Multiple Myeloma
Conditions
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 myeloma (MM).
Interventions
BIOLOGICALMapatumumab
10 mg/kg IV (in the vein), on day 1 of each 21-day cycle. Number of cycles: Treatment will continue for up to 17 cycles, or until disease progression or unacceptable toxicity.
DRUGBortezomib
1.3 mg/m\^2 IV (in the vein), twice weekly for two weeks (Days 1, 4, 8, and 11) of each 21-day cycle. Number of cycles: Treatment will continue for up to 17 cycles, or until disease progression or unacceptable toxicity.
Sponsors
Human Genome Sciences Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate disease response to mapatumumab in combination with bortezomib and bortezomib alone | 17 cycles (up to a year) |
Secondary
| Measure | Time frame |
|---|---|
| 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 period | 17 cycles (up to a year) |
Countries
Australia, Canada, India, United States
Outcome results
None listed