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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/Phase 3
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma

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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 InstitutionBaltimore, Maryland  
Local InstitutionBronx, New York  
Local InstitutionCorona, California  
Local InstitutionSpringfield, Massachusetts  
Local InstitutionLincoln, Nebraska  
Local InstitutionWilmington, North Carolina  
Local InstitutionDuncansville, Pennsylvania  
Local InstitutionNorth Charleston, South Carolina  
Local InstitutionRome, Georgia