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

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 2
Locations
United States
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, relapsed-refractory, tanespimycin

Eligibility Criteria

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

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.

Sites / Locations

  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

tanespimycin and bortezomib

bortezomib and tanespimycin

bortezomib tanespimycin

Arm Description

A patient will receive a standard dose of bortezomib followed by a high dose of tanespimycin.

A patient will receive a standard dose of bortezomib followed by a mid dose of tanespimycin.

A patient will receive a standard dose of bortezomib followed by a low dose of tanespimycin.

Outcomes

Primary Outcome Measures

Objective Response Rate

Secondary Outcome Measures

Response rate between treatment arms and time-to-event endpoints.

Full Information

First Posted
August 8, 2007
Last Updated
November 6, 2015
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00514371
Brief Title
A Study of Tanespimycin (KOS-953) in Patients With Relapsed-refractory Multiple Myeloma
Acronym
TIME-2
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

5. Study Description

Brief Summary
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.
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.

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, relapsed-refractory, tanespimycin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tanespimycin and bortezomib
Arm Type
Experimental
Arm Description
A patient will receive a standard dose of bortezomib followed by a high dose of tanespimycin.
Arm Title
bortezomib and tanespimycin
Arm Type
Experimental
Arm Description
A patient will receive a standard dose of bortezomib followed by a mid dose of tanespimycin.
Arm Title
bortezomib tanespimycin
Arm Type
Experimental
Arm Description
A patient will receive a standard dose of bortezomib followed by a low dose of tanespimycin.
Intervention Type
Drug
Intervention Name(s)
tanespimycin
Other Intervention Name(s)
BMS-722782
Intervention Description
High dose
Intervention Type
Drug
Intervention Name(s)
Bortezomib
Intervention Description
Mid dose, and low dose
Primary Outcome Measure Information:
Title
Objective Response Rate
Time Frame
approximately 3 months
Secondary Outcome Measure Information:
Title
Response rate between treatment arms and time-to-event endpoints.
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 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.
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
Local Institution
City
Berkeley
State/Province
California
ZIP/Postal Code
94704
Country
United States
Facility Name
Local Institution
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Local Institution
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Local Institution
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Local Institution
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Local Institution
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Local Institution
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
Local Institution
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Local Institution
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Local Institution
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Local Institution
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29210
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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