Safety Study of Dasatinib With Bortezomib (Velcade®) and Dexamethasone for Multiple Myeloma

A Phase I Study of Dasatinib With Bortezomib (Velcade®) and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

The purpose of this study is to determine the safety and tolerability of dasatinib with bortezomib in the treatment of relapsed or refractory multiple myeloma.

Key Inclusion Criteria:

• Confirmed diagnosis of multiple myeloma with measurable disease
• Evidence of relapsed or refractory disease and at least 2 prior therapies for multiple myeloma
• Eastern Cooperative Oncology Group Performance Status of 0 - 2
• Last treatment for multiple myeloma not within 21 days prior to study treatment initiation
• Bone marrow transplant not within 3 months prior to study treatment initiation
• Required baseline hematology and chemistry parameters.

Key Exclusion Criteria:

• Clinically significant cardiac disease (New York Heart Association Class III or IV)
• Abnormal QT interval corrected for heart rate using Fridericia's formula prolonged (>450 msec) after electrolytes have been corrected on baseline electrocardiogram
• Malabsorption syndrome or uncontrolled gastrointestinal toxicities
• Dementia, chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation
• Clinically significant pleural effusion in the previous 12 months or current ascites
• Clinically significant coagulation or platelet function disorder
• Intolerance to dasatinib and/or bortezomib
• Acute diffuse infiltrative pulmonary disease
• Prior or concurrent malignancy, except for adequately treated basal cell or squamous cell skin cancer, adequately treated Stage I or II cancer currently in complete remission, cervical carcinoma in situ, or any other cancer from which the participant has been disease-free for 3 years.