An Exploratory Phase II Study of PHA-739358 in Patients With Multiple Myeloma Harbouring the t(4;14) Translocation With or Without FGFR3 Expression
Phase 2
18 Years
75 Years
18 Years
75 Years
Not Enrolling
Both
Multiple Myeloma
Both
Multiple Myeloma
Trial Information
An Exploratory Phase II Study of PHA-739358 in Patients With Multiple Myeloma Harbouring the t(4;14) Translocation With or Without FGFR3 Expression
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Response Rate according to International Myeloma Working Group uniform response criteria for multiple myeloma.
Outcome Time Frame:
At end of each cycle
Safety Issue:
No
Authority:
United States: Food and Drug Administration
Study ID:
AURA-6202-011
NCT ID:
NCT00872300
Start Date:
October 2008
Completion Date:
September 2010
Related Keywords:
- Multiple Myeloma
- Multiple Myeloma
- Neoplasms, Plasma Cell
Name | Location |
|---|---|
| Mayo Clinic | Scottsdale, Arizona |
| The Robert H Lurie Comprehensive Cancer Center, Northwestern University | Chicago, Illinois 60611 |
