Multiple Myeloma
Conditions
Keywords
Myeloma, Multiple Myeloma, Lenalidomide, Revlimid, Dexamethasone, LBH589, Combination
Brief summary
This study will evaluate the safety of LBH589 given in combination with lenalidomide and dexamethasone in adult patients with multiple myeloma
Interventions
DRUGLBH589
PAN 5 mg and PAN 20 mg capsules
COMBINATION_PRODUCTLenalidomide
Lenalidomide 5mg or 25 mg
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the highest and safest dose of LBH589 when it is administered in combination with lenalidomide & dexamethasone | 24 weeks |
Secondary
| Measure | 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) |
Countries
Australia, France, Spain, United States
Outcome results
None listed