Phase 2 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 been confirmed, through laboratory testing of tissue or cells, to have smoldering multiple myeloma (SMM) — a condition where abnormal plasma cells are present in the bone marrow but have not yet caused serious organ damage — meeting specific blood, urine, and bone marrow measurements as defined by international guidelines.
• People who have had measurable signs of the disease within the past 4 weeks, based on specific protein levels in the blood or urine, or other recognised disease markers.
• People aged 18 years or older.
• People who are generally able to carry out everyday activities with no or only minimal limitations (assessed within the past 45 days).
• People whose blood counts and organ function (including liver, kidneys, and blood cells) meet minimum health thresholds tested within the past 45 days.
• People whose SMM is classified as high-risk for progressing to active multiple myeloma, based on specific clinical measurements and/or genetic features of the disease.
• Women who could become pregnant must have a negative pregnancy test at the start of the study and at required points throughout, and must agree to use at least one highly effective form of contraception during the study and for 3 months after the last dose of treatment.
• Women who are not able to become pregnant may also be eligible (confirm with trial site).
• Women must agree not to donate or freeze eggs for assisted reproduction during the study and for 3 months after the last dose of treatment, and should consider preserving eggs before starting treatment as cancer treatments may affect fertility.
• Women must agree not to breastfeed during the study and for 5 months after the last dose of treatment.
• Men must agree to use a condom during any activity that could result in passing ejaculate to another person, throughout the study and for 3 months after the last dose of treatment; if their partner is a woman who could become pregnant, that partner must also use a highly effective form of contraception (note: men who have had a vasectomy must still use a condom, but their partner does not need additional contraception).
• Men must agree not to donate sperm during the study and for 3 months after the last dose of treatment, and should consider preserving sperm before starting, as cancer treatments may affect fertility.
• People who are able to understand the study and are willing to sign a written consent form.
• People who are willing and able to follow the lifestyle requirements outlined in the study protocol.

Who may not be able to join:

• People who have previously received systemic (whole-body) treatments for SMM or multiple myeloma, except for one prior treatment cycle (4–5 weeks) provided there has been a 4-week break before starting this study (use of corticosteroids for unrelated conditions is allowed).
• People who are currently taking part in another clinical trial using any other experimental treatment.
• People who have received a live vaccine within 4 weeks before the scheduled start of study treatment.
• People who have a known allergy or intolerance to medications that would be required during the study, including those used to manage infusion reactions, infections, blood clotting, or fluid balance.
• People living with HIV who meet certain criteria, such as a low immune cell count, a detectable amount of virus in their blood, not being on effective HIV treatment, having recently changed HIV treatment, or being on HIV treatment that may interfere with the study drugs.
• People with an active hepatitis B infection, or with certain patterns of hepatitis B blood test results indicating active infection (some exceptions apply for people with evidence of prior hepatitis B vaccination only).
• People with an active hepatitis C infection (people who have previously been treated for hepatitis C and have had no detectable virus for at least 12 weeks after finishing that treatment may still be eligible — confirm with trial site).
• People with a chronic lung condition (COPD) where breathing tests show lung function below 50% of the expected level.
• People with moderate to severe or uncontrolled asthma in the past 2 years, or with any asthma where breathing tests show lung function below 50% of the expected level.
• People who have had an allergic reaction to substances similar to the study drugs.
• Women who are unwilling to stop breastfeeding during the study or within 5 months of the last dose.
• Men who plan to father a child during the study or within 3 months after the last dose of treatment.
• People with serious heart conditions, including severe heart failure, a heart attack or heart bypass surgery within the past 6 months, significant heart rhythm problems, uncontrolled irregular heartbeat, or unstable heart-related conditions.
• People with serious uncontrolled health conditions, including active infections, blood clots, active bleeding, lung scarring or inflammation, active autoimmune disease (with some exceptions such as vitiligo, type 1 diabetes, or a previously resolved thyroid condition), or mental health or personal circumstances that would make it difficult to follow the study requirements within the past 2 weeks.
• People who have had another active cancer requiring treatment within the past 24 months (cancers considered fully treated and very unlikely to return may be acceptable — confirm with trial site).
• People with any other condition that, in the treating doctor's judgement, would put them at risk or prevent them from completing the study requirements.
• People who are not able to make their own informed decisions will not be enrolled.

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