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POLLUX

Daratumumab, Lenalidomide, and Dexamethasone for Multiple Myeloma (POLLUX)

Phase 3N = 569NCT02076009

Population
Multiple myeloma after one or more previous lines of therapy.
Design
Phase 3 trial: 569 patients who had received one or more previous lines of therapy were randomly assigned to lenalidomide and dexamethasone alone (control) or with daratumumab. The primary end point was progression-free survival; results are from a protocol-specified interim analysis.
Primary endpoint
PFS
Arms
  • Daratumumab + lenalidomide + dexamethasone (experimental, n = 286): Daratumumab with lenalidomide and dexamethasone
  • Lenalidomide + dexamethasone (control, n = 283): Lenalidomide and dexamethasone
People
Dimopoulos MA, POLLUX Investigators
PFSHR 0.37 (95% CI 0.27–0.52)Δ 12-month PFS+23.1 pointsΔ ORR+16.5 pointsΔ ≥CR rate+23.9 pointsΔ MRD+17.8 points
Show the numbers
Results reported for POLLUX
EndpointAnalysisDaratumumab + lenalidomide + dexamethasoneLenalidomide + dexamethasoneEffect
PFSRandomised patients (569)interimmedian follow-up 13.5 monthsDimopoulos 201683.2% at 12 mo (78.3–87.2%)60.1% at 12 mo (54.0–65.7%)HR 0.37 (95% CI 0.27–0.52)P<0.001169 events of progression or death: 53 of 286 patients (18.5%) with daratumumab and 116 of 283 (41.0%) with control. P value by stratified log-rank test. Grade 3 or 4 neutropenia 51.9% versus 37.0%; daratumumab-associated infusion-related reactions 47.7%.
ORRRandomised patients (569)interimDimopoulos 201692.9%76.4%P<0.001
≥CR rateRandomised patients (569)interimDimopoulos 201643.1%19.2%P<0.001
MRDRandomised patients (569)interimDimopoulos 201622.4%4.6%P<0.001MRD negativity at a threshold of 1 tumour cell per 10^5 white cells.
Results reported for POLLUX
EndpointAnalysisDaratumumab + lenalidomide + dexamethasoneLenalidomide + dexamethasoneEffect
PFSRandomised patients (569)interimmedian follow-up 13.5 monthsDimopoulos 201683.2% at 12 mo (78.3–87.2%)60.1% at 12 mo (54.0–65.7%)HR 0.37 (95% CI 0.27–0.52)P<0.001169 events of progression or death: 53 of 286 patients (18.5%) with daratumumab and 116 of 283 (41.0%) with control. P value by stratified log-rank test. Grade 3 or 4 neutropenia 51.9% versus 37.0%; daratumumab-associated infusion-related reactions 47.7%.
ORRRandomised patients (569)interimDimopoulos 201692.9%76.4%P<0.001
≥CR rateRandomised patients (569)interimDimopoulos 201643.1%19.2%P<0.001
MRDRandomised patients (569)interimDimopoulos 201622.4%4.6%P<0.001MRD negativity at a threshold of 1 tumour cell per 10^5 white cells.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.370.27–0.52
Primary publication: Dimopoulos MA, Oriol A, Nahi H, San-Miguel J, Bahlis NJ, Usmani SZ, et al. Daratumumab, Lenalidomide, and Dexamethasone for Multiple Myeloma. N Engl J Med. 2016;375(14):1319-1331. PubMedDOI

Appears in

Sources

  1. Dimopoulos MA, Oriol A, Nahi H, San-Miguel J, Bahlis NJ, Usmani SZ, et al. Daratumumab, Lenalidomide, and Dexamethasone for Multiple Myeloma. N Engl J Med. 2016;375(14):1319-1331.

    PubMedDOI