Intensive Versus Conventional Treatment in Patients With Primary Amyloidosis

• Status: Completed
• Trial end date: 2006-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Limoges
• Collaborator: Ministry of Health, France
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Melphalan

Criteria

Inclusion Criteria:

• below 70 years of age

• biopsy proven systemic AL amyloidosis

• no more than 2 prior courses of chemotherapy

• ECOG performance status < 3

• Informed written consent

Exclusion Criteria:

• localized amyloidosis

• HIV seropositivity

• previous myelodysplasia

• concomitant serious disease