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| ID | Type | Description | Link |
|---|---|---|---|
| KAG-301 |
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This is a phase 3, open label trial for patients with multiple myeloma in first relapse. Trial will compare tanespimycin (KOS-953), in combination with a fixed dose of bortezomib versus bortezomib alone.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Active Comparator | Tanespimycin + Bortezomib |
|
| Arm B | Active Comparator | Bortezomib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tanespimycin | Drug | Solution, IV, 340mg/m2, twice weekly for 2 weeks (3 week cycle), 60 minutes infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | 6-24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival in each arm of the study | Up to 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Blood And Cancer Center | Bakersfield | California | 93309 | United States | ||
| Moores Ucsd Cancer Center |
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| Bortezomib | Drug | Solution, IV, 1.3 mg/m2, twice weekly for 2 weeks (3 weeks cycle), 3-5 minute bolus |
|
| La Jolla |
| California |
| 92093 |
| United States |
| University Of California Medical Center | San Francisco | California | 94143 | United States |
| Rocky Mountain Cancer Centers | Denver | Colorado | 80218 | United States |
| University Of Iowa Hospitals And Clinics | Iowa City | Iowa | 52242 | United States |
| University Of Kansas Medical Center | Westwood | Kansas | 66205 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Henry Ford Health System Irb | Detroit | Michigan | 48202 | United States |
| Capitol Comprehensive Cancer Care Center | Jefferson City | Missouri | 65109 | United States |
| Columbia University Medical Center (Cumc) | New York | New York | 10032 | United States |
| Wake Forest Univ Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| Kaiser Permanente Oncology/Hematology | Portland | Oregon | 97227 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| Tennessee Cancer Specialists | Knoxville | Tennessee | 37920 | United States |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| Baylor University Medical Center | Dallas | Texas | 75246 | United States |
| University Of Virginia Health System | Charlottesville | Virginia | 22908 | United States |
| Medical College Of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Local Institution | Edmonton | Alberta | T6G 1Z2 | Canada |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C112765 | tanespimycin |
| D000069286 | Bortezomib |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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