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

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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


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
South Brisbane, Queensland 4101
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South Brisbane,
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Atlanta, GA
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New York, New York 10011
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New York, NY
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San Francisco, California 94143
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San Francisco, CA
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