A Study of Tanespimycin (KOS-953) in Patients With Multiple Myeloma in First Relapse

Phase 3

Completed

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

• Registration Number: NCT00546780
• Lead Sponsor: Bristol-Myers Squibb

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.

Study Timeline

• Study First Submitted: 2007-10-17
• Study First Submitted QC: 2007-10-18
• Study First Posted: 2007-10-19
• Study Start: 2008-02
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2011-06
• Disposition First Submitted: 2011-06-21
• Disposition First Submitted QC: 2011-06-21
• Last Update Submitted: 2011-06-21
• Disposition First Posted: 2011-06-28
• Last Update Posted: 2011-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	Tanespimycin	Tanespimycin + Bortezomib
Arm A	Bortezomib	Tanespimycin + Bortezomib
Arm B	Bortezomib	Bortezomib

Primary Outcome Measures

Name	Time	Method
Progression-free survival	6-24 months

Secondary Outcome Measures

Name	Time	Method
Overall survival in each arm of the study	Up to 24 months

Trial Locations

Locations (19)

Comprehensive Blood And Cancer Center; 🇺🇸 Bakersfield, California, United States

Rocky Mountain Cancer Centers; 🇺🇸 Denver, Colorado, United States

Moores Ucsd Cancer Center; 🇺🇸 La Jolla, California, United States

University Of California Medical Center; 🇺🇸 San Francisco, California, United States

University Of Iowa Hospitals And Clinics; 🇺🇸 Iowa City, Iowa, 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

Tennessee Cancer Specialists; 🇺🇸 Knoxville, Tennessee, United States

University Of Virginia Health System; 🇺🇸 Charlottesville, Virginia, United States

Sarah Cannon Research Institute; 🇺🇸 Nashville, Tennessee, United States

Local Institution; 🇨🇦 Edmonton, Alberta, Canada

Baylor University Medical Center; 🇺🇸 Dallas, Texas, United States

Medical College Of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

University Of Kansas Medical Center; 🇺🇸 Westwood, Kansas, United States

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States