Phase 1 Study of Vorinostat and Bortezomib in Multiple Myeloma (MK-0683-015 EXT 1 (AM1))

Phase 1 Completed 34 enrolled Merck Sharp & Dohme LLC

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purposes of this study are: * To determine the maximum tolerated dose (MTD) for the combination of oral vorinostat and bortezomib in participants with advanced multiple myeloma * To assess the safety and tolerability of this regimen and to document the participant's clinical status (by anti-tumor activity) for this combination, as determined per standard of care.

Timeline

Start: 2005-09
Primary completion: 2009-12
Completion: 2011-05

Publications

Weber DM, Graef T, Hussein M, Sobecks RM, Schiller GJ, Lupinacci L, Hardwick JS, Jagannath S. Phase I trial of vorinostat combined with bortezomib for the treatment of relapsing and/or refractory multiple myeloma. Clin Lymphoma Myeloma Leuk. 2012 Oct;12(5):319-24. doi: 10.1016/j.clml.2012.07.007.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bortezomib	Small molecule	0.7 mg/m2	Other
Subject	Bortezomib	Small molecule	0.9 mg/m2	Other
Subject	Bortezomib	Small molecule	1.1 mg/m2	Other
Subject	Bortezomib	Small molecule	1.3 mg/m2	Other
Subject	Vorinostat	Small molecule	200 mg	Oral
Subject	Vorinostat	Small molecule	300 mg	Oral
Subject	Vorinostat	Small molecule	400 mg	Oral

Phase 1 Study of Vorinostat and Bortezomib in Multiple Myeloma (MK-0683-015 EXT 1 (AM1))

Summary

Timeline

Publications

Drugs

Indications