Phase 3 Myeloma Trial, Recruiting

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

Who might be able to join this trial:

• You are 18 years of age or older (or the legal age of consent in your country) at the time of signing the consent form.
• You are able to understand and sign a consent form and agree to follow the study rules.
• You have been newly diagnosed with multiple myeloma and your doctors have determined you need treatment, based on established medical guidelines.
• Your myeloma can be measured through at least one specific blood or urine test showing levels above a defined threshold (confirm with trial site for exact values).
• You have been newly diagnosed and are not a suitable candidate for high-dose chemotherapy followed by a stem cell transplant — either because of age restrictions in your country/hospital, or because you have other health conditions that make that type of treatment too risky.
• Your general health and ability to carry out daily activities meets a certain minimum level, as rated on a standard scale (from fully active to capable of limited self-care).
• Your heart, liver, kidneys, and other organs are functioning well enough, as shown by blood tests.
• If you are male, you agree to use contraception (including a condom, even after vasectomy) or remain abstinent for the duration of treatment and for at least 6 months after your last dose, and you agree not to donate sperm during this time.
• If you are female and could become pregnant, you agree to use a highly effective form of contraception during treatment and for 4 months after your last dose, and you must have two negative pregnancy tests before starting treatment.
• If you are female, you are not currently pregnant or breastfeeding.

Who may not be able to join:

• You have been diagnosed with certain other blood or plasma cell disorders, such as AL amyloidosis, Waldenström's disease, POEMS syndrome, or primary plasma cell leukemia.
• You have previously received any treatment for multiple myeloma or for smoldering (early-stage) multiple myeloma.
• Your multiple myeloma has spread to the brain or spinal fluid.
• You have had major surgery within 2 weeks before starting the trial, or have not fully recovered from surgery (note: a procedure called kyphoplasty does not count as major surgery).
• You have a serious or unstable physical or mental health condition that could affect your safety or ability to take part in the study.
• You currently have an active liver or bile duct disease (some exceptions may apply — confirm with trial site).
• You have or have had another type of cancer in addition to multiple myeloma, unless that cancer has been stable for at least 2 years and you are not receiving active treatment for it (hormonal therapy may be an exception — confirm with trial site).
• You have certain heart problems, such as untreated irregular heartbeat, a heart attack or serious heart event within the past 3 months, or severe heart failure.
• You have HIV, unless your HIV has been well controlled on treatment for at least 4 weeks, your immune cell count is high enough, and you have not had a serious HIV-related infection in the past year.
• You have hepatitis C, unless you have been successfully treated and tests show the virus is no longer detectable.
• You have hepatitis B, unless you meet specific criteria set by the trial team (confirm with trial site).
• You have an active disease affecting the surface of your eyes (except for a mild form — confirm with trial site).
• You cannot take antiviral preventive medication as required by the study.
• You cannot take blood clot prevention medication as required by the study.
• You have had a known serious allergic reaction to belantamab mafodotin or any closely related drug.
• You have had a plasma exchange procedure (plasmapheresis) within 7 days before starting the trial.
• You have received a live or live-attenuated vaccine within 30 days before your first dose of the study drug belantamab mafodotin.

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