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
18 Years
N/A
Both
Multiple Myeloma
Trial Information
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
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Objective Response Rate
Outcome Time Frame:
approximately 3 months
Safety Issue:
No
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
United States: Food and Drug Administration
Study ID:
CA200-003
NCT ID:
NCT00514371
Start Date:
August 2007
Completion Date:
February 2009
Related Keywords:
- Multiple Myeloma
- Multiple Myeloma
- Heat Shock Protein 90
- Hsp90
- KOS-953
- 17-AAG
- bortezomib
- relapsed-refractory
- tanespimycin
- Multiple Myeloma
- Neoplasms, Plasma Cell
Name | Location |
|---|---|
| Local Institution | Baltimore, Maryland |
| Local Institution | Bronx, New York |
| Local Institution | Corona, California |
| Local Institution | Springfield, Massachusetts |
| Local Institution | Lincoln, Nebraska |
| Local Institution | Wilmington, North Carolina |
| Local Institution | Duncansville, Pennsylvania |
| Local Institution | North Charleston, South Carolina |
| Local Institution | Rome, Georgia |
