Safety Study of LBH589 When Given in Combination With Lenalidomide and Dexamethasone in Adult Patients With Multiple Myeloma.
NCT ID: NCT00532675
Last Updated: 2020-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
46 participants
INTERVENTIONAL
2008-04-22
2017-11-08
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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PAN 5 mg
Panobinostat 5 mg
LBH589
PAN 5 mg and PAN 20 mg capsules
Lenalidomide
Lenalidomide 5mg or 25 mg
PAN 10 mg
Panobinostat 10 mg
LBH589
PAN 5 mg and PAN 20 mg capsules
Lenalidomide
Lenalidomide 5mg or 25 mg
PAN 20 mg
Panobinostat 20 mg
LBH589
PAN 5 mg and PAN 20 mg capsules
Lenalidomide
Lenalidomide 5mg or 25 mg
PAN 25 mg
Panobinostat 25 mg
LBH589
PAN 5 mg and PAN 20 mg capsules
Lenalidomide
Lenalidomide 5mg or 25 mg
Interventions
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LBH589
PAN 5 mg and PAN 20 mg capsules
Lenalidomide
Lenalidomide 5mg or 25 mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 neutrophil and platelet counts as well as adequate kidney and liver function.
* Able to sign informed consent and to comply with the protocol
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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UCSF Medical Center
San Francisco, California, United States
Emory University School of Medicine/Winship Cancer Institute Dept. of Winship Cancer Inst.
Atlanta, Georgia, United States
St. Vincent's Comprehensive Cancer Center
New York, New York, United States
Novartis Investigative Site
South Brisbane, Queensland, Australia
Novartis Investigative Site
Prahran, Victoria, Australia
Novartis Investigative Site
Lille, , France
Novartis Investigative Site
Montpellier, , France
Novartis Investigative Site
Nantes, , France
Novartis Investigative Site
Salamanca, Castille and León, Spain
Novartis Investigative Site
Valencia, Valencia, Spain
Countries
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Related Links
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Results for CLBH589B2206 can be found on the Novartis Clinical Trial Results Website
Other Identifiers
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2006-007030-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CLBH589B2206
Identifier Type: -
Identifier Source: org_study_id