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

NCT ID: NCT00514371

Last Updated: 2015-12-07

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

PHASE2/PHASE3

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2009-02-28

Brief Summary

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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.

Detailed Description

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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.

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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tanespimycin and bortezomib

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

Group Type EXPERIMENTAL

tanespimycin

Intervention Type DRUG

High dose

Bortezomib

Intervention Type DRUG

Mid dose, and low dose

bortezomib and tanespimycin

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

Group Type EXPERIMENTAL

tanespimycin

Intervention Type DRUG

High dose

Bortezomib

Intervention Type DRUG

Mid dose, and low dose

bortezomib tanespimycin

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

Group Type EXPERIMENTAL

tanespimycin

Intervention Type DRUG

High dose

Bortezomib

Intervention Type DRUG

Mid dose, and low dose

Interventions

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tanespimycin

High dose

Intervention Type DRUG

Bortezomib

Mid dose, and low dose

Intervention Type DRUG

Other Intervention Names

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BMS-722782

Eligibility Criteria

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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.
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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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Berkeley, California, United States

Site Status

Local Institution

San Francisco, California, United States

Site Status

Local Institution

Augusta, Georgia, United States

Site Status

Local Institution

Baltimore, Maryland, United States

Site Status

Local Institution

Boston, Massachusetts, United States

Site Status

Local Institution

Omaha, Nebraska, United States

Site Status

Local Institution

New York, New York, United States

Site Status

Local Institution

New York, New York, United States

Site Status

Local Institution

Winston-Salem, North Carolina, United States

Site Status

Local Institution

Pittsburgh, Pennsylvania, United States

Site Status

Local Institution

Columbia, South Carolina, United States

Site Status

Countries

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United States

Related Links

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http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

Other Identifiers

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KAG-302

Identifier Type: -

Identifier Source: secondary_id

CA200-003

Identifier Type: -

Identifier Source: org_study_id