A Study of Tanespimycin (KOS-953) in Patients With Relapsed-refractory Multiple Myeloma

Last updated: November 6, 2015
Sponsor: Bristol-Myers Squibb
Overall Status: Completed

Phase

2/3

Condition

Lymphoproliferative Disorders

Bone Neoplasm

Multiple Myeloma

Treatment

N/A

Clinical Study ID

NCT00514371
CA200-003
KAG-302
  • Ages > 18
  • All Genders

Study Summary

This is a phase 2/3, open label trial for patients with relapsed-refractory multiple myeloma. Study agent is tanespimycin (KOS-953), at three different dose levels in combination with a fixed dose of bortezomib.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Good performance status

  • Histologic evidence of multiple myeloma

  • Have had at least three prior treatment regimens for multiple myeloma that included both bortezomib and lenalidomide

  • No prior treatment with a heat shock 90 inhibitor or an investigational proteasome inhibitor

  • No known infections of HAV, HBV, HCV, or HIV

  • No chemotherapy, radiation therapy, or immune therapy for three weeks prior to enrollment.

Study Design

Total Participants: 22
Study Start date:
August 01, 2007
Estimated Completion Date:
February 28, 2009

Study Description

Phase 2/3 combination study comparing bortezomib plus one of three doses of tanespimycin in patients with relapsed-refractory multiple myeloma after failure of at least three prior anti-cancer therapy regimens. Prior therapy must include bortezomib and lenalidomide. Primary objective is to assess the dose-response relationship of objective response rate (ORR) using EBMT/IBMTR criteria of any three dose levels of tanespimycin (KOS-953) in combination with bortezomib after four treatment cycles.

Connect with a study center

  • Local Institution

    Berkeley, California 94704
    United States

    Site Not Available

  • Local Institution

    San Francisco, California 94143
    United States

    Site Not Available

  • Local Institution

    Augusta, Georgia 30912
    United States

    Site Not Available

  • Local Institution

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Local Institution

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Local Institution

    Omaha, Nebraska 68114
    United States

    Site Not Available

  • Local Institution

    New York, New York 10021
    United States

    Site Not Available

  • Local Institution

    Winston Salem, North Carolina 27157
    United States

    Site Not Available

  • Local Institution

    Pittsburgh, Pennsylvania 15224
    United States

    Site Not Available

  • Local Institution

    Columbia, South Carolina 29210
    United States

    Site Not Available

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