Autologous Stem Cell Rescue for Primary Amyloidosis

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00186407
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Duration (Months): 142.1
• Patients Per Site Per Month: 0.4

Study Details

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
• Anticipated 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: Apr 1, 1998
• Actual Primary Completion Date: Feb 1, 2008
• Actual Study Completion Date: Feb 1, 2010

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:1. Primary amyloidosis

1. Age < 75 years.

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

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

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

5. 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%.

6. Patients must be HIV negative.

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

8. Patients must provide signed informed consent.

9. Patients with multiple myeloma and amyloid are eligible.

Exclusion Criteria:1. prior blood or marrow transplant

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University School of Medicine	Stanford	California	United States	94305

Sponsors and Collaborators

• Stanford University

Investigators

• Principal Investigator: Sally Arai, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00186407
• Other Study ID Numbers: BMT92; 76379; BMT92
• First Posted: Sep 16, 2005
• Last Update Posted: Sep 14, 2010
• Last Verified: Sep 1, 2010

• Additional relevant MeSH terms: Immunoglobulin Light-chain Amyloidosis; Amyloidosis

Study Results

No Results Posted as of Sep 14, 2010