Multiple Myeloma Extramedulary Disease Samples FFPE

NCT07354555 | Not Yet Recruiting

• 1 other identifier: BWK-P035
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma Survival Outcome; Multiple Myeloma and Malignant Plasma Cell Neoplasms

Keywords

Myeloma; Extramedullary disease; histopathology; biomarker

Outcome Measures

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.

  Baseline

Secondary Outcomes (1)

• Evaluate FFPE analytical quality through expression rates of predefined IHC markers (CD138, CD56, MUM1, light chains).

  Baseline

Other Outcomes (1)

• Describe the distribution of anatomical sites of extramedullary disease with clinicopathological characteristics of included cases.

  Baseline

Study Arms (1)

FFPE Blocks

Samples obtained from patients with multiple myeloma extramedullary disease. The samples should be obtained in the extramedullary disease.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Patients with plasmacytoma only.
• Insufficient or non-representative FFPE material.
• Missing key diagnostic or clinical data.

Sponsors & Collaborators

• BIWAKO: lead

Study Sites (1)

BIWAKO

Lyon 06, 69006, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

The study plans to collect formalin fixed embedded samples (FFPE) and to cut unstained histopathological slides for immpunohistochemistry techniques. No DNA extraction

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Heba Rashed

  MEDARKRO

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie BREVET, Pr ; MD. PhD.

CONTACT

33628010948; m.brevet@biwako.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2025
• First Posted: January 21, 2026
• Study Start (Estimated): June 5, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)