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

• Status: Terminated
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: BB 1101; Bortezomib; Dasatinib; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

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.