Determine the Frequency of Variants in the GBA/PSAP Genes in Patients With MM or MGUS (NCT06559033) | Clinical Trial Compass
RecruitingNot Applicable
Determine the Frequency of Variants in the GBA/PSAP Genes in Patients With MM or MGUS
France300 participantsStarted 2025-10-07
Plain-language summary
No effective specific treatment is currently available for the management of Multiple Myeloma (MM) and Monoclonal Gammopathy of Undetermined Significance (MGUS). A better understanding of the pathophysiological mechanisms would make it possible to propose treatments specifically targeting the deregulated pathways.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Major patients with multiple myeloma (MM) (defined by clonal proliferation of tumour plasma cells (\>10%), presence of a monoclonal peak in serum or urine (excluding non-secretory myeloma) and organ involvement secondary to bone marrow invasion) or with MGUS (defined as bone marrow plasmacytosis of less than 10%, associated with a monoclonal protein of less than 30g/L and no clinical involvement).
* Membership of a social security scheme
* Adult having read and understood the information letter and signed the consent form
Exclusion Criteria:
* Person deprived of liberty by an administrative or judicial decision or person placed under court protection / sub-guardianship or guardianship
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is looking at genetic variants in the GBA and PSAP genes in people with myeloma or MGUS — do you think my personal or family history makes this kind of genetic screening particularly relevant for me?
2Since this study is observational and focused on measuring gene variant frequency rather than testing a new treatment, what would actually happen to me if a GBA or PSAP variant were found — would it change my current treatment plan in any way?
3Because this trial is in a 'Not Applicable' phase, meaning it's a genetic registry or observational study rather than a drug trial, what are the realistic risks or downsides of participating, such as concerns about genetic data privacy or incidental findings?
4How would joining this study fit alongside my existing care for MGUS or multiple myeloma — would it require extra clinic visits, additional blood draws, or genetic testing beyond what I'd normally have?
5Are there other genetic studies or standard-of-care genetic tests already available to me that might answer similar questions about my GBA or PSAP gene variants, and how does this trial compare to those options?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Frequency of variants in the GBA/PSAP genes in patients with MM or MGUS