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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Morie Gertz, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01606280
First received: March 15, 2012
Last updated: January 20, 2014
Last verified: January 2014
  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 Mayo Clinic:

Primary Outcome Measures:
  • Survival [ Time Frame: up to 8 years ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01606280

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

No publications provided

Responsible Party: Morie Gertz, principal investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01606280     History of Changes
Other Study ID Numbers: 11-005003
Study First Received: March 15, 2012
Last Updated: January 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Amyloidosis

Additional relevant MeSH terms:
Amyloidosis
Proteostasis Deficiencies
Metabolic Diseases

ClinicalTrials.gov processed this record on April 14, 2014