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

Study Overview
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Brief Summary
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This study will evaluate the safety of LBH589 given in combination with lenalidomide and dexamethasone in adult patients with multiple myeloma

Official Title
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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

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Drug: LBH589
* Combination Product: Lenalidomide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PAN 5 mg<br>Panobinostat 5 mg | Drug: LBH589<br>* PAN 5 mg and PAN 20 mg capsules<br>* Other names: Panobinostat, PAN;Combination Product: Lenalidomide<br>* Lenalidomide 5mg or 25 mg<br>|
| Experimental: PAN 10 mg<br>Panobinostat 10 mg | Drug: LBH589<br>* PAN 5 mg and PAN 20 mg capsules<br>* Other names: Panobinostat, PAN;Combination Product: Lenalidomide<br>* Lenalidomide 5mg or 25 mg<br>|
| Experimental: PAN 20 mg<br>Panobinostat 20 mg | Drug: LBH589<br>* PAN 5 mg and PAN 20 mg capsules<br>* Other names: Panobinostat, PAN;Combination Product: Lenalidomide<br>* Lenalidomide 5mg or 25 mg<br>|
| Experimental: PAN 25 mg<br>Panobinostat 25 mg | Drug: LBH589<br>* PAN 5 mg and PAN 20 mg capsules<br>* Other names: Panobinostat, PAN;Combination Product: Lenalidomide<br>* Lenalidomide 5mg or 25 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the highest and safest dose of LBH589 when it is administered in combination with lenalidomide & dexamethasone |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myeloma, Multiple Myeloma, Lenalidomide, Revlimid, Dexamethasone, LBH589, Combination