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TIME-2: A Study of Tanespimycin (KOS-953) in Patients With Relapsed-refractory Multiple Myeloma

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT00514371
Collaborator
(none)
22
Enrollment
11
Locations
3
Arms
18.1
Duration (Months)
2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
22 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase 2/3 Randomized, Open-Label Clinical Trial of Tanespimycin (KOS-953) Plus Bortezomib Comparing Three Doses of Tanespimycin in Patients With Relapsed-Refractory Multiple Myeloma
Study Start Date :
Aug 1, 2007
Actual Primary Completion Date :
Feb 1, 2009
Actual Study Completion Date :
Feb 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: tanespimycin and bortezomib

A patient will receive a standard dose of bortezomib followed by a high dose of tanespimycin.

Drug: tanespimycin
High dose
Other Names:
  • BMS-722782

    • Drug: Bortezomib
    Mid dose, and low dose
    Experimental: bortezomib and tanespimycin

    A patient will receive a standard dose of bortezomib followed by a mid dose of tanespimycin.

    Drug: tanespimycin
    High dose
    Other Names:
  • BMS-722782

    • Drug: Bortezomib
    Mid dose, and low dose
    Experimental: bortezomib tanespimycin

    A patient will receive a standard dose of bortezomib followed by a low dose of tanespimycin.

    Drug: tanespimycin
    High dose
    Other Names:
  • BMS-722782

    • Drug: Bortezomib
    Mid dose, and low dose

    Outcome Measures

    Primary Outcome Measures

    1. Objective Response Rate [approximately 3 months]

    Secondary Outcome Measures

    1. Response rate between treatment arms and time-to-event endpoints. [Up to 24 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Local Institution Berkeley California United States 94704
    2 Local Institution San Francisco California United States 94143
    3 Local Institution Augusta Georgia United States 30912
    4 Local Institution Baltimore Maryland United States 21201
    5 Local Institution Boston Massachusetts United States 02215
    6 Local Institution Omaha Nebraska United States 68114
    7 Local Institution New York New York United States 10011
    8 Local Institution New York New York United States 10021
    9 Local Institution Winston Salem North Carolina United States 27157
    10 Local Institution Pittsburgh Pennsylvania United States 15224
    11 Local Institution Columbia South Carolina United States 29210

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT00514371
    Other Study ID Numbers:
    • CA200-003
    • KAG-302
    First Posted:
    Aug 9, 2007
    Last Update Posted:
    Dec 7, 2015
    Last Verified:
    Nov 1, 2015
    Keywords provided by Bristol-Myers Squibb
    Multiple Myeloma
    Heat Shock Protein 90
    Hsp90
    KOS-953
    17-AAG
    bortezomib
    relapsed-refractory
    tanespimycin
    Additional relevant MeSH terms:
    Multiple Myeloma
    Neoplasms, Plasma Cell
    Bortezomib

    Study Results

    No Results Posted as of Dec 7, 2015