Multiple Myeloma
Conditions
Brief summary
The purpose of this study is to determine the antitumor activity of PHA-739358 as single agent IV infusion in adult patients with Multiple Myeloma who have a history of at least 2 previous lines of treatment for the disease.
Interventions
Weekly IV infusion for 3 consecutive weeks in a 4-week cycle
Sponsors
Study design
Eligibility
Inclusion criteria
* active multiple myeloma progressing after at least 2 prior lines of treatment * measurable disease * t(4;14) translocation * life expectancy of at least 3 months
Exclusion criteria
* uncontrolled hypertension * myocardial infarction, unstable angina, symptomatic congestive heart failure, cerebrovascular accident in the past 6 months. * pregnancy or breast feeding * active infections, including HIV
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response Rate according to International Myeloma Working Group uniform response criteria for multiple myeloma. | At end of each cycle |
Secondary
| Measure | Time frame |
|---|---|
| Overall safety profile | All cycles |
Countries
France, United States