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Sponsors and Collaborators: |
Biotest Pharmaceuticals Corporation Biotest AG |
Information provided by: | Biotest Pharmaceuticals Corporation |
ClinicalTrials.gov Identifier: | NCT00723359 |
This Phase I research study is to test the effects (good and bad) and best dose of BT062 in treating patients with relapsed or refractory multiple myeloma.
Condition | Intervention | Phase |
Multiple Myeloma |
Drug: BT062 |
Phase I |
Genetics Home Reference related topics: | aceruloplasminemia hemophilia |
MedlinePlus related topics: | Cancer Multiple Myeloma |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I Dose Escalation Study to Evaluate Maximum Tolerated Dose (MTD), Pharmacokinetics (PK), and Safety of BT062 in Subjects With Relapsed or Relapsed/Refractory Multiple Myeloma |
Estimated Enrollment: | 40 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | May 2010 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
I: Experimental |
Drug: BT062
biologic
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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: Kate Johnson, Clinical Project Manager | 508-597-5873 | KatelynJohnson@averionintl.com |
United States, Georgia | |||||
Emory University Winship Cancer Institute | Recruiting | ||||
Atlanta, Georgia, United States, 30322 | |||||
Contact: Renee Smith 404-778-5144 rgsmith@emory.edu | |||||
United States, Massachusetts | |||||
Dana-Farber Cancer Institute | Not yet recruiting | ||||
Boston, Massachusetts, United States, 02115 | |||||
Contact: Diane Warren 617-632-4295 Diane_Warren@dfci.harvard.edu | |||||
United States, New York | |||||
Roswell Park Cancer Institute | Recruiting | ||||
Buffalo, New York, United States, 14263 | |||||
Contact: Asher A. Chanan-Khan, MD 716-845-3221 Asher.Chanan-Khan@RoswellPark.org | |||||
St. Vincent's Comprehensive Cancer Center | Not yet recruiting | ||||
New York, New York, United States, 10011 | |||||
Contact: Lori Megharian 212-367-1711 Lmegherian@aptiumoncology.com |
Biotest Pharmaceuticals Corporation |
Biotest AG |
Study Director: | Kenneth C. Anderson, MD | Dana-Farber Cancer Institute |
Responsible Party: | Biotest AG ( Andrea Wartenberg-Demand, M.D. ) |
Study ID Numbers: | 969 |
First Received: | July 24, 2008 |
Last Updated: | September 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00723359 |
Health Authority: | United States: Food and Drug Administration |
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