This trial is active, not recruiting.

Condition multiple myeloma
Treatment lbh589
Phase phase 1
Targets HDAC, HIF-1a, VEGF
Sponsor Novartis Pharmaceuticals
Start date April 2008
End date December 2016
Trial size 46 participants
Trial identifier NCT00532675, 2006-007030-35, CLBH589B2206


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

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

Secondary Outcomes

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)

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Novartis.
Location data was received from the National Cancer Institute and was last updated in August 2016.