A Study of Tanespimycin (KOS-953) in Patients With Relapsed-refractory Multiple Myeloma (TIME-2)

November 6, 2015 updated by: Bristol-Myers Squibb

Phase 2/3 Randomized, Open-Label Clinical Trial of Tanespimycin (KOS-953) Plus Bortezomib Comparing Three Doses of Tanespimycin in Patients With Relapsed-Refractory Multiple Myeloma

This is a phase 2/3, open label trial for patients with relapsed-refractory multiple myeloma. Study agent is tanespimycin (KOS-953), at three different dose levels in combination with a fixed dose of bortezomib.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Phase 2/3 combination study comparing bortezomib plus one of three doses of tanespimycin in patients with relapsed-refractory multiple myeloma after failure of at least three prior anti-cancer therapy regimens. Prior therapy must include bortezomib and lenalidomide. Primary objective is to assess the dose-response relationship of objective response rate (ORR) using EBMT/IBMTR criteria of any three dose levels of tanespimycin (KOS-953) in combination with bortezomib after four treatment cycles.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 2
  • 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

  • United States
    • California
      • Berkeley, California, United States, 94704
        • Local Institution
      • San Francisco, California, United States, 94143
        • Local Institution
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Local Institution
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Local Institution
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Local Institution
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Local Institution
    • New York
      • New York, New York, United States, 10011
        • Local Institution
      • New York, New York, United States, 10021
        • Local Institution
    • North Carolina
      • Winston Salem, North Carolina, United States, 27157
        • Local Institution
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • Local Institution
    • South Carolina
      • Columbia, South Carolina, United States, 29210
        • Local Institution

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
  • Histologic evidence of multiple myeloma
  • Have had at least three prior treatment regimens for multiple myeloma that included both bortezomib and lenalidomide
  • No prior treatment with a heat shock 90 inhibitor or an investigational proteasome inhibitor
  • No known infections of HAV, HBV, HCV, or HIV
  • No chemotherapy, radiation therapy, or immune therapy for three weeks prior to enrollment.

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
Experimental: tanespimycin and bortezomib
A patient will receive a standard dose of bortezomib followed by a high dose of tanespimycin.
Drug: tanespimycin
High dose
Other Names:
  • BMS-722782
Drug: Bortezomib
Mid dose, and low dose
Experimental: bortezomib and tanespimycin
A patient will receive a standard dose of bortezomib followed by a mid dose of tanespimycin.
Drug: tanespimycin
High dose
Other Names:
  • BMS-722782
Drug: Bortezomib
Mid dose, and low dose
Experimental: bortezomib tanespimycin
A patient will receive a standard dose of bortezomib followed by a low dose of tanespimycin.
Drug: tanespimycin
High dose
Other Names:
  • BMS-722782
Drug: Bortezomib
Mid dose, and low dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective Response Rate
Time Frame: approximately 3 months
approximately 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Response rate between treatment arms and time-to-event endpoints.
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

August 1, 2007

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

August 8, 2007

First Submitted That Met QC Criteria

August 8, 2007

First Posted (Estimate)

August 9, 2007

Study Record Updates

Last Update Posted (Estimate)

December 7, 2015

Last Update Submitted That Met QC Criteria

November 6, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA200-003
  • KAG-302

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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