Phase 3 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 aged 18 or older at the time of the screening visit
• People with a confirmed diagnosis of B-cell chronic lymphocytic leukaemia (CLL) at an intermediate or high stage, as defined by recognised international criteria
• People with a confirmed diagnosis of multiple myeloma (MM) at stage II or III, as defined by recognised international criteria
• People with a confirmed diagnosis of B-cell non-Hodgkin lymphoma (NHL) at stage III or higher (including stage IV, progressive, or relapsed/recurrent disease), confirmed by tissue testing
• People who have low levels of a protective antibody called IgG (below 5 g/L), with a specific adjustment made for people with multiple myeloma to account for abnormal protein in the blood
• People who have had at least one serious bacterial or viral infection, or three or more infections of any severity, in the 12 months before the screening visit, where serious infections are defined at a specific medical severity level (Grade 3 or above)

Who may not be able to join:

• People who have had a stem cell transplant using donor cells in the past 24 months, or a transplant using their own cells in the past 3 months
• People who are currently receiving, or have received in the past 6 months, immunoglobulin replacement therapy (a treatment that supplements protective antibodies)
• People who have an active infection at the time of the screening visit (note: certain preventative anti-infective medications permitted under relevant treatment guidelines may still be allowed — confirm with trial site)
• People who currently have a second active cancer
• People with a known inherited immune system disorder (primary immunodeficiency)
• People whose life expectancy is less than 18 months
• People with a significant ongoing acute or chronic health condition that, in the investigator's opinion, could interfere with completing the trial or pose an undue medical risk
• People who have had a known serious allergic reaction to immunoglobulin products, or any severe allergic reaction to blood or blood-derived products
• People with a history of blistering skin conditions, bleeding disorders, widespread rash, recurring skin infections, or other conditions where under-the-skin (subcutaneous) injections would not be considered safe, based on the investigator's judgement
• People with a specific condition called Selective IgA Deficiency (a particular immune disorder affecting IgA antibody levels, with or without antibodies against IgA)
• People with severely reduced kidney function, as measured by a specific kidney filtration test result below a defined threshold
• People with liver enzyme levels (specific enzymes: ALT, AST, GGT, or LDH) more than three times the upper limit of the normal range at the screening visit
• People with a history of blood clot-related events — such as heart attack, stroke, or mini-stroke — either once within the past year or twice at any point in their lifetime, or a history of deep vein thrombosis (a blood clot in a deep vein)
• People currently known to have a condition that causes the blood to be too thick or to clot too easily
• People with a known previous or current hepatitis B or hepatitis C infection
• People with uncontrolled high blood pressure (above defined thresholds for both upper and lower blood pressure readings) or a resting heart rate above 100 beats per minute
• People with known substance or prescription drug misuse in the 12 months before the screening visit
• People who have taken part in another interventional clinical trial within the 30 days before screening (observational studies without any investigational treatment are permitted)

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