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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 II: Methodological and clinical recommendations for the diagnosis and follow-up of monoclonal gammopathies

  • María C. Cárdenas ORCID logo EMAIL logo , Ramón García-Sanz , Noemí Puig , David Pérez-Surribas , Juan Flores-Montero , María Ortiz-Espejo , Javier De la Rubia and Elena Cruz-Iglesias


Monoclonal gammopathies (MG) are a group of clinical entities characterized by the clonal expansion of monoclonal immunoglobulin (M-protein) secreting plasma cells (PC). This document presents the consensus recommendations of the Spanish Society of Laboratory Medicine (SEQCML) and the Spanish Society of Hematology and Hemotherapy (SEHH) for the study of MG. The recommendations were established based on scientific evidence and the opinion of experts in MG from the clinical laboratory and clinical hematology fields. Recommendations are proposed for the diagnosis of MG and for patient follow-up according to the type of MG and whether or not the patient is undergoing treatment, and to monitor the disease stability, response to therapy and disease progression. With respect to the diagnosis, we describe the most recent criteria and classification established by the International Myeloma Working Group (IMWG) for multiple myeloma (MM), smoldering MM, monoclonal gammopathy of undermined significance (MGUS) and other related entities. Indications are given about the analytical requirements and application of the different serum and urine laboratory tests (study, detection, identification and measurement of M-protein) and the bone marrow study. Recommendations on the clinical laboratory results report model are established to harmonize and ensure that all relevant information is available, including its content, expression, and interpretive comments.

Corresponding author: María C. Cárdenas, PhD, Department of Clinical Analysis, Institute of Laboratory Medicine, IdSSC, Hospital Clinico San Carlos, Madrid, Spain; and Protein Commission, Spanish Society of Laboratory Medicine (SEQCML), Barcelona, Spain, E-mail:

  1. Research ethics: Not applicable.

  2. Informed consent: Not applicable.

  3. Author contributions: The authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  4. Competing interests: María C Cárdenas, Noemí Puig, David Pérez-Surribas, Juan Flores-Montero, María Ortiz-Espejo and Elena Cruz-Iglesias state no conflict of interest. Ramón García-Sanz states: Honoraria: Amgen, Millennium/Takeda, Janssen, Incyte, Astellas, BeiGene, AstraZeneca, Pfizer. Research funding: Novartis, Gilead, Astellas, Janssen. Advisory boards: Amgen, Pharmacyclics, Millennium/Takeda. Research support/PI: Spanish National Health System, Regional Health System (Castilla y León), Spanish Association Against Cancer. Ex-president: Spanish Society of Hematology and Hemotherapy. Employee: Spanish National Health System. Javier De la Rubia states: Honoraria: Takeda, Janssen, BMS, Pfizer, GSK, Oncopeptide, Sanofi. Research funding: Takeda. Advisory boards: Amgen, Janssen, Sanofi, GSK. Employee: Spanish National Health System.

  5. Research funding: None declared.


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Supplementary Material

This article contains supplementary material (

Received: 2023-03-30
Accepted: 2023-05-29
Published Online: 2023-07-04
Published in Print: 2023-11-27

© 2023 Walter de Gruyter GmbH, Berlin/Boston

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