Pomalidomide plus bortezomib and dexamethasone for newly diagnosed multiple myeloma with renal impairment: Randomized phase II study (POM-MM-003).
Fei Xiao, Liru Wang, Fei Li et al.
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In 30 seconds
This open-label, multicenter, randomized phase II study compared pomalidomide, bortezomib, and dexamethasone (PVd) with bortezomib and dexamethasone (Vd) in 82 patients with newly diagnosed symptomatic multiple myeloma and creatinine clearance ≥15 to <60 mL/min. After four induction cycles, the rate of very good partial response or better was 72.4% with PVd versus 20.8% with Vd (p < 0.001). Renal response was also higher with PVd. Median progression-free and overall survival were not reached in either group; grade 3–4 treatment-related adverse events occurred in both arms.
Key findings
- After four induction cycles, ≥VGPR was achieved by 72.4% (42/58) with PVd versus 20.8% (5/24) with Vd (p < 0.001).
- Renal response rates were 75.9% (44/58) with PVd and 45.8% (11/24) with Vd (p = 0.009).
- Grade 3–4 treatment-related adverse events occurred in 41.4% (24/58) with PVd and 29.2% (7/24) with Vd.
- Median progression-free and overall survival were not reached in either group.
Why it matters
Renal impairment complicates treatment of newly diagnosed myeloma. In this randomized phase II comparison, adding pomalidomide to bortezomib and dexamethasone was associated with higher response and renal response rates over the induction period. These results provide comparative evidence for this population, while longer-term survival outcomes remain undetermined in the reported analysis.
What to keep in mind
The study was open-label and phase II, with 82 patients across eight centers; median progression-free and overall survival were not reached, limiting conclusions about longer-term outcomes.