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| Sponsor: | Human Genome Sciences |
|---|---|
| Information provided by: | Human Genome Sciences |
| ClinicalTrials.gov Identifier: | NCT00315757 |
Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma |
Biological: Mapatumumab Drug: Bortezomib |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
| Enrollment: | 105 |
| Study Start Date: | May 2006 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: A
Bortezomib
|
Drug: 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 Name: Velcade
|
|
Experimental: B-10
Bortezomib and Mapatumumab 10 mg/kg
|
Biological: 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.
Drug: 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 Name: Velcade
|
|
Experimental: B-20
Bortezomib and Mapatumumab 20 mg/kg
|
Biological: 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.
Drug: 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 Name: Velcade
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Arizona | |
| Mayo Clinic Arizona | |
| Scottsdale, Arizona, United States, 85259 | |
| United States, California | |
| Scripps Clinic Medical Group, Inc. | |
| La Jolla, California, United States, 92037 | |
| United States, Florida | |
| Cancer and Blood Disorders Center | |
| Lecanto, Florida, United States, 34461 | |
| United States, Illinois | |
| University of Chicago | |
| Chicago, Illinois, United States, 60637 | |
| United States, Maryland | |
| Center for Cancer and Blood Disorders | |
| Bethesda, Maryland, United States, 20817 | |
| United States, Missouri | |
| Capitol Comprehensive Cancer Care Clinic | |
| Jefferson City, Missouri, United States, 65109 | |
| United States, Nebraska | |
| Nebraska Methodist Cancer Center | |
| Omaha, Nebraska, United States, 68114 | |
| United States, New York | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263 | |
| Australia, New South Wales | |
| Department of Haematology, Royal North Shore Hospital | |
| St Leonards, New South Wales, Australia, 2065 | |
| Australia, South Australia | |
| Institute of Medical & Veterinary Science | |
| Adelaide, South Australia, Australia, 5000 | |
| Australia, Victoria | |
| Peter MacCallum Cancer Centre | |
| East Melbourne, Victoria, Australia, 3002 | |
| Clinical Haematology & BMT, Alfred Hospital | |
| Melbourne, Victoria, Australia, 3181 | |
| Canada, Alberta | |
| Tom Baker Cancer Center | |
| Calgary, Alberta, Canada, T2N 4N2 | |
| Cross Cancer Institute | |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Canada, Ontario | |
| Ottawa Health Research Institute - General Campus | |
| Ottawa, Ontario, Canada, K1Y 4E9 | |
| Canada, Quebec | |
| Notre Dame Centre Hospitalier de l'Universite de Montreal | |
| Montreal, Quebec, Canada, H2L 4M1 | |
| India | |
| Bharath Hospital & Institute of Oncology | |
| Mysore, Karnataka, India, 570 017 | |
| Bangalore Institute of Oncology | |
| Bangalore, India, 560027 | |
| Rajiv Gandhi Cancer Institute & Research Center | |
| New Delhi, India, 110 085 | |
| All India Institute of Medical Sciences | |
| New Delhi, India, 110 029 | |
| Study Chair: | David C Stump, MD | Human Genome Sciences, Inc |
More Information
| Responsible Party: | Dan Odenheimer, Human Genome Sciences, Inc |
| ClinicalTrials.gov Identifier: | NCT00315757 History of Changes |
| Other Study ID Numbers: | HGS1012-C1055 |
| Study First Received: | April 17, 2006 |
| Last Updated: | April 11, 2011 |
| Health Authority: | United States: Food and Drug Administration; Canada: Health Canada; Australia: Department of Health and Ageing Therapeutic Goods Administration; India: Drugs Controller General of India |
|
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders |
Immunoproliferative Disorders Immune System Diseases Bortezomib Antibodies, Monoclonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs |
