Clinical Trial: Phase II Trial of Enbrel in Patients With Primary Systemic Amyloidosis
Study Status: Suspended
Recruit Status: Suspended
Study Type: Interventional
Official Title:
Brief Summary: The purpose of this study is to evaluate the efficacy of Enbrel in patients with primary systemic Amyloidosis.
Detailed Summary: The primary goal of this study is to evaluate the efficacy of Enbrel in patients with primary systemic amyloidosis using a one-stage, phase II study design with an interim analysis. This study will also assess survival and progression times, symptom relief, and toxicity associated with Enbrel in primary systemic amyloidosis patients. Two groups of patients with very different risk profiles can be identified with respect to this disease. Patients with symptomatic cardiac disease and/or at least two involved organs ar at high risk and historically have a median survival less than six months. Patients without these conditions have a significantly better prognosis. Both subgroups will be studied in the present study, and essentially two phase-II clinical trials, one for each subgroup, will be run in parallel.
Sponsor: The Cleveland Clinic
Current Primary Outcome: clinical efficacy
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Duration of response and time to progression
- Evaluate overall survival
- Identify prognostic factors
- Evaluate qualitative and quantitative toxicities of Enbrel
Original Secondary Outcome: Same as current
Information By: The Cleveland Clinic
Dates:
Date Received: September 21, 2005
Date Started: February 2001
Date Completion: August 2005
Last Updated: September 21, 2005
Last Verified: August 2005
