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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

Must not have

Uncontrolled intercurrent illness including ongoing or active infection, unstable angina pectoris, psychiatric illness/social situations that would limit compliance with study requirements

Persons of childbearing potential (and persons able to father a child) who are unwilling to employ adequate contraception

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time from registration to death from any cause, assessed up to 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

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I am of childbearing age and not using birth control.

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I am immunocompromised or HIV positive and on antiretroviral therapy.

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I was diagnosed with multiple myeloma based on specific symptoms or test results.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and time from registration to death from any cause, assessed up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Event free survival

Secondary study objectives

Hematological response

Minimal residual disease (MRD) negativity rate

Organ response rates

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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

Bone Marrow Aspiration

2011

Completed Phase 2

~1740

Biospecimen Collection

2004

Completed Phase 3

~2030