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Sponsored by: |
PDL BioPharma, Inc. |
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Information provided by: | PDL BioPharma, Inc. |
ClinicalTrials.gov Identifier: | NCT00726869 |
This Phase 1/2, multi-center, open-label, multiple-dose, dose escalation study will evaluate the combination of HuLuc63 and bortezomib in subjects with MM following 1 to 3 prior therapies. For the Phase 1 portion, HuLuc63 will be administered by intravenous (IV) injection at up to 4 dose levels ranging from 2.5 mg/kg to 20.0 mg/kg within 30 minutes following the administration of IV bortezomib at 1.3 mg/m2. Bortezomib will be given in 21 day cycles (twice weekly for 2 weeks on Days 1, 4, 8, and 11 followed by a 10-day rest period). HuLuc63 will be administered as a separate infusion within 30 minutes following the bortezomib infusion on the same days as the first and last dose of each bortezomib cycle (ie, Days 1 and 11).
Condition | Intervention | Phase |
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Multiple Myeloma |
Drug: HuLuc63 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 1/2, Multi-Center, Open-Label, Dose-Escalation Study of HuLuc63 (Humanized Anti CS1 Monoclonal IgG1 Antibody) and Bortezomib in Subjects With Multiple Myeloma Following One to Three Prior Therapies. |
Estimated Enrollment: | 49 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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No Arms: Experimental
Various concentrations of HuLuc63 (2.5 mg/kg; 5.0 mg/kg; 10.0 mg/kg; and 20.0 mg/kg)
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Drug: HuLuc63
Cohort 1 - 2.5 mg/kg HuLuc63 IV with bortezomib on Days 1 & 11, with only Bortezomib IV on Days 4 & 8; Cohort 2 - 5.0 mg/kg HuLuc63 IV with bortezomib on Days 1 & 11, with only Bortezomib IV on Days 4 & 8; Cohort 3 - 10.0 mg/kg HuLuc63 IV with bortezomib on Days 1 & 11, with only Bortezomib IV on Days 4 & 8; and Cohort 4 - 20.0 mg/kg HuLuc63 IV with bortezomib on Days 1 & 11, with only Bortezomib IV on Days 4 & 8.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Must have adequate bone marrow function defined as:
Exclusion Criteria:
Contact: Richard Levine, MD | 301-272-3224 |
United States, Illinois | |
The University of Chicago Medical Center | Recruiting |
Chicago, Illinois, United States, 60637-1470 | |
Contact: Todd Zimmerman, MD 773-702-4159 | |
Contact: Tamika Harris, CRC 773-702-4367 | |
Principal Investigator: Todd Zimmerman, MD | |
United States, Massachusetts | |
Dana-Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: Ken Anderson, MD 617-632-2145 | |
Contact: Leslie Lai, CRC 617-632-4950 | |
Principal Investigator: Ken Anderson, MD | |
United States, Michigan | |
University of Michigan | Recruiting |
Ann Arbor, Michigan, United States, 48109-5936 | |
Contact: Andrzej Jakubowiak, MD 734-647-8921 | |
Contact: Charles Leister, CRC 734-936-2740 | |
Principal Investigator: Andrzej Jakubowiak, MD | |
United States, New Jersey | |
Hackensack University Medical Center | Recruiting |
Hackensack, New Jersey, United States, 07601 | |
Contact: David Siegel, MD 201-996-5890 | |
Contact: Sharon Dailey, CRC 201-996-5234 | |
Principal Investigator: David Siegel, MD | |
United States, New York | |
Roswell Park Cancer Institute | Recruiting |
Buffalo, New York, United States, 14263 | |
Contact: Asher Chanan-Khan, MD 716-845-1647 | |
Contact: Deborah Donaldson, CRC 716-845-1647 | |
Principal Investigator: Asher Chanan-Khan, MD | |
United States, Washington | |
Fred Hutchinson Cancer Research Center | Recruiting |
Seattle, Washington, United States, 98109 | |
Contact: William Bensinger, MD 206-667-4933 | |
Contact: Kathy Liliby, CRC 206-667-5836 | |
Principal Investigator: William Bensinger, MD |
Principal Investigator: | Richard Levine, MD | Quintiles |
Responsible Party: | PDL BioPharma, Inc. ( Sheldon Mullins ) |
Study ID Numbers: | HuLuc63-1702 |
Study First Received: | July 29, 2008 |
Last Updated: | July 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00726869 |
Health Authority: | United States: Food and Drug Administration |
Patients After One to three Prior Therapies |
Immunoproliferative Disorders Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Bortezomib Vascular Diseases Paraproteinemias Hemostatic Disorders |
Multiple Myeloma Antibodies Hemorrhagic Disorders Multiple myeloma Lymphoproliferative Disorders Immunoglobulins Neoplasms, Plasma Cell |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Cardiovascular Diseases Pharmacologic Actions Protease Inhibitors |