Status:
COMPLETED
Study of Mapatumumab in Combination With Bortezomib (Velcade) and Bortezomib Alone in Subjects With Relapsed or Refractory Multiple Myeloma
Lead Sponsor:
Human Genome Sciences Inc.
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy (disease response) and safety of mapatumumab in combination with bortezomib and bortezomib alone in subjects with relapsed or refractory multiple ...
Eligibility Criteria
Inclusion
- Diagnosed with multiple myeloma that is refractory or has relapsed after treatment
- Measurable serum and/or urine M-protein
- Failed 1 or 2 prior therapies for multiple myeloma
- 18 years of age or older
Exclusion
- Received more than 2 prior therapies for multiple myeloma.
- Previous cancer therapies (chemotherapy, biologic therapy, radiation therapy or immunosuppressants) within the last 3 weeks
- Received monoclonal antibodies within the last 3 weeks (chimeric or murine) or 8 weeks (human or humanized)
- Received investigational (not yet approved by a regulatory authority) agent to treat multiple myeloma within the last 4 weeks
- Subjects who received a stem cell transplant using cells from themselves in the past 16 weeks
- Subjects who received a stem cell transplant using cells from another individual
- Previously treated with bortezomib or mapatumumab
- Known HIV, hepatitis-B, hepatitis-C, or hepatitis A infection
- Infection requiring antibiotics or hospitalization within the last 2 weeks
- Major surgery within the last 4 weeks
- Diagnosis with POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes)
- History of other cancers within the past 5 years
- Pregnant or breast-feeding women
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT00315757
Start Date
May 1 2006
End Date
October 1 2010
Last Update
August 8 2013
Active Locations (20)
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1
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
2
Scripps Clinic Medical Group, Inc.
La Jolla, California, United States, 92037
3
Cancer and Blood Disorders Center
Lecanto, Florida, United States, 34461
4
University of Chicago
Chicago, Illinois, United States, 60637