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

NCT ID: NCT00546780

Last Updated: 2011-06-28

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2010-03-31

Brief Summary

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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

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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.

Conditions

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Multiple Myeloma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A

Tanespimycin + Bortezomib

Group Type ACTIVE_COMPARATOR

Tanespimycin

Intervention Type DRUG

Solution, IV, 340mg/m2, twice weekly for 2 weeks (3 week cycle), 60 minutes infusion

Bortezomib

Intervention Type DRUG

Solution, IV, 1.3 mg/m2, twice weekly for 2 weeks (3 weeks cycle), 3-5 minute bolus

Arm B

Bortezomib

Group Type ACTIVE_COMPARATOR

Bortezomib

Intervention Type DRUG

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

Intervention Type DRUG

Bortezomib

Solution, IV, 1.3 mg/m2, twice weekly for 2 weeks (3 weeks cycle), 3-5 minute bolus

Intervention Type DRUG

Other Intervention Names

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BMS-722782

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

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

Site Status

Moores Ucsd Cancer Center

La Jolla, California, United States

Site Status

University Of California Medical Center

San Francisco, California, United States

Site Status

Rocky Mountain Cancer Centers

Denver, Colorado, United States

Site Status

University Of Iowa Hospitals And Clinics

Iowa City, Iowa, United States

Site Status

University Of Kansas Medical Center

Westwood, Kansas, United States

Site Status

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Henry Ford Health System Irb

Detroit, Michigan, United States

Site Status

Capitol Comprehensive Cancer Care Center

Jefferson City, Missouri, United States

Site Status

Columbia University Medical Center (Cumc)

New York, New York, United States

Site Status

Wake Forest Univ Health Sciences

Winston-Salem, North Carolina, United States

Site Status

Kaiser Permanente Oncology/Hematology

Portland, Oregon, United States

Site Status

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status

Tennessee Cancer Specialists

Knoxville, Tennessee, United States

Site Status

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Site Status

Baylor University Medical Center

Dallas, Texas, United States

Site Status

University Of Virginia Health System

Charlottesville, Virginia, United States

Site Status

Medical College Of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Local Institution

Edmonton, Alberta, Canada

Site Status

Countries

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United States Canada

Related Links

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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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