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:

• People aged 18 to 75 years old
• People who have been diagnosed with primary plasma cell leukemia, confirmed using internationally recognised diagnostic standards (a specific type of blood cancer where abnormal plasma cells are found circulating in the blood above certain levels)
• People whose disease is measurable through specific blood, urine, or protein tests at the time of screening, meeting defined levels set by the trial
• People who are not suitable for high-dose chemotherapy followed by a stem cell transplant — either due to age (65 or older), assessed as ineligible by researchers, having a low physical functioning score (confirm with trial site), having had repeated failures to collect stem cells, or having chosen to delay that type of treatment
• People whose bone marrow sample has tested positive for a protein called BCMA, confirmed by laboratory testing
• People whose blood chemistry results (taken within 14 days before joining) meet specific thresholds for liver function and kidney function as defined by the trial
• People whose routine blood counts (taken within 7 days before joining, without recent transfusions or certain medications) meet minimum levels for white blood cells, red blood cells, and platelets as defined by the trial
• People who are able to take a blood-thinning (anticoagulant) medication as recommended by the study
• Women who are not pregnant or breastfeeding and who agree not to become pregnant during the study and for 12 months after; male participants whose partners agree not to become pregnant during the study and for 12 months after

Who may not be able to join:

• People with a confirmed diagnosis of active amyloidosis (a condition involving abnormal protein deposits in organs)
• People whose cancer has spread to the central nervous system (the brain or spinal cord)
• People who have previously received any treatment that targets BCMA, or any CAR-T cell therapy
• People who have moderate-to-severe nerve damage (peripheral neuropathy above grade 2), or nerve damage accompanied by pain, at the start of the study
• People with a known intolerance, allergic reaction, or medical reason to avoid glucocorticoids, bortezomib, lenalidomide, or BCMA-targeted CAR-T cell products
• People who have tested positive for HIV
• People with a hepatitis B infection
• People with a hepatitis C infection
• People whose life expectancy is less than 6 months
• Women who are pregnant or breastfeeding
• People with active digestive system problems that affect their ability to swallow tablets or absorb the study medication
• People who have had major surgery within 2 weeks before joining, have not fully recovered from surgery, or have surgery planned during the study period
• People who have received a live vaccine within 4 weeks before starting the study treatment
• People with serious mental health conditions, significant medical illnesses, or other conditions that — in the researcher's judgement — may affect the treatment, the person's ability to follow the study, or their ability to give informed consent
• People who require medications that cannot be safely used alongside the study treatment
• People with other diseases or complications that may interfere with the study
• People who are unwilling or unable to follow the study schedule and requirements

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