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Autologous Stem Cell Rescue for Primary Amyloidosis

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ClinicalTrials.gov Identifier: NCT00186407
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : September 14, 2010
Sponsor:
Information provided by:
Stanford University

Study Description
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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
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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
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amyloidosis

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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
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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
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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Sally Arai Stanford University
More Information
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Responsible Party: Sally Arai, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00186407    
Other Study ID Numbers: BMT92
76379
BMT92
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: September 14, 2010
Last Verified: September 2010
Additional relevant MeSH terms:
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Immunoglobulin Light-chain Amyloidosis
Amyloidosis
Proteostasis Deficiencies
Metabolic Diseases
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
 Neoplasms
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Paraproteinemias