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| ID | Type | Description | Link |
|---|---|---|---|
| KAG-302 |
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This is a phase 2/3, open label trial for patients with relapsed-refractory multiple myeloma. Study agent is tanespimycin (KOS-953), at three different dose levels in combination with a fixed dose of bortezomib.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tanespimycin and bortezomib | Experimental | A patient will receive a standard dose of bortezomib followed by a high dose of tanespimycin. |
|
| bortezomib and tanespimycin | Experimental | A patient will receive a standard dose of bortezomib followed by a mid dose of tanespimycin. |
|
| bortezomib tanespimycin | Experimental | A patient will receive a standard dose of bortezomib followed by a low dose of tanespimycin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tanespimycin | Drug | High dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | approximately 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate between treatment arms and time-to-event endpoints. | Up to 24 months |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Berkeley | California | 94704 | United States | ||
| Local Institution |
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| Bortezomib | Drug | Mid dose, and low dose |
|
| San Francisco |
| California |
| 94143 |
| United States |
| Local Institution | Augusta | Georgia | 30912 | United States |
| Local Institution | Baltimore | Maryland | 21201 | United States |
| Local Institution | Boston | Massachusetts | 02215 | United States |
| Local Institution | Omaha | Nebraska | 68114 | United States |
| Local Institution | New York | New York | 10011 | United States |
| Local Institution | New York | New York | 10021 | United States |
| Local Institution | Winston-Salem | North Carolina | 27157 | United States |
| Local Institution | Pittsburgh | Pennsylvania | 15224 | United States |
| Local Institution | Columbia | South Carolina | 29210 | United States |
| 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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