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Daratumumab-Based Regimen for Lenalidomide-Refractory Myeloma: An Italian Perspective

By: Amanda E. Ruffino, BA
Posted: Wednesday, December 6, 2023

Addressing the persistent challenge of lenalidomide-refractory multiple myeloma, Renato Zambello, MD, of Padua University School of Medicine, Italy, and colleagues investigated the efficacy and safety of the monoclonal antibody daratumumab-based combination regimen including bortezomib and dexamethasone (D-VD) exclusively in a cohort of patients who were exposed to lenalidomide or who had refractory multiple myeloma. They reported that lenalidomide exposure correlated with improved progression-free survival, positioning D-VD as a potential standard of care for lenalidomide-refractory multiple myeloma.

The study cohort comprised 57 patients with relapsed or refractory multiple myeloma, all of whom had prior exposure to lenalidomide; 77.2% were refractory to the drug. The outcomes were evaluated in terms of overall response rate, very good partial response rate, safety profile, and progression-free survival. Factors such as age, International Staging System, lactate dehydrogenase (LDH) levels, type of relapse, and high-risk fluorescence in situ hybridization (FISH) were analyzed to discern potential variations in progression-free survival.

The findings demonstrated efficacy of the D-VD combination in this patient population, with an overall response rate of 79.6% and a very good partial response rate of 43%. The safety profile was marked by a low incidence of grade 3 or 4 adverse events, except for thrombocytopenia in 21.4%. The median progression-free survival was 17 months, and no significant differences were observed in progression-free survival concerning age, International Staging System, LDH levels, type of relapse, or high-risk FISH. Of note, lenalidomide-exposed patients seemed to have a progression-free survival advantage over lenalidomide-refractory patients.

The real-world data from this study suggest the D-VD combination to be an effective and well-tolerated option for patients with lenalidomide-refractory multiple myeloma. Lenalidomide exposure seemed to correlate with improved progression-free survival, according to the study findings.

Disclosure: For the study authors’ full disclosures, visit

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