Multiple MyelomaNCT01423344
Clinical Evaluation of the Serum Free Light Chain Analysis
An observational study of Multiple Myeloma, run by Charlotte Toftmann Hansen at 1 site in Denmark.
Trial summary
Background: in patients with multiple myeloma there is a raised level of a protein, named M-protein. This M-protein is normally used to monitor disease status and evaluate response to treatment, as a decrease in M-protein is taken as evidence of therapeutic efficacy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Myeloma
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2011to Feb 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Newly diagnosed patients with multiple myeloma, with medical needs and known patients with multiple myeloma at there 1st relapse and medical needs
Who may be able to join
- diagnosis of multiple myeloma
- abnormal serum free light chains
- medical needs of anti-myeloma therapy
- receiving standard anti-myeloma therapy
Who cannot join
- dialysis
- normal serum free light chains
- dementia
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of Haematology, research unit
Odense C, 5000
Charlotte T Hansen, Fellow, 0045 24428085, charlotte.toftmann.hansen@ouh.regionsyddanmark.dk
Charlotte T Hansen, Fellow
About this study
Official title: Assessment of the Value of the Free Kappa and Free Lambda Light Chain Assay in Clinical Evaluation of Response to Treatment
Background: in patients with multiple myeloma there is a raised level of a protein, named M-protein. This M-protein is normally used to monitor disease status and evaluate response to treatment, as a decrease in M-protein is taken as evidence of therapeutic efficacy. However, the M-protein has a long half life in serum, approximately three weeks, which tend to be a practical problem, since the investigators can first determine hereafter if the treatment is effective.
A new assay has the possibility only to measure part of this protein, namely "the light chains", which also is measured in a blood sample. The half life of these light chains is much shorter, namely 2-6 hours. In theory, this means a more rapid measure of the effect of a given treatment, thereby being able to determine earlier if the treatment should continue or changed to another strategy.
Read more
Purpose: the purpose of this study is to evaluate the clinical value of the use of the serum free light chain (sFLC) assay in comparison to the M-protein in monitoring patients under treatment for multiple myeloma.
Method: the investigators measure sFLC in patients receiving there 1st treatment, either at the time of diagnosis or in the relapse setting. sFLC is measured on a regular basis, and the results are compared to the M-protein.
- Conditions
- Multiple Myeloma
- Keywords
- multiple myeloma, Free light chains
- Medical subject headings
- Multiple Myeloma
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to 50% reduction in the concentration of the abnormal serum free light chain compared to 50% reduction in M-protein
Measured: 1, 2, 3, 4 and 5 days, 2, 3 and 6 weeks after therapy,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2011 (estimated)
- Study startFeb 2011
- Primary completionFeb 2012 (estimated)
- Study completionFeb 2012 (estimated)
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.
- 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
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charlotte Toftmann Hansen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Charlotte Toftmann Hansen, University of Southern Denmark
- Investigators
- Charlotte T Hansen, Fellow, Principal investigator, Department of Haematology, research unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01423344
- Sponsor's protocol ID
- HFE-05-02
- Other IDs
- Danish Ethics comittee
- Status last verified
- Aug 2011
- First submitted
- 24 Aug 2011
- Last updated
- 25 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Value of the Free Kappa and Free Lambda Light Chain Assay in Clinical Evaluation of Response to Treatment
- ClinicalTrials.gov ID
- NCT01423344
- Acronym / sponsor ID
- HFE-05-02
- Conditions
- Multiple Myeloma
- Keywords
- multiple myeloma, Free light chains
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Charlotte Toftmann HansenUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Feb 2012 (estimated)
- Study completion
- Feb 2012 (estimated)
- First posted
- 25 Aug 2011 (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.
Background: in patients with multiple myeloma there is a raised level of a protein, named M-protein. This M-protein is normally used to monitor disease status and evaluate response to treatment, as a decrease in M-protein is taken as evidence of therapeutic efficacy. However, the M-protein has a long half life in serum, approximately three weeks, which tend to be a practical problem, since the investigators can first determine hereafter if the treatment is effective.
A new assay has the possibility only to measure part of this protein, namely "the light chains", which also is measured in a blood sample. The half life of these light chains is much shorter, namely 2-6 hours. In theory, this means a more rapid measure of the effect of a given treatment, thereby being able to determine earlier if the treatment should continue or changed to another strategy.
Purpose: the purpose of this study is to evaluate the clinical value of the use of the serum free light chain (sFLC) assay in comparison to the M-protein in monitoring patients under treatment for multiple myeloma.
Method: the investigators measure sFLC in patients receiving there 1st treatment, either at the time of diagnosis or in the relapse setting. sFLC is measured on a regular basis, and the results are compared to the M-protein.
Study design
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Newly diagnosed patients with multiple myeloma, with medical needs and known patients with multiple myeloma at there 1st relapse and medical needs
Key inclusion criteria (4 listed)
- diagnosis of multiple myeloma
- abnormal serum free light chains
- medical needs of anti-myeloma therapy
- receiving standard anti-myeloma therapy
Key exclusion criteria (3 listed)
- dialysis
- normal serum free light chains
- dementia
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
Time to 50% reduction in the concentration of the abnormal serum free light chain compared to 50% reduction in M-protein
Time frame: 1, 2, 3, 4 and 5 days, 2, 3 and 6 weeks after therapy,
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2011.
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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.
Charlotte T Hansen, Fellow principal investigator
Department of Haematology, research unit
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 Charlotte Toftmann Hansen at 1 site in Denmark.
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 3 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: status not confirmed, as of the sponsor's last update on 25 Aug 2011. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Charlotte T Hansen, Fellow (0045 24428085, charlotte.toftmann.hansen@ouh.regionsyddanmark.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to 50% reduction in the concentration of the abnormal serum free light chain compared to 50% reduction in M-protein (time frame: 1, 2, 3, 4 and 5 days, 2, 3 and 6 weeks after therapy,). 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 25 Aug 2011.