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 who have given written consent to participate in the study
• People who are older than 18 years of age at the time of signing the consent form
• People who have been formally diagnosed with multiple myeloma according to established international diagnostic guidelines
• People who have a measurable area of myeloma outside the bone marrow (at least one spot of disease 1cm or larger) that has either never had radiotherapy or has continued to grow after radiotherapy, visible on any type of medical scan
• People who have already been treated with at least two prior rounds of cancer therapy, including one drug from the proteasome inhibitor class and one from the immunomodulatory drug class, with at least one full treatment cycle completed for each round unless the cancer kept growing during that treatment
• People whose general physical functioning is rated at 0 or 1 on a standard medical activity scale, meaning they are either fully active or have only minor limitations in physically demanding activities (confirm with trial site)
• People whose treating doctor estimates they have a life expectancy of at least 3 months
• People who are able to undergo a procedure to collect white blood cells from the blood (apheresis)
• People whose recent blood test results (taken within 7 days before enrolment) meet specific minimum levels for red blood cells, white blood cells, platelets, lymphocytes, kidney function, and liver function as required by the trial (confirm with trial site for exact values)
• Women who could become pregnant must agree to use two forms of reliable contraception simultaneously — one highly effective method and one additional effective method — from the time of signing the consent form until at least one year after receiving the study treatment
• Men who are sexually active with a woman who could become pregnant or who is already pregnant must agree to use a barrier method of contraception from the time of signing the consent form until at least one year after receiving the study treatment, even after a vasectomy
• Women and men must agree not to donate eggs or sperm for at least one year after receiving the study treatment
• People who are willing and able to follow all lifestyle and treatment restrictions required throughout the study

Who may not be able to join:

• People with a known sensitivity or allergy to nickel or palladium
• People who weigh more than 105 kg or are taller than 185 cm
• People with known claustrophobia (fear of enclosed spaces)
• People who have previously received any CAR-T cell therapy
• People who have received a high cumulative dose of corticosteroid medicines (equivalent to 70mg or more of prednisone) in the 7 days before the planned cell collection procedure
• People who have previously received any treatment specifically targeting the BCMA protein
• People who have received a live or experimental vaccine (other than a COVID-19 vaccine) within 4 weeks before the planned preparatory treatment stage
• People who have received certain anti-cancer treatments too recently before the planned cell collection procedure, including experimental drugs, monoclonal antibodies, chemotherapy, targeted therapies, or radiotherapy, within specified timeframes (confirm with trial site for exact timeframes)
• People who have another active cancer that is progressing or required a treatment change in the last 24 months, with some specific exceptions for certain completely cured cancers or very low-risk cancers being monitored or managed (confirm with trial site)
• People diagnosed with plasma cell leukaemia, Waldenström's macroglobulinaemia, POEMS syndrome, or primary amyloid light-chain amyloidosis
• People with known serious allergies or intolerances to any of the study drugs or their ingredients, including boron, mannitol, or dimethyl sulfoxide
• People who are pregnant, breastfeeding, or planning to become pregnant during the study or within one year of receiving the study treatment
• People who plan to father a child during the study or within one year of receiving the study treatment
• People who have had a stroke or seizure within the 6 months before signing the consent form
• People who received a donor stem cell transplant within 6 months before the planned cell collection, or still require immunosuppressive medicines, or who have active graft-versus-host disease
• People who received their own stem cell transplant within 12 weeks before the planned cell collection procedure
• People with known active or prior myeloma involvement in the central nervous system or brain
• People who test positive for HIV, have an active hepatitis B infection, or have an active or unresolved hepatitis C infection (people with previously resolved hepatitis C may be eligible if specific test results confirm this — confirm with trial site)
• People with serious underlying medical or psychiatric conditions that could interfere with the study, including the need for continuous oxygen, active infections requiring treatment, active autoimmune disease, signs of dementia, any history of Parkinson's disease or other neurodegenerative conditions, or significant heart problems such as severe heart failure, a recent heart attack, serious heart rhythm problems, severe cardiomyopathy, or poor heart pumping function measured within 8 weeks before cell collection
• People who have had major surgery within 2 weeks before the bridging treatment phase, or who have major surgery planned during the study or within 2 weeks after receiving the study treatment (minor procedures under local anaesthetic may still be permitted)
• People who score 2 or higher on a standard myeloma-specific frailty assessment tool (confirm with trial site)
• People for whom the treating doctor believes participation would not be in their best interest, or who have any condition that could prevent them from safely receiving or tolerating the treatment

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