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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
Not Enrolling
Both
Multiple Myeloma

Thank you

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 ClinicScottsdale, Arizona  
The Robert H Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611