Early 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 are willing to take part voluntarily, have been fully informed about the study, and have signed a consent form agreeing to follow all trial procedures
• Adults aged 18 or older, of any gender
• People who have been newly diagnosed with multiple myeloma, according to recognised international diagnostic guidelines
• People whose myeloma is measurable, based on specific protein levels in the blood or urine, or abnormal levels of certain proteins in the blood (confirm with trial site for exact values)
• People whose myeloma is considered high risk, meaning at least one of the following applies: certain high-risk genetic changes in the cancer cells; advanced disease stage (R-ISS stage 3, or R2-ISS stages 3 or 4); soft tissue tumours outside the bone marrow; or a small percentage of cancer cells detected in the blood (confirm with trial site)
• People with a general health status rated as reasonably functional on a standard scale used by doctors (ECOG score 0–2)
• People whose blood test results meet minimum levels for white blood cells, platelets, haemoglobin, kidney function, and liver function (confirm with trial site for exact values)
• People who are able to have blood collected through a vein for the cell collection process
• Women who could become pregnant must have a negative pregnancy test at the start of the trial and must be willing to use reliable contraception for at least 12 months after receiving the trial treatment
• Men who are sexually active with women who could become pregnant must be willing to use reliable contraception for 1 year after receiving the trial treatment, and must not donate sperm during the trial or for 1 year afterwards

Who may not be able to join:

• People who have a form of multiple myeloma that does not produce measurable proteins (non-secretory MM)
• People who have already received treatment for multiple myeloma beyond up to 2 cycles of a specific standard combination therapy (bortezomib, lenalidomide, and dexamethasone) — this includes chemotherapy, targeted therapy, radiotherapy covering more than 5% of bone marrow, and other treatments
• Women who are pregnant or breastfeeding
• People with serious mental health conditions, a history of brain or nervous system diseases (such as epilepsy, stroke, dementia, Parkinson's disease, or spinal cord compression), or any suspected spread of disease to the central nervous system
• People who have had, or currently have, another type of cancer — including some cancers that may have been previously treated (confirm with trial site, as some exceptions may apply)
• People with an active autoimmune disease that has caused damage to organs or requires long-term immune-suppressing medication (such as Crohn's disease, rheumatoid arthritis, or lupus)
• People with any active, uncontrolled infection that has not improved with appropriate treatment, or a serious ongoing viral, bacterial, or fungal infection
• People who test positive for HIV, syphilis, hepatitis C, or active hepatitis B
• People who have received a live or mRNA vaccine within 8 weeks before screening, or an inactivated vaccine within 4 weeks before screening
• People who are allergic or intolerant to certain medications used in the trial process, including drugs used to prepare the body for cell therapy, a medication called tocilizumab, or a substance called DMSO used in the cell preparation — or people with a history of severe allergic reactions such as anaphylactic shock
• People with significant heart problems, including severe heart failure, a recent heart attack or heart surgery within the past 6 months, serious irregular heart rhythms, severe heart muscle disease, or reduced heart pumping function below a certain level (confirm with trial site)
• People with known or suspected serious lung conditions, such as COPD with significantly reduced lung function, asthma, lung disease, lung infection, or blood clots in the lungs (confirm with trial site)
• People who need supplemental oxygen to maintain normal oxygen levels, or whose blood oxygen level is below 92% when breathing normal air
• People who have had a stroke or seizure within the 6 months before the screening period
• People who have recently had major surgery, or who are planning to have major surgery after receiving the trial treatment (minor procedures under local anaesthetic, such as cataract surgery, may be acceptable — confirm with trial site)
• People who have not yet recovered from side effects of previous treatments (with some exceptions such as hair loss or mild nerve-related symptoms)
• People whom the trial doctors consider unsuitable for the trial for any other reason

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