NCT00344526

Intensive Versus Conventional Treatment in Patients With Primary Amyloidosis

Autologous Stem Cell Transplantation (ASCT) Versus Oral Melphalan and High-Dose Dexamethasone in Patients With AL (Primary)Amyloidosis. A Prospective Randomized Trial .

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (planned)
• Sponsor: University Hospital, Limoges · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Primary Systemic Amyloidosis (AL)

Interventions

Type	Name	Description
DRUG	Melphalan
DRUG	Dexamethasone
PROCEDURE	Autologous stem cell transplantation

Timeline

• Start date: 2000-01-01
• Completion: 2006-06-01
• First posted: 2006-06-26
• Last updated: 2007-06-28

Locations

8 sites across 1 country: France