Phase 3 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 or older who are willing to give written consent to participate
• People who have multiple myeloma that has come back or stopped responding to treatment, and whose disease has previously not responded to at least one drug from each of these three groups: proteasome inhibitors, immunomodulatory agents, and anti-CD38 antibody treatments
• People for whom the treating doctor has already chosen a standard backup treatment plan before the trial begins
• People whose general physical functioning is rated at a level that allows them to carry out at least some daily activities (rated 0, 1, or 2 on a standard medical scale called ECOG)
• People whose myeloma can be measured through at least one of the following blood or urine tests: a protein called M-protein detected in the blood at a certain level, M-protein detected in the urine over a 24-hour period, or an abnormal level of certain proteins called free light chains in the blood
• People whose blood counts and organ function meet minimum levels — including white blood cell count, haemoglobin, platelet count, liver enzyme levels, and kidney function — without having needed blood transfusions or growth factor injections in the 7 days before the first dose
• People whose side effects from any previous treatments have mostly resolved to a mild level before joining the trial
• People who are expected to live for at least 3 more months

Who may not be able to join:

• People whose multiple myeloma has spread to the brain or the fluid around the brain and spine
• People who also have certain related blood or protein disorders, including light chain amyloidosis, plasma cell leukaemia, Waldenström macroglobulinaemia, or POEMS syndrome
• People who have had another cancer diagnosed within the past 3 years, with some exceptions for certain low-risk skin cancers or cancers that were fully treated with no current signs of disease (confirm with trial site)
• People who have difficulty swallowing or have a digestive condition that may affect how the body absorbs medication
• People with certain heart-related concerns, including abnormal heart rhythm readings on an ECG, weak heart pumping function, uncontrolled irregular heartbeat, a heart attack or related heart procedure within the past 6 months, severe heart failure, or very high blood pressure that is not controlled
• People who have had a recent active infection requiring antibiotic, antiviral, or antifungal treatment — including oral antibiotics in the past 2 weeks, intravenous antibiotics in the past 4 weeks, or a viral respiratory illness such as COVID-19 or influenza in the past 2 weeks
• People with certain active infections detected through blood tests, including active hepatitis B, hepatitis C, active syphilis, active tuberculosis, or HIV
• People who have received a live or weakened vaccine within 4 weeks before the first dose
• People who have had major surgery within 4 weeks before the first dose, or who are expected to need major surgery during the trial
• People who have received certain myeloma treatments too recently before the trial starts, including plasmapheresis, antibody therapy, chemotherapy, targeted therapy, high-dose steroids, stem cell transplant, or CAR-T or CAR-NK cell therapy, each within specified time windows
• People who have previously had a stem cell transplant using cells from another person (allogeneic transplant)
• People who have previously received any treatment that targets a protein called BCMA
• People who plan to receive other cancer treatments or take part in another drug trial at the same time
• People with serious unstable health conditions or psychiatric disorders that could affect their safety or ability to follow the trial requirements
• People who are pregnant or breastfeeding, or people who plan to become pregnant (or whose partner plans to become pregnant) during the trial or within 6 months after the last dose, and who are unwilling to use an effective form of contraception
• People who the treating doctor considers unsuitable for any reason
• People who are unable to receive the drug bortezomib, have a contraindication to it, have had a life-threatening reaction to it, or who have nerve pain or nerve damage of a certain severity
• People who have taken a strong CYP3A4-inducing medication (a type of drug that affects how other medicines are broken down in the body) within a specific time before the first dose (confirm with trial site)
• People who have previously received the drug pomalidomide, have a reason they cannot take it, have had a blood clot in an artery or deep vein within the past 3 months, are unable or unwilling to take clot-prevention medication as required, or have had a life-threatening reaction to pomalidomide
• People who have previously received the drug selinexor, have a reason they cannot take it, or have had a life-threatening reaction to it

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