Autologous Stem Cell Rescue for Primary Amyloidosis

Stanford University

Status and phase: Completed; Phase 2

Conditions: Blood and Marrow Transplant (BMT); Amyloidosis

Treatments: Procedure: high dose chemo then auto hematopoietic cell transplant

Study type: Interventional

Funder types: Other

Identifiers

NCT00186407

BMT92

76379

NCT00186407

Details and patient eligibility

About

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

Full description

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

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)