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Sponsors and Collaborators: |
Seattle Genetics, Inc. Genentech |
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Information provided by: | Seattle Genetics, Inc. |
ClinicalTrials.gov Identifier: | NCT00525447 |
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.
Condition | Intervention | Phase |
---|---|---|
Multiple Myeloma |
Drug: SGN-40 Drug: lenalidomide Drug: dexamethasone |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I Study of SGN-40 (Anti-huCD40 mAb), Lenalidomide (Revlimid®, cc 5013), and Dexamethasone in Patients With Multiple Myeloma (MM) |
Estimated Enrollment: | 38 |
Study Start Date: | August 2007 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: SGN-40
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.
Drug: lenalidomide
Up to 25 mg daily of a 21-day cycle.
Drug: dexamethasone
40 mg administered weekly.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Terri Lowe | 866-333-7436 | clinicaltrials@seagen.com |
United States, Colorado | |
Rocky Mountain Cancer Center | Recruiting |
Denver, Colorado, United States, 80218 | |
Principal Investigator: Jeffrey Matous, MD | |
United States, Florida | |
H. Lee Moffitt Cancer Center & Research Institute | Recruiting |
Tampa, Florida, United States, 33612 | |
Principal Investigator: Mohamad Hussein, MD | |
United States, Massachusetts | |
Dana Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Principal Investigator: Nikhil Munshi, MD | |
United States, Michigan | |
Barbara Ann Karmanos Cancer Institute | Recruiting |
Detroit, Michigan, United States, 48201 | |
Principal Investigator: Jeffrey Zonder, MD | |
United States, New York | |
Weill Medical College of Cornell University | Recruiting |
New York, New York, United States, 10021 | |
Principal Investigator: Ruben Niesvizky, MD | |
United States, South Dakota | |
Avera Cancer Institute | Recruiting |
Sioux Falls, South Dakota, United States, 57105 | |
Principal Investigator: R. Vinod Parameswaran, MD | |
United States, Texas | |
Baylor University Medical Center | Recruiting |
Dallas, Texas, United States, 75426 | |
Principal Investigator: Edward Agura, MD |
Study Director: | Nancy Whiting, PharmD | Seattle Genetics, Inc. |
Responsible Party: | Seattle Genetics, Inc. ( Nancy Whiting, PharmD ) |
Study ID Numbers: | SG040-0006 |
Study First Received: | August 31, 2007 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00525447 |
Health Authority: | United States: Food and Drug Administration |
Paraproteinemias Antigens, CD40 Antibodies, Monoclonal Combined Modality Therapy Multiple Myeloma Blood Coagulation Disorders Hematologic Diseases |
Hemorrhagic Disorders Hemostatic Disorders Immunoproliferative Disorders Lymphoproliferative Disorders Vascular Diseases Antibody-Dependent Cell Cytotoxicity |
Dexamethasone Immunoproliferative Disorders Hematologic Diseases Blood Protein Disorders Blood Coagulation Disorders Lenalidomide Vascular Diseases Paraproteinemias Hemostatic Disorders |
Multiple Myeloma Antibodies, Monoclonal Antibodies Hemorrhagic Disorders Multiple myeloma Lymphoproliferative Disorders Dexamethasone acetate Immunoglobulins Neoplasms, Plasma Cell |
Anti-Inflammatory Agents Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Gastrointestinal Agents Antiemetics |
Hormones Glucocorticoids Pharmacologic Actions Neoplasms Autonomic Agents Therapeutic Uses Cardiovascular Diseases Peripheral Nervous System Agents Central Nervous System Agents |