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ALCYONE

Daratumumab plus Bortezomib, Melphalan, and Prednisone for Untreated Myeloma (ALCYONE)

Phase 3N = 706NCT02195479

Population
Newly diagnosed multiple myeloma, ineligible for autologous stem-cell transplantation.
Design
Phase 3 trial: 706 patients with newly diagnosed myeloma ineligible for stem-cell transplantation were randomly assigned to nine cycles of bortezomib, melphalan and prednisone alone (control) or with daratumumab until disease progression. The primary end point was progression-free survival; results are from a prespecified interim analysis.
Primary endpoint
PFS
Arms
  • Daratumumab + VMP (experimental): Daratumumab with bortezomib, melphalan and prednisone (nine cycles), daratumumab continued until progression
  • VMP (control): Bortezomib, melphalan and prednisone, nine cycles
People
Mateos MV
PFSHR 0.50 (95% CI 0.38–0.65)Δ 18-month PFS+21.4 pointsΔ ORR+17 pointsΔ ≥CR rate+18.2 pointsΔ MRD+16.1 points
Show the numbers
Results reported for ALCYONE
EndpointAnalysisDaratumumab + VMPVMPEffect
PFSRandomised patients (706)interimmedian follow-up 16.5 monthsMateos 201871.6% at 18 mo (65.5–76.8%)50.2% at 18 mo (43.2–56.7%)HR 0.50 (95% CI 0.38–0.65)P<0.001Grade 3 or 4 infections 23.1% versus 14.7%; treatment discontinuation due to infections 0.9% versus 1.4%; daratumumab-associated infusion-related reactions 27.7%.
ORRRandomised patients (706)interimMateos 201890.9%73.9%P<0.001
≥CR rateRandomised patients (706)interimMateos 201842.6%24.4%P<0.001
MRDRandomised patients (706)interimMateos 201822.3%6.2%P<0.001
Results reported for ALCYONE
EndpointAnalysisDaratumumab + VMPVMPEffect
PFSRandomised patients (706)interimmedian follow-up 16.5 monthsMateos 201871.6% at 18 mo (65.5–76.8%)50.2% at 18 mo (43.2–56.7%)HR 0.50 (95% CI 0.38–0.65)P<0.001Grade 3 or 4 infections 23.1% versus 14.7%; treatment discontinuation due to infections 0.9% versus 1.4%; daratumumab-associated infusion-related reactions 27.7%.
ORRRandomised patients (706)interimMateos 201890.9%73.9%P<0.001
≥CR rateRandomised patients (706)interimMateos 201842.6%24.4%P<0.001
MRDRandomised patients (706)interimMateos 201822.3%6.2%P<0.001
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.50.38–0.65
Primary publication: Mateos MV, Dimopoulos MA, Cavo M, Suzuki K, Jakubowiak A, Knop S, et al. Daratumumab plus Bortezomib, Melphalan, and Prednisone for Untreated Myeloma. N Engl J Med. 2018;378(6):518-528. PubMedDOI

Appears in

Sources

  1. Mateos MV, Dimopoulos MA, Cavo M, Suzuki K, Jakubowiak A, Knop S, et al. Daratumumab plus Bortezomib, Melphalan, and Prednisone for Untreated Myeloma. N Engl J Med. 2018;378(6):518-528.

    PubMedDOI