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Sponsors and Collaborators: |
Biotest Pharmaceuticals Corporation Biotest |
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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 |
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: Vicki Carroll 404-778-1805 vcarrol@emory.edu | |
United States, Massachusetts | |
Dana-Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: Deborah Doss 617-632-5672 Deborah_Doss@dfci.harvard.edu | |
United States, New York | |
Roswell Park Cancer Institute | Recruiting |
Buffalo, New York, United States, 14263 | |
Contact: Colleen Borsuk 716-845-1657 Colleen.Borsuk@RoswellPark.org | |
St. Vincent's Comprehensive Cancer Center | Recruiting |
New York, New York, United States, 10011 | |
Contact: Ann Marshak 212-367-0195 amarshak@aptiumoncology.com |
Study Director: | Kenneth C. Anderson, MD | Dana-Farber Cancer Institute |
Responsible Party: | Biotest AG ( Andrea Wartenberg-Demand, M.D. ) |
Study ID Numbers: | 969 |
Study First Received: | July 24, 2008 |
Last Updated: | February 11, 2009 |
ClinicalTrials.gov Identifier: | NCT00723359 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Multiple Myeloma Refractory Relapsed |
Immunoproliferative Disorders Hemorrhagic Disorders Hematologic Diseases Blood Protein Disorders Blood Coagulation Disorders Vascular Diseases |
Paraproteinemias Lymphoproliferative Disorders Hemostatic Disorders Neoplasms, Plasma Cell Multiple Myeloma |
Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Blood Protein Disorders Hematologic Diseases Vascular Diseases Paraproteinemias |
Hemostatic Disorders Multiple Myeloma Neoplasms Hemorrhagic Disorders Cardiovascular Diseases Lymphoproliferative Disorders Neoplasms, Plasma Cell |