Efficacy and safety of reduced-dose daratumumab plus bortezomib and dexamethasone (DVd-lite) in newly diagnosed MGRS patients.

Background: Clone-directed therapy is essential for managing monoclonal gammopathy of renal significance (MGRS), as it reduces the nephrotoxic monoclonal protein burden and preserves renal function. However, due to the rarity and frequent misdiagnosis of MGRS, there is no evidence-based standard first-line treatment for MGRS. Methods: This open-label, single-arm, prospective clinical trial assessed the efficacy and safety of the combination of reduced-dose daratumumab (Dara), bortezomib, and dexamethasone (DVd-lite) in ten newly diagnosed MGRS patients. The treatment protocol consisted of six cycles of the DVd-lite regimen, which included Dara (8-10 mg/kg biweekly), bortezomib (1.3 mg/m Results: The median follow-up duration of this cohort was 13.1 months (range: 4.7-17.6 months). The results showed a hematological overall response rate (ORR) of 80% and a kidney ORR of 90%. Moreover, the complete response rates in hematology and kidney were both 60%. In addition, only one patient experienced a grade 3 treatment-related adverse event. Conclusions: These findings demonstrated that the DVd-lite regimen is an effective and well-tolerated first-line treatment option for newly diagnosed MGRS patients. Clinical Trial Registration: https://www.chictr.org.cn/, identifier ChiCTR2400081273.