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Autologous Stem Cell Rescue for Primary Amyloidosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00186407
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : September 14, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
To evaluate the role of high dose therapy and autologous hematopoietic cell transplant for amyloidosis.

Condition or disease Intervention/treatment Phase
Amyloidosis Blood and Marrow Transplant (BMT) Procedure: high dose chemo then auto hematopoietic cell transplant Phase 2

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High Dose Chemotherapy and Autologous Stem Cell Rescue for Primary Amyloidosis
Study Start Date : April 1998
Primary Completion Date : February 2008
Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amyloidosis
U.S. FDA Resources

Arms and Interventions


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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 multiple myeloma and amyloid are eligible.

Exclusion Criteria:1. prior blood or marrow transplant

Contacts and Locations

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): 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

Responsible Party: Sally Arai, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00186407     History of Changes
Other Study ID Numbers: BMT92
76379
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: September 14, 2010
Last Verified: September 2010

Additional relevant MeSH terms:
Amyloidosis
Proteostasis Deficiencies
Metabolic Diseases