Clinical trial · Observational
Study to Evaluate t(11;14) Status and BCL2 Expression in Adult Participants With Multiple Myeloma (MM)
MEDICI - t(11;14) and BCL2 Expression in Patients With Multiple Myeloma: Prevalence, Stability Across Lines of Therapy and Concordance Across Sample Types
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Multiple myeloma (MM) is a rare cancer caused by abnormal survival of plasma cells (blood cells). Most trial participants with MM relapse (cancer has come back) or become non- responsive to treatment and remission gets shorter after each line of treatment. This is a study to assess t(11;14) and BCL2 expression in adult participants with newly diagnosed and relapsed/refractory (R/R) MM. Approximately 500 adult participants with newly confirmed or relapsed/refractory (R/R) multiple myeloma (MM) will be enrolled in around 15-20 countries. Participants will receive standard of care while participating in this study. No drug will be administered as a part of this study. Participants will attend regular visits during the course of the study at a hospital or clinic and will be asked to provide bone marrow and blood samples.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma (MM) | Multiple Myeloma | CURATED_EXACT | 0.85 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Participants With Multiple Myeloma
- description
- Participants with newly diagnosed and relapsed/refractory multiple myeloma will receive standard of care. Bone marrow and blood samples will be collected.
Primary outcomes (2)
- measure
- Percentage of Participants With t(11;14) Status by Fluorescence In Situ Hybridization (FISH) Analysis of Bone Marrow Plasma Cells
- timeFrame
- Up to approximately 2.5 months following last subject last visit
- description
- t(11;14) status (positive or negative) of the earliest multiple myeloma (MM) sample collected at initial diagnosis or across lines of therapies, by FISH analysis of bone marrow plasma cells is evaluated.
- measure
- Percentage of Participants With BCL2 Status by Quantitative Polymerase Chain Reaction (qPCR) Analysis of Bone Marrow Plasma Cells
- timeFrame
- Up to approximately 2.5 months following last subject last visit
- description
- BCL2 status (BCL2 high or not) of the earliest MM sample collected, either at initial diagnosis or across lines of therapies, by qPCR analysis of bone marrow plasma cells is evaluated.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: \- Confirmed newly diagnosed or relapsed/refractory (R/R) Multiple myeloma (MM) who have signed informed consent for the use of their biological material for research purposes. Exclusion Criteria: \- Participants who do not have Bone Marrow (BM) and blood sample at time of diagnosis or at confirmation of relapse.
References
Publications (1)
- DERIVEDSpencer A, Gavriatopoulou M, Coriu D, Lysen A, Gutierrez NC, Escalante F, Eugenia Fantl DB, Hajek R, Seguro F, Kaur G, Bittencourt R, Kinda SB, Chu MP, Safah H, Martinez-Lopez J, de Queiroz Crusoe E, Cordeiro de Farias DL, Offidani M, Askari E, Sevindik OG, Maisnar V, Teng CL, Hughes O, Taylor R, Lehn K, Feng D, Thiebaut-Millot R, Li X, Murray L, Jung P, Rossi EL, Kongpachith S, Nichol A, Ross JA, Hader C. Prospective real-world evaluation of t(11;14) prevalence and disease biology in multiple myeloma: MEDICI study analysis. Blood Adv. 2025 Nov 25;9(22):5814-5827. doi: 10.1182/bloodadvances.2025017214. PMID 40829119