A Study of Tanespimycin (KOS-953) in Patients With Relapsed-refractory Multiple Myeloma (TIME-2)
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00514371
First received: August 8, 2007
Last updated: September 15, 2010
Last verified: November 2009
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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:
MedlinePlus related topics:
Multiple Myeloma
Drug Information available for:
Bortezomib
U.S. FDA Resources
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
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 Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders |
Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Bortezomib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013