Autologous Stem Cell Rescue for Primary Amyloidosis - Full Text View

Sponsored by:	Stanford University
Information provided by:	Stanford University
ClinicalTrials.gov Identifier:	NCT00186407

Purpose

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

Condition	Intervention	Phase
Amyloidosis	Procedure: high dose chemo then auto hematopoietic cell transplant	Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	High Dose Chemotherapy and Autologous Stem Cell Rescue for Primary Amyloidosis

Further study details as provided by Stanford University:

Primary Outcome Measures:

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

Estimated Enrollment:	50
Study Start Date:	April 1998

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:1. Primary amyloidosis

2. Age < 75 years.

3. Patients must have their pathology reviewed and the diagnosis confirmed at Stanford University Medical Center.

4. Patients who have undergone bone marrow transplantation previously will not be eligible.

5. Patients must have a Karnofsky performance status greater than 70%.

6. 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%.

7. Patients must be HIV negative.

8. Pregnant or lactating women will not be eligible to participate.

9. Patients must provide signed informed consent.

10. Patients with mulitple myeloma and amyloid are eligible. Exclusion Criteria:1. prior blood or marrow transplant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00186407

Locations

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305

Sponsors and Collaborators

Stanford University

Investigators

Principal Investigator:

Sally Arai

Stanford University

More Information

Study ID Numbers:	BMT92, 76379, BMT92, NCT00186407
Study First Received:	September 13, 2005
Last Updated:	August 8, 2008
ClinicalTrials.gov Identifier:	NCT00186407
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Amyloidosis
Metabolic Diseases
Primary Amyloidosis
Metabolic disorder

ClinicalTrials.gov processed this record on January 15, 2009