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
18 Years
N/A
Both
Multiple Myeloma
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 Clinics | Iowa City, Iowa 52242 |
| Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
| University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
| Baylor University Medical Center | Dallas, Texas 75246 |
| Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
| Comprehensive Blood and Cancer Center | Bakersfield, California 93309 |
| Rocky Mountain Cancer Centers | Thornton, Colorado 80260 |
| Tennessee Cancer Specialists | Knoxville, Tennessee 37920 |
| Thomas Jefferson University | Philadelphia, Pennsylvania 19107-6541 |
| Henry Ford Health System Irb | Detroit, Michigan 48202 |
| University of Virginia Health System | Charlottesville, Virginia 22903 |
| Sarah Cannon Research Institute | Nashville, Tennessee 37203 |
| Kaiser Permanente Oncology/Hematology | Portland, Oregon 97227 |
| University of California Medical Center | San Francisco, California 94143 |
| Capitol Comprehensive Cancer Care Center | Jefferson City, Missouri 65109 |
| Columbia University Medical Center (Cumc) | New York, New York 10032 |
| Wake Forest Univ Health Sciences | Winston-Salem, North Carolina 27157 |
