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NCT05898646 · ClinicalTrials.gov registry record · Phase 2
Daratumumab Maintenance Therapy for Improving Survival in Patients With Light Chain Amyloidosis, EMILIA Trial
A Phase 2 study of AL Amyloidosis, sponsored by Mayo Clinic.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 96
- Enrollment target
- 2
- Study locations
NCT05898646: Recruiting Phase 2 study of AL Amyloidosis, sponsored by Mayo Clinic.
NCT05898646 is a Phase 2 study of AL Amyloidosis that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 96 participants, below the 418-participant average among 15 other AL Amyloidosis trials with a reported enrollment target (77% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05898646, a Phase 2 study of AL Amyloidosis, is actively recruiting participants, sponsored by Mayo Clinic.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 96 participants
- Enrollment target
- 2
- Study locations
Study Summary
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.
Primary Outcome
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.
Conditions Studied
Interventions
- PROCEDURE Bone Marrow Aspiration
- PROCEDURE Echocardiography Test
- OTHER Questionnaire Administration
- PROCEDURE X-Ray Imaging
- BIOLOGICAL Daratumumab
Study Locations (2)
Arizona
- Mayo Clinic in Arizona - Scottsdale
Minnesota
- Mayo Clinic in Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2023-07-17 |
| Est. Completion | 2026-12 |
| Phase | Phase 2 |
What NCT05898646 shows while recruiting
NCT05898646 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, below the 418-participant average among 15 other AL Amyloidosis trials with a reported enrollment target (77% lower).
The record links to 1 condition, with AL Amyloidosis appearing as the primary indexed condition, and to 5 interventions - of which Bone Marrow Aspiration is the first listed.
NCT05898646 reports a single indexed study location in Arizona, Minnesota.
Frequently Asked Questions
What is clinical trial NCT05898646 about?
NCT05898646 is a clinical study titled "Daratumumab Maintenance Therapy for Improving Survival in Patients With Light Chain Amyloidosis, EMILIA Trial". 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 ...
What is the current status of trial NCT05898646?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 96 participants. The study started on 2023-07-17. Estimated completion is 2026-12.
What conditions does trial NCT05898646 study?
This clinical trial studies the following conditions: AL Amyloidosis.
What interventions are being tested in trial NCT05898646?
The interventions under investigation include: Bone Marrow Aspiration (PROCEDURE), Echocardiography Test (PROCEDURE), Questionnaire Administration (OTHER), X-Ray Imaging (PROCEDURE), Daratumumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT05898646?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05898646 being conducted?
This trial has 2 study locations across Arizona, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for AL Amyloidosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05898646's enrollment target sits among peer trials
96 6th of 15 higher than 10 of 15 other AL Amyloidosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other AL Amyloidosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Daratumumab, Pomalidomide, and Dexamethasone (DPd) in Relapsed/Refractory Light Chain Amyloidosis Patients Previously Exposed to Daratumumab
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-
Siltuximab to Decrease Symptom Burden After Autologous Stem Cell Transplantation for Patients With Multiple Myeloma and AL Amyloidosis
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Ixazomib Maintenance Study in Patients With AL Amyloidosis
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Bendamustine and Dexamethasone in Patients With Relapsed AL Amyloidosis
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Ohio State University Multiple Myeloma and Amyloidosis Data Registry and Sample Resource
RECRUITING
-
Phase 1/2a Study of Belantamab Mafodotin in Relapsed or Refractory AL Amyloidosis
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