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

Last updated: June 21, 2011
Sponsor: Bristol-Myers Squibb
Overall Status: Completed

Phase

3

Condition

Multiple Myeloma

Leukemia

Red Blood Cell Disorders

Treatment

N/A

Clinical Study ID

NCT00546780
CA200-004
KAG-301
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Prior treatment with a heat shock 90 inhibitor or an investigational proteasomeinhibitor

  • Known active infections of HAV, HBV, HCV, or HIV

  • Administration of chemotherapy, radiation therapy, or immune therapy within 21 daysprior to randomization.

  • Acute diffuse infiltrate pulmonary disease or pericardial dise

Study Design

Total Participants: 31
Study Start date:
February 01, 2008
Estimated Completion Date:
March 31, 2010

Study 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.

Connect with a study center

  • Local Institution

    Edmonton, Alberta T6G 1Z2
    Canada

    Site Not Available

  • Comprehensive Blood And Cancer Center

    Bakersfield, California 93309
    United States

    Site Not Available

  • Moores Ucsd Cancer Center

    La Jolla, California 92093
    United States

    Site Not Available

  • University Of California Medical Center

    San Francisco, California 94143
    United States

    Site Not Available

  • Rocky Mountain Cancer Centers

    Denver, Colorado 80218
    United States

    Site Not Available

  • University Of Iowa Hospitals And Clinics

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • University Of Kansas Medical Center

    Westwood, Kansas 66205
    United States

    Site Not Available

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Henry Ford Health System Irb

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Capitol Comprehensive Cancer Care Center

    Jefferson City, Missouri 65109
    United States

    Site Not Available

  • Columbia University Medical Center (Cumc)

    New York, New York 10032
    United States

    Site Not Available

  • Wake Forest Univ Health Sciences

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • Kaiser Permanente Oncology/Hematology

    Portland, Oregon 97227
    United States

    Site Not Available

  • Thomas Jefferson University

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Tennessee Cancer Specialists

    Knoxville, Tennessee 37920
    United States

    Site Not Available

  • Sarah Cannon Research Institute

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Baylor University Medical Center

    Dallas, Texas 75246
    United States

    Site Not Available

  • University Of Virginia Health System

    Charlottesville, Virginia 22908
    United States

    Site Not Available

  • Medical College Of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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