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 are 18 years of age or older.
• People whose general health and ability to carry out daily activities meets a certain level of functioning (confirm with trial site).
• People who are willing and able to sign a consent form agreeing to take part.
• People who have been diagnosed with multiple myeloma, with a sufficient amount of the disease detectable in their blood, urine, or bone marrow at the time of screening.
• People whose myeloma has a specific genetic change called t(11;14), confirmed by laboratory testing.
• People who have received at least one prior treatment for myeloma, including at least one drug from each of these three groups: a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody — and whose myeloma has come back or stopped responding to their most recent treatment.
• People who have previously had an autologous stem cell transplant (using their own stem cells) may be eligible, provided it was completed more than 100 days before starting the study treatment and there is no active infection at the time of joining.
• People whose blood counts and organ function (including liver and kidneys) meet certain minimum levels as measured by blood tests (confirm with trial site).
• Women who are not pregnant or breastfeeding, and who are either not able to become pregnant or are using a highly effective form of contraception.
• Men who agree to avoid donating sperm and to either abstain from heterosexual intercourse or use a highly effective form of contraception during the study and for 6 months after the last dose of study treatment.
• People who agree not to donate blood during the study and for 28 days after finishing treatment.
• People who agree not to share their study medication with anyone else.
• People whose side effects from previous treatments have mostly resolved (to a mild level or better) before joining, except for hair loss.

Who may not be able to join:

• People who have previously been treated with Venetoclax or any anti-BCMA therapy.
• People who have received another experimental drug or standard myeloma treatment within 14 days (or five half-lives, whichever is shorter) before the first study dose, with a limited exception for a short course of steroids used in an emergency.
• People who have had plasmapheresis (a blood-filtering procedure) or radiation therapy within 7 days before the first dose.
• People who have a current disease affecting the surface of the eye (cornea), except for very mild changes.
• People who have current unstable liver or bile duct disease.
• People who have an active kidney condition, such as an infection, a need for dialysis, or another condition affecting kidney safety.
• People who have had major surgery within 4 weeks before starting the study (a procedure called kyphoplasty is not considered major surgery for this purpose).
• People who wear contact lenses, as contact lens use is not permitted during the study (bandage contact lenses may be allowed if prescribed by an eye care professional if needed).
• People who have active bleeding in the gut or mouth, or a digestive condition that may affect how oral medication is absorbed.
• People who have certain heart or blood vessel concerns as defined by the trial protocol (confirm with trial site).
• People who have had a known allergic or unusual reaction to the study drugs or to chemically similar drugs.
• People who have had another invasive cancer within the past 5 years, with some exceptions for certain early-stage or fully treated cancers (confirm with trial site).
• People who are pregnant or breastfeeding.
• People who have previously had an allogeneic stem cell transplant (using donor stem cells).
• People who have active amyloidosis, active POEMS syndrome, or active plasma cell leukaemia at the time of screening.
• People who have serious unstable medical or psychiatric conditions that could affect their safety or ability to take part in the study.
• People who are known to be positive for HIV, hepatitis B, or hepatitis C.
• People who currently have an immune or inflammatory condition requiring immunosuppressive treatment, such as lupus or rheumatoid arthritis.
• People who have received a live vaccine within 8 weeks before the first dose of study treatment.
• People who are currently using, or expect to use, certain medications or foods that are not permitted during the study (confirm with trial site).
• People who have myeloma that has spread to the brain or spinal fluid.
• People who have other significant uncontrolled medical conditions that could interfere with the study or pose a safety risk.
• People who, in the opinion of the study doctor, may not be able to follow the study requirements or for whom participation would not be in their best interest.
• People who have used certain medications that affect how the body processes drugs (specific enzyme inhibitors or inducers) within 7 days before the first dose (confirm with trial site).
• People who have consumed grapefruit, Seville oranges (including marmalade made with Seville oranges), or star fruit within 3 days before the first dose.
• People who are already participating in another clinical trial (observational studies may be an exception — confirm with trial site).

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