- Design
- Open-label, randomised (2:1), phase 2 trial
- Population
- 82 patients with newly diagnosed myeloma and CrCl 15–59 mL/min
- Primary outcome
- ≥VGPR after 4 induction cycles
- Effect
- 72.4% vs 20.8%; renal response 75.9% vs 45.8%
The open-label phase 2 POM-MM-003 trial (Med, 9 September) randomised 82 patients with newly diagnosed myeloma and creatinine clearance of 15 to 59 mL/min at eight Chinese centres, 2:1, to pomalidomide–bortezomib–dexamethasone or bortezomib–dexamethasone.
After four induction cycles, very good partial response or better was 72% against 21%, and renal response 76% against 46%. Grade 3–4 treatment-related adverse events were 41% against 29%, with one death from treatment-related ileus. Survival data are immature.
Renal recovery in myeloma depends on rapid reduction of light chains, so a deeper early response matters to nephrologists. The trial is small and open-label; quadruplet regimens with anti-CD38 antibodies are the comparator most centres would now consider.
- Adding pomalidomide tripled the rate of very good partial response or better
- Renal response rose from 46% to 76%
- Grade 3–4 toxicity was more frequent with the triplet
- Work with haematology early: rapid light-chain reduction drives kidney recovery
Why it matters
Kidney outcome in myeloma is set in the first weeks of treatment.
Don't overread it
Small, open-label phase 2 with surrogate endpoints and immature survival data.
The statistics, in plain English
With only 24 patients in the control arm, its response rate (21%, 95% CI 7% to 42%) is imprecise, though the difference from 72% is large enough to be clear.
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