Multiple MyelomaNCT04191057
Determining Normal Range for Free Light Chains in Serum Among Twins
A study testing Free light chains in people with Multiple Myeloma, run by University of California, San Francisco at 1 site in United States.
Trial summary
The objective of this study is to recruit healthy adult identical and fraternal twins for the collection of one teaspoon of blood to be sent to the Clinical Lab at San Francisco General Hospital. The serum will be tested to determine the reference range for free light chains. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Free light chains
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2018to 1 Jan 2024
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects 18-80 years.
- Must be an identical or fraternal twin (both must be recruited)
Who cannot join
- Symptoms suggestive of multiple myeloma (e.g., renal insufficiency, anemia, bone pain) -
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco General Hospital
San Francisco, California, 94306
About this study
Official title: Normal Range Study for Free Light Chains in Blood Among Identical or Fraternal Twins
The objective of this study is to recruit healthy adult identical and fraternal twins for the collection of one teaspoon of blood to be sent to the Clinical Lab at San Francisco General Hospital. The serum will be tested to determine the reference range for free light chains.
Read the detailed description
Serum free light chains are used to assist in the diagnosis of multiple myeloma. The test measures kappa (K) and lambda (L) chains, and the calculation of the ratio of kappa to lambda (K/L). Previous studies have shown that the K/L ratio does not change over time (1 year). The hypothesis of this study is that healthy twins will have a K/L ratio that are close to each other in value, suggesting that this ratio is genetically linked.
- Conditions
- Multiple Myeloma
- Being tested
- Free light chains
- Keywords
- free light chains, healthy twins
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free light chainsOther
Blood samples will be collected and analyzed
| Study group | Role | What they receive |
|---|---|---|
| Healthy twin | Experimental | Free light chains of twins compared to non-twin siblings Receives: Other: Free light chains |
What is being measured
The primary outcome is the main question the study is designed to answer.
Free light chain reference range
Determination of the normal range for free light chains
Measured: One month after the completion of the enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study start15 Aug 2018
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alan Wu, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04191057
- Sponsor's protocol ID
- 18-25508
- Status last verified
- Jan 2025
- First submitted
- 5 Dec 2019
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participants and other researchers will not have access to data.
Publications
Braga F, Infusino I, Dolci A, Panteghini M. Biological variation of free light chains in serum. Clin Chim Acta. 2013 Jan 16;415:10-1. doi: 10.1016/j.cca.2012.09.008. Epub 2012 Sep 11. No abstract available.
PubMed 22981867Katzmann JA, Clark RJ, Abraham RS, Bryant S, Lymp JF, Bradwell AR, Kyle RA. Serum reference intervals and diagnostic ranges for free kappa and free lambda immunoglobulin light chains: relative sensitivity for detection of monoclonal light chains. Clin Chem. 2002 Sep;48(9):1437-44.
PubMed 12194920
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normal Range Study for Free Light Chains in Blood Among Identical or Fraternal Twins
- ClinicalTrials.gov ID
- NCT04191057
- Acronym / sponsor ID
- 18-25508
- Conditions
- Multiple Myeloma
- Keywords
- free light chains, healthy twins
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 15 Aug 2018 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 9 Dec 2019 (actual)
- 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 objective of this study is to recruit healthy adult identical and fraternal twins for the collection of one teaspoon of blood to be sent to the Clinical Lab at San Francisco General Hospital. The serum will be tested to determine the reference range for free light chains.
Detailed description
Serum free light chains are used to assist in the diagnosis of multiple myeloma. The test measures kappa (K) and lambda (L) chains, and the calculation of the ratio of kappa to lambda (K/L). Previous studies have shown that the K/L ratio does not change over time (1 year). The hypothesis of this study is that healthy twins will have a K/L ratio that are close to each other in value, suggesting that this ratio is genetically linked.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy twin | Experimental | Other: Free light chainsFree light chains of twins compared to non-twin siblings |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy subjects 18-80 years.
- Must be an identical or fraternal twin (both must be recruited)
Key exclusion criteria (1 listed)
- Symptoms suggestive of multiple myeloma (e.g., renal insufficiency, anemia, bone pain) -
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 |
|---|---|---|
| Free light chainsBlood samples will be collected and analyzed | Other | Healthy twin |
Primary outcome
Free light chain reference range
Time frame: One month after the completion of the enrollment
Determination of the normal range for free light chains
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 14 Jan 2025.
- Background: PubMed 22981867Braga F, Infusino I, Dolci A, Panteghini M. Biological variation of free light chains in serum. Clin Chim Acta. 2013 Jan 16;415:10-1. doi: 10.1016/j.cca.2012.09.008. Epub 2012 Sep 11. No abstract available.
- Background: PubMed 12194920Katzmann JA, Clark RJ, Abraham RS, Bryant S, Lymp JF, Bradwell AR, Kyle RA. Serum reference intervals and diagnostic ranges for free kappa and free lambda immunoglobulin light chains: relative sensitivity for detection of monoclonal light chains. Clin Chem. 2002 Sep;48(9):1437-44.
- Individual participant dataSharing planned: No. Participants and other researchers will not have access to data.
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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.
Alan Wu, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Free light chains in people with Multiple Myeloma, run by University of California, San Francisco 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 2 inclusion and 1 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 14 Jan 2025. 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?
Free light chain reference range (time frame: One month after the completion of the enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04191057, which also lists 2 linked publications.
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 14 Jan 2025.