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NCT Number: NCT07482761

Multiple Myeloma t(4 ;14) FFPE Samples

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.

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Key information

Conditions

Multiple Myeloma and Malignant Plasma Cell Neoplasms Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

This retrospective observational study aims to determine the feasibility of assembling a cohort of formalin-fixed paraffin-embedded (FFPE) tissue samples from patients with 4;14 translocated 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Bone lesions samples
  • Insufficient or non-representative FFPE material.
  • Missing key diagnostic or clinical data.

Treatment and study plan

Primary outcomes

  1. Feasibility of cohort inclusion based on availability of FFPE tissue and confirmed myeloma disease with (4;14) translocation.

    Time frame: Baseline

    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.

Secondary outcomes

  1. 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.

Other outcomes

  1. Describe the distribution of treatment received by the patients with t(4;14) multiple myeloma

    Time frame: Baseline

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Marie BREVET, Pr ; MD. PhD.

CONTACT

[email protected]

+33628010948

Sponsors and collaborators

Lead sponsor

BIWAKO

Industry

Registry information

Official study title

Discovery And Validation Of New Biomarkers In The Context Of Multiple Myeloma With t(4-14) and Relapse

Acronym: MM-t4-14-FFPE

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Mar 19, 2026
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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