Multiple Myeloma Clinical Trial
A Study of Oral LBH589 in Adult Patients With Advanced Hematological Malignancies
Summary
This study evaluated safety, tolerability, pharmacokinetics and preliminary anti-leukemic or anti-tumor activity of LBH589B in adult patients with advanced hematological malignancies
Eligibility Criteria
Inclusion criteria:
Adult patients (≥18 years old) with advanced hematological malignancies who relapsed after or are refractory to standard therapy, or for which no standard therapy existed; or, were considered inappropriate candidates for standard therapy
World Health Organization (WHO) performance status ≤ 2
Patients who met protocol-specified hematologic and non-hematologic laboratory values
Patients with adequate liver and renal function
Exclusion criteria:
Concurrent brain metastases or leukemic infiltration of the cerebrospinal fluid
Peripheral neuropathy ≥ CTCAE grade 2
Unresolved diarrhea ≥ CTCAE grade 2
Concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study, including impaired heart function or clinically significant heart disease, and impaired gastrointestinal function or disease that significantly altered aborption of LBH589
Female patients who were pregnant or breast feeding
Patients who were unwilling to use an effective method of birth control
Patients who took medications specified by the protocol as prohibited for administration in combination with LBH589
Patients with another primary malignancy that required active intervention or were clinically significant
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There are 7 Locations for this study
Augusta Georgia, 30912, United States
Boston Massachusetts, 02115, United States
Houston Texas, 77030, United States
Parkville Victoria, 3002, Australia
Prahran Victoria, 3181, Australia
Frankfurt/M , 60590, Germany
Mainz , 55131, Germany
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