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

Sponsor:	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	Phase III

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

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Multiple Myeloma

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

U.S. FDA Resources

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 Study Completion Date:	May 2017
Estimated Primary Completion Date:	May 2017 (Final data collection date for primary outcome measure)

Arms	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

Detailed 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

Show 123 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

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

Investigator Inquiry form 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

No publications provided

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CA200-004, KAG-301
Study First Received:	October 17, 2007
Last Updated:	February 3, 2010
ClinicalTrials.gov Identifier:	NCT00546780 History of Changes
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
first relapse
tanespimycin
TIME-1

Additional relevant MeSH terms:

Disease Attributes
Immunoproliferative Disorders
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents
Blood Protein Disorders
Hematologic Diseases
Bortezomib
Vascular Diseases
Enzyme Inhibitors
Paraproteinemias

Hemostatic Disorders
Pharmacologic Actions
Recurrence
Protease Inhibitors
Multiple Myeloma
Neoplasms
Pathologic Processes
Hemorrhagic Disorders
Therapeutic Uses
Cardiovascular Diseases
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

ClinicalTrials.gov processed this record on February 08, 2010