Multiple Myeloma Extramedulary Disease Samples FFPE
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBIWAKO
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patients with plasmacytoma only.
Insufficient or non-representative FFPE material.
Missing key diagnostic or clinical data.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
15 Participants
are grouped into 1 trial groupGroup A: FFPE Blocks
Trial outcomes
Primary outcomes
1
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.
Time frame
BaselineSecondary 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.
Time frame
BaselineOther outcomes
1
Describe the distribution of anatomical sites of extramedullary disease with clinicopathological characteristics of included cases.
Categorization of EMD cases according to the anatomical origin of the archived tissue sample (e.g., soft tissue, liver, CNS, lymph node). Measurement is performed by reviewing sample metadata recorded at the time of diagnostic tissue processing.
Time frame
Baseline Source ClinicalTrials.gov
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