This is a phase 2/3, open label trial for patients with relapsed-refractory multiple myeloma. Study agent is tanespimycin (KOS-953), at three different dose levels in combination with a fixed dose of bortezomib.
Phase 2/3 combination study comparing bortezomib plus one of three doses of tanespimycin in patients with relapsed-refractory multiple myeloma after failure of at least three prior anti-cancer therapy regimens. Prior therapy must include bortezomib and lenalidomide. Primary objective is to assess the dose-response relationship of objective response rate (ORR) using EBMT/IBMTR criteria of any three dose levels of tanespimycin (KOS-953) in combination with bortezomib after four treatment cycles.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
22
High dose
Mid dose, and low dose
Local Institution
Berkeley, California, United States
Local Institution
San Francisco, California, United States
Local Institution
Augusta, Georgia, United States
Objective Response Rate
Time frame: approximately 3 months
Response rate between treatment arms and time-to-event endpoints.
Time frame: Up to 24 months
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Local Institution
Baltimore, Maryland, United States
Local Institution
Boston, Massachusetts, United States
Local Institution
Omaha, Nebraska, United States
Local Institution
New York, New York, United States
Local Institution
New York, New York, United States
Local Institution
Winston-Salem, North Carolina, United States
Local Institution
Pittsburgh, Pennsylvania, United States
...and 1 more locations