A Study of Tanespimycin (KOS-953) in Patients With Relapsed-Refractory Multiple Myeloma - Full Text View

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00514371

Purpose

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	Intervention	Phase
Multiple Myeloma	Drug: tanespimycin and bortezomib	Phase II Phase III

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Multiple Myeloma

Drug Information available for: Bortezomib IPI-504 17-(Allylamino)-17-demethoxygeldanamycin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
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

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Objective Response Rate [ Time Frame: approximately 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Response rate between treatment arms and time-to-event endpoints. [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	130
Study Start Date:	August 2007
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A A patient will receive a standard dose of bortezomib followed by a high dose of tanespimycin.	Drug: tanespimycin and bortezomib High dose, mid dose, and low dose.
B A patient will receive a standard dose of bortezomib followed by a mid dose of tanespimycin.	Drug: tanespimycin and bortezomib High dose, mid dose, and low dose.
C A patient will receive a standard dose of bortezomib followed by a low dose of tanespimycin.	Drug: tanespimycin and bortezomib High dose, mid dose, and low dose.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00514371

Locations

United States, California
Local Institution
San Francisco, California, United States, 94143
Local Institution
Berkeley, California, United States, 94704
United States, Georgia
Local Institution
Augusta, Georgia, United States, 30912
United States, Maryland
Local Institution
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Local Institution
Boston, Massachusetts, United States, 02215
United States, Nebraska
Local Institution
Omaha, Nebraska, United States, 68114
United States, New York
Local Institution
New York, New York, United States, 10011
Local Institution
New York, New York, United States, 10021
Local Institution
New York, New York, United States, 10021
United States, North Carolina
Local Institution
Winston Salem, North Carolina, United States, 27157
United States, Pennsylvania
Local Institution
Pittsburgh, Pennsylvania, United States, 15224
United States, South Carolina
Local Institution
Columbia, South Carolina, United States, 29210

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CA200-003, KAG-302
Study First Received:	August 8, 2007
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00514371
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

Multiple Myeloma
Heat Shock Protein 90
Hsp90
KOS-953

17-AAG
bortezomib
relapsed-refractory
tanespimycin

Study placed in the following topic categories:

Immunoproliferative Disorders
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Bortezomib
Vascular Diseases
Paraproteinemias

Hemostatic Disorders
Multiple Myeloma
Hemorrhagic Disorders
Shock
Multiple myeloma
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Cardiovascular Diseases
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009