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EMILIA
NCT05898646Phase 2
Key facts
- Status
- Recruiting
- Start
- Sep 2023
- Primary completion
- Nov 2029
- Countries
- 1
- Sponsor
- Mayo Clinic
- Modality
- Recombinant Proteins and Enzymes, Monoclonal Antibodies
- Drugs
- daratumumab
- Conditions
- light-chain amyloidosis
01
Overview
Phase 2, randomised, open-label trial of daratumumab in light-chain amyloidosis (2 arms), sponsored by Mayo Clinic. Primary endpoint: Event-Free Survival at 36 months. Started Sep 2023; status: recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
Arm I (6 cycles of daratumumab)
Daratumumab SC on day 1 of each 28-day cycle for up to 6 cycles
Arm II (18 cycles of daratumumab)
Daratumumab SC on day 1 of each 28-day cycle for up to 18 cycles
03
Who it enrols
Adults with newly diagnosed AL amyloidosis who have completed 6 cycles of Dara-CyBorD induction therapy and achieved at least a partial hematological response, without concurrent multiple myeloma or active infections.
04
Endpoints
Primary
Event-Free Survival
Secondary
Hematological Response Rate
Minimal Residual Disease Negativity Rate
Organ Response Rate
Time to Next Therapy
Time to Organ Response
Time to Deep Organ Response
Time to Organ Progression
Rate of Pneumonia, Sepsis, URI, and Grade >=3 Infection
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