This clinical trial is focused on studying a type of blood cancer called multiple myeloma, which affects the plasma cells in the bone marrow. The study is investigating the effectiveness of a combination of medications: Daratumumab, Lenalidomide, and Dexamethasone. Daratumumab, also known by its code name HuMax-CD38, is a protein-based treatment given through an injection. Lenalidomide is taken orally, and Dexamethasone can be administered both orally and intravenously. The purpose of the study is to compare two different treatment approaches: continuous therapy versus a fixed duration of therapy for patients whose multiple myeloma has returned after initial treatment.
Participants in the study will receive one of the two treatment plans. The continuous therapy group will receive the medications until the disease progresses, while the fixed duration group will receive the medications for a set period of 24 months. The study aims to determine if the fixed duration treatment is as effective as the continuous treatment in terms of overall survival over four years. Throughout the study, participants will be monitored regularly to assess their response to the treatment and any side effects they may experience.
The trial will also evaluate the quality of life of participants using questionnaires and analyze the cost-effectiveness of the treatments. The study is designed to provide valuable information on the best treatment approach for relapsed multiple myeloma, helping to improve patient care and outcomes in the future.
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