PHA-739358 for the Treatment of Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00872300
Recruitment Status : Terminated (Low recruitment rate)
First Posted : March 31, 2009
Last Update Posted : May 28, 2014
Information provided by (Responsible Party):
Nerviano Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: PHA-739358 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: An Exploratory Phase II Study of PHA-739358 in Patients With Multiple Myeloma Harbouring the t(4;14) Translocation With or Without FGFR3 Expression
Study Start Date : October 2008
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: PHA-739358
Weekly IV infusion for 3 consecutive weeks in a 4-week cycle

Primary Outcome Measures :
  1. Response Rate according to International Myeloma Working Group uniform response criteria for multiple myeloma. [ Time Frame: At end of each cycle ]

Secondary Outcome Measures :
  1. Overall safety profile [ Time Frame: All cycles ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00872300

United States, Arizona
MAYO Clinic
Scottsdale, Arizona, United States, 85259
United States, Illinois
The Robert H Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States, 60611
Hôpital Huriez, Centre Hospitalier Régional Universitaire de Lille
Lille, France, 59037
University Hospital Hôtel-Dieu
Nantes, France, 44093
Sponsors and Collaborators
Nerviano Medical Sciences

Responsible Party: Nerviano Medical Sciences Identifier: NCT00872300     History of Changes
Other Study ID Numbers: AURA-6202-011
First Posted: March 31, 2009    Key Record Dates
Last Update Posted: May 28, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases