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 who have a confirmed diagnosis of Multiple Myeloma (MM) based on internationally recognised guidelines.
• People who have recently started a treatment called teclistamab within the first 8 weeks of their planned treatment schedule, and who are expected to continue it for the next 12 months.
• People who are at least 18 years old at the time of signing the consent form.
• People who are willing and able to sign a consent form agreeing to take part (or whose legal representative can do so on their behalf).
• People who are capable of becoming pregnant and are sexually active in a way that could lead to pregnancy must agree to use a highly effective form of contraception, and to avoid donating eggs, from the screening stage until 30 days after the last dose of the study treatment.

Who may not be able to join:

• People whose myeloma has not shown at least a minimal response to teclistamab within the first 8 weeks of starting treatment.
• People who currently have a serious infection, or who have had more than one serious infection in the past 3 months before screening.
• People whose blood test before starting teclistamab (taken within 4 weeks prior) showed a certain immune protein level (polyclonal IgG) below a specific threshold, as assessed by the treating doctor.
• People who are currently receiving, or who have received within the past 16 weeks, immunoglobulin replacement products (infusions of antibodies given as a treatment).
• People who have received a specialised high-dose immunoglobulin product (such as those targeting cytomegalovirus, varicella-zoster, or hepatitis B) within 30 days before screening.
• People who have received a live viral vaccine within 30 days before screening.
• People whose general physical functioning is significantly limited, based on a standard medical scoring system (confirm with trial site for the specific score threshold).
• People who have an active viral or bacterial infection, or signs of one requiring treatment with anti-infective medications, within 1 week before joining the trial.
• People who have previously received any other type of bispecific antibody therapy targeting BCMA and CD3 (a specific category of cancer treatment).
• People who are scheduled to undergo, or who have undergone in the past 16 weeks, a blood-filtering procedure called plasmapheresis.
• People who, in the opinion of the treating doctor, are at high risk of a condition called symptomatic hyperviscosity syndrome (where the blood becomes too thick).
• People who have major surgery planned during the study period, or who have not fully recovered from a recent major surgery at the time of screening (those having minor procedures under local anaesthetic may still be eligible).
• People who have an active second cancer (other than MM), or another medical condition that is expected to result in a life expectancy of less than 2 years.
• People with a known history of serious allergic reactions (such as hives, breathing difficulty, severe low blood pressure, or anaphylaxis) to intravenous immunoglobulin (IVIG) or similar infusions.
• People who have had a blood clot, pulmonary embolism (clot in the lungs), heart attack, stroke, mini-stroke, or peripheral artery disease within the 6 months before screening.
• People who have moderate to severe kidney disease based on a specific kidney function measurement taken at screening (confirm with trial site for the exact threshold).
• People who test positive at screening for hepatitis B, hepatitis C, or HIV; however, people who were previously treated for hepatitis C and now test negative may still be eligible.
• People who have a diagnosed primary immune deficiency condition that affects the body's ability to make antibodies and requires regular immunoglobulin replacement treatment.
• People whose liver enzyme levels (AST and ALT) are persistently more than 3 times the upper normal limit at screening.
• People who have a specific immune protein deficiency (IgA deficiency below a certain level) combined with antibodies against IgA and a history of allergic reaction to IVIG.
• People with a known allergy to any ingredient in the study treatment product (IGI, 10%).
• People with a known history of substance misuse, including opiates, stimulant drugs, or other illicit substances (with the exception of cannabinoids), within 12 months of screening.
• People with anaemia (low red blood cell levels) severe enough to make routine blood draws unsafe, as determined by the treating doctor.
• People with any other medical condition, laboratory result, or physical finding that, in the opinion of the treating doctor, would make participation unsafe or interfere with completing the study.
• People who are currently receiving immune-suppressing treatments (other than those used to treat MM or standard corticosteroids), or who plan to receive such treatments during the study.
• People who are not willing or able to follow the requirements of the study protocol.
• People who have taken part, or are scheduled to take part, in another clinical trial involving an experimental treatment or device within 30 days before screening or during the study.
• People who are a family member or employee of the doctor running the trial or of the trial site staff.
• People who are pregnant, have a positive pregnancy test, or are currently breastfeeding at the time of screening or enrolment.

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