Prospective real-world evaluation of t(11;14) prevalence and disease biology in multiple myeloma: MEDICI study analysis

Genetic abnormalities in multiple myeloma (MM) influence treatment outcomes and may inform therapeutic decisions. The most common chromosomal translocation in MM is t(11;14); however, its role in disease progression is not well defined. We report results from MEDICI, a global, minimally invasive, prospective study evaluating t(11;14) status in newly diagnosed MM (NDMM) and relapsed/refractory MM (RRMM). MEDICI enrolled adult patients (≥18 years) with MM with bone marrow (BM) aspirates collected at diagnosis and/or disease relapse. The primary objective was to determine t(11;14) prevalence in patient BM samples using fluorescent in situ hybridization (FISH) with plasma cell enrichment. Samples from 525 patients (NDMM, n = 306; RRMM, n = 219) were analyzed for t(11;14), with 498 patients (95%) having successful BM FISH test. Prevalence of t(11;14) was 22.1% (110/498 patients; 95% confidence interval [CI], 18.5-26.0) in the overall patient population, 18.8% (56/298 patients; 95% CI, 14.5-23.7) in NDMM, and 27.0% (54/200 patients; 95% CI, 21.0-33.7) in RRMM. Patients with t(11;14)-positive MM were evenly distributed across disease stages (stage I, 24.1%; stage II, 20%; stage III, 21.3%); however, higher rates were observed in African American patients (RRMM odds ratio [OR], 7.27, 95% CI, 1.33-39.83; P = .022) and light-chain only disease (NDMM OR, 3.02, 95% CI, 1.33-6.87; P = .008). Chromosome 1q abnormalities occurred more often in the absence of t(11;14); however, higher frequency of mutation in the plasma cell differentiation regulator IRF4 was detected in t(11;14) presence. In conclusion, the results from MEDICI demonstrated reproducible t(11;14) detection with a real-world prevalence of 22.1% in MM. This trial was registered at www.ClinicalTrials.gov as #NCT04721002.

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Journal
Blood Advances
Published
2025-08-19
DOI
https://doi.org/10.1182/bloodadvances.2025017214
Primary Topic
Multiple Myeloma Research and Treatments
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article
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article

Prospective real-world evaluation of t(11;14) prevalence and disease biology in multiple myeloma: MEDICI study analysis

Andrew Spencer, Danielle Leão Cordeiro de Farias, Olivia Hughes, Carlos Hader et al.
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Blood Advances
Multiple Myeloma Research and Treatments
article

Prospective real-world evaluation of t(11;14) prevalence and disease biology in multiple myeloma: MEDICI study analysis

Andrew Spencer, Danielle Leão Cordeiro de Farias, Olivia Hughes, Carlos Hader, Dorotea Fantl, Sarah Kongpachith, Anna Lysén, Joaquín Martínez‐López, Fernando Escalante, Norma Carmen Gutierrez, Kristin Lehn, Rosane Bittencourt, Raphaële Thiébaut-Millot, Rebekah T. Taylor, Emily L. Rossi, Gurbakhash Kaur, Jeremy A. Ross, Ömür Gökmen Sevindik, Daniel Coriu, Paul Jung, Michael P. Chu, Sandra Bašić‐Kinda, Edvan de Queiroz Crusoé, Fernanda Salles Seguro, Chieh‐Lin Jerry Teng, Vladimír Maisnar, Massimo Offidani, Feng Dai, Maria Gavriatopoulou, Lauren Murray, Roman Hájek, Xiaotong Li, Elham Askari, Alexander Nichol, Hana Safah
article en

Abstract

Genetic abnormalities in multiple myeloma (MM) influence treatment outcomes and may inform therapeutic decisions. The most common chromosomal translocation in MM is t(11;14); however, its role in disease progression is not well defined. We report results from MEDICI, a global, minimally invasive, prospective study evaluating t(11;14) status in newly diagnosed MM (NDMM) and relapsed/refractory MM (RRMM). MEDICI enrolled adult patients (≥18 years) with MM with bone marrow (BM) aspirates collected at diagnosis and/or disease relapse. The primary objective was to determine t(11;14) prevalence in patient BM samples using fluorescent in situ hybridization (FISH) with plasma cell enrichment. Samples from 525 patients (NDMM, n = 306; RRMM, n = 219) were analyzed for t(11;14), with 498 patients (95%) having successful BM FISH test. Prevalence of t(11;14) was 22.1% (110/498 patients; 95% confidence interval [CI], 18.5-26.0) in the overall patient population, 18.8% (56/298 patients; 95% CI, 14.5-23.7) in NDMM, and 27.0% (54/200 patients; 95% CI, 21.0-33.7) in RRMM. Patients with t(11;14)-positive MM were evenly distributed across disease stages (stage I, 24.1%; stage II, 20%; stage III, 21.3%); however, higher rates were observed in African American patients (RRMM odds ratio [OR], 7.27, 95% CI, 1.33-39.83; P = .022) and light-chain only disease (NDMM OR, 3.02, 95% CI, 1.33-6.87; P = .008). Chromosome 1q abnormalities occurred more often in the absence of t(11;14); however, higher frequency of mutation in the plasma cell differentiation regulator IRF4 was detected in t(11;14) presence. In conclusion, the results from MEDICI demonstrated reproducible t(11;14) detection with a real-world prevalence of 22.1% in MM. This trial was registered at www.ClinicalTrials.gov as #NCT04721002.

Blood AdvancesVol. 9(22)
Ontario Institute for Cancer Research (CA), Tulane University (US), Marche Polytechnic University (IT), Oslo University Hospital (NO), University Hospital Centre Zagreb (HR), Carol Davila University of Medicine and Pharmacy (RO), University of Ostrava (CZ), National and Kapodistrian University of Athens (GR), Charles University (CZ), Tulane Medical Center (US), Hospital Italiano de Buenos Aires (AR), AbbVie (United States) (US), Istanbul Medipol University (TR), University Hospital Ostrava (CZ), Instituto do Câncer do Estado de São Paulo (BR), Taichung Veterans General Hospital (TW), Southwestern Medical Center (US), Hospital de Clínicas de Porto Alegre (BR), Hospital Universitario 12 De Octubre (ES), Bağcılar Eğitim ve Araştırma Hastanesi (TR), Alexandra Hospital (GR), Beneficência Portuguesa de São Paulo (BR), Alberta Cancer Foundation (CA), Hospital São Rafael (BR), Hospital Universitario Fundación Jiménez Díaz (ES), Instituto de Investigación Biomédica de Salamanca (ES), University Hospital Hradec Králové (CZ), Centro de Investigación del Cáncer (ES), Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (BR), Centro de Investigación Biomédica en Red de Cáncer (ES), Institutul Clinic Fundeni (RO), Alfred Health (AU), Tanabe Research Laboratories (US), Complejo Asistencial Universitario de Palencia (ES), Monash University (AU), Montgomery County Community College (US), The University of Texas Southwestern Medical Center (US)
Amgen, Bristol-Myers Squibb, Pfizer, Sanofi, Celgene, BeiGene, International Myeloma Society, Astellas Pharma
Life below water
Openalex Percentile: Top 74%
Multiple Myeloma Research and Treatments
DOIOpen Access PDFOpenAlex
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