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NCT00872300 Clinical Trial

PHA-739358 for the Treatment of Multiple Myeloma

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00872300
Other study ID # AURA-6202-011
Secondary ID
Status Terminated
Phase Phase 2
First received March 30, 2009
Last updated May 13, 2014
Start date October 2008
Est. completion date September 2010

Study information
Verified date May 2014
Source Nerviano Medical Sciences
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 7
Est. completion date September 2010
Est. primary completion date September 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Drug:
• PHA-739358
Weekly IV infusion for 3 consecutive weeks in a 4-week cycle

Locations
Country Name City State
France Hôpital Huriez, Centre Hospitalier Régional Universitaire de Lille Lille
France University Hospital Hôtel-Dieu Nantes
United States The Robert H Lurie Comprehensive Cancer Center, Northwestern University Chicago Illinois
United States MAYO Clinic Scottsdale Arizona

Sponsors (1)
Lead Sponsor Collaborator
Nerviano Medical Sciences

Countries where clinical trial is conducted

United States,  France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Response Rate according to International Myeloma Working Group uniform response criteria for multiple myeloma. At end of each cycle No
Secondary Overall safety profile All cycles Yes
See also
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Active, not recruiting NCT03989414 - A Study to Determine the Recommended Dose and Regimen and to Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM) Phase 1/Phase 2
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Completed NCT02546167 - CART-BCMA Cells for Multiple Myeloma Phase 1