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 18 years of age or older at the time of signing the consent form.
• People who are willing to voluntarily sign a consent form to take part in the study.
• People who have been diagnosed with multiple myeloma and/or light-chain amyloidosis that has come back or stopped responding to treatment, with signs of the disease that can be measured at the screening visit.
• People with multiple myeloma who have already received at least two previous treatments, including certain types of therapies (such as a proteasome inhibitor, an immunomodulatory drug, or an anti-CD38 antibody); people whose disease came back within 18 months of starting their first treatment may also be considered.
• People with amyloidosis who have already received at least one previous treatment including a proteasome inhibitor or an anti-CD38 antibody; people whose disease did not respond well enough to those treatments may also be considered.
• People whose general health and ability to carry out daily activities falls within an acceptable range on a standard medical scale (ECOG score of 0, 1, or 2) (confirm with trial site).
• Women who could become pregnant must have a negative pregnancy blood test before starting treatment, and all sexually active participants — both male and female — must agree to use effective contraception throughout the study.
• People who have recovered sufficiently from side effects of previous treatments (confirm with trial site for specific grade levels), with exceptions for hair loss and certain nerve-related side effects.
• People who are able and willing to attend all required study visits and follow the study's requirements.
• People with relapsed multiple myeloma who previously had a donor stem cell transplant may be eligible, provided there is no sign of graft-versus-host disease and they have been off any immune-suppressing medication for at least one month before joining.

Who may not be able to join:

• People who have a known medical reason why they cannot receive the study treatment or procedure, or who are expected to need other treatments that would interfere with the study.
• People with known significant disease affecting the brain or spinal cord related to their condition.
• People whose liver is not functioning well enough, based on specific blood test results being above acceptable levels (confirm with trial site for exact values).
• People whose kidneys are not functioning well enough, based on kidney filtration levels being too low (confirm with trial site for exact values).
• People with certain abnormal blood clotting test results, unless they are already on a stable dose of blood-thinning medication for a clotting condition (confirm with trial site).
• People whose blood cell counts are too low — including white blood cells, platelets, or red blood cells — as measured by specific blood tests; people with very low levels of a certain type of white blood cell (lymphocytes) may also be excluded, as this could affect the ability to make the study's CAR-T cells.
• People whose heart is not pumping effectively enough, based on a heart scan showing the pumping function is below 40%.
• People who are currently taking ongoing immune-suppressing medications such as cyclosporine or systemic steroids (low replacement doses of steroids may be allowed — confirm with trial site).
• People with serious other health conditions that, in the doctor's judgement, would put them at undue risk or interfere with the study — for example, severe liver disease, serious infection, or recent significant injury.
• People who are known to be HIV positive.
• People with an active hepatitis B or hepatitis C infection.
• People with an active CMV (cytomegalovirus) infection.
• People who have had a stroke, unstable chest pain, a heart attack, or a serious heart rhythm problem requiring treatment within the past 3 months.
• People with ongoing irregular heart rhythm (atrial fibrillation) where the heart rate is not well controlled.
• People who have had a second, separate cancer that required treatment within the last 2 years, or that is not currently in full remission.
• People who have had a blood clot in a vein (such as a pulmonary embolism or deep vein thrombosis) requiring blood-thinning medication, and who also meet certain additional conditions — such as having been on blood thinners for less than one month, having had a significant bleeding episode in the last 30 days, or still experiencing symptoms from the clot (such as breathlessness or needing extra oxygen).
• Women who are pregnant or breastfeeding.
• People who have taken part in another interventional clinical trial within 30 days before the screening visit.

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