RecruitingPhase 2NCT05898646

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

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


Sponsor

Mayo Clinic

Enrollment

96 participants

Start Date

Jul 17, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Biospecimen Collection, a procedure called Bone Marrow Aspiration, and others for people with al amyloidosis. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBone Marrow Aspiration

Undergo bone marrow aspiration

BIOLOGICALDaratumumab

Given SC

PROCEDUREEchocardiography Test

Undergo echocardiography

OTHERQuestionnaire Administration

Ancillary studies

PROCEDUREX-Ray Imaging

Undergo x-ray imaging

PROCEDUREBiospecimen Collection

Undergo blood sample collection


Locations(2)

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

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NCT05898646


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