This study is for people with high-risk smoldering myeloma, a condition where abnormal plasma cells grow in the bone marrow but do not yet cause symptoms. It tests if adding daratumumab, a type of immunotherapy, to the usual chemotherapy drugs lenalidomide and dexamethasone, helps better in preventing the disease from progressing.
Key Points:
- Study Duration: Treatment lasts up to 24 months, with follow-ups for up to 15 years.
- Visits Needed: Regular visits for drug administration and health monitoring are required.
- Potential Risks: Includes drug side effects like infusion reactions or infections.
Participants are randomly assigned to receive either the combination of all three drugs or just the chemotherapy drugs. Eligibility requires specific blood and urine tests, and participants must agree to use birth control and not donate blood or sperm during the study. Pregnant women or those planning to become pregnant cannot participate. This study aims to extend survival and improve quality of life for those with high-risk smoldering myeloma.