Study of Mapatumumab in Combination With Bortezomib (Velcade) and Bortezomib Alone in Subjects With Relapsed or Refractory Multiple Myeloma
NCT ID: NCT00315757
Last Updated: 2013-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
105 participants
INTERVENTIONAL
2006-05-31
2010-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
Bortezomib
Bortezomib
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.
B-10
Bortezomib and Mapatumumab 10 mg/kg
Mapatumumab
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.
Bortezomib
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.
B-20
Bortezomib and Mapatumumab 20 mg/kg
Mapatumumab
20 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.
Bortezomib
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.
Interventions
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Mapatumumab
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.
Mapatumumab
20 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.
Bortezomib
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Measurable serum and/or urine M-protein
* Failed 1 or 2 prior therapies for multiple myeloma
* 18 years of age or older
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Human Genome Sciences Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_CHAIR
GlaxoSmithKline
Locations
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Mayo Clinic Arizona
Scottsdale, Arizona, United States
Scripps Clinic Medical Group, Inc.
La Jolla, California, United States
Cancer and Blood Disorders Center
Lecanto, Florida, United States
University of Chicago
Chicago, Illinois, United States
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States
Capitol Comprehensive Cancer Care Clinic
Jefferson City, Missouri, United States
Nebraska Methodist Cancer Center
Omaha, Nebraska, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Department of Haematology, Royal North Shore Hospital
St Leonards, New South Wales, 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
Tom Baker Cancer Center
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
Ottawa Health Research Institute - General Campus
Ottawa, Ontario, Canada
Notre Dame Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, 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
Countries
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Other Identifiers
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HGS1012-C1055
Identifier Type: -
Identifier Source: org_study_id