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:

• People who are willing and able to sign and date a consent form agreeing to take part in the study.
• People who are willing to follow all study procedures and are available for the full duration of the study.
• People aged 18 years or older.
• People who have been diagnosed with multiple myeloma, confirmed using internationally recognised diagnostic guidelines.
• People whose doctors have planned for them to receive teclistamab or talquetamab as part of their standard cancer treatment.
• People who have previously received at least one of a specific group of cancer treatments that work by engaging the immune system's T-cells (including certain bispecific or trispecific antibodies, or CAR-T cell therapies targeting proteins such as BCMA, GPRC5d, CD3, CD38, or FcRL5) (confirm with trial site for exact list).
• People whose blood test results during the screening period meet certain minimum levels for red blood cells, platelets, and white blood cells, and whose liver function tests fall within acceptable ranges (confirm with trial site for exact values).
• People who are able to swallow tablets and are willing to follow a specific pre-treatment medication schedule using a drug called sirolimus.
• People who are well enough to carry out some daily activities independently, based on a standard medical assessment scale (confirm with trial site for exact scoring details).
• Males who are able to father children and are willing to use condoms or other reliable contraception throughout the study.
• People who agree to follow specific lifestyle guidelines for the duration of the study.

Who may not be able to join:

• People whose multiple myeloma is advancing very quickly and who, in their doctor's judgement, need to start cancer treatment immediately.
• People who have recently taken certain medications, including: steroid medicines (corticosteroids) within one week before treatment starts; certain immune-suppressing drugs (calcineurin inhibitors or mTOR inhibitors, such as tacrolimus, everolimus, temsirolimus, or sirolimus); certain antibody-based medicines that target inflammation (such as infliximab or siltuximab); certain anti-inflammatory medicines called JAK inhibitors (such as ruxolitinib); or any other experimental drug within the past 28 days.
• People who have previously had a stem cell or bone marrow transplant from another person (allogeneic transplant).
• People who have an active, uncontrolled infection in the seven days before treatment starts.
• People who have had an uncontrolled blood clotting event within the three months before treatment starts.
• People who have had a heart attack or acute coronary event within the six months before treatment starts.
• People with uncontrolled inflammatory bowel disease.
• People with an active hepatitis B, hepatitis C, or HIV infection.
• People with uncontrolled rheumatological (autoimmune joint or tissue) conditions.
• People taking a type of blood pressure medication called an ACE inhibitor within one week of treatment starting — although the trial site may be able to include people if that medication is switched to a related type of blood pressure medicine called an angiotensin receptor blocker (confirm with trial site).
• People taking certain medications that interact with sirolimus (known as CYP3A4/p-gp inhibitors or inducers) within seven days before or after sirolimus doses are given (confirm with trial site for the full list of affected medications).
• People who have another currently active cancer, or a history of a cancer that has spread to other parts of the body, that could affect the safety or results of the trial.
• People who are pregnant or breastfeeding.
• People who have a known allergy to sirolimus (the study drug used in the pre-treatment phase).

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