|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Applied Molecular Evolution |
|---|---|
| Collaborator: |
Eli Lilly and Company |
| Information provided by: | Applied Molecular Evolution |
| ClinicalTrials.gov Identifier: | NCT00689507 |
Purpose
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: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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) |
Eligibility| 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:
Contacts and Locations| Contact: Susan Carpenter, PhD | 858-597-4990 | carpentersu@lilly.com |
| United States, Alabama | |
| University of Alabama | Recruiting |
| Birmingham, Alabama, United States, 35294-3300 | |
| Contact: Gail Dubose 205-975-7162 gail.dubose@ccc.uab.edu | |
| Principal Investigator: Andres Forero-Torres, MD | |
| 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, Pennsylvania | |
| Fox Chase Cancer Center | Recruiting |
| Philadelphia, Pennsylvania, United States, 19111 | |
| Principal Investigator: Hossein Borghaei, DO | |
| Study Director: | Susan Carpenter, PhD | Applied Molecular Evolution |
More Information
| Responsible Party: | Susan Carpenter, PhD, Applied Molecular Evolution/Eli Lilly |
| ClinicalTrials.gov Identifier: | NCT00689507 History of Changes |
| Other Study ID Numbers: | H9S-MC-JDCF(a) |
| Study First Received: | May 29, 2008 |
| Last Updated: | August 11, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
Multiple Myeloma Relapsed Refractory Bortezomib Velcade |
|
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 Bortezomib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |