Autologous Stem Cell Rescue for Primary Amyloidosis

NCT ID: NCT00186407

Last Updated: 2010-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-04-30

Study Completion Date

2010-02-28

Brief Summary

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

Detailed Description

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

Conditions

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Amyloidosis Blood and Marrow Transplant (BMT)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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high dose chemo then auto hematopoietic cell transplant

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Stanford University School of Medicine

Principal Investigators

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Sally Arai

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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76379

Identifier Type: -

Identifier Source: secondary_id

BMT92

Identifier Type: -

Identifier Source: secondary_id

NCT00186407

Identifier Type: -

Identifier Source: secondary_id

BMT92

Identifier Type: -

Identifier Source: org_study_id