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 able to understand and sign a consent form agreeing to take part in the study.
• People who have received the commercial CAR-T cell therapy called cilta-cel between 3 and 6 months ago for myeloma that came back or stopped responding to treatment, and who have not shown signs of the disease getting worse since that treatment.
• People whose myeloma has certain high-risk genetic features (such as specific chromosome changes known as del17p, t(4;14), or t(14;16)), or who have had myeloma that spread outside the bone marrow (called extramedullary disease).
• People who have previously been treated with more than 2 different treatment regimens, including one from each of these three drug types: an immunomodulatory drug, a proteasome inhibitor, and a CD38 monoclonal antibody.
• People who are able to attend all scheduled study visits and follow the study requirements.
• People who have already had a specific disease-tracking test called a ClonoSeq ID completed before enrolling, which is used to monitor very small amounts of remaining myeloma in the body.
• People with a physical fitness score of 0 or 1 on a standard medical scale (meaning fully active or able to do light activity), as assessed by the treating doctor.
• People with liver-related blood test results (bilirubin, AST, and ALT) within acceptable ranges, unless a specific inherited liver condition called Gilbert syndrome is the cause of an elevated bilirubin result.
• People with adequate bone marrow function, as assessed by the trial site (confirm with trial site for specific values).

Who may not be able to join:

• People who have an ongoing active infection that is getting worse despite treatment, is causing symptoms, or requires antibiotic treatment given through a drip (intravenously).
• People who are still experiencing cytokine release syndrome (CRS) or a brain-related side effect called ICANS at any level of severity following their CAR-T cell therapy.
• People who currently have plasma cell leukaemia (an aggressive form of myeloma in the blood).
• People whose myeloma has spread to the central nervous system, including the membranes around the brain and spinal cord.
• People who have a history of a nerve condition called Guillain-Barré syndrome.
• People with serious uncontrolled medical conditions such as uncontrolled diabetes, heart failure, heart disease, high blood pressure, unstable chest pain, abnormal heart rhythms, or significant lung, liver, or kidney disease — unless the kidney problems are thought to be caused by the myeloma itself, in which case the treating doctor will assess the risk individually.
• People who are pregnant or currently breastfeeding.
• People who are currently receiving any other cancer treatments at the same time.
• People who have an active infection with HIV, hepatitis B, or hepatitis C. People who test positive for hepatitis B only because of a hepatitis B vaccine are still considered eligible. People who previously had hepatitis C and were treated with the aim of curing it are also considered eligible.
• People whose kidneys are failing and who require dialysis.

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