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Intensive Versus Conventional Treatment in Patients With Primary Amyloidosis

NCT ID: NCT00344526

Last Updated: 2007-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-01-31

Study Completion Date

2006-06-30

Brief Summary

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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

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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.

Conditions

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Primary Systemic Amyloidosis (AL)

Keywords

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AL amyloidosis Autologous stem cell transplantation Melphalan Dexamethasone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Melphalan

Intervention Type DRUG

Dexamethasone

Intervention Type DRUG

Autologous stem cell transplantation

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, France

OTHER_GOV

Sponsor Role collaborator

University Hospital, Limoges

OTHER

Sponsor Role lead

Principal Investigators

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Arnaud Jaccard, MD

Role: PRINCIPAL_INVESTIGATOR

CH Limoges

Locations

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Service des Maladies du Sang

Lille, , France

Site Status

Service d'Hématologie et de Thérapie cellulaire

Limoges, , France

Site Status

Service d'hématologie clinique

Nantes, , France

Site Status

Service d'hématologie Clinique, Groupe Hospitalier Pitié-Salpétrière

Paris, , France

Site Status

Service d'hématologie clinique, Hôpital Necker

Paris, , France

Site Status

Service d'immuno-hématologie, Hôpital Saint-Louis

Paris, , France

Site Status

Service d'hématologie

Toulouse, , France

Site Status

Hématologie Clinique

Tours, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 17855669 (View on PubMed)

Other Identifiers

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I00001

Identifier Type: -

Identifier Source: org_study_id