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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00514371
First received: August 8, 2007
Last updated: September 15, 2010
Last verified: November 2009
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma
Drug: tanespimycin and bortezomib
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Objective Response Rate [ Time Frame: approximately 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate between treatment arms and time-to-event endpoints. [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: August 2007
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A
A patient will receive a standard dose of bortezomib followed by a high dose of tanespimycin.
Drug: tanespimycin and bortezomib
High dose, mid dose, and low dose.
Other Name: BMS-722782
B
A patient will receive a standard dose of bortezomib followed by a mid dose of tanespimycin.
Drug: tanespimycin and bortezomib
High dose, mid dose, and low dose.
Other Name: BMS-722782
C
A patient will receive a standard dose of bortezomib followed by a low dose of tanespimycin.
Drug: tanespimycin and bortezomib
High dose, mid dose, and low dose.
Other Name: BMS-722782

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00514371

Locations
United States, California
Local Institution
Berkeley, California, United States, 94704
Local Institution
San Francisco, California, United States, 94143
United States, Georgia
Local Institution
Augusta, Georgia, United States, 30912
United States, Maryland
Local Institution
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Local Institution
Boston, Massachusetts, United States, 02215
United States, Nebraska
Local Institution
Omaha, Nebraska, United States, 68114
United States, New York
Local Institution
New York, New York, United States, 10011
Local Institution
New York, New York, United States, 10021
United States, North Carolina
Local Institution
Winston Salem, North Carolina, United States, 27157
United States, Pennsylvania
Local Institution
Pittsburgh, Pennsylvania, United States, 15224
United States, South Carolina
Local Institution
Columbia, South Carolina, United States, 29210
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00514371     History of Changes
Other Study ID Numbers: CA200-003, KAG-302
Study First Received: August 8, 2007
Last Updated: September 15, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Multiple Myeloma
Heat Shock Protein 90
Hsp90
KOS-953
17-AAG
bortezomib
relapsed-refractory
tanespimycin

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases
Bortezomib
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014