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 who are willing to volunteer, have been fully informed about the trial, and have signed a consent form agreeing to complete all trial procedures.
• People aged 18 to 75 years old (any gender).
• People whose life expectancy is more than 12 weeks.
• People who have been previously diagnosed with multiple myeloma according to internationally recognised diagnostic standards (IMWG criteria).
• People who show at least one of the following in their test results: a serum M protein level of 5 g/L or higher; a urine M protein level of 200 mg or more in a 24-hour sample; or an affected serum free light chain level of 100 mg/L or higher with an abnormal light chain ratio.
• People whose multiple myeloma has come back or stopped responding to treatment, and who have already received at least 3 prior treatment regimens that included at least one proteasome inhibitor and one immunomodulator (two specific types of myeloma medicines).
• People whose myeloma has progressed within 12 months of their most recent myeloma treatment, or whose disease did not reach at least a minimal response — or got worse — within 60 days of that treatment.
• People with a general health performance score of 0, 1, or 2 on the ECOG scale, meaning they are reasonably mobile and able to care for themselves (confirm with trial site).
• People who are either not eligible for a stem cell transplant using their own cells, or whose myeloma has come back after such a transplant and who need further treatment in the treating doctor's judgement.
• People whose liver, kidney, and heart-lung function meet specific test thresholds, including kidney filtration rate, liver enzyme and bilirubin levels, heart pumping function above 50%, and resting blood oxygen level above 95% (confirm specific values with trial site).
• People who are able to have a suitable vein line set up for cell collection, have no medical reasons preventing white blood cell collection, and whose blood counts (haemoglobin, platelets, and neutrophils) meet minimum levels required for that procedure (confirm with trial site).

Who may not be able to join:

• People who have a history of central nervous system conditions such as seizures, paralysis, stroke, severe brain injury, dementia, Parkinson's disease, or psychosis, or whose myeloma is known to have spread to the brain or surrounding membranes.
• People diagnosed with plasma cell leukaemia, Waldenström's macroglobulinaemia, POEMS syndrome, or primary light chain amyloidosis (specific related blood or plasma cell conditions).
• People who have another cancer that is not well controlled, with the exception of certain fully treated cancers such as some skin cancers, localised prostate cancer, ductal carcinoma in situ, thyroid cancer, or cervical carcinoma in situ — all after complete treatment.
• People who have any active infection that is not under control, including tuberculosis, or any serious fungal, bacterial, viral, or other infection requiring intravenous treatment within the 14 days before enrolment.
• People who test positive for active hepatitis B virus, hepatitis C virus with detectable virus in the blood, HIV, or syphilis.
• People with uncontrolled serious health conditions such as unstable angina, recent stroke or mini-stroke (within 6 months), recent heart attack (within 6 months), severe heart failure, uncontrolled diabetes, serious heart rhythm problems, or poorly controlled liver, kidney, or metabolic disease.
• People who have a pacemaker or a brain pacemaker implanted.
• People who have previously received CAR-T therapy or other gene-modified cell therapies, or any treatment that targets the BCMA protein on myeloma cells.
• People who have had a stem cell transplant within the two months before screening, or who are currently receiving immune-suppressing treatment related to graft-versus-host disease.
• People who have received ongoing whole-body steroid treatment in the 14 days before screening and who are expected to need long-term steroid therapy during the trial (inhaled or topical steroids may be acceptable — confirm with trial site), or who have received any systemic anti-cancer therapy (other than localised treatment) in that period.
• People who have received a live attenuated vaccine within 4 weeks before the cell collection procedure.
• People who, within the past two years, have experienced organ damage from an autoimmune disease (such as Crohn's disease, rheumatoid arthritis, or lupus), or who have needed systemic immune-suppressing medicines to manage such a condition.
• People who are pregnant or breastfeeding, or who plan to become pregnant during treatment or within one year after treatment — unless willing to use a highly reliable method of contraception for that period. This also applies to male participants whose partner plans to become pregnant within one year of the cell infusion.
• People who have a condition that would prevent them from understanding or signing the consent form, or who are unwilling or unable to follow the trial procedures.
• People who have had a severe allergic reaction to any of the medicines used in this trial.
• People whom the treating doctor considers unsuitable for this trial for any other reason.

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