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OpenTrials
Completed

NCT Number: NCT00186407

Autologous Stem Cell Rescue for Primary Amyloidosis

To evaluate the role of high dose therapy and autologous hematopoietic cell transplant for amyloidosis.

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Key information

Conditions

Amyloidosis Blood and Marrow Transplant (BMT) Metabolic Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

About this study

To learn about the use of high dose chemotherapy followed by transplantation using peripheral blood stem cells.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

1. Primary amyloidosis

  • Age < 75 years.
  • Patients must have their pathology reviewed and the diagnosis confirmed at Stanford University Medical Center.
  • Patients who have undergone bone marrow transplantation previously will not be eligible.
  • Patients must have a Karnofsky performance status greater than 70%.
  • Patients must have a serum creatinine less than 2 mg/dl or creatinine clearance greater than 30 ml/min, bilirubin less than 2 mg/dl, transaminases less than two times normal, left ventricular ejection fraction >45% on echocardiography, cardiac index > 1.8 liters/min/m^2 and pulmonary function tests demonstrating FEV1 and DLCO > 60%.
  • Patients must be HIV negative.
  • Pregnant or lactating women will not be eligible to participate.
  • Patients must provide signed informed consent.
  • Patients with multiple myeloma and amyloid are eligible.

Exclusion criteria

1. prior blood or marrow transplant

Treatment and study plan

high dose chemo then auto hematopoietic cell transplant

Procedure

Primary outcomes

  1. To evaluate the role of high dose therapy and autologous hematopoietic cell transplant for amyloidosis

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

High Dose Chemotherapy and Autologous Stem Cell Rescue for Primary Amyloidosis

Important dates

Study start
1998
Primary completion
2008
Study completion
2010
First posted
Sep 16, 2005
Registry last updated
Sep 14, 2010

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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