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PX-171-003-A1

A phase 2 study of single-agent carfilzomib (PX-171-003-A1) in patients with relapsed and refractory multiple myeloma

Phase 2NCT00511238

Population
Relapsed and refractory myeloma; 95% refractory to their last therapy and 80% refractory or intolerant to both bortezomib and lenalidomide; median of five previous lines.
Design
Open-label, single-arm phase 2 study: carfilzomib 20 mg per square metre intravenously twice weekly for 3 of 4 weeks in cycle 1, then 27 mg per square metre for up to 12 cycles. The primary end point was overall response rate (partial response or better). 266 patients were evaluable for safety and 257 for efficacy.
Primary endpoint
ORR
Arms
  • Carfilzomib monotherapy (experimental, n = 266): Carfilzomib 20 mg/m2 then 27 mg/m2 twice weekly for 3 of 4 weeks
People
Siegel DS
Show the numbers
Results reported for PX-171-003-A1
EndpointAnalysisCarfilzomib monotherapyControlEffect
ORRPatients evaluable for efficacy (257)primarySiegel 201223.7%—Common adverse events were fatigue (49%), anemia (46%), nausea (45%) and thrombocytopenia (39%). Peripheral neuropathy occurred in 33 patients (12.4%) and 33 patients (12.4%) withdrew because of an adverse event.
DORPatients evaluable for efficacy (257)primarySiegel 2012median 7.8 months——
OSPatients evaluable for efficacy (257)primarySiegel 2012median 15.6 months——
Results reported for PX-171-003-A1
EndpointAnalysisCarfilzomib monotherapyControlEffect
ORRPatients evaluable for efficacy (257)primarySiegel 201223.7%—Common adverse events were fatigue (49%), anemia (46%), nausea (45%) and thrombocytopenia (39%). Peripheral neuropathy occurred in 33 patients (12.4%) and 33 patients (12.4%) withdrew because of an adverse event.
DORPatients evaluable for efficacy (257)primarySiegel 2012median 7.8 months——
OSPatients evaluable for efficacy (257)primarySiegel 2012median 15.6 months——
Illustrative — modelled from reported values, not trial data. DOR, primary.
0%25%50%75%100%051015Months (modelled)
  • Carfilzomib monotherapy (experimental)

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

Data table (modelled values)
MonthsCarfilzomib monotherapy
0100.0%
564.1%
1041.1%
1526.4%
2016.9%
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%0102030Months (modelled)
  • Carfilzomib monotherapy (experimental)

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

Data table (modelled values)
MonthsCarfilzomib monotherapy
0100.0%
1064.1%
2041.1%
2927.6%
3917.7%
Primary publication: Siegel DS, Martin T, Wang M, Vij R, Jakubowiak AJ, Lonial S, et al. A phase 2 study of single-agent carfilzomib (PX-171-003-A1) in patients with relapsed and refractory multiple myeloma. Blood. 2012;120(14):2817-25. PubMedDOI

Appears in

Sources

  1. Siegel DS, Martin T, Wang M, Vij R, Jakubowiak AJ, Lonial S, et al. A phase 2 study of single-agent carfilzomib (PX-171-003-A1) in patients with relapsed and refractory multiple myeloma. Blood. 2012;120(14):2817-25.

    PubMedDOI