Discontinuation of Maintenance Therapy for Patients with Multiple Myeloma in Sustained MRD Negative Remission Without High-Risk Features

What this Trial Is About

Researchers are studying patients with Multiple Myeloma who have completed at least two years of maintenance therapy or have stopped maintenance due to side effects, focusing on those in sustained minimal residual disease (MRD) negative remission without high-risk features. The study aims to evaluate the risk of disease progression after stopping maintenance therapy and to assess how many remain in MRD negative remission 12 months after discontinuation. This non-randomized, interventional trial divides participants into groups based on disease status and treatment continuation preferences. Participants are divided into two main groups: those with detectable disease who continue maintenance therapy, and those in remission who may choose to continue or discontinue maintenance therapy. The discontinuation group includes patients who stopped earlier due to side effects but achieved sustained MRD negative remission. Patients continuing therapy will be monitored every three months or more often if needed, while those discontinuing therapy will be regularly assessed with blood tests and bone marrow MRD by next generation flow cytometry. Disease progression will lead to treatment changes and withdrawal from the study. Throughout the study, participants will undergo monitoring of disease status, quality of life assessments, and regular blood and bone marrow testing. The primary measurement is the number of patients maintaining MRD negative remission 12 months after stopping maintenance therapy. Secondary outcomes include remission status at 24 months, progression-free survival at one and two years, and comparisons of quality of life between groups. The study will last over several years, with ongoing monitoring and follow-up to understand maintenance therapy's impact on disease control and patient well-being.

Discontinuation Study