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

Phase 2

Completed

• Conditions: Multiple Myeloma
• Interventions: Drug: tanespimycin; Drug: Bortezomib

• Registration Number: NCT00514371
• Lead Sponsor: Bristol-Myers Squibb

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.

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-08-08
• Study First Submitted QC: 2007-08-08
• Study First Posted: 2007-08-09
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Disposition First Submitted: 2010-09-10
• Disposition First Submitted QC: 2010-09-10
• Disposition First Posted: 2010-09-14
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-06
• Last Update Posted: 2015-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tanespimycin and bortezomib	tanespimycin	A patient will receive a standard dose of bortezomib followed by a high dose of tanespimycin.
bortezomib and tanespimycin	tanespimycin	A patient will receive a standard dose of bortezomib followed by a mid dose of tanespimycin.
tanespimycin and bortezomib	Bortezomib	A patient will receive a standard dose of bortezomib followed by a high dose of tanespimycin.
bortezomib tanespimycin	tanespimycin	A patient will receive a standard dose of bortezomib followed by a low dose of tanespimycin.
bortezomib and tanespimycin	Bortezomib	A patient will receive a standard dose of bortezomib followed by a mid dose of tanespimycin.
bortezomib tanespimycin	Bortezomib	A patient will receive a standard dose of bortezomib followed by a low dose of tanespimycin.

Primary Outcome Measures

Name	Time	Method
Objective Response Rate	approximately 3 months

Secondary Outcome Measures

Name	Time	Method
Response rate between treatment arms and time-to-event endpoints.	Up to 24 months

Trial Locations

Locations (1)

Local Institution; 🇺🇸 Columbia, South Carolina, United States