Phase 1 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:

• People who have been diagnosed with high-risk smoldering multiple myeloma (a pre-cancer blood condition that has not yet become active), confirmed by all three of the following: at least 10% abnormal plasma cells found in a bone marrow sample, a reduction in certain normal antibody levels in the blood, and at least 95% of plasma cells in the bone marrow being abnormal on a specialised cell test.
• People whose kidneys are working at a certain minimum level, as measured by a specific calculation of kidney function (confirm with trial site).
• People aged 18 or older.
• People who have a general health and activity level rated 0, 1, or 2 on a standard medical scale, meaning they are fully active to somewhat limited but still able to care for themselves.
• People whose blood counts meet minimum levels — including white blood cells, red blood cells, and platelets — as confirmed by blood tests (confirm with trial site for exact values).
• People whose liver is functioning within acceptable ranges, as confirmed by blood tests.
• Women who could become pregnant and who agree to use highly effective contraception during the trial and for 4 months after the last dose of the study drug, and who agree not to donate eggs during that same period.
• Women who could become pregnant must have a negative pregnancy test within 72 hours before the first dose of the study drug, and also before each later dose.
• Male participants who agree to use a condom (even after a vasectomy) or remain abstinent from the first dose until at least 6 months after the last dose, and whose female partners of childbearing potential also use a highly effective method of contraception during that time.
• Male participants who agree not to donate sperm during the trial and for at least 6 months after the last dose of the study drug.
• People who are able to give informed consent to participate.
• People who are newly diagnosed with smoldering myeloma, or who have not previously received standard chemotherapy treatments approved specifically for smoldering multiple myeloma. People who have previously taken part in another clinical trial or received non-approved treatments for smoldering myeloma may still be eligible.

Who may not be able to join:

• People whose smoldering myeloma has progressed to active (symptomatic) myeloma, indicated by signs such as high calcium levels in the blood, significant kidney problems, severe anaemia, bone damage visible on scans, 60% or more abnormal plasma cells in the bone marrow, certain abnormal protein ratios in the blood, or more than one focal lesion on an MRI scan.
• People who are currently using corticosteroid medications, unless they are on a stable, long-term low dose for a breathing condition or a hormone disorder, or using inhaled, nasal spray, or eye-drop forms of steroids.
• People who have received or are currently receiving radiotherapy.
• People who have previously received or are currently receiving standard chemotherapy approved for smoldering multiple myeloma.
• People with a condition called plasma cell leukaemia (an aggressive form of blood cancer).
• Women who are pregnant or breastfeeding.
• People with an active hepatitis B or hepatitis C infection.
• People with a known HIV infection.
• People with a known allergic or serious reaction to drugs that are chemically similar to the study drug, belantamab mafodotin.
• People receiving any other cancer treatment at the same time.
• People with serious heart conditions, including severe heart failure symptoms, uncontrolled high blood pressure, certain heart muscle diseases, or a heart attack, heart procedure, or related event within the past 3 months, or currently uncontrolled abnormal heart rhythms.
• People with uncontrolled ongoing illness, including an active infection needing treatment, or a mental health or personal situation that could make it difficult to follow the study requirements.
• People who cannot take required medications given alongside the study drug, such as pre-medications or fluids.
• People who have had major surgery within 1 month before joining the trial.
• People who have or have had another cancer, unless that cancer has been medically stable for at least 2 years. People who have been cured of certain non-melanoma skin cancers may be eligible without this 2-year waiting period.
• People with an active kidney condition such as an infection, need for dialysis, or another kidney problem that could affect safety (people with protein in their urine alone may still be eligible if they meet the kidney function criteria above).
• People with any signs of active bleeding from the mouth, digestive tract, or internally.
• People who have received a monoclonal antibody treatment (a type of targeted therapy drug) within 30 days before the first dose of the study drug.
• People with cirrhosis or unstable liver or bile duct disease, shown by symptoms such as fluid build-up in the abdomen, confusion, bleeding problems, low protein levels, swollen veins in the oesophagus or stomach, persistent jaundice, or confirmed cirrhosis.
• People with active disease affecting the surface of the eye (cornea), except for very mild changes.
• People who wear contact lenses, unless specifically directed to do so by the study eye doctor.
• People with severe dry eye disease or people who have vision in only one eye.

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