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 newly diagnosed with multiple myeloma and are considered suitable candidates for a stem cell transplant.
• People whose multiple myeloma is classified as "high-risk," meaning certain specific genetic changes have been found in their cancer cells.
• People whose myeloma has responded to initial (induction) treatment, with at least a "partial response" (a meaningful reduction in cancer markers).
• People aged 18 to 75 years. Non-English-speaking participants are also eligible.
• People who are reasonably functional in daily life, as measured by a standard health scoring tool (a score of 70 or above on the Karnofsky scale — confirm with trial site).
• People whose liver is working well enough, based on standard blood test results within specified limits.
• People whose kidneys are working well enough, based on a calculated kidney function measurement of at least 40 mL/min.
• People who agree not to donate blood while taking lenalidomide (one of the study drugs) and for 28 days after stopping it.
• People who agree to enrol in a special safety program required for lenalidomide use (called the REMS program).
• Women who could become pregnant must agree to use highly effective contraception — plus one additional method — starting at least 28 days before treatment, throughout the study, and for at least 28 days after the last lenalidomide dose and at least 4 months after the last dose of the other study drug (elranatamab). They must also agree not to donate eggs during this period, and must have a negative pregnancy test before starting.
• Men must agree to use contraception during treatment and for up to 4 months after their last dose of elranatamab, and must agree not to donate sperm during this period.

Who may not be able to join:

• People who have had a serious allergic reaction to drugs chemically or biologically similar to elranatamab or other drugs used in this trial.
• People currently taking certain medications that could interact with the study drugs — particularly drugs processed by the liver's CYP enzyme system (such as warfarin, cyclosporine, certain statins, some antibiotics, some antidepressants, and others listed in the trial criteria). The trial site will assess whether current medications are a concern (confirm with trial site).
• People whose myeloma got worse at any point before the maintenance phase of treatment.
• People with a form of myeloma that cannot be measured through standard blood or urine protein tests, unless the disease is visible on a PET scan or bone marrow test.
• People with a related but different blood condition called Waldenström's macroglobulinaemia.
• People with a condition called POEMS syndrome.
• People with "smouldering" myeloma, which is an early stage that is not yet causing symptoms.
• People with plasma cell leukaemia.
• People whose myeloma is classified as "standard-risk" (without the high-risk genetic changes required for this trial).
• People with myeloma that has come back or stopped responding to previous treatment.
• People with an active kidney condition such as an infection or the need for dialysis (though people with protein in the urine caused by myeloma itself may still be eligible if other criteria are met).
• People with serious, unstable liver or bile duct disease, such as fluid build-up in the abdomen, yellowing of the skin, or cirrhosis. Stable, milder liver conditions may be acceptable (confirm with trial site).
• People with active, uncontrolled lung disease.
• People who have recently taken another experimental drug or standard myeloma treatment (including steroids) within 14 days or five half-lives of the first study dose, whichever is shorter.
• People with any signs of active bleeding from internal tissues or mucous membranes.
• People with an active, uncontrolled infection.
• People with significant heart problems, including certain irregular heart rhythms, a recent heart attack or heart procedure within the past 3 months, severe heart failure, or blood pressure that cannot be controlled even with three blood pressure medications.
• People with a known HIV infection.
• People with an active hepatitis B or hepatitis C infection.
• People with another active cancer, unless it has been medically stable for at least 2 years and is not expected to interfere with the trial. People with treated non-melanoma skin cancer may be eligible without the 2-year waiting period.
• People who are pregnant or breastfeeding.
• People with significant cognitive impairment, serious unstable medical conditions, or psychiatric disorders that could interfere with safely participating in or consenting to the trial.

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