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PERSEUS

Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone for Multiple Myeloma (PERSEUS)

Phase 3N = 709NCT03710603

Population
Transplant-eligible newly diagnosed multiple myeloma.
Design
Phase 3 trial: 709 transplantation-eligible patients were randomly assigned to subcutaneous daratumumab with VRd induction and consolidation and lenalidomide maintenance, or to VRd and lenalidomide maintenance alone. The primary end point was progression-free survival; key secondary end points were complete response or better and MRD-negative status.
Primary endpoint
PFS
Arms
  • Daratumumab + VRd (experimental): Subcutaneous daratumumab with VRd induction and consolidation and lenalidomide maintenance
  • VRd (control): VRd induction and consolidation and lenalidomide maintenance
People
Sonneveld P, PERSEUS Trial Investigators
PFSHR 0.42 (95% CI 0.30–0.59)Δ 48-month PFS+16.6 pointsΔ ≥CR rate+17.8 pointsΔ MRD+27.7 points
Show the numbers
Results reported for PERSEUS
EndpointAnalysisDaratumumab + VRdVRdEffect
PFSRandomised patients (709)interimmedian follow-up 47.5 monthsSonneveld 202484.3% at 4 y67.7% at 4 yHR 0.42 (95% CI 0.30–0.59)P<0.001The P value crossed the prespecified stopping boundary (P = 0.0126); the abstract does not use the word interim. Death occurred in 34 patients with D-VRd and 44 with VRd. Grade 3 or 4 neutropenia 62.1% versus 51.0%; thrombocytopenia 29.1% versus 17.3%; serious adverse events 57.0% versus 49.3%.
≥CR rateRandomised patients (709)interimmedian follow-up 47.5 monthsSonneveld 202487.9%70.1%P<0.001
MRDRandomised patients (709)interimmedian follow-up 47.5 monthsSonneveld 202475.2%47.5%P<0.001
Results reported for PERSEUS
EndpointAnalysisDaratumumab + VRdVRdEffect
PFSRandomised patients (709)interimmedian follow-up 47.5 monthsSonneveld 202484.3% at 4 y67.7% at 4 yHR 0.42 (95% CI 0.30–0.59)P<0.001The P value crossed the prespecified stopping boundary (P = 0.0126); the abstract does not use the word interim. Death occurred in 34 patients with D-VRd and 44 with VRd. Grade 3 or 4 neutropenia 62.1% versus 51.0%; thrombocytopenia 29.1% versus 17.3%; serious adverse events 57.0% versus 49.3%.
≥CR rateRandomised patients (709)interimmedian follow-up 47.5 monthsSonneveld 202487.9%70.1%P<0.001
MRDRandomised patients (709)interimmedian follow-up 47.5 monthsSonneveld 202475.2%47.5%P<0.001
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.420.3–0.59
Primary publication: Sonneveld P, Dimopoulos MA, Boccadoro M, Quach H, Ho PJ, Beksac M, et al. Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone for Multiple Myeloma. N Engl J Med. 2024;390(4):301-313. PubMedDOI

Appears in

Sources

  1. Sonneveld P, Dimopoulos MA, Boccadoro M, Quach H, Ho PJ, Beksac M, et al. Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone for Multiple Myeloma. N Engl J Med. 2024;390(4):301-313.

    PubMedDOI