This study is testing how well a combination of drugs called lenalidomide and dexamethasone, with or without daratumumab, works for patients with high-risk smoldering myeloma. Smoldering myeloma is a condition where abnormal cells grow in the bone marrow but have not yet caused symptoms. Lenalidomide and dexamethasone are drugs that help stop cancer cells from growing. Daratumumab is an immunotherapy drug that helps the body's immune system fight cancer cells.
Patients will be randomly placed in one of two groups. One group will get all three drugs, while the other group will get only lenalidomide and dexamethasone. Treatment will last up to 24 months, and patients will be followed for up to 15 years to see how well the treatment works and if there are any side effects.
- The study involves taking medications and regular check-ups for up to 24 months.
- Participants will be monitored for up to 15 years to track health outcomes.
- There may be side effects, and patients must meet specific health criteria to participate.