Intensive Versus Conventional Treatment in Patients With Primary Amyloidosis

• 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
• 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

Procedure: Autologous stem cell transplantation

Drug: Melphalan

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