Phase II Study Comparing Shorter Versus Longer Daratumumab Maintenance Therapy in Patients With Light Chain Amyloidosis

What this Trial Is About

Researchers are evaluating the effects of shorter versus longer maintenance therapy using daratumumab in patients with light chain AL amyloidosis who have already completed initial treatment with daratumumab. This phase II trial aims to compare the survival outcomes between maintenance therapy lasting 3-6 cycles versus 18 cycles. Daratumumab is a monoclonal antibody that targets the CD38 protein on certain immune and cancer cells, and it is commonly used as initial treatment for AL amyloidosis, but its role during maintenance therapy is not yet clear. Participants are randomly assigned to one of two groups. One group receives daratumumab subcutaneously once every 28 days for up to 6 cycles, while the other group receives the same treatment for up to 18 cycles, barring disease progression or unacceptable side effects. Both groups undergo various procedures including x-ray imaging, bone marrow aspiration, blood sample collection, and optional bone marrow biopsies throughout the study. Patients with heart involvement also have echocardiography performed during the trial. During the study, participants are closely monitored through these tests and questionnaires, including the PROMIS-29 health questionnaire, to assess quality of life and treatment effects. After completing treatment, patients attend follow-up visits every three months for up to three years, then survival status is monitored for up to five years. The primary outcome measured is event-free survival up to 36 months, with secondary outcomes including blood response, organ response, disease progression, infection rates, and overall survival.

Daratumumab Maintenance Therapy for Improving Survival in Patients With Light Chain Amyloidosis, EMILIA Trial