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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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This is a Phase I, open-label, multi-dose trial to define the MTD and tolerability of a regimen including lenalidomide, dexamethasone, and intravenous SGN-40 in patients with relapsed multiple myeloma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SGN-40 | Drug | 2-12 mg/kg IV (in the vein) on Days 1, 4, 8, 15, and 22 of Cycle 1; 4-12 mg/kg IV (in the vein) on Days 1, 8, 15, and 22 of Cycles 2-4; 4-12 mg/kg IV (in the vein) on Days 1, 8, and 15 of Cycles 5-8. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events and lab abnormalities. | Within 3 weeks of final infusion of SGN-40 |
| Measure | Description | Time Frame |
|---|---|---|
| Best clinical response, progression-free survival, and overall survival. | Study duration | |
| PK profile. | Within 3 weeks of final infusion of SGN-40 | |
| Anti-drug antibody immune responses. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nancy Whiting, PharmD | Seagen Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rocky Mountain Cancer Center | Denver | Colorado | 80218 | United States | ||
| H. Lee Moffitt Cancer Center & Research Institute |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006474 | Hemorrhagic Disorders |
| D020141 | Hemostatic Disorders |
| D007160 | Immunoproliferative Disorders |
| D008232 | Lymphoproliferative Disorders |
| D010265 | Paraproteinemias |
| D014652 | Vascular Diseases |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C543331 | dacetuzumab |
| D000077269 | Lenalidomide |
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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|
| lenalidomide | Drug | Up to 25 mg daily of a 21-day cycle. |
|
|
| dexamethasone | Drug | 40 mg administered weekly. |
|
|
| Within 3 weeks of final infusion of SGN-40 |
| Tampa |
| Florida |
| 33612 |
| United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Nebraska Methodist Hospital | Omaha | Nebraska | 68114 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Weill Medical College of Cornell University | New York | New York | 10021 | United States |
| Avera Cancer Institute | Sioux Falls | South Dakota | 57105 | United States |
| Baylor University Medical Center | Dallas | Texas | 75246 | United States |
| D001796 |
| Blood Protein Disorders |
| D006425 | Hemic and Lymphatic Diseases |
| D007154 | Immune System Diseases |
| D008206 | Lymphatic Diseases |
| 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 |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |