Status:
COMPLETED
Intensive Versus Conventional Treatment in Patients With Primary Amyloidosis
Lead Sponsor:
University Hospital, Limoges
Collaborating Sponsors:
Ministry of Health, France
Conditions:
Primary Systemic Amyloidosis (AL)
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- localized amyloidosis
- HIV seropositivity
- previous myelodysplasia
- concomitant serious disease
Key Trial Info
Start Date :
January 1 2000
Trial Type :
INTERVENTIONAL
End Date :
June 1 2006
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00344526
Start Date
January 1 2000
End Date
June 1 2006
Last Update
June 28 2007
Active Locations (8)
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1
Service des Maladies du Sang
Lille, France
2
Service d'Hématologie et de Thérapie cellulaire
Limoges, France
3
Service d'hématologie clinique
Nantes, France
4
Service d'hématologie Clinique, Groupe Hospitalier Pitié-Salpétrière
Paris, France