Protein Tyrosine Kinases (PTK) in Multiple Myeloma

• Status: Completed
• Trial end date: 2006-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether or not cancer cells in the body are affected by PTK and whether it affects the growth of these cells.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Brigham and Women's Hospital; Novartis
• Treatments: Vatalanib

Criteria

Inclusion Criteria:

• Older than 18 years of age.

• Confirmed diagnosis of active progressive multiple myeloma

• History of > 2 prior cytotoxic treatment regimens. Bone marrow transplantation will be considered as one regimen.

• Current measurable disease based on serum and/or urine M protein and/or measurable plasmacytoma.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

• Absolute neutrophil count (ANC) > 1,500 mm3

• Platelets > 100,000 mm3

• Serum creatinine < 1.5 upper limit of normal (ULN)

• Serum bilirubin < 1.5 ULN

• AST/AGOT and ALT/SGPT < 3.0 ULN

• Life expectancy > 12 weeks

Exclusion Criteria:

• Chemotherapy < 3 weeks prior to registration.

• Biologic or immunotherapy < 2 weeks prior to registration

• Full field radiotherapy < 4 weeks or limited field radiotherapy < 2 weeks prior to registration.

• History or presence of central nervous system (CNS) disease

• History of leukemia

• History of another primary malignancy with the exception of inactive basal or squamous cell carcinoma of the skin

• Major surgery < 4 weeks prior to registration

• Prior therapy with anti-vascular endothelial growth factor (VEGF) agents excluding thalidomide, Revimid, velcade and arsenic trioxide

• Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung

• Pleural effusion or ascites that cause respiratory compromise

• Female patients that are pregnant or breast feeding

• Uncontrolled high blood pressure, history of labile hypertension or history of poor compliance with an antihypertensive regimen

• Unstable angina pectoris

• Symptomatic congestive heart failure

• Myocardial infarction < 6 months prior to registration

• Serious uncontrolled cardiac arrhythmia

• Uncontrolled diabetes

• Active or uncontrolled infection

• Acute or chronic liver disease

• Impairment of gastrointestinal (GI) function or GI disease

• Confirmed HIV infection