drugset / Trial / NCT02467010

Relapse Myeloma; Cyclofosfamide; Bortezomib; Maintenance

NCT02467010 ↗

Phase 2 Completed 73 enrolled University Medical Center Groningen
NaSingle-groupOpen-labelTreatment

Summary

Bortezomib and cyclophosphamide in combination with dexamethasone has already demonstrated high response rates in refractory multiple myeloma. Low dose continuous cyclophosphamide, also called metronomic scheduling, minimize toxic side effects and eliminate the obligatory rest periods. Combining cyclophosphamide with bortezomib might target distinct aspects of a myeloma functionality. The objectives of the present study are whether patients with refractory or relapsed multiple myeloma after reinduction with bortezomib, cyclophosphamide and dexamethasone will benefit from maintenance therapy with bortezomib and cyclophosphamide with acceptable side-effects. Recently two studies have shown with thalidomide that maintenance therapy might improve EFS and one study also the OS.

Timeline

Start
2008-09
Primary completion
2013-07
Completion
2013-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Bortezomib Small molecule — —
Subject Cyclophosphamide Other / unclassified 50 mg —
Subject Dexamethasone Small molecule — —

Indications