Phase 2 Myeloma Trial, Recruiting

Written by an AI model from the 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 at the time of giving consent.
• People who have been diagnosed with multiple myeloma that has come back or stopped responding to treatment, and who have received at least one previous treatment for myeloma.
• People whose myeloma can be measured through specific blood, urine, or bone marrow tests, or through scans showing tumours outside the bone marrow.
• People who have previously received many types of myeloma treatments, including certain targeted therapies (such as carfilzomib or anti-CD38 antibodies like daratumumab), as long as the disease did not stop responding to the combination of daratumumab and carfilzomib used together.
• People whose last anti-CD38 antibody treatment (e.g. daratumumab or isatuximab) was more than 6 months before the start of study treatment.
• People who have had a previous bone marrow transplant from a donor, provided they are no longer taking ongoing medication to treat graft-versus-host disease.
• People who have previously received certain advanced cell therapies targeting a protein called BCMA (such as CAR-T therapy, antibody-drug treatments, or bispecific therapies), provided there are no ongoing serious side effects from those treatments.
• People whose blood counts and organ function (blood cells, kidneys, liver) meet certain minimum levels on tests done within 28 days before joining.
• People with a general health/activity level rated at 2 or below on a standard medical scale (called ECOG), or above 2 only if the reduced activity is due to bone pain expected to improve with treatment — tested within 28 days before joining.
• People with a known HIV diagnosis may be considered if their virus levels are undetectable on testing, with or without treatment, and their immune cell count meets a minimum level.
• People with a history of hepatitis B or hepatitis C may be considered if their virus levels are undetectable on testing, with or without treatment.
• Women who could become pregnant and are sexually active with a male partner must have a negative pregnancy test within 7 days before joining, and must agree to use effective contraception or abstain from heterosexual activity from the time of consent, throughout the study, and for 6 months after the last dose.
• Men who could father a child must agree to use effective contraception or abstain from heterosexual activity from the start of treatment, throughout the study, and for 3 months after the last dose, and must agree not to donate sperm during this time.
• People willing and able to follow all study procedures for the full duration of the trial, as assessed by the enrolling doctor.
• People willing to provide bone marrow biopsy and blood samples for research purposes.
• People who will have finished any antibiotic treatment for an active infection by the time study treatment is due to start.

Who may not be able to join:

• People currently pregnant or breastfeeding.
• People with an active infection that requires ongoing treatment at the time study treatment starts.
• People with another active cancer that is progressing and requires urgent or new treatment (exceptions include certain skin cancers, early-stage cervical or bladder cancer, prostate cancer on stable hormone therapy, or cancers for which the person has been cancer-free for at least three years, or where a curative procedure has been completed).
• People with cancer that has spread to the brain and is currently causing symptoms (confirm with trial site).
• People who have had a severe allergic reaction (grade 3 or higher) to an anti-CD38 antibody that, in the doctor's opinion, rules out using these medications.
• People with serious uncontrolled health conditions, including severe heart failure, unstable chest pain, uncontrolled irregular heartbeat, or serious mental health or social situations that would make it difficult to follow the study requirements.
• People who have taken an experimental drug within 14 days before joining the trial.
• People with a digestive condition that prevents them from swallowing tablets or absorbing oral medications.
• People who have taken certain medications that strongly affect how the body processes drugs (specific CYP3A inhibitors or inducers, including some antibiotics, antifungals, heart medications, herbal supplements such as St. John's Wort, and grapefruit) within 7 days before the first treatment day, or who are unable to stop taking such medications.
• People who have previously received a medication called selinexor or any drug in the same class (SINE compounds).
• People who have received an anti-CD38 therapy (such as daratumumab or isatuximab) within 6 months before joining the trial.
• People whose heart imaging shows the heart pumping function (LVEF) is below 40%, tested within 60 days before joining.
• People who currently have plasma cell leukaemia at the time of joining.
• People with a history of POEMS syndrome or a condition called primary AL amyloidosis.

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