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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00546780
Recruitment Status : Completed
First Posted : October 19, 2007
Last Update Posted : June 28, 2011
Sponsor:
Information provided by:
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE October 17, 2007
First Posted Date  ICMJE October 19, 2007
Last Update Posted Date June 28, 2011
Study Start Date  ICMJE February 2008
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 21, 2008)
Progression-free survival [ Time Frame: 6-24 months ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 21, 2008)
Overall survival in each arm of the study [ Time Frame: Up to 24 months ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Tanespimycin (KOS-953) in Patients With Multiple Myeloma in First Relapse
Official Title  ICMJE 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
Brief Summary 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Myeloma
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Arm A
    Tanespimycin + Bortezomib
    Interventions:
    • Drug: Tanespimycin
    • Drug: Bortezomib
  • Active Comparator: Arm B
    Bortezomib
    Intervention: Drug: Bortezomib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 10, 2011)
31
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE March 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries Austria,   Czech Republic,   France,   Germany,   Greece,   Ireland,   Italy,   Netherlands,   Poland,   Spain,   United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT00546780
Other Study ID Numbers  ICMJE CA200-004
KAG-301
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Study Director, Bristol-Myers Squibb
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Bristol-Myers Squibb
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP