Autologous Stem Cell Rescue for Primary Amyloidosis

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

high dose chemo then auto hematopoietic cell transplant

About this trial

This is an interventional treatment trial for Amyloidosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Stanford University School of Medicine

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00186407

First Posted

September 13, 2005

Last Updated

September 10, 2010

Sponsor

Stanford University

1. Study Identification

Unique Protocol Identification Number

NCT00186407

Brief Title

Autologous Stem Cell Rescue for Primary Amyloidosis

Official Title

High Dose Chemotherapy and Autologous Stem Cell Rescue for Primary Amyloidosis

Study Type

Interventional

2. Study Status

Record Verification Date

September 2010

Overall Recruitment Status

Completed

Study Start Date

April 1998 (undefined)

Primary Completion Date

February 2008 (Actual)

Study Completion Date

February 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Stanford University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Amyloidosis, Blood and Marrow Transplant (BMT)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

high dose chemo then auto hematopoietic cell transplant

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sally Arai

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford University School of Medicine

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

Amyloidosis, Blood and Marrow Transplant (BMT)

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial