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Bending the Curve Trial by Trial
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DREAMM-8

Belantamab Mafodotin, Pomalidomide, and Dexamethasone in Multiple Myeloma (DREAMM-8)

Phase 3N = 302NCT04484623

Population
Lenalidomide-exposed relapsed or refractory multiple myeloma after at least one line of therapy.
Design
Phase 3, randomized, open-label trial of belantamab mafodotin, pomalidomide and dexamethasone (BPd) versus pomalidomide, bortezomib and dexamethasone (PVd) in lenalidomide-exposed patients with relapsed or refractory myeloma after at least one line of therapy. The primary end point was progression-free survival.
Primary endpoint
PFS
Arms
  • Belantamab mafodotin + Pd (experimental, n = 155): Belantamab mafodotin with pomalidomide and dexamethasone
  • PVd (control, n = 147): Pomalidomide, bortezomib and dexamethasone
People
Dimopoulos MA
PFSHR 0.52 (95% CI 0.37–0.73)Δ 12-month PFS+20 pointsΔ ORR+5 pointsΔ ≥CR rate+24 points
Show the numbers
Results reported for DREAMM-8
EndpointAnalysisBelantamab mafodotin + PdPVdEffect
PFSRandomised patients (302)primarymedian follow-up 21.8 monthsDimopoulos 202471% at 12 mo (63–78%)51% at 12 mo (42–60%)HR 0.52 (95% CI 0.37–0.73)P<0.001Grade 3 or higher adverse events occurred in 94% with BPd and 76% with PVd. Ocular events occurred in 89% with BPd (grade 3 or 4 in 43%) and 30% with PVd (2%); they led to discontinuation in 9% with BPd and no patients with PVd. Overall survival data were immature.
ORRRandomised patients (302)primaryDimopoulos 202477% (70–84%)72% (64–79%)—
≥CR rateRandomised patients (302)primaryDimopoulos 202440% (32–48%)16% (11–23%)—
Results reported for DREAMM-8
EndpointAnalysisBelantamab mafodotin + PdPVdEffect
PFSRandomised patients (302)primarymedian follow-up 21.8 monthsDimopoulos 202471% at 12 mo (63–78%)51% at 12 mo (42–60%)HR 0.52 (95% CI 0.37–0.73)P<0.001Grade 3 or higher adverse events occurred in 94% with BPd and 76% with PVd. Ocular events occurred in 89% with BPd (grade 3 or 4 in 43%) and 30% with PVd (2%); they led to discontinuation in 9% with BPd and no patients with PVd. Overall survival data were immature.
ORRRandomised patients (302)primaryDimopoulos 202477% (70–84%)72% (64–79%)—
≥CR rateRandomised patients (302)primaryDimopoulos 202440% (32–48%)16% (11–23%)—
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.520.37–0.73
Primary publication: Dimopoulos MA, Beksac M, Pour L, Delimpasi S, Vorobyev V, Quach H, et al. Belantamab Mafodotin, Pomalidomide, and Dexamethasone in Multiple Myeloma. N Engl J Med. 2024;391(5):408-421. PubMedDOI

Appears in

Sources

  1. Dimopoulos MA, Beksac M, Pour L, Delimpasi S, Vorobyev V, Quach H, et al. Belantamab Mafodotin, Pomalidomide, and Dexamethasone in Multiple Myeloma. N Engl J Med. 2024;391(5):408-421.

    PubMedDOI