Clinical trial NCT00514371: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Heat Shock Protein 90
Hsp90
KOS-953
17-AAG
bortezomib
relapsed-refractory
tanespimycin
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2007-08-09
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Objective Response Rate
timeFrame: approximately 3 months
Secondary outcomes:
measure: Response rate between treatment arms and time-to-event endpoints.
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: Local Institution
state: California
city: San Francisco
country: United States
facility: Local Institution
state: California
city: Augusta
country: United States
facility: Local Institution
state: Georgia
city: Baltimore
country: United States
facility: Local Institution
state: Maryland
city: Boston
country: United States
facility: Local Institution
state: Massachusetts
city: Omaha
country: United States
facility: Local Institution
state: Nebraska
city: New York
country: United States
facility: Local Institution
state: New York
city: New York
country: United States
facility: Local Institution
state: New York
city: Winston Salem
country: United States
facility: Local Institution
state: North Carolina
city: Pittsburgh
country: United States
facility: Local Institution
state: Pennsylvania
city: Columbia
country: United States
facility: Local Institution
state: South Carolina
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: