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Autologous Stem Cell Rescue for Primary Amyloidosis

High Dose Chemotherapy and Autologous Stem Cell Rescue for Primary Amyloidosis

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00186407
Enrollment
50
Registered
2005-09-16
Start date
1998-04-30
Completion date
2010-02-28
Last updated
2010-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyloidosis, Blood and Marrow Transplant (BMT)

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.

Interventions

Sponsors

Stanford University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026