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:

• You are 18 years of age or older at the time of signing the consent form.
• You are willing and able to sign a consent form to participate voluntarily.
• You have been diagnosed with multiple myeloma that has come back or stopped responding to treatment, and your disease can be measured through blood, urine, tissue, or bone marrow tests at the start of the study.
• You have previously received at least three different types of treatment for your multiple myeloma, including one from each of these groups: a proteasome inhibitor, an immunomodulatory drug (IMiD), and an anti-CD38 antibody.
• For one part of the trial (Part 1a): you either have myeloma that has spread outside the bones, or you have previously received a therapy that targets a protein called BCMA.
• Your general health and ability to carry out daily activities meets a certain level, as measured by a standard medical scale (called ECOG 0–2), meaning you are fully active to somewhat limited but still able to care for yourself (confirm with trial site).
• If you are a woman who could become pregnant, you must have a negative pregnancy test before starting treatment, and you and any sexually active male participants must agree to use effective birth control throughout the study.
• Any side effects from previous treatments have mostly recovered to a mild or stable level, with some specific exceptions allowed (confirm with trial site).
• You are able and willing to attend all required study visits and follow the study plan.
• If you have previously had a stem cell transplant from a donor, you must show no signs of graft-versus-host disease and must have been off any immune-suppressing medication for at least one month before joining.

Who may not be able to join:

• You have a medical reason that prevents you from receiving the study treatment or undergoing the required procedures.
• You have a known large or significant spread of myeloma to the central nervous system (brain or spinal cord).
• Your liver is not functioning well enough, based on specific blood test results (confirm with trial site).
• Your kidneys are not functioning well enough, based on a specific measurement of how well they filter your blood (confirm with trial site).
• Your blood clotting levels are outside a certain range, unless you have been on a stable dose of blood-thinning medication for a clotting event for at least one month (confirm with trial site).
• Your blood counts are too low — specifically, your white blood cells, platelets, or red blood cells fall below certain levels; people with very low lymphocyte counts may also be excluded depending on the investigator's judgment.
• Your heart is not pumping strongly enough, based on a heart function test (confirm with trial site).
• You are currently taking ongoing immune-suppressing medications such as cyclosporine or high-dose steroids (low replacement doses of steroids may be allowed — confirm with trial site).
• You have a serious illness or condition that the study doctor believes would put you at significant risk or interfere with the study, such as severe liver disease or active infection.
• You are known to be HIV positive.
• You have an active Hepatitis B or Hepatitis C infection, confirmed by specific blood tests.
• You have an active CMV (cytomegalovirus) infection.
• You have had a stroke, severe chest pain (unstable angina), a heart attack, or a serious heart rhythm problem requiring treatment within the past 3 months.
• You have ongoing atrial fibrillation (an irregular heart rhythm) with a heart rate that is not well controlled.
• You have had another type of cancer that required treatment in the last 2 years or is not fully in remission — though some exceptions apply, such as certain treated skin cancers or prostate cancer controlled by hormone therapy.
• You have had a blood clot (such as a deep vein thrombosis or pulmonary embolism) requiring blood thinners, and you either have not been on a stable dose for at least one month, have had a significant bleeding episode in the last 30 days, or are still experiencing symptoms from that clot.
• You are currently pregnant or breastfeeding.

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