Study of Mapatumumab in Combination With Bortezomib (Velcade) and Bortezomib Alone in Subjects With Relapsed or Refractory Multiple Myeloma - Full Text View

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:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Multiple Myeloma

Drug Information available for: Bortezomib Mapatumumab

U.S. FDA Resources

Further study details as provided by Human Genome Sciences:

Primary Outcome Measures:

To evaluate disease response to mapatumumab in combination with bortezomib and bortezomib alone [ Time Frame: 17 cycles (up to a year) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 [ Time Frame: 17 cycles (up to a year) ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	100
Study Start Date:	May 2006
Estimated Study Completion Date:	October 2008
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator 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.
B-10: Experimental 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.
B-20: Experimental 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00315757

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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
Rajiv Gandhi Cancer Institute & Research Center
New Delhi, India, 110 085
All India Institute of Medical Sciences
New Delhi, India, 110 029
Bangalore Institute of Oncology
Bangalore, India, 560027
India, Karnataka
Bharath Hospital & Institute of Oncology
Mysore, Karnataka, India, 570 017

Sponsors and Collaborators

Human Genome Sciences

Investigators

Study Chair:

David C Stump, MD

Human Genome Sciences, Inc

More Information

No publications provided

Responsible Party:	Human Genome Sciences, Inc ( Dan Odenheimer )
Study ID Numbers:	HGS1012-C1055
Study First Received:	April 17, 2006
Last Updated:	March 18, 2008
ClinicalTrials.gov Identifier:	NCT00315757 History of Changes
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

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Immunoproliferative Disorders
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents
Blood Protein Disorders
Hematologic Diseases
Physiological Effects of Drugs
Bortezomib
Vascular Diseases
Enzyme Inhibitors

Paraproteinemias
Hemostatic Disorders
Pharmacologic Actions
Protease Inhibitors
Multiple Myeloma
Antibodies, Monoclonal
Neoplasms
Hemorrhagic Disorders
Therapeutic Uses
Cardiovascular Diseases
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

ClinicalTrials.gov processed this record on November 22, 2009