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:

• Your bone marrow biopsy (taken within the last 30 days) must show that at least 10% of your bone marrow cells are myeloma (plasma) cells.
• You must have a confirmed diagnosis of multiple myeloma.
• Your myeloma must be measurable through at least one of the following: a specific protein in your blood or urine, an abnormal light chain level in your blood, or a biopsy-confirmed myeloma tumour.
• You must have already received at least 3 different treatment regimens for your multiple myeloma.
• You must be 18 years of age or older.
• You must be able to understand and sign a consent form agreeing to take part.
• You must be well enough to carry out some daily activities (a doctor will assess this using a standard scale called ECOG 0–2).
• You must be willing to use reliable birth control during the study and for four months after receiving the preparative treatment.
• If you are a woman who could become pregnant, you must have a negative pregnancy test before starting treatment.
• You must test negative for HIV.
• You must either test negative for hepatitis B, or if positive, show no detectable virus in your blood (confirm with trial site).
• You must test negative for hepatitis C, or if the antibody test is positive, show no detectable virus in your blood.
• You must test negative for syphilis.
• Your white blood cell (infection-fighting cell) count must be at or above a certain level without the help of growth factor medications.
• Your platelet count (cells that help blood clot) must be at or above a certain level without needing blood transfusions.
• Your haemoglobin (a measure of red blood cells) must be above a certain level.
• Less than 5% of your white blood cells in the bloodstream can be myeloma plasma cells.
• At least 14 days must have passed since your last cancer treatment before starting the preparatory chemotherapy, and any side effects from that treatment must have mostly resolved.
• You must not be taking steroid medications (above a low dose) within 2 weeks before certain procedures, or for 30 days after receiving the cell therapy — unless medically necessary.
• Your heart must be pumping at a certain level of efficiency (45% or more), confirmed by a heart scan within the last 6 weeks.

Who may not be able to join:

• You have a second cancer that has needed treatment in the last 3 years, or that is not in full remission — except for certain successfully treated, non-spreading skin cancers.
• You are currently pregnant or breastfeeding.
• You have an active infection causing a fever or requiring antibiotic/antiviral treatment, or another serious uncontrolled medical condition.
• You have an active hepatitis B or hepatitis C infection detected through blood testing.
• You are currently taking steroid medications above a low dose within 2 weeks before certain key steps in the treatment process.
• Your liver is not functioning well enough, based on specific blood test results.
• Your kidneys are not functioning well enough, based on a measure of how well they filter your blood.
• You have had a severe allergic reaction to any of the medications used in this study.
• Your myeloma has spread to your central nervous system (brain or spinal cord).
• You have taken part in another experimental study or received an experimental treatment or device within 15 days before the cell collection procedure — unless your prior treatment was a specific drug called belantamab mafodotin.

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