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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01606280
First Posted: May 25, 2012
Last Update Posted: January 22, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Morie Gertz, Mayo Clinic
  Purpose
This study examines the value of stem cell transplantation in managing light chain amyloidisis.

Condition
Amyloidosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Reporting of Amyloidosis Stem Cell Transplantation Outcomes

Resource links provided by NLM:


Further study details as provided by Morie Gertz, Mayo Clinic:

Primary Outcome Measures:
  • Survival [ Time Frame: up to 8 years ]

Enrollment: 400
Study Start Date: June 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Detailed 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?

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient receiving transplantation
Criteria

Inclusion Criteria:

  • Eligible for Stem cell transplantation less than age 75

Exclusion Criteria:

  • Creatinine > 3.0
  • BNP > 10000
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01606280


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
  More Information

Responsible Party: Morie Gertz, principal investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01606280     History of Changes
Other Study ID Numbers: 11-005003
First Submitted: March 15, 2012
First Posted: May 25, 2012
Last Update Posted: January 22, 2014
Last Verified: January 2014

Keywords provided by Morie Gertz, Mayo Clinic:
Amyloidosis

Additional relevant MeSH terms:
Amyloidosis
Proteostasis Deficiencies
Metabolic Diseases


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