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NCT01606280 Clinical Trial

Long-term Outcomes of Patients With Primary Amyloidosis After Stem Cell Transplantation

Amyloidosis Clinical Trial

Official title:
Reporting of Amyloidosis Stem Cell Transplantation Outcomes

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01606280
Other study ID # 11-005003
Secondary ID
Status Completed
Phase N/A
First received March 15, 2012
Last updated January 20, 2014
Start date June 2011
Est. completion date June 2013

Study information
Verified date January 2014
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

This study examines the value of stem cell transplantation in managing light chain amyloidisis.

Description:

1. How does age at diagnosis affect prognosis in primary amyloidosis?

2. How do lab values at diagnosis such as Creatinine, AST/ALT, total serum protein, serum gamma globulin/immunoglobulin levels affect prognosis in primary amyloidosis?

3. How does degree of organ involvement/number of organs involved affect prognosis in primary amyloidosis?

4. How does initial treatment affect prognosis in primary amyloidosis?

4. How do the specifics the stem cell transplant protocol affect prognosis in primary amyloidosis?

Recruitment information / eligibility
Status Completed
Enrollment 400
Est. completion date June 2013
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Eligible for Stem cell transplantation less than age 75

Exclusion Criteria:

- Creatinine > 3.0

- BNP > 10000

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Mayo Clinic Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Survival up to 8 years No
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