Multiple Myeloma t(4 ;14) FFPE Samples
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 4;14 translocated 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 myeloma with a t(4;14) translocation
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
Bone lesions samples
Insufficient or non-representative FFPE material.
Missing key diagnostic or clinical data.
Trial population
The study population consists of adult patients diagnosed with t(4;14) myeloma 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
20 Participants
are grouped into 1 trial groupGroup A: FFPE samples
Trial outcomes
Primary outcomes
1
Feasibility of cohort inclusion based on availability of FFPE tissue and confirmed myeloma disease with (4;14) translocation.
Number of participants who meet both criteria: - confirmation of t(4;14) 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 treatment received by the patients with t(4;14) multiple myeloma
Categorization of treatment (according to treatment class and line of therapy, including proteasome inhibitors, immunomodulatory drugs, anti-CD38 monoclonal antibodies, and other targeted agents). Data are collected by reviewing sample metadata recorded at the time of diagnostic tissue processing.
Time frame
Baseline Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: