Multiple Myeloma Clinical Trial
Official title:
A Phase 2, Multi-Center, Open-Label, Randomized Study of Mapatumumab (TRM-1 [HGS1012], a Fully Human Monoclonal Antibody to TRAIL-R1) in Combination With Bortezomib (Velcade) and Bortezomib Alone in Subjects With Relapsed or Refractory Multiple Myeloma
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).
Status | Completed |
Enrollment | 105 |
Est. completion date | October 2010 |
Est. primary completion date | October 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | Institute of Medical & Veterinary Science | Adelaide | South Australia |
Australia | Peter MacCallum Cancer Centre | East Melbourne | Victoria |
Australia | Clinical Haematology & BMT, Alfred Hospital | Melbourne | Victoria |
Australia | Department of Haematology, Royal North Shore Hospital | St Leonards | New South Wales |
Canada | Tom Baker Cancer Center | Calgary | Alberta |
Canada | Cross Cancer Institute | Edmonton | Alberta |
Canada | Notre Dame Centre Hospitalier de l'Universite de Montreal | Montreal | Quebec |
Canada | Ottawa Health Research Institute - General Campus | Ottawa | Ontario |
India | Bangalore Institute of Oncology | Bangalore | |
India | Bharath Hospital & Institute of Oncology | Mysore | Karnataka |
India | All India Institute of Medical Sciences | New Delhi | |
India | Rajiv Gandhi Cancer Institute & Research Center | New Delhi | |
United States | Center for Cancer and Blood Disorders | Bethesda | Maryland |
United States | Roswell Park Cancer Institute | Buffalo | New York |
United States | University of Chicago | Chicago | Illinois |
United States | Capitol Comprehensive Cancer Care Clinic | Jefferson City | Missouri |
United States | Scripps Clinic Medical Group, Inc. | La Jolla | California |
United States | Cancer and Blood Disorders Center | Lecanto | Florida |
United States | Nebraska Methodist Cancer Center | Omaha | Nebraska |
United States | Mayo Clinic Arizona | Scottsdale | Arizona |
Lead Sponsor | Collaborator |
---|---|
Human Genome Sciences Inc. |
United States, Australia, Canada, India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluate disease response to mapatumumab in combination with bortezomib and bortezomib alone | 17 cycles (up to a year) | No | |
Secondary | 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) | Yes |
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