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Intensive Versus Conventional Treatment in Patients With Primary Amyloidosis

This study has been completed.
Ministry of Health, France
Information provided by:
University Hospital, Limoges Identifier:
First received: June 22, 2006
Last updated: June 27, 2007
Last verified: June 2007
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.

Condition Intervention Phase
Primary Systemic Amyloidosis (AL) Drug: Melphalan Drug: Dexamethasone Procedure: Autologous stem cell transplantation Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autologous Stem Cell Transplantation (ASCT) Versus Oral Melphalan and High-Dose Dexamethasone in Patients With AL (Primary)Amyloidosis. A Prospective Randomized Trial .

Resource links provided by NLM:

Further study details as provided by University Hospital, Limoges:

Primary Outcome Measures:
  • survival

Secondary Outcome Measures:
  • hematologic responses
  • clinical responses

Estimated Enrollment: 100
Study Start Date: January 2000
Study Completion Date: June 2006
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.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00344526

Service des Maladies du Sang
Lille, France
Service d'Hématologie et de Thérapie cellulaire
Limoges, France
Service d'hématologie clinique
Nantes, France
Service d'hématologie clinique, Hôpital Necker
Paris, France
Service d'immuno-hématologie, Hôpital Saint-Louis
Paris, France
Service d’hématologie Clinique, Groupe Hospitalier Pitié-Salpétrière
Paris, France
Service d'hématologie
Toulouse, France
Hématologie Clinique
Tours, France
Sponsors and Collaborators
University Hospital, Limoges
Ministry of Health, France
Principal Investigator: Arnaud Jaccard, MD CH Limoges
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00344526     History of Changes
Other Study ID Numbers: I00001
Study First Received: June 22, 2006
Last Updated: June 27, 2007

Keywords provided by University Hospital, Limoges:
AL amyloidosis
Autologous stem cell transplantation

Additional relevant MeSH terms:
Proteostasis Deficiencies
Metabolic Diseases
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors processed this record on September 19, 2017