Multiple MyelomaNCT01018927
Detecting Early Myocardial Infiltration w/Amyloid & Light Chain Deposition Disease in Multiple Myeloma Subjects
An observational study of Multiple Myeloma, run by University of Arkansas at 1 site in United States.
Trial summary
The purpose of this study is to see if MRI techniques can be used for early evaluation of cardiac amyloidosis which is sometimes seen in individuals with multiple myeloma. Cardiac amyloidosis is a medical disorder that decreases heart function. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Administering three additional MRI images
- Type of treatment
- Medical device
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to 30 May 2017
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Multiple Myeloma subjects
Who may be able to join
- All races and ethnic groups
- Male and female ages 18-80 years of age
- History of multiple myeloma
- CMR study for evaluation for cardiac amyloidosis
Who cannot join
- Pregnant women
- Subject with a metallic or electronic or other device that could be affected by the magnet
Trial locations and contacts
1 site in 1 country.
United States1 site
University or Arkansas for Medical Sciences (UAMS)
Little Rock, Arkansas, 72205
About this study
Official title: Role of Cardiac MR (CMR) In Detecting Features of Early Myocardial Infiltration With Amyloid and Light Chain Deposition Disease in Subjects With Multiple Myeloma
The purpose of this study is to see if MRI techniques can be used for early evaluation of cardiac amyloidosis which is sometimes seen in individuals with multiple myeloma. Cardiac amyloidosis is a medical disorder that decreases heart function.
Read the detailed description
The purpose is to investigate the use of multiple newer CMR techniques for early evaluation of cardiac amyloidosis in multiple myeloma.
- Conditions
- Multiple Myeloma
- Being tested
- Administering three additional MRI images
- Keywords
- Cardiac MR (CMR), Early Myocardial Infiltration, Amyloid, Light Chain Deposition Disease, Multiple Myeloma
- Medical subject headings
- Multiple Myeloma, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administering three additional MRI imagesDevice
Three additional MRI images to determine the role of cardiac MR (CMR) in detecting features of early myocardial infiltration
| Study group | Role | What they receive |
|---|---|---|
| Additional MRI images | Prospective review of 100 CMR studies performed on multiple myeloma patients referred for cardiac evaluation by MRI. Three additional MRI images will be performed to determine the role of cardiac MR (CMR) in detecting features of early myocardial infiltration Receives: Device: Administering three additional MRI images |
What is being measured
The primary outcome is the main question the study is designed to answer.
This study is to see if MRI techniques can be used for early evaluation of cardiac amyloidosis which is sometimes seen in individuals with multiple myeloma.
Measured: The time frame is five additional minutes & three additional images during and MRI.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study startJun 2009
- Primary completion30 May 2017
- Study completion30 May 2017
Why it stopped: PI does not have time to continue study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Collaborators
- Siemens Molecular Imaging
- Responsible party
- Sponsor
- Investigators
- Tarun Pandey, Principal investigator, University of Arkansas for Medical Sciences (UAMS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01018927
- Sponsor's protocol ID
- 110104
- Status last verified
- May 2017
- First submitted
- 16 Nov 2009
- Last updated
- 31 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Cardiac MR (CMR) In Detecting Features of Early Myocardial Infiltration With Amyloid and Light Chain Deposition Disease in Subjects With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT01018927
- Acronym / sponsor ID
- 110104
- Conditions
- Multiple Myeloma
- Keywords
- Cardiac MR (CMR), Early Myocardial Infiltration, Amyloid, Light Chain Deposition Disease, Multiple Myeloma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI does not have time to continue study
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Collaborators
- Siemens Molecular Imaging
- Study start
- Jun 2009
- Primary completion
- 30 May 2017 (actual)
- Study completion
- 30 May 2017 (actual)
- First posted
- 25 Nov 2009 (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.
The purpose of this study is to see if MRI techniques can be used for early evaluation of cardiac amyloidosis which is sometimes seen in individuals with multiple myeloma. Cardiac amyloidosis is a medical disorder that decreases heart function.
Detailed description
The purpose is to investigate the use of multiple newer CMR techniques for early evaluation of cardiac amyloidosis in multiple myeloma.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Additional MRI images | – | Device: Administering three additional MRI imagesProspective review of 100 CMR studies performed on multiple myeloma patients referred for cardiac evaluation by MRI. Three additional MRI images will be performed to determine the role of cardiac MR (CMR) in detecting features of early myocardial infiltration |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Multiple Myeloma subjects
Key inclusion criteria (4 listed)
- All races and ethnic groups
- Male and female ages 18-80 years of age
- History of multiple myeloma
- CMR study for evaluation for cardiac amyloidosis
Key exclusion criteria (2 listed)
- Pregnant women
- Subject with a metallic or electronic or other device that could be affected by the magnet
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Administering three additional MRI imagesThree additional MRI images to determine the role of cardiac MR (CMR) in detecting features of early myocardial infiltration | Device | Additional MRI images |
Primary outcome
This study is to see if MRI techniques can be used for early evaluation of cardiac amyloidosis which is sometimes seen in individuals with multiple myeloma.
Time frame: The time frame is five additional minutes & three additional images during and MRI.
Results and safety
The study was stopped early (reason given: PI does not have time to continue study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
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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.
Tarun Pandey principal investigator
University of Arkansas for Medical Sciences (UAMS)
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 Multiple Myeloma, run by University of Arkansas 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 4 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: stopped early, as of the sponsor's last update on 31 May 2017. 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 was stopped early (reason given: PI does not have time to continue study). Results are not available in the source record.
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?
This study is to see if MRI techniques can be used for early evaluation of cardiac amyloidosis which is sometimes seen in individuals with multiple myeloma. (time frame: The time frame is five additional minutes & three additional images during and MRI.). 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 31 May 2017.