Study of Mapatumumab in Combination With Bortezomib (Velcade) and Bortezomib Alone in Subjects With Relapsed or Refractory Multiple Myeloma
- Registration Number
- NCT00315757
- Lead Sponsor
- Human Genome Sciences Inc.
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 105
- 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
- PARALLEL
- Arm && Interventions
Group Intervention Description B-20 Mapatumumab Bortezomib and Mapatumumab 20 mg/kg B-20 Bortezomib Bortezomib and Mapatumumab 20 mg/kg A Bortezomib Bortezomib B-10 Mapatumumab Bortezomib and Mapatumumab 10 mg/kg B-10 Bortezomib Bortezomib and Mapatumumab 10 mg/kg
- Primary Outcome Measures
Name Time Method To evaluate disease response to mapatumumab in combination with bortezomib and bortezomib alone 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 period 17 cycles (up to a year)
Trial Locations
- Locations (20)
University of Chicago
🇺🇸Chicago, Illinois, United States
Institute of Medical & Veterinary Science
🇦🇺Adelaide, South Australia, Australia
Scripps Clinic Medical Group, Inc.
🇺🇸La Jolla, California, United States
Cancer and Blood Disorders Center
🇺🇸Lecanto, Florida, United States
Capitol Comprehensive Cancer Care Clinic
🇺🇸Jefferson City, Missouri, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Tom Baker Cancer Center
🇨🇦Calgary, Alberta, Canada
Ottawa Health Research Institute - General Campus
🇨🇦Ottawa, Ontario, Canada
Nebraska Methodist Cancer Center
🇺🇸Omaha, Nebraska, United States
Department of Haematology, Royal North Shore Hospital
🇦🇺St Leonards, New South Wales, Australia
Notre Dame Centre Hospitalier de l'Universite de Montreal
🇨🇦Montreal, Quebec, Canada
Mayo Clinic Arizona
🇺🇸Scottsdale, Arizona, United States
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
Bharath Hospital & Institute of Oncology
🇮🇳Mysore, Karnataka, India
Bangalore Institute of Oncology
🇮🇳Bangalore, India
All India Institute of Medical Sciences
🇮🇳New Delhi, India
Rajiv Gandhi Cancer Institute & Research Center
🇮🇳New Delhi, India
Center for Cancer and Blood Disorders
🇺🇸Bethesda, Maryland, United States
Peter MacCallum Cancer Centre
🇦🇺East Melbourne, Victoria, Australia
Clinical Haematology & BMT, Alfred Hospital
🇦🇺Melbourne, Victoria, Australia