Study met primary efficacy endpoint of non-inferiority between subcutaneous and intravenous administration. Study results also indicated overall similar safety profile with differences in incidence of peripheral neuropathy.
The US Food and Drug Administration (FDA) has approved subcutaneous VELCADE for the treatment of multiple myeloma. This approval was based on a large, international clinical trial that studied VELCADE injected under the skin compared with VELCADE injected into a vein. The 222 patients in this study had been treated for their myeloma and relapsed.
Randomized Phase III Trial of Consolidation Therapy with Bortezomib (Velcade®) & Lenalidomide (Revlimid®) - Dexamethasone (VRD) versus Bortezomib (Velcade®:) - Dexamethasone (VD) for Patients With Multiple Myeloma Who Have Completed a Dexamethasone Based Induction Regimen
Part of the IMF's Understanding series, this booklet covers the basics, including: What is VELCADE®? How does it work? How is VELCADE® given? How is it used in clinical practice today? What are the side effects?
The approval is based on data from a Phase III study demonstrating that subcutaneous administration of bortezomib is equally effective as intravenous bortezomib but is associated with a significant reduction in the frequency and severity of side effects.