Clinical trial
Daratumumab Maintenance Therapy for Improving Survival in Patients With Light Chain Amyloidosis, EMILIA Trial
Daratumumab Maintenance Therapy for Improving Survival in Patients With Light Chain Amyloidosis, EMILIA Trial
ClinicalTrials.gov ID: NCT05898646
Sponsor: Mayo Clinic
Information provided by: Mayo Clinic (Responsible Party)
Last Update Posted: 2023-09-07
Brief Summary:
The purpose of this study is to determine the event-free survival (EFS) after 3-6 versus 18 cycles of daratumumab maintenance following 6 cycles induction of daratumumab-CyBorD in newly diagnosed AL amyloidosis.
OFFICIAL TITLE
Phase II Study Evaluating Maintenance in Light Chain Amyloidosis (EMILIA)
INTERVENTION / TREATMENT
Procedure: Bone Marrow Biopsy
Biological: Daratumumab
Procedure: Echocardiography
Other: Questionnaire Administration
Procedure: X-Ray Imaging
| Category | Value |
|---|---|
| Study Start (Actual) | 2023-07-17 |
| Primary Completion (Actual) | 2024-11-01 |
| Study Completion (Estimated) | 2024-11-01 |
| Enrollment (Actual) | 96 |
| Study Type | Interventional |
| Phase | Phase 2 |
| Other Study ID Numbers |
MC220802
NCI-2023-03819 (Registry Identifier) (REGISTRY: CTRP (Clinical Trial Reporting Program)) 22-011048 (Other Identifier) (OTHER: Mayo Clinic Institutional Review Board) MC220802 (Other Identifier) (OTHER: Mayo Clinic) |