being received — people with previously cured non-melanoma skin cancer are generally not subject to this 2-year requirement
• People with certain heart or cardiovascular conditions, including: untreated significant heart rhythm problems or electrical abnormalities on a heart trace; a heart attack or certain heart procedures within approximately 6–12 weeks before screening; moderate to severe heart failure (Class III or IV by standard classification); or uncontrolled high blood pressure
• People with a known allergy or sensitivity to belantamab mafodotin or any of its ingredients
• People living with HIV who do not meet specific requirements around viral load, immune cell counts, treatment stability, and infection history (confirm with trial site)
• People with hepatitis B who do not meet specific requirements around viral activity and antiviral treatment status (confirm with trial site); note that evidence of previous hepatitis B vaccination alone does not exclude participation
• People with a positive hepatitis C test result, unless they have completed successful antiviral treatment, tested negative for hepatitis C RNA, and completed a required waiting period (confirm with trial site)
• People with active corneal (eye surface) disease, except for a mild form called punctate keratopathy
• People who have had plasmapheresis (a blood-filtering procedure) within 7 days before registration
• People who have previously received a donor stem cell transplant from another person (allogeneic transplant)
• People who have received a live or live-attenuated vaccine within 30 days before registration (COVID-19 vaccines are permitted at any point during the study)
• People who are currently pregnant or breastfeeding
• People who plan to wear contact lenses during treatment with belantamab mafodotin (contact lens use may be reviewed after treatment ends, subject to confirmation from an eye care specialist; bandage contact lenses prescribed by an eye care professional for a specific eye condition are permitted)

Important: Always verify eligibility with the trial site directly before applying.