Safety Study of LBH589 When Given in Combination With Lenalidomide and Dexamethasone in Adult Patients With Multiple Myeloma.

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00532675

Collaborator

(none)

Enrollment

Locations

Arms

114.6

Actual Duration (Months)

4.6

Patients Per Site

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Drug: LBH589 Combination Product: Lenalidomide	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

46 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Apr 22, 2008

Actual Primary Completion Date :

Nov 8, 2017

Actual Study Completion Date :

Nov 8, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PAN 5 mg Panobinostat 5 mg	Drug: LBH589 PAN 5 mg and PAN 20 mg capsules Other Names: Panobinostat, PAN Combination Product: Lenalidomide Lenalidomide 5mg or 25 mg
Experimental: PAN 10 mg Panobinostat 10 mg	Drug: LBH589 PAN 5 mg and PAN 20 mg capsules Other Names: Panobinostat, PAN Combination Product: Lenalidomide Lenalidomide 5mg or 25 mg
Experimental: PAN 20 mg Panobinostat 20 mg	Drug: LBH589 PAN 5 mg and PAN 20 mg capsules Other Names: Panobinostat, PAN Combination Product: Lenalidomide Lenalidomide 5mg or 25 mg
Experimental: PAN 25 mg Panobinostat 25 mg	Drug: LBH589 PAN 5 mg and PAN 20 mg capsules Other Names: Panobinostat, PAN Combination Product: Lenalidomide Lenalidomide 5mg or 25 mg

Outcome Measures

Primary Outcome Measures

To determine the highest and safest dose of LBH589 when it is administered in combination with lenalidomide & dexamethasone [24 weeks]

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 [Da1 to Day 3 (week 1 of first cycle)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCSF Medical Center	San Francisco	California	United States	94143
2	Emory University School of Medicine/Winship Cancer Institute Dept. of Winship Cancer Inst.	Atlanta	Georgia	United States	30322
3	St. Vincent's Comprehensive Cancer Center	New York	New York	United States	10011
4	Novartis Investigative Site	South Brisbane	Queensland	Australia	4101
5	Novartis Investigative Site	Prahran	Victoria	Australia	3181
6	Novartis Investigative Site	Lille		France	59037
7	Novartis Investigative Site	Montpellier cedex 5		France	34295
8	Novartis Investigative Site	Nantes		France	44035
9	Novartis Investigative Site	Salamanca	Castilla Y Leon	Spain	37007
10	Novartis Investigative Site	Valencia	Comunidad Valenciana	Spain	46026