drugset / Trial / NCT00344526

Intensive Versus Conventional Treatment in Patients With Primary Amyloidosis

NCT00344526

RandomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2000-01
Primary completion
Completion
2006-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule 40 mg Oral
Subject Melphalan Small molecule 10 mg/m2 Intravenous
Subject Melphalan Small molecule 140 mg/m2 Intravenous
Subject Melphalan Small molecule 200 mg/m2 Intravenous