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Daratumumab Maintenance Therapy for Amyloidosis
Phase 2
Recruiting
Led By Eli Muchtar, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histological confirmation of AL amyloidosis with adequate typing (mass spectrometry, immunohistochemistry, immunofluorescence, immunogold)
AL amyloidosis with organ disease requiring therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from registration to death from any cause, assessed up to 5 years
Awards & highlights
Study Summary
This trial tests whether fewer maintenance cycles of a drug can work as well as more cycles to treat AL amyloidosis.
Who is the study for?
This trial is for adults with newly diagnosed AL amyloidosis who've completed specific induction therapy and achieved a certain response level. They must have good enough health to perform daily activities, be able to complete questionnaires, and agree to follow-up visits. Pregnant or nursing individuals, those with hepatitis B/C or HIV on treatment, and patients with multiple myeloma are excluded.Check my eligibility
What is being tested?
The EMILIA Trial is testing whether daratumumab maintenance therapy can extend the time without disease symptoms after initial treatment in AL amyloidosis patients. It compares the effects of continuing daratumumab for 3-6 cycles versus 18 cycles following an induction phase.See study design
What are the potential side effects?
Daratumumab may cause side effects like infusion reactions (symptoms similar to allergic reactions during drug administration), fatigue, nausea, low blood cell counts increasing infection risk, and potential heart or lung complications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition is confirmed as AL amyloidosis through specific testing.
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I have AL amyloidosis affecting my organs and need treatment.
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I can care for myself but may not be able to do heavy physical work.
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My blood cancer has responded well to my first treatment.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time from registration to death from any cause, assessed up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from registration to death from any cause, assessed up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Event free survival
Secondary outcome measures
Hematological response
Minimal residual disease (MRD) negativity rate
Organ response rates
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (6 cycles of daratumumab)Experimental Treatment6 Interventions
Patients receive daratumumab subcutaneously (SC) on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity for up to 6 cycles on study. Patients also undergo x-ray imaging at screening and bone marrow biopsy and blood sample collection throughout the study. Patients with cardiac involvement also undergo echocardiography throughout the trial.
Group II: Arm II (18 cycles of daratumumab)Active Control6 Interventions
Patients receive daratumumab SC on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity for up to 18 cycles on study. Patients also undergo x-ray imaging at screening and bone marrow biopsy and blood sample collection throughout the study. Patients with cardiac involvement also undergo echocardiography throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1700
Bone Marrow Aspiration
2011
Completed Phase 2
~1740
Daratumumab
2014
Completed Phase 3
~1990
Echocardiography
2013
Completed Phase 4
~11670
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,216 Previous Clinical Trials
3,767,392 Total Patients Enrolled
Eli Muchtar, M.D.Principal InvestigatorMayo Clinic in Rochester
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your blood platelet count is at least 50,000 per cubic millimeter.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.Your body has enough infection-fighting white blood cells.I am of childbearing age and not using birth control.I finished my daratumumab-based treatment less than 84 days ago.My condition is confirmed as AL amyloidosis through specific testing.I have AL amyloidosis affecting my organs and need treatment.I am immunocompromised or HIV positive and on antiretroviral therapy.I have had specific blood tests for my cancer before starting treatment.I was treated with daratumumab and dexamethasone because other drugs were too harsh for me.I can care for myself but may not be able to do heavy physical work.I was diagnosed with multiple myeloma based on specific symptoms or test results.My blood cancer has responded well to my first treatment.I am 18 years old or older.Your hemoglobin level is at least 8.0 grams per deciliter.I have tested positive for hepatitis B or C.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (6 cycles of daratumumab)
- Group 2: Arm II (18 cycles of daratumumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the administration granted authorization for Arm I (6 cycles of daratumumab)?
"Our team has rated the safety of Arm I (6 cycles of daratumumab) as a 2 due to Phase 2 clinical trial data which provides evidence for its security, but not yet any proof that it is effective."
Answered by AI
Are there any remaining vacancies for individuals interested in participating in this clinical trial?
"The information posted to clinicaltrials.gov shows that this particular research study is not currently recruiting participants. It was initially listed on June 1st, 2023 and the posting has been amended since then; however, 102 other medical trials are actively seeking volunteers at present."
Answered by AI
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