Not yet recruitingOBSERVATIONAL

Multiple Myeloma t(4 ;14) FFPE Samples

This research wants to understand if we can use existing archived tissue samples from patients with a particular type of multiple myeloma (a cancer of plasma cells in the bone marrow). Specifically, we are looking at samples from patients who have a genetic change called a t(4;14) translocation. We will also gather information about these patients' health journeys. The main goal is to see if these old samples and health records are good enough and comprehensive enough to be used for future scientific studies. This could help researchers discover new markers or features of the disease, which might lead to better ways to diagnose or treat multiple myeloma in the future. No new tests or treatments are involved; we are simply looking at information that has already been collected as part of routine care.

At a glance

Status

Not yet recruiting

Sponsor

BIWAKO

Enrolment target

Start

05 Jul 2026

Estimated completion

01 Jun 2027

Multiple Myeloma and Malignant Plasma Cell Neoplasms

What is this study about?

This research project is called an "observational study." This means that doctors and scientists are simply looking at information that has already been collected, rather than giving new treatments or asking patients to have extra tests. They want to look specifically at people who have a type of blood cancer called multiple myeloma, where the body makes too many abnormal immune cells called plasma cells, often in the bone marrow. This study focuses on a particular type of multiple myeloma where the cells have a specific genetic change, or 'fault', called a t(4;14) translocation.

The main aim is to see if past tissue samples, which are stored at hospitals, can be useful for new research. These samples are called 'FFPE' samples – short for Formalin-Fixed Paraffin-Embedded. They are very small pieces of tissue, like from a biopsy, that have been preserved so they can be kept for a long time. Researchers will also look at medical information linked to these samples, which tells them about the patients' health and treatment history. By linking these samples to patient information, scientists hope to build a valuable collection that can be used for future studies to better understand multiple myeloma.

Ultimately, this project is about laying the groundwork for future discoveries. If we can successfully gather and link these old samples with patient data, it will help scientists identify new 'biomarkers'. Biomarkers are like clues in the body that can tell us more about a disease, how it might behave, or how it might respond to treatment. Finding new biomarkers could lead to better ways to diagnose multiple myeloma earlier, monitor it more effectively, or even develop new, more personalised treatments down the line. It's a way of using historical medical information to help patients in the future.

Key takeaways

This study uses existing, anonymous patient data and tissue samples.
It focuses on a specific genetic change in multiple myeloma (t(4;14)).
The goal is to see if these historical samples are good for new research.
It helps build a foundation for future discoveries about the disease.
No new tests, treatments, or patient involvement are required.
Information gathered could lead to better diagnosis or treatment for future patients.

Who may be eligible?

To be included in this study, the patient must be an adult (18 years or older) and have a confirmed diagnosis of multiple myeloma with a specific genetic change called a t(4;14) translocation. Their diagnosis must have been made within the last 10 years, and there needs to be a suitable archived tissue sample from their diagnosis available, along with their associated health records.

Patients would not be included if their tissue sample comes from a bone lesion, or if the archived tissue sample is not good enough or doesn't properly show the cancer. Also, if important medical information or follow-up details are missing from their records, they wouldn't be suitable for this specific study. This is because the study relies on having complete information to be useful for future research.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you an adult (18 or over)?
Do you have a confirmed diagnosis of multiple myeloma?
Do your myeloma cells have the t(4;14) genetic change?
Was your diagnosis made in the last 10 years?
Did you have a tissue sample taken during your diagnosis that was kept at the hospital?
Are your medical records complete enough regarding your diagnosis and follow-up?

Answer every question to see your result.

What does participation involve?

If you were to be part of a study like this, you wouldn't need to do anything new or different. This is because it is a 'retrospective observational study,' which means researchers are only looking at information and tissue samples that were already collected from you as part of your routine medical care in the past. You wouldn't have any extra doctor's visits, new assessments, or be asked to take any new medications. There are no follow-up appointments connected to this research, and it doesn't involve any direct contact with patients. The study simply involves researchers going through existing medical records and archived tissue samples.

Potential risks and benefits

There are no direct risks to you as a patient involved in this study because no new tests, treatments, or procedures are being done. Researchers are only looking at your existing, anonymous medical records and tissue samples. The main benefit is to future patients: the information gathered could help scientists better understand multiple myeloma with the t(4;14) translocation, potentially leading to new ways to diagnose or treat the disease later on. Your right to privacy is protected; all information is handled confidentially and anonymised where possible. As this study doesn't involve direct patient participation, the concept of 'withdrawal' in the traditional sense doesn't apply once anonymised data and samples are included, but hospitals always maintain careful oversight of how patient data is used for research.

Locations (1)

BIWAKO
Verified postcode
Lyon, France

Common questions

What is multiple myeloma?

Multiple myeloma is a type of cancer that affects plasma cells, which are a type of white blood cell found in the bone marrow. These cells help fight infection, but in myeloma, they grow abnormally and cause problems.

What does t(4;14) translocation mean?

This refers to a specific genetic change in the myeloma cells. It means that parts of two different chromosomes (number 4 and number 14) have swapped places, which might affect how the disease behaves.

What are FFPE samples?

FFPE stands for Formalin-Fixed Paraffin-Embedded. These are small pieces of tissue, often from a biopsy, that have been specially treated and stored in wax (paraffin) at the hospital. They are kept for a long time for diagnostic purposes and sometimes for research.

Will I know if my samples are used?

As this study uses existing, anonymised records and samples, individual patients will not be directly informed if their specific samples are included. The research is conducted with strict privacy and ethical approvals.

Will this study benefit me directly?

This particular study is foundational; it aims to build a resource for future research. While it won't directly change your current treatment or care, the findings could ultimately lead to better understanding and treatment options for people with multiple myeloma in the future.

How to find out more

Marie BREVET, Pr ; MD. PhD.

m.brevet@biwako.fr +33628010948 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.