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Enbrel in Primary Systemic Amyloidosis
NCT00224393Phase 2
Key facts
- Status
- Completed
- Start
- Feb 2001
- Sponsor
- Cleveland Clinic
- Modality
- Fc-Fusion Proteins
- Drugs
- etanercept
- Conditions
- primary systemic amyloidosis
01
Overview
Phase 2, open-label trial of etanercept in primary systemic amyloidosis (2 arms), sponsored by Cleveland Clinic. Primary endpoint: Clinical Efficacy. Started Feb 2001; status: completed.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
High Risk
Patients with symptomatic cardiac disease and/or at least two involved organs
Better Prognosis
Patients without symptomatic cardiac disease and <2 involved organs
03
Who it enrols
Adults with primary systemic amyloidosis (AL) with symptomatic organ involvement, adequate organ function, and ECOG 0-3. Excludes non-AL amyloidosis, clinically overt multiple myeloma, and recent use of specific anti-plasma cell therapies.
04
Endpoints
Primary
Clinical Efficacy
Secondary
Duration of Response
Time to Progression
Overall Survival
Prognostic Factors
Qualitative and Quantitative Toxicities
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