Multiple Myeloma Clinical Trial
Official title:
Phase I/II Trial of Sorafenib and Weekly Bortezomib in the Treatment of Patients With Relapsed or Refractory Multiple Myeloma
This is a single-arm Phase I/II study of sorafenib and bortezomib with dose optimization in
initial patients. The initial patients on the dose-finding portion of this study will be
enrolled through a single institution. Following establishment of the Phase II dose the
study will open enrollment throughout the Sarah Cannon Research Institute (SCRI) Oncology
Research Consortium.
The purpose of this study is to develop the combination of bortezomib (which is proven to be
clinically active in patients with multiple myeloma) with sorafenib (a potent inhibitor of
angiogenesis). This regimen will be developed in a schedule that is convenient for patients,
and that is as minimally toxic to patients as possible.
Primary Objective:
To evaluate the efficacy of sorafenib with weekly bortezomib, as measured by objective
response rate and progression-free survival in patients with relapsed/refractory multiple
myeloma.
Secondary Objective:
To evaluate the feasibility and toxicity of sorafenib with weekly bortezomib in the
treatment of patients with relapsed/refractory multiple myeloma.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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