Multiple Myeloma t(4 ;14) FFPE Samples (MM-t4-14-FFPE)

March 14, 2026 updated by: BIWAKO

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

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.

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 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.

Study Type

Observational

Enrollment (Estimated)

20

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

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 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.

Description

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.

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 samples
Samples obtained from patients with multiple myeloma disease and confirmed 4;14 translocation. Tissu samples should be obtained (nos aspirate)

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 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.
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 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.
Baseline

Collaborators and Investigators

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

Sponsor

BIWAKO

Investigators

  • Principal Investigator: Heba RASHED, MEDARKCRO

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)

July 5, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

March 14, 2026

First Submitted That Met QC Criteria

March 14, 2026

First Posted (Actual)

March 19, 2026

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 14, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BWK-P035b

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.

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