Research

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

This study has been suspended.

Verified By Bristol-Myers Squibb, April 2009

Sponsors:	Bristol-Myers Squibb
Information Provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00546780

Purpose

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.

Condition	Intervention	Phase
Multiple Myeloma	Drug: Tanespimycin Drug: Bortezomib	Phase3

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
Official Title:	Phase 3 Randomized, Open-Label Clinical Trial of Tanespimycin (KOS-953) Plus Bortezomib Compared to Bortezomib Alone in Patients With Multiple Myeloma in First Relapse

Further study details as provided by Bristol-Myers Squibb

Primary Outcome Measures:

Progression-free survival [ Time Frame: 6-24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall survival in each arm of the study [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	740
Study Start Date:	February 2008
Estimated Completion Date:	December 2016

Arm	Assigned Interventions
Arm A: Active Comparator Tanespimycin + Bortezomib	Drug: Tanespimycin Solution, IV, 340mg/m2, twice weekly for 2 weeks (3 week cycle), 60 minutes infusion Drug: Bortezomib Solution, IV, 1.3 mg/m2, twice weekly for 2 weeks (3 weeks cycle), 3-5 minute bolus
Arm B: Active Comparator Bortezomib	Drug: Bortezomib Solution, IV, 1.3 mg/m2, twice weekly for 2 weeks (3 weeks cycle), 3-5 minute bolus

Detail 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.

Eligibility

Ages Eligible for Study:	18 Years And Older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 Criteria:
Prior treatment with a heat shock 90 inhibitor or an investigational proteasome inhibitor
Known active infections of HAV, HBV, HCV, or HIV
Administration of chemotherapy, radiation therapy, or immune therapy within 21 days prior to randomization.
Acute diffuse infiltrate pulmonary disease or pericardial dise

Contacts And Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00546780

Locations

Wake Forest Univ Health Sciences

Winston-Salem North Carolina, 27157

Sponsors And Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure Investigator Inquiry form For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm

Study ID Numbers:	CA200-004 , KAG-301
Study First Received:	2007-10-17
Last Updated:	2009-11-16
ClinicalTrials.gov Identifier:	NCT00546780
Health Authority:	United States: Food and Drug Administration

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