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Phase 3 Randomized, Open-Label Clinical Trial of Tanespimycin (KOS-953) Plus Bortezomib Compared to Bortezomib Alone in Patients With Multiple Myeloma in First Relapse


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

Thank you

Trial Information

Phase 3 Randomized, Open-Label Clinical Trial of Tanespimycin (KOS-953) Plus Bortezomib Compared to Bortezomib Alone in Patients With Multiple Myeloma in First Relapse


Phase 3 combination study comparing tanespimycin (KOS-953) plus bortezomib to bortezomib
alone in patients with multiple myeloma in first relapse after failure of previous
anti-cancer therapy and/or bone marrow transplantation. Primary objective is to compare the
progression-free survival (PFS) associated with the use of tanespimycin (KOS-953) in
combination with bortezomib versus that associated with administration of bortezomib alone.


Inclusion Criteria:



- Good Performance Status

- Documented evidence of multiple myeloma

- Documented progression of disease after initial response to one line of therapy

- Measurable disease (serum M-protein >.5g/dl or > 200 mg urinary M protein excretion)

Exclusion Criteria:

- Prior treatment with a heat shock 90 inhibitor or an investigational proteasome
inhibitor

- Known active infections of HAV, HBV, HCV, or HIV

- Administration of chemotherapy, radiation therapy, or immune therapy within 21 days
prior to randomization.

- Acute diffuse infiltrate pulmonary disease or pericardial dise

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Time Frame:

6-24 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:

CA200-004

NCT ID:

NCT00546780

Start Date:

February 2008

Completion Date:

March 2010

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Heat Shock Protein 90
  • Hsp90
  • KOS-953
  • 17-AAG
  • bortezomib
  • first relapse
  • tanespimycin
  • TIME-1
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
Medical College of WisconsinMilwaukee, Wisconsin  53226
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
University of Kansas Medical CenterKansas City, Kansas  66160-7353
Baylor University Medical CenterDallas, Texas  75246
Moores UCSD Cancer CenterLa Jolla, California  92093-0658
Comprehensive Blood and Cancer CenterBakersfield, California  93309
Rocky Mountain Cancer CentersThornton, Colorado  80260
Tennessee Cancer SpecialistsKnoxville, Tennessee  37920
Thomas Jefferson UniversityPhiladelphia, Pennsylvania  19107-6541
Henry Ford Health System IrbDetroit, Michigan  48202
University of Virginia Health SystemCharlottesville, Virginia  22903
Sarah Cannon Research InstituteNashville, Tennessee  37203
Kaiser Permanente Oncology/HematologyPortland, Oregon  97227
University of California Medical CenterSan Francisco, California  94143
Capitol Comprehensive Cancer Care CenterJefferson City, Missouri  65109
Columbia University Medical Center (Cumc)New York, New York  10032
Wake Forest Univ Health SciencesWinston-Salem, North Carolina  27157