- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00186407
Autologous Stem Cell Rescue for Primary Amyloidosis
High Dose Chemotherapy and Autologous Stem Cell Rescue for Primary Amyloidosis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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California
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Stanford, California, United States, 94305
- Stanford University School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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To evaluate the role of high dose therapy and autologous hematopoietic cell transplant for amyloidosis
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sally Arai, Stanford University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BMT92
- 76379
- NCT00186407
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Peking Union Medical College HospitalRecruitingLight Chain (AL) Amyloidosis | Venetoclax | CCND1 TranslocationChina
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Tufts Medical CenterSanofiWithdrawnAmyloidosis | Light Chain (AL) Amyloidosis
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