DysglobulinemiaPreFamDysNCT02853214
Familial Dysglobulinemia
A study testing Genetic analysis of peripheral blood samples in people with Dysglobulinemia, run by Hospices Civils de Lyon at 47 sites in France.
Trial summary
Multiple Myeloma (MM) is a malignant proliferation of monoclonal plasma cells. Myeloma accounts for almost 14% of all hematologic cancers and is essentially incurable. Myeloma commonly evolves from a precursor disease, Monoclonal gammopathy of undetermined significance (MGUS). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dysglobulinemia
- What is being tested?
- Genetic analysis of peripheral blood samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,868 participants
- Where
- 47 sitesFrance
- Study dates
- 6 Feb 2008to 25 Sep 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 2 cases per family at least
- 1 case alive at least
- biological material available for 1 case at least
- Patients give their informed consent
- attached to the French Health protection service
Who cannot join
- Age under 18
Trial locations and contacts
47 sites in 1 country.
47 sites in 1 country
France47 sites
CHU d'ABBEVILLE
Abbeville, 80100
CHU Amiens Picardie
Amiens, 80054
CHU Groupe Hospitalier Sud Hématologie Clinique
Amiens
CH d'Avignon
Avignon, 84902
CHU de Besançon
Besançon, 25030
CH de Blois Service d'Hématologie
Blois
Hôpital Avicenne Service d'Hématologie
Bobigny
Service d'Hématologie clinique et Thérapie Cellulaire, CHU de BORDEAUX
Bordeaux
CHU Morvan
Brest
Service d'hématologie Clinique
Caen, 14000
Hématolgie- Hôpital privé Cesson-Sévigné
Cesson-Sévigné, 35510
CH William Morey, Service d'Hémato-Oncologie
Chalon-sur-Saône, 71321
CHU de Chartres
Chartres, 28018
Département d'Oncogénitique - Centre Jean Perrin
Clermont-Ferrand, 63011
Hôpital Sud Francilien
Corbeil-Essonnes, 91100
Service d'Hématologie Clinique, CHU de Dijon
Dijon, 21000
Centre Hospitalier de Dunkerque
Dunkirk, 59 385
Service de Médecine Interne-Hématologie, CHU de Fort de France Fort de France
Fort-de-France, Martinique, 97200
GHM, Institut Daniel Hollard
Grenoble, 38000
CHU Albert Michallon
Grenoble, 38043
Service d'Hématologie, CHU de Versailles
Le Chesnay, 78150
Centre Jean Bernard Clinique Victor Hugo
Le Mans, 72000
Service d'Onco-hématologie, Hôpital Saint-Vincent GH-ICL
Lille, 59000
Service des Maladies du Sang CHU Lille
Lille
Département d'Oncogénétique, Centre Paoli Calmettes
Marseille
CHR-Metz-Thionville, Hôpital de Mercy, Service d'Hématologie
Metz, 57085
CHU d'Annecy
Metz-Tessy, 74374
Hôpital Saint-Eloi, Département d'Hématologie clinique
Montpellier, 34295
Service d'Oncologie Médical, Centre Azuréen de Canrérologie-1
Mougins, 06250
CHU-HÔTEL -Dieu de Nantes
Nantes, 44093
Hôpital de l'Archet 1
Nice, 06202
CHU Carémeau
Nîmes, 30029
Institut Curie
Paris, 75248
Hôpital St Antoine Service des maladies du Sang
Paris
Jean Paul FermandService Immuno-Hématologie Hôpital Saint Louis
Paris
Hospices Civils de Lyon
Pierre-Bénite, 69495
Service d'Oncologie-Radiothérapie - CHU Pointe-à-Pitre/Abymes Guadeloupe
Pointe à Pitre, Guadeloupe, 97159
CHU de Poitiers
Poitiers, 86021
Hôpital Robert Debré Service du Professeur A. DELMER Hématologie Clinique
Reims
CHU de Rennes Hôpital Sud
Rennes
CH de Rodez
Rodez, 12027
Hôpital de Saint- Germain en Laye
Saint-Germain-en-Laye, 78100
Département d'Hématologie à l'Institut de Cancérologie de la Loire
Saint-Priest-en-Jarez, 42270
Hôpital Purpan Service d'Hématologie
Toulouse, 31059
Centre Hospitalier de Valence
Valence, 26953
CHU de Nancy, Hôpital de Brabois
Vandœuvre-lès-Nancy
Hôpital Privé de Villeneuve d'Ascq
Villeneuve-d'Ascq, 59650
About this study
Official title: Identification of Genetic Factors Predisposing to Dysglobulinemia
Multiple Myeloma (MM) is a malignant proliferation of monoclonal plasma cells. Myeloma accounts for almost 14% of all hematologic cancers and is essentially incurable. Myeloma commonly evolves from a precursor disease, Monoclonal gammopathy of undetermined significance (MGUS). Despite intensive study, the etiology of MGUS and myeloma are unknown and no lifestyle or environmental exposure factors have been identified that are consistently linked to increased risk of MM, MGUS or the transition between the two.
The overall goal is to identify risk genes for dysglobulinemia, and more specifically Multiple Myeloma. This will involve the conservation of cells in a bank and genetic sequencing on samples obtained from families with at least two cases of dysglobulinemia. Material used for sequencing is likely to include fresh peripheral blood cells or lymphoblastoid lines established from peripheral blood lymphocytes of patients.
- Conditions
- Dysglobulinemia
- Being tested
- Genetic analysis of peripheral blood samples
- Keywords
- Dysglobulinemia, Multiple Myeloma, MGUS, Waldenström, genetic factors, Sequencing
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetic analysis of peripheral blood samplesGenetic
M.D investigators report the identified families with all the information: description of the familial area (for example: 2 cases father and son), last medical report for the case with the type of dysglobulinemia, monoclonal component isotype, medical background and contact information for one of the patients or cases with Name/surname/Date of Birth/address and phone. They contact the patient to explain the study and establish the family pedigree. They collect the information on all the family members and send to the patient a mail: an information note on the study, a prescription for the blood sample and the informed consents. They proceed in the same way for the relatives with the additional prescription: EIP. They organize the logistic in the medical lab or hospital chosen by the person. They receive 4 Heparin and 1 serum tubes for each and with this, they obtain a large amount of biological material for the genetic analysis thanks to the establishment of lymphoblastoid cell lines
| Study group | Role | What they receive |
|---|---|---|
| Identification of genetic factors in dysglobulinemia cases | Experimental | Not described Receives: Genetic: Genetic analysis of peripheral blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Data of a bank cells, clinically annotated, from families with at least 2 cases of dysglobulinemia and at least 1 case alive.plasma cell dysplasia
The investigator collects blood samples from patients with dysglobulinemia and their relatives and with this, the investigators constitutes the bank cells thanks to the establishment of lymphoblastoid cell lines.
The investigator considers as "dysglobulinemia" cases patients with Multiple Myeloma, MGUS, Waldenström's disease and MGUS (monoclonal gammopathy of unknown significance ) as wells as plasmacytomas confirmed histologically or cytologically.
Measured: up to 48 months
Secondary outcomes (1)
Single Nucleotide Polymorphism array for identification of polymorphisms predictive of dysglobulinemia
The biological material, obtained from fresh peripheral blood cells and from Lymphoblastoid cells lines, is used for pangenic sequencing. It allows to better understand the mechanism of genetic variations who could be involve in the myeloma genesis
Measured: at day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2016 (estimated)
- Study start6 Feb 2008
- Primary completion25 Sep 2023
- Study completion25 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DysglobulinemiaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- 1,868 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles DUMONTET, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02853214
- Sponsor's protocol ID
- 2007-460
- Other IDs
- 2007-A00644-49
- Acronym
- PreFamDys
- Status last verified
- Aug 2025
- First submitted
- 13 Jul 2016
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Dumontet C, Demangel D, Galia P, Karlin L, Roche L, Fauvernier M, Golfier C, Laude MC, Leleu X, Rodon P, Roussel M, Azais I, Doyen C, Slama B, Manier S, Decaux O, Pertesi M, Beaumont M, Caillot D, Boyle EM, Cliquennois M, Cony-Makhoul P, Doncker AV, Dorvaux V, Petillon MO, Fontan J, Hivert B, Leduc I, Leyronnas C, Macro M, Maigre M, Mariette C, Mineur P, Rigaudeau S, Royer B, Vincent L, Mckay J, Perrial E, Garderet L. Clinical characteristics and outcome of 318 families with familial monoclonal gammopathy: A multicenter Intergroupe Francophone du Myelome study. Am J Hematol. 2023 Feb;98(2):264-271. doi: 10.1002/ajh.26785. Epub 2023 Jan 1.
PubMed 36588407
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Genetic Factors Predisposing to Dysglobulinemia
- ClinicalTrials.gov ID
- NCT02853214
- Acronym / sponsor ID
- PreFamDys / 2007-460
- Conditions
- Dysglobulinemia
- Keywords
- Dysglobulinemia, Multiple Myeloma, MGUS, Waldenström, genetic factors, Sequencing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,868 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 6 Feb 2008 (actual)
- Primary completion
- 25 Sep 2023 (actual)
- Study completion
- 25 Sep 2023 (actual)
- First posted
- 2 Aug 2016 (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.
Multiple Myeloma (MM) is a malignant proliferation of monoclonal plasma cells. Myeloma accounts for almost 14% of all hematologic cancers and is essentially incurable. Myeloma commonly evolves from a precursor disease, Monoclonal gammopathy of undetermined significance (MGUS). Despite intensive study, the etiology of MGUS and myeloma are unknown and no lifestyle or environmental exposure factors have been identified that are consistently linked to increased risk of MM, MGUS or the transition between the two.
The overall goal is to identify risk genes for dysglobulinemia, and more specifically Multiple Myeloma. This will involve the conservation of cells in a bank and genetic sequencing on samples obtained from families with at least two cases of dysglobulinemia. Material used for sequencing is likely to include fresh peripheral blood cells or lymphoblastoid lines established from peripheral blood lymphocytes of patients.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Identification of genetic factors in dysglobulinemia cases | Experimental | Genetic: Genetic analysis of peripheral blood samples |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 2 cases per family at least
- 1 case alive at least
- biological material available for 1 case at least
- Patients give their informed consent
- attached to the French Health protection service
Key exclusion criteria (1 listed)
- Age under 18
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 |
|---|---|---|
| Genetic analysis of peripheral blood samplesM.D investigators report the identified families with all the information: description of the familial area (for example: 2 cases father and son), last medical report for the case with the type of dysglobulinemia, monoclonal component isotype, medical background and contact information for one of the patients or cases with Name/surname/Date of Birth/address and phone. They contact the patient to explain the study and establish the family pedigree. They collect the information on all the family members and send to the patient a mail: an information note on the study, a prescription for the blood sample and the informed consents. They proceed in the same way for the relatives with the additional prescription: EIP. They organize the logistic in the medical lab or hospital chosen by the person. They receive 4 Heparin and 1 serum tubes for each and with this, they obtain a large amount of biological material for the genetic analysis thanks to the establishment of lymphoblastoid cell lines | Genetic | Identification of genetic factors in dysglobulinemia cases |
Primary outcome
Data of a bank cells, clinically annotated, from families with at least 2 cases of dysglobulinemia and at least 1 case alive.plasma cell dysplasia
Time frame: up to 48 months
The investigator collects blood samples from patients with dysglobulinemia and their relatives and with this, the investigators constitutes the bank cells thanks to the establishment of lymphoblastoid cell lines. The investigator considers as "dysglobulinemia" cases patients with Multiple Myeloma, MGUS, Waldenström's disease and MGUS (monoclonal gammopathy of unknown significance ) as wells as plasmacytomas confirmed histologically or cytologically.
1 secondary outcome
Single Nucleotide Polymorphism array for identification of polymorphisms predictive of dysglobulinemia
Time frame: at day 0
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 3 Sep 2025.
- Results publication: PubMed 36588407Dumontet C, Demangel D, Galia P, Karlin L, Roche L, Fauvernier M, Golfier C, Laude MC, Leleu X, Rodon P, Roussel M, Azais I, Doyen C, Slama B, Manier S, Decaux O, Pertesi M, Beaumont M, Caillot D, Boyle EM, Cliquennois M, Cony-Makhoul P, Doncker AV, Dorvaux V, Petillon MO, Fontan J, Hivert B, Leduc I, Leyronnas C, Macro M, Maigre M, Mariette C, Mineur P, Rigaudeau S, Royer B, Vincent L, Mckay J, Perrial E, Garderet L. Clinical characteristics and outcome of 318 families with familial monoclonal gammopathy: A multicenter Intergroupe Francophone du Myelome study. Am J Hematol. 2023 Feb;98(2):264-271. doi: 10.1002/ajh.26785. Epub 2023 Jan 1.
- Individual participant dataSharing planned: No
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.
Charles DUMONTET principal investigator
Hospices Civils de Lyon
47 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Genetic analysis of peripheral blood samples in people with Dysglobulinemia, run by Hospices Civils de Lyon at 47 sites in France.
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 5 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 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in France. 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?
Data of a bank cells, clinically annotated, from families with at least 2 cases of dysglobulinemia and at least 1 case alive.plasma cell dysplasia (time frame: up to 48 months). 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 NCT02853214, which also lists 1 linked publication.
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 3 Sep 2025.