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

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00532675
• Other study ID #: CLBH589B2206
• Secondary ID: 2006-007030-35
• Status: Completed
• Phase: Phase 1
• Start date: April 22, 2008
• Est. completion date: November 8, 2017

Study information

• Verified date: February 2020
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: November 8, 2017
• Est. primary completion date: November 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• LBH589
PAN 5 mg and PAN 20 mg capsules

Combination Product:
• Lenalidomide
Lenalidomide 5mg or 25 mg

Locations

Country	Name	City	State
Australia	Novartis Investigative Site	Prahran	Victoria
Australia	Novartis Investigative Site	South Brisbane	Queensland
France	Novartis Investigative Site	Lille
France	Novartis Investigative Site	Montpellier cedex 5
France	Novartis Investigative Site	Nantes
Spain	Novartis Investigative Site	Salamanca	Castilla Y Leon
Spain	Novartis Investigative Site	Valencia	Comunidad Valenciana
United States	Emory University School of Medicine/Winship Cancer Institute Dept. of Winship Cancer Inst.	Atlanta	Georgia
United States	St. Vincent's Comprehensive Cancer Center	New York	New York
United States	UCSF Medical Center	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  France,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the highest and safest dose of LBH589 when it is administered in combination with lenalidomide & dexamethasone		24 weeks
Secondary	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)

External Links

•   Results for CLBH589B2206 can be found on the Novartis Clinical Trial Results Website