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| Sponsor: | Facet Biotech |
|---|---|
| Collaborator: |
Bristol-Myers Squibb |
| Information provided by (Responsible Party): | Facet Biotech |
| ClinicalTrials.gov Identifier: | NCT00726869 |
Purpose
This Phase 1/2, multi-center, open-label, multiple-dose, dose escalation study will evaluate the combination of elotuzumab and bortezomib in subjects with MM following 1 to 3 prior therapies. For the Phase 1 portion, elotuzumab will be administered by intravenous (IV) infusion at up to 4 dose levels ranging from 2.5 mg/kg to 20.0 mg/kg within 30 minutes following the administration of bortezomib at 1.3 mg/m^2 IV bolus. 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). Elotuzumab will be administered as a separate infusion within 30 minutes following bortezomib administration on the same days as the first and last dose of each bortezomib cycle (ie, Days 1 and 11).
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma |
Drug: Elotuzumab (HuLuc63) |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1/2, Multi-Center, Open-label, Dose-escalation Study of Elotuzumab (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: | September 2011 |
| Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: elotuzumab
Various concentrations of elotuzumab (2.5 mg/kg; 5.0 mg/kg; 10.0 mg/kg; and 20.0 mg/kg)
|
Drug: Elotuzumab (HuLuc63)
Cohort 1 - 2.5 mg/kg elotuzumab IV with bortezomib on Days 1 & 11, with only Bortezomib IV on Days 4 & 8; Cohort 2 - 5.0 mg/kg elotuzumab IV with bortezomib on Days 1 & 11, with only Bortezomib IV on Days 4 & 8; Cohort 3 - 10.0 mg/kg elotuzumab 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.
Other Name: Elotuzumab
|
Eligibility| 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:
Contacts and Locations| United States, California | |
| USC/Norris Cancer Center | |
| Los Angeles, California, United States, 90033 | |
| United States, Illinois | |
| The University of Chicago Medical Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Michigan | |
| University of Michigan | |
| Ann Arbor, Michigan, United States, 48109-5936 | |
| United States, New Jersey | |
| Hackensack University Medical Center | |
| Hackensack, New Jersey, United States, 07601 | |
| United States, New York | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263 | |
| United States, Ohio | |
| Ohio State University Medical Center | |
| Columbus, Ohio, United States, 43210 | |
| United States, Washington | |
| Fred Hutchinson Cancer Research Center | |
| Seattle, Washington, United States, 98109 | |
More Information
| Responsible Party: | Facet Biotech |
| ClinicalTrials.gov Identifier: | NCT00726869 History of Changes |
| Other Study ID Numbers: | HuLuc63-1702 |
| Study First Received: | July 29, 2008 |
| Last Updated: | August 30, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Patients After One to three Prior Therapies |
|
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders |
Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Bortezomib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |