Safety Study of LBH589 When Given in Combination With Lenalidomide and Dexamethasone in Adult Patients With Multiple Myeloma.
Status: | Completed |
---|---|
Conditions: | Blood Cancer, Hematology, Hematology |
Therapuetic Areas: | Hematology, Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/28/2018 |
Start Date: | April 22, 2008 |
End Date: | November 8, 2017 |
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
This study will evaluate the safety of LBH589 given in combination with lenalidomide and
dexamethasone in adult patients with multiple myeloma
dexamethasone in adult patients with multiple myeloma
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
We found this trial at
4
sites
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Atlanta, Georgia 30322
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