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.