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

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tanespimycin
Bortezomib
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, Heat Shock Protein 90, Hsp90, KOS-953, 17-AAG, bortezomib, first relapse, tanespimycin, TIME-1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Comprehensive Blood And Cancer Center
  • Moores Ucsd Cancer Center
  • University Of California Medical Center
  • Rocky Mountain Cancer Centers
  • University Of Iowa Hospitals And Clinics
  • University Of Kansas Medical Center
  • Dana-Farber Cancer Institute
  • Henry Ford Health System Irb
  • Capitol Comprehensive Cancer Care Center
  • Columbia University Medical Center (Cumc)
  • Wake Forest Univ Health Sciences
  • Kaiser Permanente Oncology/Hematology
  • Thomas Jefferson University
  • Tennessee Cancer Specialists
  • Sarah Cannon Research Institute
  • Baylor University Medical Center
  • University Of Virginia Health System
  • Medical College Of Wisconsin
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Arm A

Arm B

Arm Description

Tanespimycin + Bortezomib

Bortezomib

Outcomes

Primary Outcome Measures

Progression-free survival

Secondary Outcome Measures

Overall survival in each arm of the study

Full Information

First Posted
October 17, 2007
Last Updated
June 21, 2011
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00546780
Brief Title
A Study of Tanespimycin (KOS-953) in Patients With Multiple Myeloma in First Relapse
Acronym
BMS TIME-1
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 Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple Myeloma, Heat Shock Protein 90, Hsp90, KOS-953, 17-AAG, bortezomib, first relapse, tanespimycin, TIME-1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Active Comparator
Arm Description
Tanespimycin + Bortezomib
Arm Title
Arm B
Arm Type
Active Comparator
Arm Description
Bortezomib
Intervention Type
Drug
Intervention Name(s)
Tanespimycin
Other Intervention Name(s)
BMS-722782
Intervention Description
Solution, IV, 340mg/m2, twice weekly for 2 weeks (3 week cycle), 60 minutes infusion
Intervention Type
Drug
Intervention Name(s)
Bortezomib
Intervention Description
Solution, IV, 1.3 mg/m2, twice weekly for 2 weeks (3 weeks cycle), 3-5 minute bolus
Primary Outcome Measure Information:
Title
Progression-free survival
Time Frame
6-24 months
Secondary Outcome Measure Information:
Title
Overall survival in each arm of the study
Time Frame
Up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Comprehensive Blood And Cancer Center
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Moores Ucsd Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
University Of California Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
University Of Iowa Hospitals And Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University Of Kansas Medical Center
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Henry Ford Health System Irb
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Capitol Comprehensive Cancer Care Center
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65109
Country
United States
Facility Name
Columbia University Medical Center (Cumc)
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Wake Forest Univ Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Kaiser Permanente Oncology/Hematology
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Tennessee Cancer Specialists
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
University Of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Medical College Of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Local Institution
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada

12. IPD Sharing Statement

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

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