drugset / Trial / NCT01286077

Velcade Consolidation Bone Study

NCT01286077 ↗

Phase 2 Completed 106 enrolled Janssen-Cilag International NV
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to assess the effect of bortezomib on myeloma-related bone disease, analyzing bone mineral density (BMD) in patients with Multiple Myeloma (MMY) who have received high dose chemotherapy and autologous stem cell transplantation for primary treatment of MMY (single- or double-transplant). Eligible patients will be randomized (study treatment assigned by chance like flipping a coin) to either bortezomib or observation alone. Patients in the bortezomib arm will receive treatment of bortezomib for a total of 4 cycles. All subjects will be followed for a total of 24 months after randomization.

Timeline

Start
2009-09
Primary completion
2012-11
Completion
2014-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Bortezomib Small molecule 1.6 mg/m2 Intravenous

Indications