NCT01606280

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 25, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

January 22, 2014

Status Verified

January 1, 2014

Enrollment Period

2 years

First QC Date

March 15, 2012

Last Update Submit

January 20, 2014

Conditions

Amyloidosis

Keywords

Amyloidosis

Outcome Measures

Primary Outcomes (1)

  • Survival

    up to 8 years

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient receiving transplantation

You may qualify if:

  • Eligible for Stem cell transplantation less than age 75

You may not qualify if:

  • Creatinine \> 3.0
  • BNP \> 10000

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Amyloidosis

Condition Hierarchy (Ancestors)

Proteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

March 15, 2012

First Posted

May 25, 2012

Study Start

June 1, 2011

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

January 22, 2014

Record last verified: 2014-01

Locations

US(1)