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RECRUITING
NCT05898646
PHASE2

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

Sponsor: Mayo Clinic

View on ClinicalTrials.gov

Summary

This phase II trial compares shorter-duration versus longer-duration maintenance therapy with daratumumab for improving survival in patients who have received initial treatment with daratumumab for light chain (AL) amyloidosis. Maintenance therapy is treatment that is given to help keep cancer from coming back after it has disappeared following initial therapy. Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and cancer cells, including myeloma cells. Daratumumab may block CD38 and help the immune system kill cancer cells. Daratumumab is commonly prescribed as initial treatment for patients with AL amyloidosis. However, it is not known what role daratumumab may play in the maintenance therapy period of patients with AL amyloidosis. This phase II trial compares shorter duration maintenance to longer duration maintenance for improving survival in patients with AL amyloidosis.

Official title: Phase II Study Evaluating Maintenance in Light Chain Amyloidosis (EMILIA)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

96

Start Date

2023-07-17

Completion Date

2026-11-30

Last Updated

2026-03-30

Healthy Volunteers

No

Conditions

Interventions

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow aspiration

BIOLOGICAL

Daratumumab

Given SC

PROCEDURE

Echocardiography Test

Undergo echocardiography

OTHER

Questionnaire Administration

Ancillary studies

PROCEDURE

X-Ray Imaging

Undergo x-ray imaging

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

Locations (2)

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States