Velcade (Bortezomib) Consolidation After Transplant

Phase 3 Completed 256 enrolled Janssen Scientific Affairs, LLC

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to determine if bortezomib when added to consolidation treatment with thalidomide and prednisolone leads to an improved response in patients with multiple myeloma who have undergone autologous stem cell transplant and initial treatment with bortezomib, cyclophosphamide, and dexamethasone.

Timeline

Start: 2012-01-13
Primary completion: 2015-12-30
Completion: 2018-01-09

Publications

Horvath N, Spencer A, Kenealy M, Joshua D, Campbell PJ, Lee JJ, Hou J, Qiu L, Kalff A, Khong T, Londhe A, Siggins S, van Kooten Losio M, Eisbacher M, Prince HM. Phase 3 study of subcutaneous bortezomib, thalidomide, and prednisolone consolidation after subcutaneous bortezomib-based induction and autologous stem cell transplantation in patients with previously untreated multiple myeloma: the VCAT study. Leuk Lymphoma. 2019 Sep;60(9):2122-2133. doi: 10.1080/10428194.2019.1579322. Epub 2019 Feb 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bortezomib	Small molecule	1.3 mg/m2	Subcutaneous
Background	Cyclophosphamide	Other / unclassified	300 mg/m2	Oral
Background	Dexamethasone	Small molecule	20 mg	Oral
Background	Prednisolone	Other / unclassified	50 mg	Oral
Background	Thalidomide	Other / unclassified	100 mg	Oral

Velcade (Bortezomib) Consolidation After Transplant

Summary

Timeline

Publications

Drugs

Indications