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 able to understand the study and sign a consent form voluntarily
• People who are 18 years of age or older at the time of signing the consent form
• People who are able to attend scheduled study visits and follow the study requirements
• People who have multiple myeloma (MM) that has come back or stopped responding to treatment — either returning after a period of stability, or progressing during or within 60 days of finishing the most recent treatment
• People who have previously been treated with at least one drug from each of these three groups: an immunomodulatory drug (lenalidomide or pomalidomide), a proteasome inhibitor (bortezomib, ixazomib, or carfilzomib), and an anti-CD38 drug (daratumumab or isatuximab) — these could have been given separately or together
• People for whom no effective standard treatment options remain
• People who have had a stem cell transplant using their own cells, provided it took place more than 12 weeks before joining the study and there is no active infection at the time
• People whose disease is measurable through specific blood or urine test results taken within 28 days before starting the study drug (confirm with trial site for exact thresholds)
• People with a general health and activity level that meets the study's performance score requirement (a standard medical score of 2 or lower, meaning the person is able to carry out basic self-care but may not be able to do heavy physical work)
• Women of childbearing potential who have a negative pregnancy test and who agree to either avoid heterosexual intercourse or use required birth control methods as outlined by the study
• Men with a female partner who could become pregnant, who agree to use effective contraception from the first dose until 90 days after the last dose
• People who are able to swallow and take oral (by mouth) medications
• People whose side effects from previous treatments have mostly resolved to a mild level or less, except for hair loss or effects considered permanent (confirm with trial site)
• People whose recent blood test results meet all of the following requirements, measured within 7 days before the first study drug dose:
  • A healthy enough level of infection-fighting white blood cells (neutrophils), without having received growth factor injections in the 7 days before testing
  • Liver enzyme levels (AST and ALT) within an acceptable range
  • Kidneys functioning at a sufficient level
  • Platelet counts at or above the required level (a lower threshold may apply for people with heavy myeloma involvement in the bone marrow), without having received a platelet transfusion in the 72 hours before the count used for eligibility
  • Haemoglobin (red blood cell measure) at or above the required level, without having received a red blood cell transfusion in the 72 hours before the result used for eligibility
  • Total bilirubin (a liver marker) within acceptable limits, unless the person has a condition called Gilbert's disease
  • Albumin (a blood protein) at or above the required level
  • Calcium levels within acceptable limits

Who may not be able to join:

• People with a known active history of amyloidosis, POEMS syndrome, or plasma cell leukaemia
• People with serious or unstable medical or psychiatric conditions that could affect their safety, their ability to give consent, or their ability to follow the study procedures
• People who are pregnant or breastfeeding
• People with a second cancer that is actively contributing to their illness or requiring active treatment (other than hormonal therapy), unless the second cancer has been stable for at least 2 years — certain early-stage, treated, or low-risk cancers may still be eligible (confirm with trial site)
• People with certain heart or cardiovascular concerns, including: an abnormal heart electrical reading beyond the study threshold; significant uncontrolled heart rhythm problems; a heart attack, coronary event, or heart procedure within the past six months; severe heart failure (Class III or IV); uncontrolled high blood pressure; or a heart pumping function below 40%
• People with an active HIV, hepatitis B, or hepatitis C infection — some people with past or resolved hepatitis B or C infection may still be eligible under specific conditions (confirm with trial site)
• People with current active liver or bile duct disease, with the exception of certain stable or minor conditions such as Gilbert's syndrome or asymptomatic gallstones
• People with severe or uncontrolled disease affecting the lungs, liver, kidneys, or heart
• People with a significant current or past history of brain or nervous system conditions such as stroke, epilepsy, blood vessel inflammation in the brain, neurodegenerative disease, or myeloma affecting the brain or spinal cord — people with a past stroke or epilepsy who have been free of symptoms for 2 years and meet other conditions may still be eligible (confirm with trial site)
• People with a known active infection currently requiring treatment
• People currently taking systemic immune-suppressing medications (such as azathioprine, methotrexate, or anti-TNF agents), with the exception of low-dose corticosteroids or inhaled corticosteroids for breathing conditions
• People with signs of active bleeding from internal organs or mucous membranes
• People with a significant blockage affecting urinary flow
• People who have received radiotherapy or systemic cancer treatment within 14 days before starting the study drug
• People who have used an investigational (experimental) drug within 21 days, or within five half-lives of that drug, whichever is shorter, before the first study dose
• People who have had major surgery within 28 days before starting the study
• People with a known allergic reaction or sensitivity to drugs chemically related to liposomal curcumin

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