A Phase I/II Study of Escalating Doses of Bortezomib in Conjunction With High Dose Melphalan as a Conditioning Regimen for Autologous Peripheral Blood Stem Cell Transplantation in Patients With Multiple Myeloma
Multiple myeloma is the second most common hematological malignancy that has affected
approximately 40,000 Americans.Conventional chemotherapy has achieved limited control of
this disease but studies have reported improved response rates for patients who are treated
with dose-intense therapy and autologous hematopoietic stem cell transplantation. This Phase
I/II study will investigate the potential of combination therapy of dose-intense melphalan
with escalating doses of bortezomib.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose The maximum tolerated dose of bortezomib (MTD) will be defined as the dose level prior to that resulting in two out of six patients experiencing a DLT
3 years
Yes
Scott D Rowley, MD
Principal Investigator
Director-Blood and Marrow Transplantation Program
United States: Institutional Review Board
06.05.109B
NCT00784823
January 2007
December 2009
Name | Location |
---|---|
Hackensack University Medical Center | Hackensack, New Jersey 07601 |