Intensive Versus Conventional Treatment in Patients With Primary Amyloidosis

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by:
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT00344526
First received: June 22, 2006
Last updated: June 27, 2007
Last verified: June 2007
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00344526

Locations
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'immuno-hématologie, Hôpital Saint-Louis
Paris, France
Service d'hématologie clinique, Hôpital Necker
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
Principal Investigator: Arnaud Jaccard, MD CH Limoges
  More Information

No publications provided by University Hospital, Limoges

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00344526     History of Changes
Other Study ID Numbers: I00001
Study First Received: June 22, 2006
Last Updated: June 27, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Amyloidosis
Proteostasis Deficiencies
Metabolic Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Melphalan
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on July 28, 2014