Protein Tyrosine Kinases (PTK) in Multiple Myeloma
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of PTK787/ZK222584 in Multiple Myeloma|
- To determine the effectiveness of PTK in treating patients with relapsed or refractory myeloma
- To evaluate the progression free survival of patients treated with PTK
- to investigate the safety of PTK in patients with relapsed/refractory multiple myeloma
|Study Start Date:||December 2003|
|Study Completion Date:||October 2006|
|Primary Completion Date:||October 2006 (Final data collection date for primary outcome measure)|
Patients will take PTK orally once a day for the duration of their time on the study. Each cycle of chemotherapy will last for 4 weeks.
Measurement of vital signs will be done weekly during the first month of treatment.
Physical exam, vital signs, blood work, a quality of life assessment, and x-ray or MRI wil be performed every 4 weeks.
Patients will remain on the study until their disease fails to respond to treatment or there are intolerable side effects. Typically treatment is performed for 12 weeks and up to one year in patients that are stable and responding.
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Nikhil Munshi, MD||Dana-Farber Cancer Institute|