A Study of Tanespimycin (KOS-953) in Patients With Multiple Myeloma in First Relapse
NCT ID: NCT00546780
Last Updated: 2011-06-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
31 participants
INTERVENTIONAL
2008-02-29
2010-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A
Tanespimycin + Bortezomib
Tanespimycin
Solution, IV, 340mg/m2, twice weekly for 2 weeks (3 week cycle), 60 minutes infusion
Bortezomib
Solution, IV, 1.3 mg/m2, twice weekly for 2 weeks (3 weeks cycle), 3-5 minute bolus
Arm B
Bortezomib
Bortezomib
Solution, IV, 1.3 mg/m2, twice weekly for 2 weeks (3 weeks cycle), 3-5 minute bolus
Interventions
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Tanespimycin
Solution, IV, 340mg/m2, twice weekly for 2 weeks (3 week cycle), 60 minutes infusion
Bortezomib
Solution, IV, 1.3 mg/m2, twice weekly for 2 weeks (3 weeks cycle), 3-5 minute bolus
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Bristol-Myers Squibb
Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Comprehensive Blood And Cancer Center
Bakersfield, California, United States
Moores Ucsd Cancer Center
La Jolla, California, United States
University Of California Medical Center
San Francisco, California, United States
Rocky Mountain Cancer Centers
Denver, Colorado, United States
University Of Iowa Hospitals And Clinics
Iowa City, Iowa, United States
University Of Kansas Medical Center
Westwood, Kansas, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Henry Ford Health System Irb
Detroit, Michigan, United States
Capitol Comprehensive Cancer Care Center
Jefferson City, Missouri, United States
Columbia University Medical Center (Cumc)
New York, New York, United States
Wake Forest Univ Health Sciences
Winston-Salem, North Carolina, United States
Kaiser Permanente Oncology/Hematology
Portland, Oregon, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Tennessee Cancer Specialists
Knoxville, Tennessee, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Baylor University Medical Center
Dallas, Texas, United States
University Of Virginia Health System
Charlottesville, Virginia, United States
Medical College Of Wisconsin
Milwaukee, Wisconsin, United States
Local Institution
Edmonton, Alberta, Canada
Countries
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Related Links
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Investigator Inquiry form
Other Identifiers
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KAG-301
Identifier Type: -
Identifier Source: secondary_id
CA200-004
Identifier Type: -
Identifier Source: org_study_id
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