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CASSIOPEIA

Bortezomib, thalidomide, and dexamethasone with or without daratumumab before and after autologous stem-cell transplantation for newly diagnosed multiple myeloma (CASSIOPEIA)

Phase 3N = 1,085NCT02541383

Population
Transplant-eligible newly diagnosed multiple myeloma.
Design
Two-part, randomised, open-label phase 3 study at 111 European sites: 1085 transplant-eligible patients were randomly assigned 1:1 to four pre-transplant induction and two post-transplant consolidation cycles of VTd alone or with daratumumab. The primary end point of part 1 was stringent complete response 100 days after transplantation; part 2 (maintenance) was ongoing.
Primary endpoint
sCR rate
Arms
  • Daratumumab + VTd (experimental, n = 543): Daratumumab with bortezomib, thalidomide and dexamethasone before and after autologous stem-cell transplantation
  • VTd (control, n = 542): Bortezomib, thalidomide and dexamethasone before and after autologous stem-cell transplantation
People
Moreau P
Δ sCR rate+9 pointsΔ ≥CR rate+13 pointsΔ MRD+20 pointsPFSHR 0.47 (95% CI 0.33–0.67)
Show the numbers
Results reported for CASSIOPEIA
EndpointAnalysisDaratumumab + VTdVTdEffect
sCR rateITT population (1085)primaryMoreau 201929%20%P=0.0010Assessed 100 days after transplantation. Odds ratio 1.60 (95% CI 1.21 to 2.12); 157 of 543 versus 110 of 542 patients.
≥CR rateRandomised patients (1085)primaryMoreau 201939%26%P<0.0001
MRDRandomised patients (1085)primaryMoreau 201964%44%P<0.0001
PFSRandomised patients (1085)interimMoreau 2019——HR 0.47 (95% CI 0.33–0.67)P<0.0001Reported with the part 1 analysis; part 2 was ongoing. The abstract does not use the word interim for this analysis. 46 deaths on study were observed (14 versus 32; 0.43, 95% CI 0.23 to 0.80, as printed in the abstract). Grade 3 or 4 neutropenia 28% versus 15%; lymphopenia 17% versus 10%; stomatitis 13% versus 16%.
Results reported for CASSIOPEIA
EndpointAnalysisDaratumumab + VTdVTdEffect
sCR rateITT population (1085)primaryMoreau 201929%20%P=0.0010Assessed 100 days after transplantation. Odds ratio 1.60 (95% CI 1.21 to 2.12); 157 of 543 versus 110 of 542 patients.
≥CR rateRandomised patients (1085)primaryMoreau 201939%26%P<0.0001
MRDRandomised patients (1085)primaryMoreau 201964%44%P<0.0001
PFSRandomised patients (1085)interimMoreau 2019——HR 0.47 (95% CI 0.33–0.67)P<0.0001Reported with the part 1 analysis; part 2 was ongoing. The abstract does not use the word interim for this analysis. 46 deaths on study were observed (14 versus 32; 0.43, 95% CI 0.23 to 0.80, as printed in the abstract). Grade 3 or 4 neutropenia 28% versus 15%; lymphopenia 17% versus 10%; stomatitis 13% versus 16%.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.470.33–0.67
Primary publication: Moreau P, Attal M, Hulin C, Arnulf B, Belhadj K, Benboubker L, et al. Bortezomib, thalidomide, and dexamethasone with or without daratumumab before and after autologous stem-cell transplantation for newly diagnosed multiple myeloma (CASSIOPEIA): a randomised, open-label, phase 3 study. Lancet. 2019;394(10192):29-38. PubMedDOI

Appears in

Sources

  1. Moreau P, Attal M, Hulin C, Arnulf B, Belhadj K, Benboubker L, et al. Bortezomib, thalidomide, and dexamethasone with or without daratumumab before and after autologous stem-cell transplantation for newly diagnosed multiple myeloma (CASSIOPEIA): a randomised, open-label, phase 3 study. Lancet. 2019;394(10192):29-38.

    PubMedDOI