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OpenTrials
Completed

NCT Number: NCT00344526

Intensive Versus Conventional Treatment in Patients With Primary Amyloidosis

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.

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Key information

Conditions

Primary Systemic Amyloidosis (AL) Amyloidosis Immune System Diseases Immunoglobulin Light-chain Amyloidosis Immunoproliferative Disorders Lymphoproliferative Disorders Metabolic Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Nutritional and Metabolic Diseases Paraproteinemias Proteostasis Deficiencies

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Service des Maladies du Sang, Lille, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

melphalan

Drug

Dexamethasone

Drug

Autologous Stem Cell Transplantation

Procedure

Primary outcomes

  1. survival

Secondary outcomes

  1. hematologic responses

  2. clinical responses

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Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Collaborators

  • Ministry of Health, France

Registry information

Official study title

Autologous Stem Cell Transplantation (ASCT) Versus Oral Melphalan and High-Dose Dexamethasone in Patients With AL (Primary)Amyloidosis. A Prospective Randomized Trial .

Important dates

Study start
2000
Study completion
2006
First posted
Jun 26, 2006
Registry last updated
Jun 28, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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