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| Sponsor: | Biotest Pharmaceuticals Corporation |
|---|---|
| Collaborator: |
Biotest |
| Information provided by (Responsible Party): | Biotest Pharmaceuticals Corporation |
| ClinicalTrials.gov Identifier: | NCT01001442 |
Purpose
This Phase I/IIa clinical study is to test safety and anti-tumor activity of BT062 to define the best dose in treating patients with relapsed or refractory multiple myeloma with multiple doses of BT062.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma |
Drug: BT062 |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I/IIa Multi-Dose Escalation Study to Evaluate Maximum Tolerated Dose (MTD), Pharmacokinetics (PK), Safety and Efficacy of BT062 in Subjects With Relapsed or Relapsed/Refractory Multiple Myeloma |
| Estimated Enrollment: | 70 |
| Study Start Date: | August 2010 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: BT062 |
Drug: BT062
intravenous administration
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Michelle Beelitz, Manager Clin. Research | 561-989-5577 | mbeelitz@biotestpharma.com |
| United States, Georgia | |
| Emory University Winship Cancer Institute | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| United States, Illinois | |
| The University of Chicago | Recruiting |
| Chicago, Illinois, United States, 60637 | |
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| United States, New York | |
| Roswell Park Cancer Institute | Recruiting |
| Buffalo, New York, United States, 14263 | |
| The Mount Sinai School of Medicine | Recruiting |
| New York, New York, United States, 10029 | |
| Study Director: | Kenneth C. Anderson, MD | Dana-Farber Cancer Institute |
More Information
| Responsible Party: | Biotest Pharmaceuticals Corporation |
| ClinicalTrials.gov Identifier: | NCT01001442 History of Changes |
| Other Study ID Numbers: | 975 |
| Study First Received: | October 22, 2009 |
| Last Updated: | December 15, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Multiple myeloma Relapsed Refractory |
|
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 |