Autologous Stem Cell Rescue for Primary Amyloidosis

Amyloidosis Clinical Trial

Official title:

High Dose Chemotherapy and Autologous Stem Cell Rescue for Primary Amyloidosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00186407
• Other study ID #: BMT92
• Secondary ID: 76379BMT92
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: September 10, 2010
• Start date: April 1998
• Est. completion date: February 2010

Study information

• Verified date: September 2010
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2010
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Amyloidosis
• Blood and Marrow Transplant (BMT)

Intervention

Procedure:
• high dose chemo then auto hematopoietic cell transplant

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the role of high dose therapy and autologous hematopoietic cell transplant for amyloidosis		unknown	No