AmyloidosisNCT01606280
Long-term Outcomes of Patients With Primary Amyloidosis After Stem Cell Transplantation
An observational study of Amyloidosis, run by Mayo Clinic at 1 site in United States.
Trial summary
This study examines the value of stem cell transplantation in managing light chain amyloidisis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Amyloidosis
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient receiving transplantation
Who may be able to join
- Eligible for Stem cell transplantation less than age 75
Who cannot join
- Creatinine > 3.0
- BNP > 10000
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reporting of Amyloidosis Stem Cell Transplantation Outcomes
This study examines the value of stem cell transplantation in managing light chain amyloidisis.
Read the detailed description
- How does age at diagnosis affect prognosis in primary amyloidosis?
- How do lab values at diagnosis such as Creatinine, AST/ALT, total serum protein, serum gamma globulin/immunoglobulin levels affect prognosis in primary amyloidosis?
- How does degree of organ involvement/number of organs involved affect prognosis in primary amyloidosis?
- How does initial treatment affect prognosis in primary amyloidosis?
- How do the specifics the stem cell transplant protocol affect prognosis in primary amyloidosis?
- Conditions
- Amyloidosis
- Keywords
- Amyloidosis
- Medical subject headings
- Amyloidosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Measured: up to 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2012 (estimated)
- Study startJun 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmyloidosisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Morie Gertz, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01606280
- Sponsor's protocol ID
- 11-005003
- Status last verified
- Jan 2014
- First submitted
- 15 Mar 2012
- Last updated
- 22 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reporting of Amyloidosis Stem Cell Transplantation Outcomes
- ClinicalTrials.gov ID
- NCT01606280
- Acronym / sponsor ID
- 11-005003
- Conditions
- Amyloidosis
- Keywords
- Amyloidosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 25 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examines the value of stem cell transplantation in managing light chain amyloidisis.
Detailed description
- How does age at diagnosis affect prognosis in primary amyloidosis?
- How do lab values at diagnosis such as Creatinine, AST/ALT, total serum protein, serum gamma globulin/immunoglobulin levels affect prognosis in primary amyloidosis?
- How does degree of organ involvement/number of organs involved affect prognosis in primary amyloidosis?
- How does initial treatment affect prognosis in primary amyloidosis?
- How do the specifics the stem cell transplant protocol affect prognosis in primary amyloidosis?
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient receiving transplantation
Key inclusion criteria (1 listed)
- Eligible for Stem cell transplantation less than age 75
Key exclusion criteria (2 listed)
- Creatinine > 3.0
- BNP > 10000
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survival
Time frame: up to 8 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2014.
Related trials for Amyloidosis
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
Active, not recruitingPhase 2
A Study to Evaluate the Safety and Biomarker Effects of RO7269162 in Participants at Risk for or at the Prodromal Stage of Alzheimer's Disease (AD)
Alzheimer's Disease
Active, not recruitingObservational study
A Retrospective Observational Study of Epidemiology and Outcomes in Transthyretin Amyloid Cardiomyopathy in Germany
ATTR-CM (Transthyretin Amyloid Cardiomyopathy)
Active, not recruitingPhase 3
EPIC-ATTR: A Study to Evaluate the Effect of Eplontersen on the Transthyretin Reduction and Long-term Safety in Chinese Subjects With Transthyretin Amyloid Cardiomyopathy
Transthyretin Amyloid Cardiomyopathy
RecruitingObservational study
PET Imaging in the Baltimore Longitudinal Study of Aging (BLSA)
Aging
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amyloidosis, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: up to 8 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2014.