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

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ClinicalTrials.gov Identifier: NCT00546780
Recruitment Status : Completed
First Posted : October 19, 2007
Last Update Posted : June 28, 2011
Information provided by:
Bristol-Myers Squibb

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Tanespimycin Drug: Bortezomib Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : February 2008
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Bortezomib

Arm Intervention/treatment
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
Drug: Bortezomib
Solution, IV, 1.3 mg/m2, twice weekly for 2 weeks (3 weeks cycle), 3-5 minute bolus

Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: 6-24 months ]

Secondary Outcome Measures :
  1. Overall survival in each arm of the study [ Time Frame: Up to 24 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00546780

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Sponsors and Collaborators
Bristol-Myers Squibb
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
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Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00546780    
Other Study ID Numbers: CA200-004
First Posted: October 19, 2007    Key Record Dates
Last Update Posted: June 28, 2011
Last Verified: June 2011
Keywords provided by Bristol-Myers Squibb:
Multiple Myeloma
Heat Shock Protein 90
first relapse
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Disease Attributes
Pathologic Processes
Antineoplastic Agents