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Safety Study of LBH589 When Given in Combination With Lenalidomide and Dexamethasone in Adult Patients With Multiple Myeloma
This study is currently recruiting participants.
Verified by Novartis, September 2008
Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00532675
  Purpose

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

Genetics Home Reference related topics: aceruloplasminemia hemophilia
MedlinePlus related topics: Cancer Multiple Myeloma
Drug Information available for: Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Lenalidomide CC 5013
U.S. FDA Resources
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

Further study details as provided by Novartis:

Primary Outcome Measures:
  • To determine the highest and safest dose of LBH589 when it is administered in combination with lenalidomide & dexamethasone

Secondary Outcome Measures:
  • Safety and tolerability assessed by monitoring of adverse events, serious adverse events and laboratory parameters To characterize the pharmacokinetic profile of the study treatment To characterize the pharmacodynamic profile of the study treatment

Estimated Enrollment: 45
Study Start Date: September 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  • Patients must have a diagnosis of active multiple myeloma
  • Patients must have received at least one prior line of therapy and their disease has relapsed..
  • Patients must be suitable for treatment with lenalidomide & dexamethasone.
  • Adults ≥ 18 years old
  • ECOG Performance Status ≤ 2
  • Life expectancy > 12 weeks
  • Patients must have acceptable neutophil and platelet counts as well as adequate kidney and liver function.
  • Able to sign informed consent and to comply with the protocol

Exclusion criteria

  • Primary refractory MM
  • Peripheral neuropathy ≥ CTCAE grade 2
  • Impaired cardiac function or clinically significant cardiac diseases
  • Impairment of GI function or GI disease that may significantly alter the absorption of LBH589
  • Patients with diarrhea > CTCAE grade 1
  • Patients using medications that have a relative risk of prolonging the QT interval
  • Concomitant use of CYP3A4 inhibitors
  • Patients with a history of deep vein thrombosis or thromboembolism within < 6 months prior to starting study treatment
  • Patients who have undergone major surgery ≤ 4 weeks prior to starting study drug or who have not recovered from side effects of such therapy
  • Women who are pregnant or breast feeding or women of childbearing potential (WOCBP) not using 2 reliable forms of birth control
  • Male patients whose sexual partners are WOCBP and who are unable to use a latex condom during sexual contact (even if they have undergone a vasectomy)
  • Patients with any significant history of non-compliance to medical regimens or unwilling or unable to comply with the instructions given to him/her by the study staff.
  • Other protocol defined inclusion/exclusion criteria may apply
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00532675

Contacts
Contact: Novartis U.S. 1 800 340 6843
Contact: Novartis Basel 41 61 324 1111

Locations
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
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Novartis
  More Information

Related Info  This link exits the ClinicalTrials.gov site

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

Keywords provided by Novartis:
Myeloma
Multiple Myeloma
Lenalidomide
Revlimid
Dexamethasone
LBH589
Combination

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 16, 2009