drugset / Trial / NCT02188537

Nelfinavir as Bortezomib-sensitizing Drug in Patients With Proteasome Inhibitor-nonresponsive Myeloma

NCT02188537

Phase 2 Completed 34 enrolled Swiss Cancer Institute
NaSingle-groupOpen-labelTreatment

Summary

Trial objectives: To decide whether the addition of nelfinavir to the approved antimyeloma therapy with bortezomib and dexamethasone has sufficient activity in proteasome inhibitor-resistant myeloma patients to merit further clinical investigation in a prospective controlled trial. Additional research questions: To collect myeloma cell samples from proteasome inhibitor-resistant myeloma patients for the assessment of the biology of proteasome inhibitor resistance and the identification of predictive markers for response to nelfinavir-based antimyeloma therapy.

Timeline

Start
2014-12-02
Primary completion
2016-07-26
Completion
2018-04-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Nelfinavir Other / unclassified 2500 mg Oral
Background Bortezomib Small molecule 1.3 mg/m2 Intravenous
Background Dexamethasone Small molecule 20 mg Oral

Indications