Clinical Trial: Intensive Versus Conventional Treatment in Patients With Primary Amyloidosis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Autologous Stem Cell Transplantation (ASCT) Versus Oral Melphalan and High-Dose Dexamethasone in Patients With AL (Primary)Amyloidosis. A Prospective Randomized Trial .
Brief Summary: AL amyloidosis is caused by a clonal plasma cell dyscrasia and characterized by progressive deposition of amyloid fibrils derived from monoclonal Ig light chains, leading to multisystem organ failure and death. The prognosis for AL amyloidosis with conventional treatment remains poor, Autologous stem cell transplantation (ASCT) for AL amyloidosis produces high hematologic and organ responses. However, treatment-related mortality remains high and reported series are subject to selection bias.
Detailed Summary: A prospective randomized trial was conducted to compare in AL amyloidosis ASCT (melphalan 140 or 200 mg/m2 depending on age and clinical status supported with ASCT collected with G-CSF alone) and the oral regimen M-Dex (melphalan 10 mg/m2 and dexamethasone 40 mg for 4 days each months up to 18 months). The objectives were to compare survival and hematologic and clinical responses.
Sponsor: University Hospital, Limoges
Current Primary Outcome: survival
Original Primary Outcome: Same as current
Current Secondary Outcome:
- hematologic responses
- clinical responses
Original Secondary Outcome: Same as current
Information By: University Hospital, Limoges
Dates:
Date Received: June 22, 2006
Date Started: January 2000
Date Completion:
Last Updated: June 27, 2007
Last Verified: June 2007
