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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00344526
Date of registration: 22/06/2006
Prospective Registration: No
Primary sponsor: University Hospital, Limoges
Public title: Intensive Versus Conventional Treatment in Patients With Primary Amyloidosis
Scientific title: Autologous Stem Cell Transplantation (ASCT) Versus Oral Melphalan and High-Dose Dexamethasone in Patients With AL (Primary)Amyloidosis. A Prospective Randomized Trial .
Date of first enrolment: January 2000
Target sample size: 100
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00344526
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 3
Countries of recruitment
France
Contacts
Name:     Arnaud Jaccard, MD
Address: 
Telephone:
Email:
Affiliation:  CH Limoges
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Primary Systemic Amyloidosis (AL)
Intervention(s)
Drug: Dexamethasone
Drug: Melphalan
Procedure: Autologous stem cell transplantation
Primary Outcome(s)
survival
Secondary Outcome(s)
clinical responses
hematologic responses
Secondary ID(s)
I00001
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ministry of Health, France
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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