Multiple Myeloma Extramedulary Disease Samples FFPE (MMExFFPE)

March 19, 2026 updated by: BIWAKO

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.

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Lyon 06, France, 69006
        • BIWAKO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
FFPE Blocks
Samples obtained from patients with multiple myeloma extramedullary disease. The samples should be obtained in the extramedullary disease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate FFPE analytical quality through expression rates of predefined IHC markers (CD138, CD56, MUM1, light chains).
Time Frame: 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.
Baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Describe the distribution of anatomical sites of extramedullary disease with clinicopathological characteristics of included cases.
Time Frame: Baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BIWAKO

Investigators

  • Principal Investigator: Heba Rashed, MEDARKRO

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 5, 2026

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

November 30, 2025

First Submitted That Met QC Criteria

January 15, 2026

First Posted (Actual)

January 21, 2026

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BWK-P035

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Multiple Myeloma Survival Outcome

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Togo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe