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 myeloma (MM).
- Registration Number
- CTRI/2009/091/000354
- Lead Sponsor
- Human Genome Sciences, Inc.14200 Shady Grove RoadRockville, Maryland, 20850, USA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
?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
?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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate disease response to mapatumumab in combination with bortezomib and bortezomib aloneTimepoint: 17 cycles (up to a year)
- Secondary Outcome Measures
Name Time Method To evaluate the safety, including the frequency and severity of adverse events and laboratory abnormalities, of mapatumumab in combination with bortezomib and bortezomib alone throughout the study periodTimepoint: 17 cycles (up to a year)