Clinical trial NCT00532675: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Multiple Myeloma
Keywords: Myeloma
Multiple Myeloma
Lenalidomide
Revlimid
Dexamethasone
LBH589
Combination
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-09-20
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: To determine the highest and safest dose of LBH589 when it is administered in combination with lenalidomide & dexamethasone
timeFrame: 24 weeks
Secondary outcomes:
measure: 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
timeFrame: Da1 to Day 3 (week 1 of first cycle)
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Medical Center
state: California
city: Atlanta
country: United States
facility: Emory University School of Medicine/Winship Cancer Institute Dept. of Winship Cancer Inst.
state: Georgia
city: New York
country: United States
facility: St. Vincent's Comprehensive Cancer Center
state: New York
city: South Brisbane
country: Australia
facility: Novartis Investigative Site
state: Queensland
city: Prahran
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Lille
country: France
facility: Novartis Investigative Site
city: Montpellier cedex 5
country: France
facility: Novartis Investigative Site
city: Nantes
country: France
facility: Novartis Investigative Site
city: Salamanca
country: Spain
facility: Novartis Investigative Site
state: Castilla Y Leon
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: