Back to resultsIntensive Versus Conventional Treatment in Patients With Primary Amyloidosis
Primary Purpose
Primary Systemic Amyloidosis (AL)
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Melphalan
Dexamethasone
Autologous stem cell transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Primary Systemic Amyloidosis (AL) focused on measuring AL amyloidosis, Autologous stem cell transplantation, Melphalan, Dexamethasone
Eligibility 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
Sites / Locations
- Service des Maladies du Sang
- Service d'Hématologie et de Thérapie cellulaire
- Service d'hématologie clinique
- Service d'hématologie Clinique, Groupe Hospitalier Pitié-Salpétrière
- Service d'hématologie clinique, Hôpital Necker
- Service d'immuno-hématologie, Hôpital Saint-Louis
- Service d'hématologie
- Hématologie Clinique
Outcomes
Primary Outcome Measures
survival
Secondary Outcome Measures
hematologic responses
clinical responses
Full Information
NCT ID
NCT00344526
First Posted
June 22, 2006
Last Updated
June 27, 2007
Sponsor
University Hospital, Limoges
Collaborators
Ministry of Health, France
1. Study Identification
Unique Protocol Identification Number
NCT00344526
Brief Title
Intensive Versus Conventional Treatment in Patients With Primary Amyloidosis
Official Title
Autologous Stem Cell Transplantation (ASCT) Versus Oral Melphalan and High-Dose Dexamethasone in Patients With AL (Primary)Amyloidosis. A Prospective Randomized Trial .
Study Type
Interventional
2. Study Status
Record Verification Date
June 2007
Overall Recruitment Status
Completed
Study Start Date
January 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Limoges
Collaborators
Ministry of Health, France
4. Oversight
5. Study Description
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 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.
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 oral regimen M-Dex (melphalan 10 mg/m2 and dexamethasone 40 mg for 4 days each months up to 18 months). The objectives were to compare survival and hematologic and clinical responses.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Systemic Amyloidosis (AL)
Keywords
AL amyloidosis, Autologous stem cell transplantation, Melphalan, Dexamethasone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Melphalan
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Type
Procedure
Intervention Name(s)
Autologous stem cell transplantation
Primary Outcome Measure Information:
Title
survival
Secondary Outcome Measure Information:
Title
hematologic responses
Title
clinical responses
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnaud Jaccard, MD
Organizational Affiliation
CH Limoges
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service des Maladies du Sang
City
Lille
Country
France
Facility Name
Service d'Hématologie et de Thérapie cellulaire
City
Limoges
Country
France
Facility Name
Service d'hématologie clinique
City
Nantes
Country
France
Facility Name
Service d'hématologie Clinique, Groupe Hospitalier Pitié-Salpétrière
City
Paris
Country
France
Facility Name
Service d'hématologie clinique, Hôpital Necker
City
Paris
Country
France
Facility Name
Service d'immuno-hématologie, Hôpital Saint-Louis
City
Paris
Country
France
Facility Name
Service d'hématologie
City
Toulouse
Country
France
Facility Name
Hématologie Clinique
City
Tours
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
17855669
Citation
Jaccard A, Moreau P, Leblond V, Leleu X, Benboubker L, Hermine O, Recher C, Asli B, Lioure B, Royer B, Jardin F, Bridoux F, Grosbois B, Jaubert J, Piette JC, Ronco P, Quet F, Cogne M, Fermand JP; Myelome Autogreffe (MAG) and Intergroupe Francophone du Myelome (IFM) Intergroup. High-dose melphalan versus melphalan plus dexamethasone for AL amyloidosis. N Engl J Med. 2007 Sep 13;357(11):1083-93. doi: 10.1056/NEJMoa070484.
Results Reference
derived
Learn more about this trial
Intensive Versus Conventional Treatment in Patients With Primary Amyloidosis
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