Bortezomib-Dexamethasone-Doxorubicin-Study

Phase 2 Completed 72 enrolled Austrian Forum Against Cancer

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The primary objective of the study is to evaluate the activity of BDD in subjects with acute renal failure as measured by· reversal of acute renal failureSecondary objectives· tumor response (complete and partial response)· To evaluate the safety of Bortezomib- Doxorubicin-Dexamethasone in this patient population· to evaluate the activity of Bortezomib- Doxorubicin -Dexamethasone on progression free survival · to evaluate the activity of Bortezomib- Doxorubicin -Dexamethasone on overall survival

Timeline

Start: 2006-02
Primary completion: 2008-11
Completion: 2009-11

Publications

Ludwig H, Adam Z, Hajek R, Greil R, Tothova E, Keil F, Autzinger EM, Thaler J, Gisslinger H, Lang A, Egyed M, Womastek I, Zojer N. Light chain-induced acute renal failure can be reversed by bortezomib-doxorubicin-dexamethasone in multiple myeloma: results of a phase II study. J Clin Oncol. 2010 Oct 20;28(30):4635-41. doi: 10.1200/JCO.2010.28.1238. Epub 2010 Sep 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bortezomib	Small molecule	1 mg/m2	—
Subject	Bortezomib	Small molecule	1.3 mg/m2	—
Subject	Dexamethasone	Small molecule	40 mg	—
Subject	Doxorubicin	Other / unclassified	9 mg/m2	—

Bortezomib-Dexamethasone-Doxorubicin-Study

Summary

Timeline

Publications

Drugs

Indications