Multiple Myeloma and Malignant Plasma Cell Neoplasms, Multiple Myeloma Survival Outcome
Conditions
Keywords
Myeloma, Extramedullary disease, histopathology, biomarker
Brief 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. 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.
Interventions
None listed
Sponsors
BIWAKO
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Patients with plasmacytoma only. * Insufficient or non-representative FFPE material. * Missing key diagnostic or clinical data.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of cohort inclusion based on availability of FFPE tissue and confirmed extramedullary disease. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate FFPE analytical quality through expression rates of predefined IHC markers (CD138, CD56, MUM1, light chains). | Baseline | 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. |
Countries
France
Contacts
CONTACTMarie BREVET, Pr ; MD. PhD.
PRINCIPAL_INVESTIGATORHeba Rashed
MEDARKRO
Outcome results
None listed