An Italian Delphi consensus on the current and future burden and clinical management of lenalidomide-refractory multiple myeloma

BACKGROUND: Refractoriness to lenalidomide in patients treated for multiple myeloma (MM) is increasing. Exploring opinions of experts on the burden of lenalidomide-refractory MM and on current and future therapeutic options is critical for optimizing care in this setting. METHODS: From January to July 2024, we conducted a modified Delphi study involving 12 haematologists in Italy. The project followed the best practices for Delphi studies, including anonymity, iteration, controlled feedback, definition and analysis of consensus. RESULTS: Two rounds were required to complete the Delphi process. Participation of clinicians was complete. Experts agreed that more than 80% of Italian patients starting second-line therapy are expected to be refractory to lenalidomide in 2026. Full consensus emerged (100% of panellists) that the main clinical unmet needs in this patient setting are the approval and access to novel (immuno)therapies with new mechanisms of action. More than two-thirds of panellists also agreed, in principle, to the use of T-cell redirecting therapies, including CAR-T and bispecific antibodies, from the second-line of treatment onwards. No clear patient characteristics emerged to drive therapeutic options in specific subgroups of subjects with lenalidomide-refractory MM. CONCLUSIONS: This Delphi consensus study reported a major clinical unmet need of newly available and accessible therapeutic options for lenalidomide-refractory MM, already starting from the second-line of treatment.