Multiple Myeloma Survival OutcomeMMExFFPENCT07354555
Multiple Myeloma Extramedulary Disease Samples FFPE
An observational study of Multiple Myeloma Survival Outcome and Multiple Myeloma and Malignant Plasma Cell Neoplasms, run by BIWAKO at 1 site in France.
Trial summary
This observational study aims to evaluate the feasibility of assembling a retrospective cohort of formalin-fixed paraffin-embedded (FFPE) tissue samples from patients with extramedullary multiple myeloma, together with their associated clinical and pathological data. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma Survival Outcome, Multiple Myeloma and Malignant Plasma Cell Neoplasms
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 5 Jun 2026to 1 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: The study population consists of adult patients diagnosed with extramedullary myeloma (excluding plasmacytoma) for whom a representative FFPE block from a surgical specimen was obtained as part of routine clinical care within the past 10 years. Only cases with sufficient clinical, pathological, and follow-up data are included. All samples were collected outside the context of research activities.
Who may be able to join
- Adult patients with histologically confirmed extramedullary myeloma (excluding plasmacytoma).
- Availability of a representative FFPE block from a surgical specimen.
- Diagnosis established within the past 10 years.
- Availability of associated clinical and follow-up data.
Who cannot join
- Patients with plasmacytoma only.
- Insufficient or non-representative FFPE material.
- Missing key diagnostic or clinical data.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Discovery And Validation Of New Biomarkers In The Context Of Multiple Myeloma Extramedulary Disease
This observational study aims to evaluate the feasibility of assembling a retrospective cohort of formalin-fixed paraffin-embedded (FFPE) tissue samples from patients with extramedullary multiple myeloma, together with their associated clinical and pathological data. The study will determine whether these archived samples are suitable for exploratory biomarker assessment.
No intervention is performed. All FFPE samples and clinical data originate exclusively from routine diagnostic procedures and will be analyzed retrospectively for research purposes.
Read the detailed description
This retrospective observational study aims to determine the feasibility of assembling a cohort of formalin-fixed paraffin-embedded (FFPE) tissue samples from patients with extramedullary multiple myeloma and linking these materials with associated clinical and pathological data. All samples originate from routine diagnostic procedures performed as part of standard clinical care; no prospective interventions or additional tissue collection are involved.
The study evaluates whether archived FFPE specimens and corresponding clinical information can be systematically identified, retrieved, and abstracted using a predefined standardized workflow. Histopathological review and immunohistochemical markers routinely assessed during diagnostic work-up (CD138, CD56, MUM1, light chains) will be used to confirm the diagnosis and describe tumor features. Feasibility will be defined by the proportion of screened cases for which both adequate FFPE material and sufficient clinical data are available to allow inclusion.
The purpose of the study is to generate a structured dataset enabling future biomarker research and to assess whether the operational workflow used for case identification, data abstraction, and sample processing can be reliably scaled for larger retrospective cohorts.
- Keywords
- Myeloma, Extramedullary disease, histopathology, biomarker
- Medical subject headings
- Multiple Myeloma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| FFPE Blocks | Samples obtained from patients with multiple myeloma extramedullary disease. The samples should be obtained in the extramedullary disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of cohort inclusion based on availability of FFPE tissue and confirmed extramedullary disease.
Number of participants who meet both criteria:
- confirmation of extramedullary disease using predefined clinical and histopathological criteria, and
- availability of an adequate FFPE tissue block suitable for inclusion.
Feasibility will be quantified by reporting the proportion of eligible participants among all patients screened for potential inclusion.
Measured: Baseline
Secondary outcomes (1)
Evaluate FFPE analytical quality through expression rates of predefined IHC markers (CD138, CD56, MUM1, light chains).
Percentage of cases showing immunoreactivity for selected markers based on standard immunohistochemistry performed during diagnostic work-up. Marker expression is recorded as positive or negative according to predefined laboratory thresholds.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start5 Jun 2026 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma Survival OutcomeStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BIWAKO
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Heba Rashed, Principal investigator, MEDARKRO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07354555
- Sponsor's protocol ID
- BWK-P035
- Acronym
- MMExFFPE
- Status last verified
- Mar 2026
- First submitted
- 30 Nov 2025
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discovery And Validation Of New Biomarkers In The Context Of Multiple Myeloma Extramedulary Disease
- ClinicalTrials.gov ID
- NCT07354555
- Acronym / sponsor ID
- MMExFFPE / BWK-P035
- Keywords
- Myeloma, Extramedullary disease, histopathology, biomarker
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- BIWAKOIndustry (pharma, biotech, devices)
- Study start
- 5 Jun 2026 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 21 Jan 2026 (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.
This observational study aims to evaluate the feasibility of assembling a retrospective cohort of formalin-fixed paraffin-embedded (FFPE) tissue samples from patients with extramedullary multiple myeloma, together with their associated clinical and pathological data. The study will determine whether these archived samples are suitable for exploratory biomarker assessment.
No intervention is performed. All FFPE samples and clinical data originate exclusively from routine diagnostic procedures and will be analyzed retrospectively for research purposes.
Detailed description
This retrospective observational study aims to determine the feasibility of assembling a cohort of formalin-fixed paraffin-embedded (FFPE) tissue samples from patients with extramedullary multiple myeloma and linking these materials with associated clinical and pathological data. All samples originate from routine diagnostic procedures performed as part of standard clinical care; no prospective interventions or additional tissue collection are involved.
The study evaluates whether archived FFPE specimens and corresponding clinical information can be systematically identified, retrieved, and abstracted using a predefined standardized workflow. Histopathological review and immunohistochemical markers routinely assessed during diagnostic work-up (CD138, CD56, MUM1, light chains) will be used to confirm the diagnosis and describe tumor features. Feasibility will be defined by the proportion of screened cases for which both adequate FFPE material and sufficient clinical data are available to allow inclusion.
The purpose of the study is to generate a structured dataset enabling future biomarker research and to assess whether the operational workflow used for case identification, data abstraction, and sample processing can be reliably scaled for larger retrospective cohorts.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FFPE Blocks | – | –Samples obtained from patients with multiple myeloma extramedullary disease. The samples should be obtained in the extramedullary disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients diagnosed with extramedullary myeloma (excluding plasmacytoma) for whom a representative FFPE block from a surgical specimen was obtained as part of routine clinical care within the past 10 years. Only cases with sufficient clinical, pathological, and follow-up data are included. All samples were collected outside the context of research activities.
Key inclusion criteria (4 listed)
- Adult patients with histologically confirmed extramedullary myeloma (excluding plasmacytoma).
- Availability of a representative FFPE block from a surgical specimen.
- Diagnosis established within the past 10 years.
- Availability of associated clinical and follow-up data.
Key exclusion criteria (3 listed)
- Patients with plasmacytoma only.
- Insufficient or non-representative FFPE material.
- Missing key diagnostic or clinical data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Feasibility of cohort inclusion based on availability of FFPE tissue and confirmed extramedullary disease.
Time frame: Baseline
Number of participants who meet both criteria: * confirmation of extramedullary disease using predefined clinical and histopathological criteria, and * availability of an adequate FFPE tissue block suitable for inclusion. Feasibility will be quantified by reporting the proportion of eligible participants among all patients screened for potential inclusion.
1 secondary outcome
Evaluate FFPE analytical quality through expression rates of predefined IHC markers (CD138, CD56, MUM1, light chains).
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- 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.
Heba Rashed principal investigator
MEDARKRO
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 Survival Outcome and Multiple Myeloma and Malignant Plasma Cell Neoplasms, run by BIWAKO 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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 20 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie BREVET, Pr ; MD. PhD. (33628010948, m.brevet@biwako.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of cohort inclusion based on availability of FFPE tissue and confirmed extramedullary disease. (time frame: Baseline). 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 20 Mar 2026; AzTrials last refreshed its copy on 26 Oct 2026.