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Sponsors and Collaborators: |
Applied Molecular Evolution Eli Lilly and Company |
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Information provided by: | Applied Molecular Evolution |
ClinicalTrials.gov Identifier: | NCT00689507 |
This is a study of a drug known as LY2127399, which will be given with a common treatment for multiple myeloma called bortezomib (Velcade). The primary purpose of this study is to (1)Determine the safety of LY2127399 in combination with bortezomib and any side effects that might be associated with it; (2)Assess whether LY2127399 in combination with bortezomib may help patients with relapsed or refractory multiple myeloma; (3)How much LY2127399 should be given to patients along with bortezomib.
Condition | Intervention | Phase |
---|---|---|
Relapsed or Refractory Multiple Myeloma |
Biological: LY2127399 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | A Phase 1 Safety Study of LY2127399 in Combination With Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma |
Estimated Enrollment: | 50 |
Study Start Date: | March 2008 |
Estimated Primary Completion Date: | June 2010 (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:
Have adequate organ function including:
Exclusion Criteria:
Contact: Susan Carpenter, PhD | 858-597-4990 | carpentersu@lilly.com |
United States, California | |
UCLA | Recruiting |
Los Angeles, California, United States, 90024 | |
Contact: Rose Malone 310-794-0244 rmalone@mednet.ucla.edu | |
United States, Iowa | |
University of Iowa Hospitals and Clinics | Recruiting |
Iowa City, Iowa, United States, 52242 | |
Principal Investigator: Raymond Hohl, MD | |
United States, Massachusetts | |
Dana Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Principal Investigator: Noopur Raje, MD | |
United States, Nebraska | |
University of Nebraska Medical Center | Recruiting |
Omaha, Nebraska, United States, 68198 | |
Principal Investigator: Julie Vose, MD | |
United States, New York | |
St. Vincent's Comprehensive Cancer Center | Not yet recruiting |
New York, New York, United States, 10011 | |
Principal Investigator: Sundar Jagannath, MD | |
United States, Pennsylvania | |
Fox Chase Cancer Center | Recruiting |
Philadelphia, Pennsylvania, United States, 19111 | |
Principal Investigator: Hossein Borghaei, DO |
Study Director: | Susan Carpenter, PhD | Applied Molecular Evolution |
Responsible Party: | Applied Molecular Evolution/Eli Lilly ( Susan Carpenter, PhD ) |
Study ID Numbers: | H9S-MC-JDCF(a) |
Study First Received: | May 29, 2008 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00689507 |
Health Authority: | United States: Food and Drug Administration |
Multiple Myeloma Relapsed Refractory Bortezomib Velcade |
Immunoproliferative Disorders Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Bortezomib Vascular Diseases Paraproteinemias |
Hemostatic Disorders Multiple Myeloma Hemorrhagic Disorders Multiple myeloma Lymphoproliferative Disorders Neoplasms, Plasma Cell |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Cardiovascular Diseases Pharmacologic Actions Protease Inhibitors |