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

January 20, 2014 updated by: Morie Gertz, Mayo Clinic

Reporting of Amyloidosis Stem Cell Transplantation Outcomes

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient receiving transplantation

Description

Inclusion Criteria:

  • Eligible for Stem cell transplantation less than age 75

Exclusion Criteria:

  • Creatinine > 3.0
  • BNP > 10000

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival
Time Frame: up to 8 years
up to 8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

March 15, 2012

First Submitted That Met QC Criteria

May 23, 2012

First Posted (Estimate)

May 25, 2012

Study Record Updates

Last Update Posted (Estimate)

January 22, 2014

Last Update Submitted That Met QC Criteria

January 20, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-005003

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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