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Sponsored by: |
PDL BioPharma, Inc. |
Information provided by: | PDL BioPharma, Inc. |
ClinicalTrials.gov Identifier: | NCT00425347 |
To identify the MTD of HuLuc63 administered intravenously (IV) for 4 doses.2. To evaluate the safety of HuLuc63 IV given every other week for 4 doses.
Condition | Intervention | Phase |
Multiple Myeloma |
Drug: HuLuc63 |
Phase I |
Genetics Home Reference related topics: | aceruloplasminemia hemophilia |
MedlinePlus related topics: | Cancer Multiple Myeloma |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study |
Official Title: | Phase I, Multi-Center, Open-Label, Dose Escalation Study of HuLuc63 (Humanized Anti-CS1 Monoclonal IgG1 Antibody) in Subjects With Advanced Multiple Myeloma |
Estimated Enrollment: | 50 |
Study Start Date: | December 2006 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Eligible subjects will be considered for inclusion in this study if they meet all of the following criteria:
Exclusion Criteria:
Subjects will be ineligible for this study if they meet any one of the following criteria:
United States, Arkansas | |||||
Arkansas Cancer Research Center | Recruiting | ||||
Little Rock, Arkansas, United States, 72205 | |||||
Contact: Monica Whitwell 501-526-6990 ext 2441 | |||||
Principal Investigator: Frits van Rhee, M.D. | |||||
United States, California | |||||
USC/Norris Cancer Hospital | Recruiting | ||||
Los Angeles, California, United States, 90033 | |||||
Contact: Lori Vergara 323-865-3938 | |||||
Principal Investigator: Ann Mohrbacher, M.D. | |||||
United States, Illinois | |||||
Northwestern University Feinberg School of Medicine | Recruiting | ||||
Chicago, Illinois, United States, 60611 | |||||
Contact: Simbi Acharya 312-695-1383 | |||||
Principal Investigator: Seema Singhal, M.D. | |||||
United States, Massachusetts | |||||
University of Massachusetts Memorial Healthcare- Univ. Campus | Recruiting | ||||
Worcester, Massachusetts, United States, 01655 | |||||
Contact: Tara Roy 508-856-1797 | |||||
Principal Investigator: Samer Al-Homsi, M.D. | |||||
Dana-Farber Cancer Institute | Recruiting | ||||
Boston, Massachusetts, United States, 02115 | |||||
Contact: Deanna Tocco 617-632-3619 | |||||
Principal Investigator: Nikhil Munshi, M.D. | |||||
United States, Michigan | |||||
Wayne State University | Recruiting | ||||
Detroit, Michigan, United States, 48201 | |||||
Contact: Zhiwei Sun 313-576-9453 | |||||
Principal Investigator: Jeffrey A. Zonder, M.D. | |||||
United States, Ohio | |||||
Cleveland Clinic | Recruiting | ||||
Cleveland, Ohio, United States, 44195 | |||||
Contact: Becky Habecker 216-445-2612 | |||||
Principal Investigator: Robert Dean, MD | |||||
United States, Washington | |||||
Fred Hutchinson Cancer Research Center | Recruiting | ||||
Seattle, Washington, United States, 98109 | |||||
Contact: Kathy Lilleby, RN 206-667-5836 | |||||
Principal Investigator: William Bensinger, MD |
PDL BioPharma, Inc. |
Principal Investigator: | William Bensinger, MD | Fred Hutchinson Cancer Research Center |
Principal Investigator: | Robert Dean, MD | Cleveland Clinic |
Principal Investigator: | Frits van Rhee, M.D. | Arkansas Cancer Research Center |
Principal Investigator: | Seema Singhal, M.D. | Northwestern University Feinberg School of Medicine |
Principal Investigator: | Jeffrey A. Zonder, M.D. | Wayne State University |
Principal Investigator: | Samer Al-Homsi, M.D. | University of Massachusetts Memorial Healthcare |
Principal Investigator: | Nikhil Munshi, M.D. | Dana-Farber Cancer Institute |
Principal Investigator: | Ann Mohrbacher, M.D. | USC/Norris Cancer Hospital |
Related Info 
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Responsible Party: | Not applicable for this trial. ( Not applicable for this trial. ) |
Study ID Numbers: | HuLuc63-1701 |
First Received: | January 18, 2007 |
Last Updated: | December 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00425347 |
Health Authority: | United States: Food and Drug Administration |
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