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Autologous Stem Cell Rescue for Primary Amyloidosis

This study has been completed.
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00186407
First received: September 13, 2005
Last updated: September 10, 2010
Last verified: September 2010
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: High Dose Chemotherapy and Autologous Stem Cell Rescue for Primary Amyloidosis

Resource links provided by NLM:


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 [ Time Frame: unknown ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: April 1998
Study Completion Date: February 2010
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
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 multiple myeloma and amyloid are eligible.

Exclusion Criteria:1. prior blood or marrow transplant

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Sally Arai, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00186407     History of Changes
Other Study ID Numbers: BMT92, 76379, BMT92
Study First Received: September 13, 2005
Last Updated: September 10, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Amyloidosis
Metabolic Diseases
Proteostasis Deficiencies

ClinicalTrials.gov processed this record on November 25, 2014