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

Bristol-Myers Squibb (BMS)

Status and phase

Terminated

Phase 1

Conditions

Multiple Myeloma

Treatments

Drug: Dasatinib

Drug: Bortezomib

Drug: Dexamethasone

Study type

Interventional

Funder types

Industry

Identifiers

NCT00560352

CA180-181

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.