Phase 1 Myeloma Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults aged 18 or older of any race, where women must have had a surgical procedure that means they cannot become pregnant, or must be postmenopausal, and men must have had a permanent sterilisation procedure or agree to use contraception during the study
• People who have an advanced blood cancer that has come back, stopped responding to treatment, or continued to worsen after receiving standard available treatments
• People whose side effects from any previous cancer treatments have mostly resolved to a mild level or better before joining (with some exceptions allowed for mild-to-moderate hair loss or nerve-related symptoms)
• People with adequate kidney and liver function, as assessed by the trial team
• People who are reasonably well and able to carry out basic daily activities, as measured by a standard medical scale called the ECOG performance status (score of 2 or below)
• People who are able to attend all required study visits, including a monitoring period that involves staying at the study site and providing samples of bowel movements and urine
• People who are able to understand the study information, willing to sign the consent form, and able to follow the study requirements

Who may not be able to join:

• People diagnosed with a specific type of blood cancer called acute promyelocytic leukaemia
• People with certain abnormal heart rhythm readings on an ECG, specifically where a measurement called the QTcF is above 480 milliseconds (confirm with trial site for details around bundle branch block)
• People with a history of a specific dangerous heart rhythm problem called torsades de pointes
• People whose heart pumping function is at or below 45%, as measured by a heart scan called an echocardiogram
• People with certain other serious health conditions that could make the study unsafe or affect the results, including wounds that are not healing properly, heart failure, unstable chest pain, certain heart rhythm problems requiring treatment, a heart attack or acute coronary event in the past 6 months, serious lung disease causing breathlessness at rest or with very little effort, uncontrolled high blood pressure, or diabetes with more than 2 episodes of a serious complication called ketoacidosis in the past 6 months
• People who have had surgery to remove part of the stomach or intestines in a way that could affect how the body absorbs or removes medications taken by mouth (straightforward appendix removal or hernia repair are generally still allowed)
• People with a history of serious difficulty swallowing, short bowel syndrome, slow stomach emptying, bowel diseases, poor nutrient absorption, a need for nutrition through a drip or feeding tube, or any other condition that limits the ability to take or absorb medications taken by mouth
• People with cognitive, psychological, or emotional difficulties that could affect their ability to receive treatment as required by the study or to properly participate in the informed consent process
• People who have experienced a blocked bowel, a tunnel-like opening between the bowel and another organ, a hole in the digestive tract, or an infection or abscess inside the abdomen within the past 6 months (unless the trial investigator and medical monitor approve)
• People with an active, uncontrolled infection caused by bacteria, a virus, or a fungus that requires treatment given through a drip or injection
• People with test results indicating an active hepatitis infection or active HIV infection (people whose results reflect a past vaccination rather than active infection may still be considered)
• People who have received a stem cell transplant, a type of immune cell therapy called chimeric antigen receptor cell therapy, or other modified T-cell therapy within the past 60 days
• People who have received an infusion of donor immune cells within the past 28 days, are currently taking medications to suppress the immune system following a stem cell transplant, or have an active condition called graft-versus-host disease (GVHD) requiring active medical treatment beyond topical creams for skin-related GVHD
• People who have taken a type of medication called systemic calcineurin inhibitors within the past 2 weeks
• People who have received other anti-cancer treatments or taken part in another experimental treatment study within the past 14 days, or within 5 half-lives of the previous treatment, whichever is the shorter period
• People who have had major surgery within the past 28 days
• People with a known allergy or intolerance to any ingredient in the study treatment
• People who have taken part in more than 2 studies involving a radioactive (radiolabelled) drug in the past 12 months, or who have taken part in 1 or 2 such studies but where the most recent dose was not far enough in the past (confirm specific timeframes with trial site)
• People with poor access to veins in the arms or hands, making blood draws or injections difficult
• People who have had significant exposure to radiation for medical or other reasons, or who currently work in a role that requires monitoring of radiation exposure, within the past 12 months
• People who the trial investigator considers should not participate for any other reason

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