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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00532675




Registration number
NCT00532675
Ethics application status
Date submitted
18/09/2007
Date registered
20/09/2007
Date last updated
26/10/2018

Titles & IDs
Public title
Safety Study of LBH589 When Given in Combination With Lenalidomide and Dexamethasone in Adult Patients With Multiple Myeloma.
Scientific 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
Secondary ID [1] 0 0
2006-007030-35
Secondary ID [2] 0 0
CLBH589B2206
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LBH589
Combination Product - Lenalidomide

Experimental: PAN 5 mg - Panobinostat 5 mg

Experimental: PAN 10 mg - Panobinostat 10 mg

Experimental: PAN 20 mg - Panobinostat 20 mg

Experimental: PAN 25 mg - Panobinostat 25 mg


Treatment: Drugs: LBH589
PAN 5 mg and PAN 20 mg capsules

Combination Product: Lenalidomide
Lenalidomide 5mg or 25 mg

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Combination Product
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To determine the highest and safest dose of LBH589 when it is administered in combination with lenalidomide & dexamethasone
Timepoint [1] 0 0
24 weeks
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
Da1 to Day 3 (week 1 of first cycle)

Eligibility
Key inclusion 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - South Brisbane
Recruitment hospital [2] 0 0
Novartis Investigative Site - Prahran
Recruitment postcode(s) [1] 0 0
4101 - South Brisbane
Recruitment postcode(s) [2] 0 0
3181 - Prahran
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
France
State/province [4] 0 0
Lille
Country [5] 0 0
France
State/province [5] 0 0
Montpellier cedex 5
Country [6] 0 0
France
State/province [6] 0 0
Nantes
Country [7] 0 0
Spain
State/province [7] 0 0
Castilla Y Leon
Country [8] 0 0
Spain
State/province [8] 0 0
Comunidad Valenciana

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will evaluate the safety of LBH589 given in combination with lenalidomide and
dexamethasone in adult patients with multiple myeloma
Trial website
https://clinicaltrials.gov/show/NCT00532675
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications