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| Name | Class |
|---|---|
| Exelixis | INDUSTRY |
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To evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BMS-833923 administered alone, in combination with lenalidomide plus dexamethasone, or in combination with bortezomib in subjects with relapsed or refractory multiple myeloma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | BMS-833923 (Starting dose is a loading dose of 60 mg for 7 days with a 30 mg daily dose thereafter) |
|
| Arm 2 | Active Comparator | BMS-833923 (MTD or below) Lenalidomide (at or below the recommended prescribing dose) Dexamethasone (40 mg) |
|
| Arm 3 | Active Comparator | BMS-833923 (MTD or below) Bortezomib (at or below the recommended prescribing dose) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-833923 | Drug | Capsule, Oral, Once daily, 6 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To establish DLT(s), MTD, and Phase 2 dose range and schedule of BMS-833923 administered alone, in combination with two dose levels of lenalidomide plus dexamethasone, or with two dose levels of bortezomib in subjects with relapsed or refractory MM | For Treatment Arms A and B, outcome would be measured for approximately 5 months on Days 1, 8, 15, and 28 for Cycles 1 and 2 and then every 28 days for the following cycles |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerability of BMS-833923 as a single agent or in combination with two dose levels of lenalidomide plus a fixed low-dose of dexamethasone or in combination with two dose levels of bortezomib | For Treatment Arms A and B, outcome would be measured for approximately 5 months on Days 1, 8, 15, and 28 for Cycles 1 and 2 and then every 28 days for the following cycles | |
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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 |
|---|---|---|---|---|---|---|
| City Of Hope National Medical Center | Duarte | California | 91010 | United States | ||
| Moores Ucsd Cancer Center |
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| Lenalidomide |
| Drug |
Capsule, Oral, Once daily, 6 months |
|
|
| Dexamethasone | Drug | Capsule, Oral, Once a week, 6 months |
|
| Bortezomib | Drug | Powder, IV, On days 1, 4, 8, 11, 6 months |
|
|
| To evaluate the Pharmacokinetics of BMS-833923 |
| For Treatment Arms A and B, outcome would be measured for approximately 5 months on Days 1, 8, 15, and 28 for Cycles 1 and 2 and then every 28 days for the following cycles |
| To evaluate the Pharmacodynamics effects of BMS-833923 | For Treatment Arms A and B, outcome would be measured for approximately 5 months on Days 1, 8, 15, and 28 for Cycles 1 and 2 and then every 28 days for the following cycles |
| La Jolla |
| California |
| 92093 |
| United States |
| Local Institution | Los Angeles | California | 90048 | United States |
| The Sidney Kimmel Comprehensive Cancer Center | Baltimore | Maryland | 21231 | United States |
| Local Institution | Detroit | Michigan | 48201 | United States |
| John Theurer Cancer Center | Hackensack | New Jersey | 07601 | United States |
| Oncology Consultants, Pa | Houston | Texas | 77024 | United States |
| Cancer Therapy And Research Center | San Antonio | Texas | 78229 | United States |
| ID | Term |
|---|---|
| D046248 | Pyloric Stenosis, Hypertrophic |
| ID | Term |
|---|---|
| D011707 | Pyloric Stenosis |
| D017219 | Gastric Outlet Obstruction |
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C583051 | BMS-833923 |
| D000077269 | Lenalidomide |
| D003907 | Dexamethasone |
| D000069286 | Bortezomib |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D011719 | Pyrazines |
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