Back to resultsPHA-739358 for the Treatment of Multiple Myeloma
Primary Purpose
Multiple Myeloma
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PHA-739358
Sponsored by
About this trial
This is an interventional supportive care trial for Multiple Myeloma
Eligibility Criteria
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
Sites / Locations
- MAYO Clinic
- The Robert H Lurie Comprehensive Cancer Center, Northwestern University
- Hôpital Huriez, Centre Hospitalier Régional Universitaire de Lille
- University Hospital Hôtel-Dieu
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Response Rate according to International Myeloma Working Group uniform response criteria for multiple myeloma.
Secondary Outcome Measures
Overall safety profile
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00872300
Brief Title
PHA-739358 for the Treatment of Multiple Myeloma
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 Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Terminated
Why Stopped
Low recruitment rate
Study Start Date
October 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nerviano Medical Sciences
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
PHA-739358
Intervention Description
Weekly IV infusion for 3 consecutive weeks in a 4-week cycle
Primary Outcome Measure Information:
Title
Response Rate according to International Myeloma Working Group uniform response criteria for multiple myeloma.
Time Frame
At end of each cycle
Secondary Outcome Measure Information:
Title
Overall safety profile
Time Frame
All cycles
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
MAYO Clinic
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
The Robert H Lurie Comprehensive Cancer Center, Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Hôpital Huriez, Centre Hospitalier Régional Universitaire de Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
University Hospital Hôtel-Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
12. IPD Sharing Statement
Learn more about this trial
PHA-739358 for the Treatment of Multiple Myeloma
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