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Sponsored by: |
Novartis |
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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 |
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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 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria
Exclusion criteria
Contact: Novartis U.S. | 1 800 340 6843 | |
Contact: Novartis Basel | 41 61 324 1111 |
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 Chair: | Novartis | Novartis |
Responsible Party: | Novartis ( External Affairs ) |
Study ID Numbers: | CLBH589B2206 |
Study First Received: | September 18, 2007 |
Last Updated: | September 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00532675 |
Health Authority: | United States: Food and Drug Administration; Australia: Therapeutic Goods Administration; France: Agence Française de Sécurité Sanitaire des Produits de Santé; Italy: Istituto Superiore di Sanità; Spain: Spanish Drug Agency |
Myeloma Multiple Myeloma Lenalidomide Revlimid |
Dexamethasone LBH589 Combination |
Dexamethasone Immunoproliferative Disorders Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Lenalidomide Vascular Diseases Paraproteinemias |
Hemostatic Disorders Multiple Myeloma Hemorrhagic Disorders Multiple myeloma Lymphoproliferative Disorders Dexamethasone acetate Neoplasms, Plasma Cell |
Anti-Inflammatory Agents Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Gastrointestinal Agents Antiemetics |
Hormones Glucocorticoids Pharmacologic Actions Neoplasms Autonomic Agents Therapeutic Uses Cardiovascular Diseases Peripheral Nervous System Agents Central Nervous System Agents |