Clinical trial NCT00546780: A Study of Tanespimycin (KOS-953) in Patients With Multiple Myeloma in First Relapse
Official title: Phase 3 Randomized, Open-Label Clinical Trial of Tanespimycin (KOS-953) Plus Bortezomib Compared to Bortezomib Alone in Patients With Multiple Myeloma in First Relapse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Heat Shock Protein 90
Hsp90
KOS-953
17-AAG
bortezomib
first relapse
tanespimycin
TIME-1
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2007-10-19
Enrollment: 31
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 3, open label trial for patients with multiple myeloma in first relapse. Trial will compare tanespimycin (KOS-953), in combination with a fixed dose of bortezomib versus bortezomib alone.

Detailed description: Phase 3 combination study comparing tanespimycin (KOS-953) plus bortezomib to bortezomib alone in patients with multiple myeloma in first relapse after failure of previous anti-cancer therapy and/or bone marrow transplantation. Primary objective is to compare the progression-free survival (PFS) associated with the use of tanespimycin (KOS-953) in combination with bortezomib versus that associated with administration of bortezomib alone.

Eligibility criteria: Inclusion Criteria:

* Good Performance Status
* Documented evidence of multiple myeloma
* Documented progression of disease after initial response to one line of therapy
* Measurable disease (serum M-protein \>.5g/dl or \> 200 mg urinary M protein excretion)

Exclusion Criteria:

* Prior treatment with a heat shock 90 inhibitor or an investigational proteasome inhibitor
* Known active infections of HAV, HBV, HCV, or HIV
* Administration of chemotherapy, radiation therapy, or immune therapy within 21 days prior to randomization.
* Acute diffuse infiltrate pulmonary disease or pericardial dise

Primary outcomes:
measure: Progression-free survival
timeFrame: 6-24 months
Secondary outcomes:
measure: Overall survival in each arm of the study
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Comprehensive Blood And Cancer Center
state: California
city: La Jolla
country: United States
facility: Moores Ucsd Cancer Center
state: California
city: San Francisco
country: United States
facility: University Of California Medical Center
state: California
city: Denver
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Iowa City
country: United States
facility: University Of Iowa Hospitals And Clinics
state: Iowa
city: Westwood
country: United States
facility: University Of Kansas Medical Center
state: Kansas
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System Irb
state: Michigan
city: Jefferson City
country: United States
facility: Capitol Comprehensive Cancer Care Center
state: Missouri
city: New York
country: United States
facility: Columbia University Medical Center (Cumc)
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest Univ Health Sciences
state: North Carolina
city: Portland
country: United States
facility: Kaiser Permanente Oncology/Hematology
state: Oregon
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Knoxville
country: United States
facility: Tennessee Cancer Specialists
state: Tennessee
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Charlottesville
country: United States
facility: University Of Virginia Health System
state: Virginia
city: Milwaukee
country: United States
facility: Medical College Of Wisconsin
state: Wisconsin
city: Edmonton
country: Canada
facility: Local Institution
state: Alberta
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: