A reduced-frequency targeted combination regimen ( DVd-lite) for the treatment of newly diagnosed multiple myeloma with renal impairment: A single-center, open-label, prospective clinical study

Abstract Objective: This study aimed to evaluate the efficacy and safety of the reduced-frequency targeted combination regimen DVd-lite (daratumumab, bortezomib, and dexamethasone) in patients with newly diagnosed multiple myeloma (NDMM) and renal impairment. Method: In this single-center, open-label, prospective clinical study, 19 patients aged 48–78 years with NDMM and renal impairment were enrolled and treated with the DVd-lite regimen. The primary endpoints were hematologic and renal response rates, while secondary endpoints included adverse event profiles. This study was registered on the ChiCTR platform (No. ChiCTR2400081273). Result: Among the 18 evaluable patients, the median follow-up was 8.1 months (range: 1.2–17.1 months). The overall hematologic response rate (ORR) was 88.9%, including six patients with complete response (CR) or better, four with very good partial response (VGPR), and six with partial response (PR). The renal response rate was 66.7%, comprising six CRs, five PRs, and one minor response (MR). All patients experienced treatment-emergent adverse events (TEAEs), predominantly grade ≤2 infusion reactions (n=8). Other common TEAEs included constipation (n=4), thrombocytopenia (n=4), and peripheral neuropathy (n=4). Two cases of serious TEAEs (respiratory tract infections) were reported. Most TEAEs were manageable with dose adjustments and supportive care, with no treatment-related fatalities. Results: The DVd-lite regimen demonstrates favorable efficacy and safety in NDMM patients with renal impairment, supporting its potential as a therapeutic option for this high-risk population. Keywords: Daratumumab; Multiple myeloma; Kidney damage; Efficacy; Safety