Multiple MyelomaMMSPORADGENNCT05331313
The Aim is to Identify Recurrent Genomic Mutations and/or Predisposing Polymorphisms in Patients With Sporadic Cases of Multiple Myeloma
An observational study of Multiple Myeloma, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
There is a growing body of data suggesting that the the risk of developing multiple myeloma, or myelomagenesis, is associated with genetic alterations occurring in the tumor cells. A limited number of candidate genes and polymorphisms have been reported in patients with this disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- DNA sequencing
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2022to 31 Aug 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient samples will be accrued from Intergroupe Francophone du Myélome (IFM) centers in France, in the context of primary care clinics. The investigators aim to collect up to 1,000 samples.
Who may be able to join
- diagnosis of multiple myeloma
- availability of abnormal plasmocytes
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Genomic Alterations in Sporadic Cases of Multiple Myeloma
There is a growing body of data suggesting that the the risk of developing multiple myeloma, or myelomagenesis, is associated with genetic alterations occurring in the tumor cells. A limited number of candidate genes and polymorphisms have been reported in patients with this disease. In this study the investigators will compare the genetic information obtained on purified abnormal plasmocytes obtained from patients with multiple myeloma with available public databases in an effort to identify and if possible validate the role of certain mutations and/or polymorphisms in myelomagenesis. Plasmocytes will be obtained by immunomagnetic enrichment using CD138+ beads.
- Conditions
- Multiple Myeloma
- Being tested
- DNA sequencing
- Keywords
- genetic predisposition, mutations, sporadic, multiple myeloma
- Medical subject headings
- Multiple Myeloma, Genetic Predisposition to Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA sequencingGenetic
The aim of this study is to perform DNA sequencing on abnormal plasmocytes obtained from patients with multiple myeloma, in order to identify alterations which are associated with the existence of this disease. DNA analyses will be performed in a single experiment once all samples have been collected.
| Study group | Role | What they receive |
|---|---|---|
| patients with a diagnosis of multiple myeloma | This study will involve a single patient group, namely patients with a diagnosis of multiple myeloma diagnosed by a bone marrow aspirate with cytological analysis of the bone marrow smear.Bone marrow samples obtained during the routine follow-up will undergo plasmocyte enrichment using immunopurification using CD138+ beads and nucleic acids will be extracted for sequencing. Receives: Genetic: DNA sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
DNA mutations associated with the existence of multiple myeloma
DNA data acquired in myeloma patient samples will be compared to those of healthy subjects using publically available databases.
Measured: baseline, pre-intervention/procedure/surgery
DNA mutations associated with the existence of multiple myeloma
DNA data acquired in myeloma patient samples will be compared to those of healthy subjects using publically available databases.
Measured: during the intervention/procedure/surgery
DNA mutations associated with the existence of multiple myeloma
DNA data acquired in myeloma patient samples will be compared to those of healthy subjects using publically available databases.
Measured: immediately after the intervention/procedure/surgery
DNA mutations associated with the existence of multiple myeloma
DNA data acquired in myeloma patient samples will be compared to those of healthy subjects using publically available databases.
Measured: at 1 year
DNA mutations associated with the existence of multiple myeloma
DNA data acquired in myeloma patient samples will be compared to those of healthy subjects using publically available databases.
Measured: up to 24 weeks
DNA mutations associated with the existence of multiple myeloma
DNA data acquired in myeloma patient samples will be compared to those of healthy subjects using publically available databases.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start1 Dec 2022 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion31 Aug 2024 (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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05331313
- Sponsor's protocol ID
- 69HCL21_0492
- Acronym
- MMSPORADGEN
- Status last verified
- Mar 2022
- First submitted
- 31 Mar 2022
- Last updated
- 15 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Genomic Alterations in Sporadic Cases of Multiple Myeloma
- ClinicalTrials.gov ID
- NCT05331313
- Acronym / sponsor ID
- MMSPORADGEN / 69HCL21_0492
- Conditions
- Multiple Myeloma
- Keywords
- genetic predisposition, mutations, sporadic, multiple myeloma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 15 Apr 2022 (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.
There is a growing body of data suggesting that the the risk of developing multiple myeloma, or myelomagenesis, is associated with genetic alterations occurring in the tumor cells. A limited number of candidate genes and polymorphisms have been reported in patients with this disease. In this study the investigators will compare the genetic information obtained on purified abnormal plasmocytes obtained from patients with multiple myeloma with available public databases in an effort to identify and if possible validate the role of certain mutations and/or polymorphisms in myelomagenesis. Plasmocytes will be obtained by immunomagnetic enrichment using CD138+ beads.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with a diagnosis of multiple myeloma | – | Genetic: DNA sequencingThis study will involve a single patient group, namely patients with a diagnosis of multiple myeloma diagnosed by a bone marrow aspirate with cytological analysis of the bone marrow smear.Bone marrow samples obtained during the routine follow-up will undergo plasmocyte enrichment using immunopurification using CD138+ beads and nucleic acids will be extracted for sequencing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient samples will be accrued from Intergroupe Francophone du Myélome (IFM) centers in France, in the context of primary care clinics. The investigators aim to collect up to 1,000 samples.
Key inclusion criteria (2 listed)
- diagnosis of multiple myeloma
- availability of abnormal plasmocytes
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| DNA sequencingThe aim of this study is to perform DNA sequencing on abnormal plasmocytes obtained from patients with multiple myeloma, in order to identify alterations which are associated with the existence of this disease. DNA analyses will be performed in a single experiment once all samples have been collected. | Genetic | patients with a diagnosis of multiple myeloma |
Primary outcome
DNA mutations associated with the existence of multiple myeloma
Time frame: baseline, pre-intervention/procedure/surgery
DNA data acquired in myeloma patient samples will be compared to those of healthy subjects using publically available databases.
DNA mutations associated with the existence of multiple myeloma
Time frame: during the intervention/procedure/surgery
DNA data acquired in myeloma patient samples will be compared to those of healthy subjects using publically available databases.
DNA mutations associated with the existence of multiple myeloma
Time frame: immediately after the intervention/procedure/surgery
DNA data acquired in myeloma patient samples will be compared to those of healthy subjects using publically available databases.
DNA mutations associated with the existence of multiple myeloma
Time frame: at 1 year
DNA data acquired in myeloma patient samples will be compared to those of healthy subjects using publically available databases.
DNA mutations associated with the existence of multiple myeloma
Time frame: up to 24 weeks
DNA data acquired in myeloma patient samples will be compared to those of healthy subjects using publically available databases.
DNA mutations associated with the existence of multiple myeloma
Time frame: through study completion, an average of 1 year
DNA data acquired in myeloma patient samples will be compared to those of healthy subjects using publically available databases.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2022.
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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.
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 Hospices Civils de Lyon at 1 site 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 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: status not confirmed, as of the sponsor's last update on 15 Apr 2022. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Charles DUMONTET, Pr (04 78 46 83 40 ext. +33, charles.dumontet@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DNA mutations associated with the existence of multiple myeloma (time frame: baseline, pre-intervention/procedure/surgery). The study lists 6 primary outcomes in all. 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 15 Apr 2022.