Study of Mapatumumab in Combination With Bortezomib (Velcade) and Bortezomib Alone in Subjects With Relapsed or Refractory Multiple Myeloma
Multiple Myeloma
About this trial
This is an interventional treatment trial for Multiple Myeloma
Eligibility Criteria
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
Sites / Locations
- Mayo Clinic Arizona
- Scripps Clinic Medical Group, Inc.
- Cancer and Blood Disorders Center
- University of Chicago
- Center for Cancer and Blood Disorders
- Capitol Comprehensive Cancer Care Clinic
- Nebraska Methodist Cancer Center
- Roswell Park Cancer Institute
- Department of Haematology, Royal North Shore Hospital
- Institute of Medical & Veterinary Science
- Peter MacCallum Cancer Centre
- Clinical Haematology & BMT, Alfred Hospital
- Tom Baker Cancer Center
- Cross Cancer Institute
- Ottawa Health Research Institute - General Campus
- Notre Dame Centre Hospitalier de l'Universite de Montreal
- Bharath Hospital & Institute of Oncology
- Bangalore Institute of Oncology
- All India Institute of Medical Sciences
- Rajiv Gandhi Cancer Institute & Research Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Experimental
A
B-10
B-20
Bortezomib
Bortezomib and Mapatumumab 10 mg/kg
Bortezomib and Mapatumumab 20 mg/kg