Trial Information

Summary: A phase 2, randomized study of mapatumumab (TRM-1 [HGS1012], a fully human monoclonal antibody to TRAIL-R1) in combination with bortezomib (VelcadeŽ) or bortezomib alone in patients with relapsed or refractory multiple myeloma.

Mapatumumab (TRM-1, TRAIL-R1 monoclonal antibody) is an investigational (experimental) drug being developed by Human Genome Sciences, Inc. This is a Phase 2 study that will compare the effects, good and bad, of mapatumumab plus bortezomib (VelcadeŽ) with bortezomib alone in the treatment of multiple myeloma. In this study, you will get bortezomib and may or may not receive mapatumumab in addition. This study will include approximately 100 subjects, with about 67 subjects receiving mapatumumab plus bortezomib and 33 subjects receiving bortezomib alone. Mapatumumab will be given once every 21 days and bortezomib will be given twice weekly for 2 weeks followed by 1 week of rest (4 doses every 21 days) for a maximum of about 1 year. How the treatment affects your cancer and how you tolerate treatment will determine how long you receive treatment.

Ages Eligible for Study:18 Years and above
Genders Eligible for Study: Both

Primary 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

Primary Exclusion Criteria:

• Received a non-FDA approved investigational agent within the last 4 weeks
• Previous cancer therapies (chemotherapy, biologic therapy, immunosuppressants, monoclonal antibodies or radiation therapy) within the last 3 weeks, 8 weeks for human or humanized monoclonal antibodies
• Received more than 2 prior therapies for multiple myeloma.
• Received an autologous stem cell transplant (SCT) within the past 16 weeks
• Previously treated with bortezomib or mapatumumab
• 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

For more information,

If you would like to learn more about participating in this study, please send an e-mail message using the form below.