Status:
COMPLETED
Autologous Stem Cell Rescue for Primary Amyloidosis
Lead Sponsor:
Stanford University
Conditions:
Amyloidosis
Blood and Marrow Transplant (BMT)
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
To evaluate the role of high dose therapy and autologous hematopoietic cell transplant for amyloidosis.
Detailed Description
To learn about the use of high dose chemotherapy followed by transplantation using peripheral blood stem cells.
Eligibility Criteria
Inclusion
- 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
- prior blood or marrow transplant
Key Trial Info
Start Date :
April 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2010
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00186407
Start Date
April 1 1998
End Date
February 1 2010
Last Update
September 14 2010
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305