Understanding VELCADE as a Subcutaneous (SQ) Injection
New! Tip Card on Subcutaneous VELCADE
Patients Personifying Progress:
Subcutaneous VELCADE® Site
The VELCADE® Website
VELCADE® Downloadable Resources
Randomized Phase III Study Comparing Conventional-Dose Treatment Using a Combination of Lenalidomide (Revlimid®), Bortezomib (Velcade®), and Dexamethasone (RVD) to High-Dose Treatment with Stem Cell Transplant in the Initial Management of Myeloma in Patients up to 65 Years of Age
Open Velcade® (bortezomib) Trials
Eastern Cooperative Oncology Group Clinical Trial:E1A05
Understanding VELCADE® (bortezomib) for Injection
Addition of bortezomib statistically enhanced the PFS and OS in previously untreated MM
Triple Drug Combination Beats Standard Treatment in Myeloma Trial
Subcutaneous VELCADE® Approved in the EU for the Treatment of Multiple Myeloma
FDA Approves Subcutaneous Administration of VELCADE® In All Approved Indications
VELCADE Reimbursement Assistance Program
Millennium: The Takeda Oncology Company's Web Site
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.
This study, sponsored by Dr. Paul Richardson of the Dana-Farber Cancer Institute, was designed to answer a very important question in myeloma: In the era of novel drugs, is high-dose therapy (HDT) still necessary in the initial management of multiple myeloma in younger patients? In this study, the addition of HDT to conventional dose treatment (RVD) as compared to conventional-dose treatment (RVD) alone would be considered superior if it significantly prolongs progression-free survival by at least 9 months.
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?
Dr. Brian Durie discussed the randomized phase 3 SWOGG S0777 trial that investigated the addition of bortezomib to lenalidomide and dexamethasone for previously untreated multiple myeloma patients without an intend for immediate autologous stem cell transplant.
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.
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.