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

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ClinicalTrials.gov Identifier: NCT01606280
Recruitment Status : Completed
First Posted : May 25, 2012
Last Update Posted : January 22, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study examines the value of stem cell transplantation in managing light chain amyloidisis.

Condition or disease
Amyloidosis

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?


Study Design

Study Type : Observational
Actual Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Reporting of Amyloidosis Stem Cell Transplantation Outcomes
Study Start Date : June 2011
Primary Completion Date : June 2013
Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amyloidosis
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

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

Eligibility Criteria

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 Posted: May 25, 2012    Key Record Dates
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