Actively Recruiting
Phase II Study Comparing Shorter Versus Longer Daratumumab Maintenance Therapy for Improving Survival in Patients With Light Chain Amyloidosis
Led by Mayo Clinic · Updated on 2026-03-30
96
Participants Needed
2
Research Sites
N/A
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
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.
CONDITIONS
Brief 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
- AL amyloidosis with organ disease requiring therapy at diagnosis
- 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 after induction
- Eastern Cooperative Oncology Group performance status 0 to 3
- Hemoglobin level of at least 8.0 g/dL within 28 days prior to registration
- Absolute neutrophil count of at least 1000/mm3 within 28 days prior to registration
- Platelet count of at least 50,000/mm3 within 28 days prior to registration
- Negative pregnancy test within 7 days prior to registration for persons of childbearing potential
- Able to provide informed consent within 90 days before registration
- Able to complete questionnaires independently or with help
- Willing to return for follow-up visits during active monitoring
You will not qualify if you...
- Pregnant or nursing persons
- Persons of childbearing potential or able to father a child who do not use adequate contraception
- Received more than one cycle of daratumumab maintenance therapy after induction and before registration
- Diagnosis of multiple myeloma with defined criteria including high calcium, renal insufficiency, anemia, bone lesions, or high plasma cell levels
- Seropositive for hepatitis B surface antigen or active HBV infection
- Immunocompromised patients with HIV on antiretroviral therapy
- Uncontrolled illnesses such as ongoing infection, unstable angina, or psychiatric/social issues limiting study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 or 18 cycles of 28 days each
Participants receive daratumumab subcutaneously on day 1 of each 28-day cycle for up to 6 or 18 cycles depending on their assigned arm. During treatment, participants undergo bone marrow aspiration, blood sample collection, and optional bone marrow biopsy. Participants with cardiac involvement also have echocardiography assessments throughout the trial.
1 visit every 28 days for up to 6 or 18 cycles
Duration - Up to 36 months after treatment completion
After completing treatment, participants are followed up every 3 months for up to 36 months from registration to monitor their health status and survival.
Quarterly visits every 3 months for up to 36 months
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
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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