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A Study of Tanespimycin (KOS-953) in Patients With Multiple Myeloma in First Relapse (BMS TIME-1)

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00546780
First received: October 17, 2007
Last updated: June 21, 2011
Last verified: June 2011
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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:

Drug Information available for: Bortezomib
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 ]

Enrollment: 31
Study Start Date: February 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm A
Tanespimycin + Bortezomib
 Drug: Tanespimycin
Solution, IV, 340mg/m2, twice weekly for 2 weeks (3 week cycle), 60 minutes infusion
Other Name: BMS-722782
Drug: Bortezomib
Solution, IV, 1.3 mg/m2, twice weekly for 2 weeks (3 weeks cycle), 3-5 minute bolus
Active Comparator: Arm B
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 19 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb 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: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00546780     History of Changes
Other Study ID Numbers: CA200-004, KAG-301
Study First Received: October 17, 2007
Last Updated: June 21, 2011
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:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
 Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Bortezomib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013