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Sponsored by: |
Novartis Pharmaceuticals |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00532675 |
This study will evaluate the safety of LBH589 given in combination with lenalidomide and dexamethasone in adult patients with multiple myeloma
Condition | Intervention | Phase |
---|---|---|
Multiple Myeloma |
Drug: LBH589 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase Ib, Multi-Center, Open-Label, Dose-Escalation Study of Oral LBH589 When Administered in Combination With Oral Lenalidomide & Dexamethasone in Adult Patients With Multiple Myeloma |
Estimated Enrollment: | 45 |
Study Start Date: | September 2007 |
Estimated Primary Completion Date: | October 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:
Exclusion criteria:
Contact: Novartis Pharmaceuticals | 800-340-6843 |
United States, Georgia | |
Winship Cancer Institute - Emory University | Recruiting |
Atlanta, Georgia, United States, 30322 | |
Contact: Renee Smith 404-778-5144 sloni@emory.edu | |
United States, New York | |
St. Vincent's Comprehensive Cancer Center | Recruiting |
New York, New York, United States, 10011 | |
Contact: Maria Peteillo-Myers 212-367-0817 | |
Principal Investigator: Sundar Jagannath | |
Australia | |
Novartis Investigative Site | Recruiting |
Brisbane, Australia | |
Novartis Investigative Site | Not yet recruiting |
Wooloongabba, Australia | |
Novartis Investigative Site | Recruiting |
Melbourne, Australia | |
France | |
Novartis Investigative site | Not yet recruiting |
Nantes, France | |
Novartis Investigative Site | Not yet recruiting |
Lille, France | |
Italy | |
Novartis Investigative Site | Recruiting |
Torino, Italy | |
Novartis Investigative Site | Not yet recruiting |
Bologna, Italy | |
Spain | |
Novartis Investigative Site | Recruiting |
Salamanca, Spain |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | Novartis Pharmaceuticals ( External Affairs ) |
Study ID Numbers: | CLBH589B2206 |
Study First Received: | September 18, 2007 |
Last Updated: | June 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00532675 History of Changes |
Health Authority: | United States: Food and Drug Administration; Australia: Department of Health and Ageing Therapeutic Goods Administration; France: Afssaps - French Health Products Safety Agency; Italy: Ministry of Health; Spain: Spanish Agency of Medicines |
Myeloma Multiple Myeloma Lenalidomide Revlimid |
Dexamethasone LBH589 Combination |
Anti-Inflammatory Agents Dexamethasone Immunoproliferative Disorders Antineoplastic Agents, Hormonal Blood Protein Disorders Hematologic Diseases Hormone Antagonists Blood Coagulation Disorders Hormones, Hormone Substitutes, and Hormone Antagonists Lenalidomide Vascular Diseases |
Antiemetics Paraproteinemias Hemostatic Disorders Hormones Glucocorticoids Multiple Myeloma Hemorrhagic Disorders Peripheral Nervous System Agents Lymphoproliferative Disorders Dexamethasone acetate Neoplasms, Plasma Cell |
Anti-Inflammatory Agents Dexamethasone Antineoplastic Agents Blood Protein Disorders Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Paraproteinemias Hemostatic Disorders Hormones Hemorrhagic Disorders Therapeutic Uses Cardiovascular Diseases Dexamethasone acetate Immunoproliferative Disorders |
Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Hematologic Diseases Vascular Diseases Lenalidomide Gastrointestinal Agents Glucocorticoids Pharmacologic Actions Multiple Myeloma Neoplasms Autonomic Agents Peripheral Nervous System Agents Lymphoproliferative Disorders Central Nervous System Agents |