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| Sponsor: | Acetylon Pharmaceuticals Incorporated |
|---|---|
| Collaborator: |
The Leukemia and Lymphoma Society |
| Information provided by (Responsible Party): | Acetylon Pharmaceuticals Incorporated |
| ClinicalTrials.gov Identifier: | NCT01323751 |
Purpose
Phase 1(a & b): To evaluate the side effects and determine the best dose of oral ACY-1215 as monotherapy, and also in combination with bortezomib and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma.
Phase 2a: To determine the objective response rate of oral ACY-1215 in combination with bortezomib and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma |
Drug: ACY-1215 |
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 1/2, Open-Label, Multicenter Study of ACY-1215 Administered Orally as Monotherapy and in Combination With Bortezomib and Dexamethasone for the Treatment of Relapsed or Relapsed/Refractory Multiple Myeloma |
| Estimated Enrollment: | 120 |
| Study Start Date: | July 2011 |
| Estimated Primary Completion Date: | December 2013 (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:
Patient has relapsed or relapsed/refractory MM with measurable disease parameters according to the International Myeloma Working Group (IMWG) Criteria
Patient has adequate bone marrow reserve, as evidenced by:
Exclusion Criteria
Patient has received any of the following therapies:
Contacts and Locations| Contact: Gina Leone | 617-245-1300 | gleone@acetylon.com |
| United States, Georgia | |
| Winship Cancer Institute, Emory University | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Jennifer Schreiber Merriweather, RN 404-778-5920 jennifer.schreiber@emoryhealthcare.org | |
| Principal Investigator: Sagar Lonial, MD | |
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Chi La 617-724-5251 cla@partners.org | |
| Principal Investigator: Noopur Raje, MD | |
| United States, New York | |
| Mt. Sinai Medical Center | Recruiting |
| New York, New York, United States, 10029 | |
| Contact: Kenneth Lau 212-241-7846 kenneth.lau@mssm.edu | |
| Contact: Lisa La 212-241-8615 lisala@mssm.edu | |
| Principal Investigator: Sundar Jagganath, MD | |
| United States, Pennsylvania | |
| University of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Kristy Walsh 215-615-4822 kristy.walsh@uphs.upenn.edu | |
| Principal Investigator: Dan Vogl, MD | |
| United States, Texas | |
| MD Anderson Cancer Center | Not yet recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Martha Anderson, RN 713-794-1079 mlanderson1@mdanderson.org | |
| Principal Investigator: Robert Z Orlowski, PhD, MD | |
| United States, Wisconsin | |
| Medical College of Wisconsin - Clinical Cancer Center | Recruiting |
| Milwaukee, Wisconsin, United States, 53226 | |
| Contact: Paulette Jacobs 414-805-4594 pjacobs@mcw.edu | |
| Principal Investigator: Parameswaran Hari, M.D. | |
| Principal Investigator: | Sagar Lonial, MD | Winship Cancer Institute, Emory University |
More Information
| Responsible Party: | Acetylon Pharmaceuticals Incorporated |
| ClinicalTrials.gov Identifier: | NCT01323751 History of Changes |
| Other Study ID Numbers: | ACY-100 |
| Study First Received: | February 25, 2011 |
| Last Updated: | April 20, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
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 Dexamethasone acetate |
Dexamethasone Dexamethasone 21-phosphate Bortezomib BB 1101 Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones |