Phase 1 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 diagnosed with multiple myeloma that has come back or stopped responding to treatment, who have previously received at least two lines of treatment, including a proteasome inhibitor, an IMiD (a type of immune-modulating drug), and an anti-CD38 antibody (a type of targeted therapy).
• People whose multiple myeloma can be measured through blood, urine, bone marrow, or imaging tests in specific ways (confirm with trial site for exact measurements required).
• People who received a type of targeted treatment called a BCMA-directed therapy (such as an antibody-drug conjugate or CAR T-cell therapy) more than 90 days before joining — but not a BCMA-targeted bispecific antibody, which is not allowed.
• People who received a different type of bispecific antibody (targeting something other than BCMA) more than 60 days before joining.
• People who had an allogeneic (donor) stem cell transplant more than 6 months before joining.
• Adults aged 18 or older.
• People who are generally well enough to carry out daily activities, or whose reduced physical functioning is due only to bone pain (confirm with trial site).
• People whose blood counts, liver function, kidney function, and calcium levels meet specific minimum thresholds as assessed by the trial site.
• People whose side effects from previous treatments have mostly resolved before joining.
• Women who are not pregnant or breastfeeding, and who either cannot become pregnant or agree to use two highly effective forms of contraception during the trial and for at least 6 months after the last dose, and who meet specific pregnancy testing requirements set out in the trial's pregnancy prevention plan.
• Men who agree to use a condom during sexual contact with a pregnant partner or a partner who could become pregnant, during the trial and for 28 days after the last dose — even if they have had a vasectomy — and who agree not to donate sperm during this period.
• People who have given signed, informed consent and are willing and able to follow all trial visits, tests, and procedures.

Who may not be able to join:

• People who have previously been treated with a BCMA-targeted bispecific antibody.
• People who have previously been treated with mezigdomide (the study drug).
• People who have received anti-myeloma treatment (including steroids) within 14 days, or a blood-filtering procedure called plasmapheresis within 7 days, before the first dose.
• People who have taken another experimental drug within 21 days (or longer, depending on the drug) before the first dose.
• People who have had radiation therapy within 14 days before joining (with some limited exceptions for bone lesions — confirm with trial site).
• People who have received a live or investigational vaccine within 4 weeks before the first dose (non-live authorised vaccines such as COVID-19 vaccines are generally allowed).
• People who had an autologous (own) stem cell transplant within 60 days, or a donor stem cell transplant within 6 months, before joining.
• People who received CAR T-cell therapy within 90 days before joining.
• People with a condition called primary AL amyloidosis.
• People who have had major surgery within 4 weeks before starting the trial.
• People with signs of active internal bleeding.
• People with active kidney disease (though kidney problems caused by the myeloma itself may be considered — confirm with trial site).
• People with active liver or bile duct disease, with some exceptions such as Gilbert's syndrome or asymptomatic gallstones.
• People with a history of another cancer, unless they have been free of it or medically stable for 2 or more years, with some specific exceptions for certain treated early-stage cancers (confirm with trial site).
• People with significant heart problems, including certain heart rhythm abnormalities, a heart attack or coronary procedure within the past 3 months, a stroke or seizure within the past 6 months, or severe heart failure.
• People with a known serious allergic reaction to the study drugs or their ingredients.
• People who are pregnant or breastfeeding.
• People with an active infection currently requiring treatment.
• People with HIV infection, unless they meet specific criteria related to their HIV treatment and health status (confirm with trial site).
• People who test positive for active hepatitis B infection (some exceptions may apply — confirm with trial site).
• People with active hepatitis C infection confirmed by a specific blood test.
• People with serious unstable medical or psychiatric conditions that could affect their safety or ability to take part.
• People who have taken certain strong medications that affect how the body processes drugs (strong CYP3A modulators) or certain stomach acid medications called proton-pump inhibitors (such as omeprazole or pantoprazole) within 2 weeks of starting the trial.

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