Recommendations for the study of monoclonal gammopathies in the clinical laboratory. A consensus of the Spanish society of laboratory medicine and the Spanish society of hematology and hemotherapy. Part III: clinical and analytical recommendations for the study of monoclonal gammopathies by MALDI-TOF mass spectrometry
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Cristina Agulló
,
Noemí Puig
,
Nerea Varo
,
María Ortiz-Espejo
Abstract
Monoclonal gammopathies (MGs) represent a diverse group of plasma cell disorders that range from asymptomatic premalignant conditions to aggressive malignancies such as multiple myeloma (MM). Mass spectrometry (MS) based serum analysis offers a non-invasive, highly sensitive alternative to conventional techniques for identifying and quantifying M-proteins. It enables more precise assessment of treatment response and residual disease, particularly in patients with suspected complete response (CR), those not eligible for bone marrow procedures, or those treated with monoclonal antibodies that may interfere with standard assays. This guideline document, endorsed by the Spanish Society of Laboratory Medicine (SEMEDLAB) and the Spanish Society of Hematology (SEHH), provides comprehensive recommendations for the clinical and analytical application of MS in the detection and monitoring of M-proteins in patients with MGs. The document outlines optimal use of MS at diagnosis, during follow-up, and in reporting practices, with a focus on standardized implementation, interpretative criteria, and clinical decision-making support.
Acknowledgments
We thank the Leukemia & Lymphoma Society for its support in the development of these guidelines. The authors also thank Nuno Barbosa and Andrea Diaz for their valuable contributions and support in the coordination of the project.
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Research ethics: Not applicable.
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Informed consent: Not applicable.
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Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
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Use of Large Language Models, AI and Machine Learning Tools: None declared.
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Conflict of interest: C.A. has has received honoraria from The Binding Site as speaker. N.P. has received honoraria from Amgen, Celgene, Janssen, Takeda, and The Binding Site; has served in a consulting or advisory role for Amgen, Celgene, Janssen, and Takeda; has served on a speakers’ bureau for Celgene; has received research funding from Celgene, Janssen, Amgen, and Takeda; and has received travel, accommodations, and expenses from Amgen, Celgene, Janssen, and Takeda. B.P. has received consultancy, honoraria, research funding, and speaker’s bureau for Amgen, Bristol Myers Squibb, Celgene, Janssen, Novartis, Roche, and Sanofi; has received unrestricted grants from Celgene, EngMab, and Takeda; and has served in a consultancy for Celgene, Janssen, and Sanofi. J.M.-L. has served in a consultancy and speaker’s bureau and received honoraria and research funding for Amgen, Astellas, Bristol Myers Squibb, Janssen, Novartis, Roche, and Sanofi; and has received unrestricted grants from Bristol Myers Squibb. RG-S. declares honoraria from Janssen, Takeda, and Amgen, a consulting or advisory role for Janssen, research funding from Gilead (Inst) and Incyte (Inst), patents, royalties, other intellectual property for BIOMED 2 primers (Inst), and travel expenses from Janssen and Takeda (I). JdlR. declares consultancy for Amgen, Celgene, Takeda, Janssen, and AbbVie. J.F.S.-M. has served in a consultancy or advisory role for AbbVie, Amgen, Bristol Myers Squibb, Celgene, GSK, Janssen, Karyopharm, MSD, Novartis, Roche, Sanofi, SecuraBio, and Takeda. M.-V.M. has received honoraria and membership on an entity’s Board of Directors or advisory committees for Janssen, Celgene, Takeda, Amgen, Adaptive, GSK, Sanofi, and Oncopeptides; and has received honoraria from membership in Board of Directors or advisory committees for AbbVie, Roche, Pfizer, Regeneron, and Seattle Genetics. The remaining authors declared no competing financial interests. All other authors have no conflicts of interest to disclose.
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Research funding: C. Agulló was supported by the Leukemia and Lymphoma Society (grant 6660-23).
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Data availability: Not applicable.
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