Multiple Myeloma Clinical Trial

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A Study of Tanespimycin (KOS-953) in Patients With Relapsed-refractory Multiple Myeloma

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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.

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Full 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.

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Eligibility Criteria

Inclusion Criteria:

Good performance status
Histologic evidence of multiple myeloma
Have had at least three prior treatment regimens for multiple myeloma that included both bortezomib and lenalidomide
No prior treatment with a heat shock 90 inhibitor or an investigational proteasome inhibitor
No known infections of HAV, HBV, HCV, or HIV
No chemotherapy, radiation therapy, or immune therapy for three weeks prior to enrollment.

Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

22

Study ID:

NCT00514371

Recruitment Status:

Completed

Sponsor:

Bristol-Myers Squibb

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There are 11 Locations for this study

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Local Institution
Berkeley California, 94704, United States
Local Institution
San Francisco California, 94143, United States
Local Institution
Augusta Georgia, 30912, United States
Local Institution
Baltimore Maryland, 21201, United States
Local Institution
Boston Massachusetts, 02215, United States
Local Institution
Omaha Nebraska, 68114, United States
Local Institution
New York New York, 10011, United States
Local Institution
New York New York, 10021, United States
Local Institution
Winston Salem North Carolina, 27157, United States
Local Institution
Pittsburgh Pennsylvania, 15224, United States
Local Institution
Columbia South Carolina, 29210, United States
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Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

22

Study ID:

NCT00514371

Recruitment Status:

Completed

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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