Spots Global Cancer Trial Database for A Study of Tanespimycin (KOS-953) in Patients With Relapsed-refractory Multiple Myeloma
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Trial Identification
Brief Title: A Study of Tanespimycin (KOS-953) in Patients With Relapsed-refractory Multiple Myeloma
Official Title: Phase 2/3 Randomized, Open-Label Clinical Trial of Tanespimycin (KOS-953) Plus Bortezomib Comparing Three Doses of Tanespimycin in Patients With Relapsed-Refractory Multiple Myeloma
Study ID: NCT00514371
Conditions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Local Institution, Berkeley, California, United States
Local Institution, San Francisco, California, United States
Local Institution, Augusta, Georgia, United States
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
Local Institution, Columbia, South Carolina, United States
Contact Details
Name: Bristol-Myers Squibb
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR
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