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

June 21, 2011 updated by: Bristol-Myers Squibb

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

31

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Local Institution
  • United States
    • California
      • Bakersfield, California, United States, 93309
        • Comprehensive Blood and Cancer Center
      • La Jolla, California, United States, 92093
        • Moores UCSD Cancer Center
      • San Francisco, California, United States, 94143
        • University of California Medical Center
    • Colorado
      • Denver, Colorado, United States, 80218
        • Rocky Mountain Cancer Centers
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Kansas
      • Westwood, Kansas, United States, 66205
        • University of Kansas Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System Irb
    • Missouri
      • Jefferson City, Missouri, United States, 65109
        • Capitol Comprehensive Cancer Care Center
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center (CUMC)
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Univ Health Sciences
    • Oregon
      • Portland, Oregon, United States, 97227
        • Kaiser Permanente Oncology/Hematology
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • Tennessee Cancer Specialists
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor University Medical Center
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Health System
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival
Time Frame: 6-24 months
6-24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival in each arm of the study
Time Frame: Up to 24 months
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

October 17, 2007

First Submitted That Met QC Criteria

October 18, 2007

First Posted (Estimate)

October 19, 2007

Study Record Updates

Last Update Posted (Estimate)

June 28, 2011

Last Update Submitted That Met QC Criteria

June 21, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA200-004
  • KAG-301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe