Actively Recruiting
Daratumumab Maintenance Therapy for Improving Survival in Patients With Light Chain Amyloidosis, EMILIA Trial
Led by Mayo Clinic · Updated on 2026-03-30
96
Participants Needed
2
Research Sites
176 weeks
Total Duration
On this page
Sponsors
M
Mayo Clinic
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Daratumumab Maintenance Therapy for Improving Survival in Patients With Light Chain Amyloidosis, EMILIA Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histological confirmation of AL amyloidosis with proper typing methods
- AL amyloidosis with organ disease requiring therapy at diagnosis
- Monoclonal protein studies available from diagnosis before induction therapy
- Completed or plan to complete 6 cycles of daratumumab-cyclophosphamide-bortezomib-dexamethasone induction treatment
- Achieved hematological complete response, very good partial response, or partial response with organ improvement after induction
- Patients who had bortezomib and/or cyclophosphamide omitted due to toxicity are allowed if at least daratumumab and dexamethasone were given
- ECOG performance status 0 to 3
- Hemoglobin level at least 8.0 g/dL within 28 days prior to registration
- Absolute neutrophil count at least 1000/mm3 within 28 days prior to registration
- Platelet count at least 50,000/mm3 within 28 days prior to registration
- Negative pregnancy test within 7 days prior to registration for persons who can become pregnant
- Provide written informed consent within 90 days prior to registration
- Ability to complete questionnaires independently or with help
- Willing to return for follow-up visits during active monitoring phase
You will not qualify if you...
- Pregnant or nursing persons
- Persons of childbearing potential or able to father a child who do not agree to use contraception
- Received more than 1 cycle of daratumumab maintenance after induction and before registration
- Diagnosis of multiple myeloma based on hypercalcemia, renal insufficiency, anemia, bone lesions, or high plasma cell counts
- Positive for hepatitis B surface antigen or active hepatitis B infection
- Immunocompromised patients or known HIV positive patients receiving antiretroviral therapy
- Uncontrolled illness including ongoing infection, unstable angina, or psychiatric/social conditions limiting compliance
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
Actively Recruiting
2
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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