Skip to content
Bending the Curve Trial by Trial
?

ASPIRE

Carfilzomib, lenalidomide, and dexamethasone for relapsed multiple myeloma (ASPIRE)

Phase 3N = 792NCT01080391

Population
Relapsed multiple myeloma.
Design
Phase 3 trial: 792 patients with relapsed myeloma were randomly assigned to carfilzomib with lenalidomide and dexamethasone or to lenalidomide and dexamethasone alone. The primary end point was progression-free survival; results are from the interim analysis.
Primary endpoint
PFS
Arms
  • Carfilzomib + Rd (experimental): Carfilzomib with lenalidomide and dexamethasone
  • Rd (control): Lenalidomide and dexamethasone
People
Stewart AK
PFSHR 0.69 (95% CI 0.57–0.83)Δ median PFS+8.7 monthsOSHR 0.79 (95% CI 0.63–0.99)Δ 24-month OS+8.3 pointsΔ ORR+20.4 pointsΔ ≥CR rate+22.5 points
Show the numbers
Results reported for ASPIRE
EndpointAnalysisCarfilzomib + RdRdEffect
PFSRandomised patients (792)interimStewart 2015median 26.3 monthsmedian 17.6 monthsHR 0.69 (95% CI 0.57–0.83)P=0.0001
OSRandomised patients (792)interimStewart 201573.3% at 2 y65% at 2 yHR 0.79 (95% CI 0.63–0.99)P=0.04Median overall survival was not reached in either group at the interim analysis.
ORRRandomised patients (792)interimStewart 201587.1%66.7%P<0.001Grade 3 or higher adverse events 83.7% versus 80.7%; discontinuation owing to adverse events 15.3% versus 17.7%.
≥CR rateRandomised patients (792)interimStewart 201531.8%9.3%—
sCR rateRandomised patients (792)interimStewart 201514.1%4.3%—
Results reported for ASPIRE
EndpointAnalysisCarfilzomib + RdRdEffect
PFSRandomised patients (792)interimStewart 2015median 26.3 monthsmedian 17.6 monthsHR 0.69 (95% CI 0.57–0.83)P=0.0001
OSRandomised patients (792)interimStewart 201573.3% at 2 y65% at 2 yHR 0.79 (95% CI 0.63–0.99)P=0.04Median overall survival was not reached in either group at the interim analysis.
ORRRandomised patients (792)interimStewart 201587.1%66.7%P<0.001Grade 3 or higher adverse events 83.7% versus 80.7%; discontinuation owing to adverse events 15.3% versus 17.7%.
≥CR rateRandomised patients (792)interimStewart 201531.8%9.3%—
sCR rateRandomised patients (792)interimStewart 201514.1%4.3%—
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFSOS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.690.57–0.83
OS0.790.63–0.99
Illustrative — modelled from reported values, not trial data. PFS, interim.
0%25%50%75%100%0102030405060Months (modelled)
  • Carfilzomib + Rd (experimental)
  • Rd (control)

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

Data table (modelled values)
MonthsCarfilzomib + RdRd
0100.0%100.0%
1665.6%53.3%
3341.9%27.3%
4927.5%14.5%
6617.6%7.4%
Primary publication: Stewart AK, Rajkumar SV, Dimopoulos MA, Masszi T, Špička I, Oriol A, et al. Carfilzomib, lenalidomide, and dexamethasone for relapsed multiple myeloma. N Engl J Med. 2015;372(2):142-52. PubMedDOI

Appears in

Sources

  1. Stewart AK, Rajkumar SV, Dimopoulos MA, Masszi T, Špička I, Oriol A, et al. Carfilzomib, lenalidomide, and dexamethasone for relapsed multiple myeloma. N Engl J Med. 2015;372(2):142-52.

    PubMedDOI