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Intensive Versus Conventional Treatment in Patients With Primary Amyloidosis

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ClinicalTrials.gov Identifier: NCT00344526
Recruitment Status : Completed
First Posted : June 26, 2006
Last Update Posted : June 28, 2007
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by:
University Hospital, Limoges

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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
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 .
Study Start Date : January 2000
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amyloidosis




Primary Outcome Measures :
  1. survival

Secondary Outcome Measures :
  1. hematologic responses
  2. clinical responses


Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00344526


Locations
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France
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
Investigators
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Principal Investigator: Arnaud Jaccard, MD CH Limoges

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00344526     History of Changes
Other Study ID Numbers: I00001
First Posted: June 26, 2006    Key Record Dates
Last Update Posted: June 28, 2007
Last Verified: June 2007
Keywords provided by University Hospital, Limoges:
AL amyloidosis
Autologous stem cell transplantation
Melphalan
Dexamethasone
Additional relevant MeSH terms:
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Immunoglobulin Light-chain Amyloidosis
Immunosuppressive Agents
Amyloidosis
Proteostasis Deficiencies
Metabolic Diseases
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Paraproteinemias
Dexamethasone
Dexamethasone acetate
Melphalan
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action