Daratumumab Maintenance for AL Amyloidosis (EMILIA Trial)
This study, called the EMILIA Trial, is looking at how long patients with light chain (AL) amyloidosis should receive daratumumab as maintenance therapy. Daratumumab is a medication that helps your immune system fight certain cells by targeting a protein called CD38. The trial compares two different durations of daratumumab maintenance therapy (3-6 cycles versus 18 cycles) after patients have already received initial treatment with daratumumab. The main goal is to see if one duration leads to better event-free survival (how long you live without the disease getting worse or other specific events occurring). You may be able to join if you are 18 or older and have AL amyloidosis that requires treatment. The study plans to enroll 96 participants.
- Study design
- This is a Phase II interventional study comparing two different durations of daratumumab maintenance therapy. It plans to enroll 96 participants.
- What's involved
- You would undergo procedures like bone marrow aspiration, echocardiography, and X-ray imaging. You would also receive daratumumab injections and complete questionnaires.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your event-free survival will be measured for up to 36 months from when you join the study.
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NCT05898646
Daratumumab Maintenance Therapy for Improving Survival in Patients With Light Chain Amyloidosis, EMILIA Trial
Recruiting
PHASE2Ages 18+InterventionalTreatmentMayo ClinicInvestigator-initiated
~96 participants
Updated 2026-03-30 on ClinicalTrials.gov
What's tested:Bone Marrow AspirationDaratumumabEchocardiography TestQuestionnaire AdministrationX-Ray ImagingBiospecimen Collection
At a glance
Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Event free survival
Measured over From registration up to 36 months
Conditions
Where it's being run
2 sites across 2 statesArizona1
Minnesota1
Study leadership
- Taxiarchis Kourelis, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic in Rochester
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Age \>= 18 years
Histological confirmation of AL amyloidosis with adequate typing (mass spectrometry, immunohistochemistry, immunofluorescence, immunogold)
AL amyloidosis with organ disease requiring therapy
NOTE: Disease requiring therapy is referred to the time of diagnosis. There are no limitations in baseline measurable disease parameters
Patients must have monoclonal protein studies (serum free light chain assay, serum immunofixation or serum MASS-FIX) obtained at time of diagnosis before induction therapy initiated and available for review to be enrolled.
NOTE: Patients are allowed to participate in this study if urine electrophoresis immunofixation study was not done at time of diagnosis or cannot be obtained
Patients must have completed 6 cycles of daratumumab (Dara)-CyBorD-based induction treatment prior to registration or have a plan to complete cycle 6 prior to cycle 1 day 1. NOTE: treatment in the study is allowed only after the completion of 6 cycles of induction
Patients must have achieved a hematological complete response (CR) (irrespective of organ response achievement) or hematological very good partial response (VGPR) (irrespective of organ response achievement) or hematological low-difference in involved and uninvolved free light chain (dFLC) partial response (PR) (irrespective of organ response achievement) or hematological PR with at least one organ response after receiving Dara-CyBorD-based induction.
NOTE: Patients with baseline dFLC \< 5 mg/dL, must have achieved hematological CR, or dFLC \< 1 mg/dL or achieved organ response prior to randomization
Patients in whom bortezomib and/or cyclophosphamide were omitted from induction due to toxicity concerns or adverse effects are allowed. Patients must receive at least daratumumab and dexamethasone at induction to qualify for the study
NOTE: Dexamethasone use does not need to be carried to end of induction for eligibility consideration
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, 2 or 3
Hemoglobin \>= 8.0 g/dL (obtained =\< 28 days prior to registration)
Absolute neutrophil count (ANC) \>= 1000/mm\^3 (obtained =\< 28 days prior to registration)
Platelet count \>= 50,000/mm\^3 (obtained =\< 28 days prior to registration)
Negative pregnancy test done =\< 7 days prior to registration, for persons of childbearing potential only.
NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Provide written informed consent
NOTE: Informed consent required =\< 90 days prior registration
Ability to complete questionnaire(s) by themselves or with assistance
Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
Exclusion
Any of the following because this study involves an agent that has possible genotoxic, mutagenic and teratogenic effects:
Pregnant persons
Nursing persons
Persons of childbearing potential (and persons able to father a child) who are unwilling to employ adequate contraception
Received \>1 cycle of daratumumab maintenance after end of induction therapy and prior to registration
Multiple myeloma at time of diagnosis as defined by any of the following:
Hypercalcemia: Serum calcium \> 1 mg/dL higher than upper limit of normal or \> 11 mg/dL
Renal insufficiency: Creatinine clearance \< 40 mL per min or serum creatinine \> 2 mg/dL attributed to high circulating light chains (i.e. cast nephropathy) or hypercalcemia
Anemia: Hemoglobin \> 2 g/dL below lower limit of normal, or \< 10 g/dL, attributed to high marrow myeloma infiltration
Bone lesions: \>= 1 osteolytic lesion on skeletal x-ray, computed tomography (CT), or positron emission tomography (PET)-CT (bone imaging is not mandatory but based on clinical suspicion)
Clonal bone marrow plasma cells \>= 60%
\> 1 focal lesion on magnetic resonance imaging (MRI) (MRI is not mandatory but based on clinical suspicion)
If bone imaging (CT, MRI, PET-CT) was not done at time of diagnosis it is not needed to be performed at registration to rule out bone disease
\>= 40% BMPCs irrespective of the above
The study will allow patients with involved: uninvolved serum-free light chain (sFLC) ratio \>= 100 if this is the only criteria that defines amyloidosis if all the above criteria are not met
Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen \[HBsAg\]). Note: Subjects with resolved infection (i.e., subjects who are HBsAg negative but positive for antibodies to hepatitis B core antigen \[anti-HBc\] and/or antibodies to hepatitis B surface antigen \[anti-HBs\]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels. Those who are PCR positive will be excluded. EXCEPTION: Subjects with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR
Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy.
NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial
Uncontrolled intercurrent illness including, but not limited to:
Ongoing or active infection
Unstable angina pectoris
Psychiatric illness/social situations that would limit compliance with study requirements
What this trial measures
- Event free survivalFrom registration up to 36 months
The point estimate for the hazard ratio and corresponding one-sided 85% confidence interval will be generated with a stratified Cox regression (using the trial stratification factors) that has treatment arm as an exploratory variable.