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Daratumumab Maintenance Therapy for Improving Survival in Patients With Light Chain Amyloidosis, EMILIA Trial

StatusRecruiting
PhasePhase 2
Started2023-09-06
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 36 months later Nov 30, 2026 → Nov 30, 2029
See other at-risk trials from Mayo Clinic

Amendment history

2026-10-02
Primary completion pushed: 2026-11-30 → 2029-11-30
Completion pushed: 2026-11-30 → 2031-11-30
2026-03-26
Study Identification, Study Status v17
Primary completion date2026-12→2026-11-30
Completion date2026-12→2026-11-30
2026-01-09
Study Status, Eligibility v16
Eligibility criteria+2 characters
[...] to registration or have a plan to complete cycle 6 prior to Cyclecycle Day1 day 1. NOTE: treatment in the study is allowed only after the c [...]
2025-12-31
Study Status, Eligibility v15
Eligibility criteria-1 characters
[...] to registration or have a plan to complete cycle 6 prior to registrationCycle Day 1. NOTE: treatment in the study is allowed only after the com [...]
2025-12-23
Study Status, Sponsor/Collaborators, Oversight v14
Collaborators+31 characters
National Cancer Institute (NCI)
Show 13 earlier versions
2025-07-22
Study Status, Study Description, Arms and Interventions v13
Study description+66 characters
[...] study. Patients also undergo x-ray imaging at screening and undergo bone marrow aspiration, blood sample collection, and optional bone marrow biopsy and blood sample collection throughout the study. Patients with cardiac involvement also [...] study. Patients also undergo x-ray imaging at screening and undergo bone marrow aspiration, blood sample collection, and optional bone marrow biopsy and blood sample collection throughout the study. Patients with cardiac involvement also [...]
2025-07-10
Study Identification, Study Status, Contacts/Locations v12
Study sitescontacts updated at 2 of 2 sites
2025-05-21
Study Status, Oversight, Study Description, Arms and Interventions, Eligibility v11
InterventionsBiospecimen Collection (Procedure), Bone Marrow Aspiration (Procedure), Daratumumab (Biological), Echocardiography (Procedure)…→Biospecimen Collection (Procedure), Bone Marrow Aspiration (Procedure), Daratumumab (Biological), Echocardiography Test (Procedure)…
Eligibility criteria+138 characters
[...] cles of daratumumab (Dara)-CyBorD-based induction treatment =<prior 84to daysregistration or have a plan to complete cycle 6 prior to registration. NOTE: treatment in the study is allowed only after the completion of 6 cycles of induction Patients must have achieved a hematological complete respons [...]
Study description+18 characters
[...] study. Patients also undergo x-ray imaging at screening and optional bone marrow biopsy and blood sample collection throughout t [...] study. Patients also undergo x-ray imaging at screening and optional bone marrow biopsy and blood sample collection throughout t [...]
2025-04-21
Study Identification, Study Status, Oversight, Contacts/Locations v10
Study sitescontacts updated at 2 of 2 sites
Study titlerevised
Daratumumab Maintenance Therapy for Improving Survival in Patients withWith Light Chain Amyloidosis, EMILIA Trial
2024-11-12
Study Identification, Study Status, Oversight, Contacts/Locations v9
Primary completion date2024-11-01→2026-12
Completion date2024-11-01→2026-12
Study sites3→2
Study titlerevised
Daratumumab Maintenance Therapy for Improving Survival in Patients Withwith Light Chain Amyloidosis, EMILIA Trial
2024-07-09
Study Status, Contacts/Locations v8
Study sitescontacts updated at 1 of 3 sites
2024-05-20
Study Status, Study Description v7
Study descriptionrevised
[...] mpletion of study treatment, patients are followed up every 63 months for up to 36 months from registration, and then up to 5 years from starting the study for survival status.
2024-01-15
Study Status v6
Re-verified, no change to tracked fields
2024-01-04
Study Status, Study Description, Arms and Interventions, Eligibility v5
InterventionsBone Marrow Biopsy (Procedure), Daratumumab (Biological), Echocardiography (Procedure), Questionnaire Administration (Other), X-Ray Imaging…→Biospecimen Collection (Procedure), Bone Marrow Aspiration (Procedure), Daratumumab (Biological), Echocardiography (Procedure)…
Eligibility criteria+597 characters
[...] diagnosis or cannot be obtained Patients must have completed 6 cycles of daratumumab (Dara)-CyBorD-based induction treatment =< 84 d [...] 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 t [...] t defines amyloidosis if all the above criteria are not met KnownSeropositive tofor havehepatitis presenceB of(defined by a positive test for hepatitis B surface antigen [HBsAg]). Note: Subjects with resolved infection (HBsAg)i.e., orsubjects who [...] [...]
Study description+2,802 characters
PRIMARY OBJECTIVE: I. To determine the event-free survival (EFS) after 3-6 versus 18 cycles of daratumumab maintenance following 6 cycles induction of daratumumab-cyclophosphamide-bortezomib-dexamethasone (CyBorD) in newly diagnosed AL amyloidosis. SECONDARY OBJECTIVES: I. To determine the rate of h [...]
2023-09-26
Study Status, Contacts/Locations v4
Study sitesdetails revised at 1 of 3 sites
2023-09-05
Study Identification, Study Status v3
Primary completion date2024-11→2024-11-01
Completion date2024-11→2024-11-01
2023-08-23
Not Yet Recruiting→Recruiting Study Status, Oversight, Contacts/Locations, References v2
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2023-11→2024-11
Completion date2023-11→2024-11
Start dateestimated 2023-07→confirmed 2023-07-17
Study sitesdetails revised at 3 of 3 sites
2023-06-27
Study Status v1
Start date2023-06→2023-07
2023-06-02
Original filing
Mayo Clinic
1,015 trials monitored
See 115 trials at risk
Amyloidosis
300 trials monitored
See 19 trials at risk
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.
Trial Details
NCT Number NCT05898646
Lead Sponsor Mayo Clinic
Collaborators: National Cancer Institute (NCI)
Conditions AL Amyloidosis
Enrollment 96 participants
Start Date 2023-09-06
Primary Completion 2029-11-30 (estimated)
Study Completion 2031-11-30 (estimated)
Updated on ClinicalTrials.gov 2026-10-01