Pomalidomide plus bortezomib and dexamethasone for newly diagnosed multiple myeloma with renal impairment: Randomized phase II study (POM-MM-003).

BACKGROUND: POM-MM-003 study compared pomalidomide-bortezomib-dexamethasone (PVd) with Vd in newly diagnosed multiple myeloma (NDMM) patients with RI. METHODS: POM-MM-003 was open-label, randomized, phase II study done at eight centers in China (ClinicalTrials.gov: NCT05432414). Patients with symptomatic NDMM with RI (creatinine clearance ≥15 to <60 mL/min) were randomly 2:1 to PVd and Vd groups for two 21-day induction cycles, followed by additional 2-cycle same treatment when achieving minor response. Primary endpoint was very good partial response or better (≥VGPR) after 4-cycle induction. FINDINGS: Between January 18, 2023 and December 2, 2024, 82 patients were randomized to PVd (n = 58) and Vd (n = 24) groups. After 4-cycle induction, PVd resulted in a significantly higher ≥ VGPR rate (72.4% [42/58; 95% CI: 59.1-83.3] vs. 20.8% [5/24; 95% CI: 7.1-42.2]; p < 0.001) and renal response rate (75.9% [44/58; 95% CI: 62.8-86.1] vs. 45.8% [11/24; 95% CI: 25.6-67.2]; p = 0.009) versus Vd after 4-cycle induction. Median progression-free survival (PFS) and overall survival (OS) in both groups were not reached. Grade 3-4 treatment-related adverse events (TRAEs) occurred in 41.4% (24/58) of patients with PVd and 29.2% (7/24) with Vd. Only one case in the PVd group died of treatment-related ileus. CONCLUSIONS: PVd may represent a potential treatment option for this patient population. FUNDING: This trial was sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (2021072900001) and was funded by the National Natural Science Foundation of China (no. 82370203), the Beijing Natural Science Foundation (no. 7264339), and the Peking University People's Hospital Scientific Research Development Funds (RDJP2025-06).