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Bending the Curve Trial by Trial
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DREAMM-7

Belantamab Mafodotin, Bortezomib, and Dexamethasone for Multiple Myeloma (DREAMM-7)

Phase 3N = 494NCT04246047

Population
Multiple myeloma with progression after at least one line of therapy.
Design
Phase 3, open-label, randomized trial of belantamab mafodotin, bortezomib and dexamethasone (BVd) versus daratumumab, bortezomib and dexamethasone (DVd) in patients with progression after at least one line of therapy. The primary end point was progression-free survival; key secondary end points were overall survival, response duration and MRD-negative status.
Primary endpoint
PFS
Arms
  • Belantamab mafodotin + Vd (experimental, n = 243): Belantamab mafodotin with bortezomib and dexamethasone
  • Daratumumab + Vd (control, n = 251): Daratumumab with bortezomib and dexamethasone
People
Hungria V
PFSHR 0.41 (95% CI 0.31–0.53)Δ median PFS+23.2 monthsΔ 18-month OS+11 pointsΔ MRD+15 points
Show the numbers
Results reported for DREAMM-7
EndpointAnalysisBelantamab mafodotin + VdDaratumumab + VdEffect
PFSRandomised patients (494)primarymedian follow-up 28.2 monthsHungria 2024median 36.6 monthsmedian 13.4 months (11.1–17.5)HR 0.41 (95% CI 0.31–0.53)P<0.001The 95% CI of the BVd median is 28.4 months to not reached (lower bound only). Grade 3 or higher adverse events occurred in 95% with BVd and 78% with DVd; ocular events in 79% and 29%.
OSRandomised patients (494)primaryHungria 202484% at 18 mo73% at 18 moKey secondary end point; no hazard ratio or p value in the abstract.
MRDRandomised patients (494)primaryHungria 202425%10%Complete response or better plus MRD-negative status.
Results reported for DREAMM-7
EndpointAnalysisBelantamab mafodotin + VdDaratumumab + VdEffect
PFSRandomised patients (494)primarymedian follow-up 28.2 monthsHungria 2024median 36.6 monthsmedian 13.4 months (11.1–17.5)HR 0.41 (95% CI 0.31–0.53)P<0.001The 95% CI of the BVd median is 28.4 months to not reached (lower bound only). Grade 3 or higher adverse events occurred in 95% with BVd and 78% with DVd; ocular events in 79% and 29%.
OSRandomised patients (494)primaryHungria 202484% at 18 mo73% at 18 moKey secondary end point; no hazard ratio or p value in the abstract.
MRDRandomised patients (494)primaryHungria 202425%10%Complete response or better plus MRD-negative status.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.410.31–0.53
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%020406080Months (modelled)
  • Belantamab mafodotin + Vd (experimental)
  • Daratumumab + Vd (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsBelantamab mafodotin + VdDaratumumab + Vd
0100.0%100.0%
2364.7%30.4%
4641.8%9.3%
6927.1%2.8%
9217.5%0.9%
Primary publication: Hungria V, Robak P, Hus M, Zherebtsova V, Ward C, Ho PJ, et al. Belantamab Mafodotin, Bortezomib, and Dexamethasone for Multiple Myeloma. N Engl J Med. 2024;391(5):393-407. PubMedDOI

Appears in

Sources

  1. Hungria V, Robak P, Hus M, Zherebtsova V, Ward C, Ho PJ, et al. Belantamab Mafodotin, Bortezomib, and Dexamethasone for Multiple Myeloma. N Engl J Med. 2024;391(5):393-407.

    PubMedDOI