New guidelines for the treatment and the management of myeloma and smouldering myeloma
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On July 7th, 2025, new clinical management guidelines for myeloma and smouldering myeloma were published in Nature Reviews Clinical Oncology by myeloma experts. These guidelines are written to guide doctors and healthcare professionals in myeloma and smouldering myeloma diagnosis, treatment and follow-up, based on the most up-to-date scientific knowledge. The last treatment guidelines were published in 2021 by two scientific societies: the European Hematology Association (EHA) and the European Society For Medical Oncology (ESMO). The new guidelines are developed by EHA and the European Myeloma Network (EMN).
They provide guidance for the use of established treatments as well as newly approved immunotherapies, and recommendations for complications and adverse events, such as bone disease, renal impairment and infections, cytokine-release syndrome and immune effector cell-associated neurotoxicity syndrome.
Lead author of the guidelines, Dr. Meletios Dimopoulos, who is Professor and Chairman of the Department of Clinical Therapeutics at the National and Kapodistrian University of Athens School of Medicine, in Greece, stated:
“These updated recommendations will provide an opportunity for myeloma patients in Europe to receive the best available treatment and will harmonise treatment practices along all European countries.”
What do the recommendations include?
- 14 new treatment regimens that have been approved by the EMA (European medicines agency) and/or the FDA (Food and drug administration, USA), including newly approved medicines.
- Newly diagnosed myeloma patients: recommendations for treatment depend on whether patients are eligible for autologous stem cell transplant or not. Regardless of this, patients are now recommended to have an anti-CD38 monoclonal antibody medication, such as daratumumab or isatuximab, in combination with other therapies as first-line treatment.
- Myeloma patients after first relapse: recommendations for treatment depend on what medications patients develop resistance to, or do not work for the patient, especially to anti-CD38 monoclonal antibodies, lenalidomide (an immunomodulatory medication) or bortezomib (a proteosome inhibitor). Medications that can be considered at second line (amongst other options) now include: a CAR T-cell therapy, ciltacabtagene autoleucel, and a treatment combination with belantamab mafodotin.
- Myeloma patients after second or subsequent relapse: depending on prior treatments, medications and therapies that can be considered (amongst other options) now include:
o CAR T-cell therapies such as ciltacabtagene autoleucel or idecabtagene vicleucel
o Bispecific antibodies such as teclistamab, elranatamab, linvoseltamab and talquetamab
o A belantamab mafodotin treatment combination
o Melphalan flufenamide, a peptide drug conjugate derived from the chemotherapeutic agent melphalan
“These treatment guidelines can be implemented now because our recommendations are based on approved regimens from EMA or regimens that are very likely to be approved by the end of the year. We believe that the EHA/EMN recommendations may help the reimbursement process of the best available treatment for myeloma patients throughout the European countries.”