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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
ClinicalTrials.gov Identifier:
NCT00315757
First received: April 17, 2006
Last updated: October 29, 2012
Last verified: October 2012
History of Changes
  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 2

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

Resource links provided by NLM:

Drug Information available for: Bortezomib
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

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 ]

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
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

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
Sponsors and Collaborators
Human Genome Sciences Inc., a GSK Company
Investigators
Study Chair: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
ClinicalTrials.gov Identifier: NCT00315757     History of Changes
Other Study ID Numbers: HGS1012-C1055
Study First Received: April 17, 2006
Last Updated: October 29, 2012
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:
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

ClinicalTrials.gov processed this record on May 19, 2013