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

NCT05898646 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2026-03-30

No results posted yet for this study

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.

Conditions

  • AL Amyloidosis

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Taxiarchis Kourelis, MD · Mayo Clinic in Rochester

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-17
Primary Completion
2026-11-30
Completion
2026-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05898646 on ClinicalTrials.gov