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:

• The participant, or their legal representative, must be willing to sign a consent form showing they understand the study and agree to take part.
• A person must have a confirmed diagnosis of multiple myeloma based on standard international guidelines.
• A person must have previously been treated with at least two of the following three types of cancer drugs (either separately or in combination): an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 drug.
• A person must have measurable signs of the disease at the screening stage, based on specific blood, urine, or protein level tests (confirm with trial site for exact thresholds).
• A person must have a general health and activity level rated at 0 or 1 on a standard medical scale, meaning they are either fully active or have only minor limitations in physically demanding activities.
• A person must have an estimated life expectancy of more than 12 weeks.
• A person must have recovered from most side effects of previous cancer treatments before joining (hair loss is an exception).
• A person must have adequate blood counts and organ function at the time of screening.
• Female participants who could become pregnant must have a negative pregnancy test at screening, and those who are sexually active must use highly effective contraception during the study and for 3 months after the last dose.
• Male participants must agree to use reliable contraception (such as barrier methods or abstinence) and must not donate sperm during the study and for 3 months after the last dose.

Who may not be able to join:

• People with certain related blood or plasma cell conditions, including plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome, or primary light-chain amyloidosis.
• People who have received certain cancer treatments too recently before the study starts — including some targeted therapies, chemotherapy, experimental drugs, radiation therapy, stem cell transplants, or organ transplants — depending on the type and timing of treatment (confirm with trial site for specific timeframes).
• People who have previously been treated with any therapy that targets a protein called BCMA, including CAR-T cell therapies targeting BCMA.
• People with active graft-versus-host disease (a condition that can occur after a donor stem cell transplant) that is moderate to severe or requires ongoing treatment.
• People who have had another cancer or a bone marrow condition called myelodysplastic syndrome within the past 5 years, with some exceptions for certain early-stage or fully treated skin or localised cancers.
• People with multiple myeloma that has spread to the brain or spinal fluid, or other uncontrolled spread to the central nervous system.
• People with certain serious neurological conditions affecting the brain, or evidence of inflammation or blood vessel problems in the brain on a brain scan.
• People with certain significant heart conditions, including recent heart attack, recent heart procedures, serious irregular heart rhythms, severe heart failure, significant heart valve abnormalities, poor heart pumping function, abnormal heart electrical readings (QT interval) above set thresholds, an implantable defibrillator, or uncontrolled high blood pressure.
• People with a known allergy to monoclonal antibody drugs or to externally sourced immunoglobulin (antibody-based medicines).
• People who have had major surgery or a significant injury within 4 weeks before starting the study, or who need planned surgery during the trial, and whose related side effects have not yet resolved.
• People who have been regularly taking high-dose steroid medicines in the 4 weeks before the study, or who are expected to need higher than a low specified steroid dose during the trial, or who have taken other immune-suppressing medications within 4 weeks before starting.
• People with active hepatitis B, hepatitis C, or HIV infection, based on specific blood test results.
• People with an active, uncontrolled infection currently requiring antibiotic or antiviral treatment taken by mouth or through a drip.
• People with uncontrolled fluid build-up around the lungs, heart, or abdomen that requires drainage more than once a month.
• People who are pregnant or breastfeeding.
• People with a known mental health condition that may affect their ability to follow the study requirements, or who are considered unlikely to comply with the study.
• People who have received a live vaccine within 4 weeks before starting the study.
• People with other serious health conditions, abnormal test results, or other circumstances that the trial doctor considers unsuitable for participation.

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