A Dose Escalation Study of the Histone Deacetylase Inhibitor (HDACi) JNJ 26481585 in Combination With VELCADE (Bortezomib) and Dexamethasone for Patients With Relapsed Multiple Myeloma

Phase 1 Completed 18 enrolled Janssen Research & Development, LLC

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the safety and tolerability and to establish the maximum tolerated dose of JNJ-26481585 combined with VELCADE and dexamethasone.

Timeline

Start: 2011-09-16
Primary completion: 2013-11-19
Completion: 2013-11-19

Publications

Results Moreau P, Facon T, Touzeau C, Benboubker L, Delain M, Badamo-Dotzis J, Phelps C, Doty C, Smit H, Fourneau N, Forslund A, Hellemans P, Leleu X. Quisinostat, bortezomib, and dexamethasone combination therapy for relapsed multiple myeloma. Leuk Lymphoma. 2016 Jul;57(7):1546-59. doi: 10.3109/10428194.2015.1117611. Epub 2016 Jan 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Quisinostat	Small molecule	6 mg	Oral
Subject	Quisinostat	Small molecule	8 mg	Oral
Subject	Quisinostat	Small molecule	10 mg	Oral
Subject	Quisinostat	Small molecule	12 mg	Oral
Background	Bortezomib	Small molecule	1.3 mg/m2	Subcutaneous
Background	Dexamethasone	Small molecule	20 mg	Oral

A Dose Escalation Study of the Histone Deacetylase Inhibitor (HDACi) JNJ 26481585 in Combination With VELCADE (Bortezomib) and Dexamethasone for Patients With Relapsed Multiple Myeloma

Summary

Timeline

Publications

Drugs

Indications