Study to Evaluate Optimized Retreatment and Prolonged Therapy With Bortezomib

NCT01910987 ↗

Phase 3 Completed 80 enrolled Janssen-Cilag International NV

RandomizedParallel-groupOpen-labelTreatment

Summary

The objective of this study is to describe the effect of optimized retreatment with bortezomib in combination with dexamethasone followed by prolonged therapy with bortezomib, versus standard retreatment with bortezomib in combination with dexamethasone on progression free survival (PFS).

Timeline

Start: 2013-04
Primary completion: 2016-02
Completion: 2016-02

Publications

Terpos E, Gobbi M, Potamianou A, Lahaye M, Couturier C, Cavo M. Retreatment and prolonged therapy with subcutaneous bortezomib in patients with relapsed multiple myeloma: A randomized, controlled, phase III study. Eur J Haematol. 2018 Jan;100(1):10-19. doi: 10.1111/ejh.12937. Epub 2017 Oct 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bortezomib	Small molecule	1.3 mg/m2	Subcutaneous
Subject	Dexamethasone	Small molecule	20 mg	Oral

Study to Evaluate Optimized Retreatment and Prolonged Therapy With Bortezomib

Summary

Timeline

Publications

Drugs

Indications