Safety Study of LBH589 When Given in Combination With Lenalidomide and Dexamethasone in Adult Patients With Multiple Myeloma.
Primary Purpose
Multiple Myeloma
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
LBH589
Lenalidomide
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Myeloma, Multiple Myeloma, Lenalidomide, Revlimid, Dexamethasone, LBH589, Combination
Eligibility 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 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:
- 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
Sites / Locations
- UCSF Medical Center
- Emory University School of Medicine/Winship Cancer Institute Dept. of Winship Cancer Inst.
- St. Vincent's Comprehensive Cancer Center
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
PAN 5 mg
PAN 10 mg
PAN 20 mg
PAN 25 mg
Arm Description
Panobinostat 5 mg
Panobinostat 10 mg
Panobinostat 20 mg
Panobinostat 25 mg
Outcomes
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
Full Information
NCT ID
NCT00532675
First Posted
September 18, 2007
Last Updated
December 16, 2020
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00532675
Brief Title
Safety Study of LBH589 When Given in Combination With Lenalidomide and Dexamethasone in Adult Patients With Multiple Myeloma.
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
April 22, 2008 (Actual)
Primary Completion Date
November 8, 2017 (Actual)
Study Completion Date
November 8, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate the safety of LBH589 given in combination with lenalidomide and dexamethasone in adult patients with multiple myeloma
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Myeloma, Multiple Myeloma, Lenalidomide, Revlimid, Dexamethasone, LBH589, Combination
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PAN 5 mg
Arm Type
Experimental
Arm Description
Panobinostat 5 mg
Arm Title
PAN 10 mg
Arm Type
Experimental
Arm Description
Panobinostat 10 mg
Arm Title
PAN 20 mg
Arm Type
Experimental
Arm Description
Panobinostat 20 mg
Arm Title
PAN 25 mg
Arm Type
Experimental
Arm Description
Panobinostat 25 mg
Intervention Type
Drug
Intervention Name(s)
LBH589
Other Intervention Name(s)
Panobinostat, PAN
Intervention Description
PAN 5 mg and PAN 20 mg capsules
Intervention Type
Combination Product
Intervention Name(s)
Lenalidomide
Intervention Description
Lenalidomide 5mg or 25 mg
Primary Outcome Measure Information:
Title
To determine the highest and safest dose of LBH589 when it is administered in combination with lenalidomide & dexamethasone
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
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
Time Frame
Da1 to Day 3 (week 1 of first cycle)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 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:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
UCSF Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Emory University School of Medicine/Winship Cancer Institute Dept. of Winship Cancer Inst.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
St. Vincent's Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
Novartis Investigative Site
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Novartis Investigative Site
City
Prahran
State/Province
Victoria
ZIP/Postal Code
3181
Country
Australia
Facility Name
Novartis Investigative Site
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Novartis Investigative Site
City
Montpellier cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
Novartis Investigative Site
City
Nantes
ZIP/Postal Code
44035
Country
France
Facility Name
Novartis Investigative Site
City
Salamanca
State/Province
Castilla Y Leon
ZIP/Postal Code
37007
Country
Spain
Facility Name
Novartis Investigative Site
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46026
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=17260
Description
Results for CLBH589B2206 can be found on the Novartis Clinical Trial Results Website
Learn more about this trial
Safety Study of LBH589 When Given in Combination With Lenalidomide and Dexamethasone in Adult Patients With Multiple Myeloma.
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