Study of Mapatumumab in Combination With Bortezomib (Velcade) and Bortezomib Alone in Subjects With Relapsed or Refractory Multiple Myeloma
Information source: Human Genome Sciences
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple Myeloma
Intervention: Mapatumumab (Biological); Mapatumumab (Biological); Bortezomib (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Human Genome Sciences Official(s) and/or principal investigator(s):
David C Stump, MD, Study Chair, Affiliation: Human Genome Sciences, Inc
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).
Clinical Details
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
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: To evaluate disease response to mapatumumab in combination with bortezomib and bortezomib alone
Secondary outcome: 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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Rajiv Gandhi Cancer Institute & Research Center, New Delhi 110 085, India
All India Institute of Medical Sciences, New Delhi 110 029, India
Bangalore Institute of Oncology, Bangalore 560027, India
Tom Baker Cancer Center, Calgary, Alberta T2N 4N2, Canada
Cross Cancer Institute, Edmonton, Alberta T6G 1Z2, Canada
Mayo Clinic Arizona, Scottsdale, Arizona 85259, United States
Scripps Clinic Medical Group, Inc., La Jolla, California 92037, United States
Cancer and Blood Disorders Center, Lecanto, Florida 34461, United States
University of Chicago, Chicago, Illinois 60637, United States
Bharath Hospital & Institute of Oncology, Mysore, Karnataka 570 017, India
Center for Cancer and Blood Disorders, Bethesda, Maryland 20817, United States
Capitol Comprehensive Cancer Care Clinic, Jefferson City, Missouri 65109, United States
Nebraska Methodist Cancer Center, Omaha, Nebraska 68114, United States
Department of Haematology, Royal North Shore Hospital, St Leonards, New South Wales 2065, Australia
Roswell Park Cancer Institute, Buffalo, New York 14263, United States
Ottawa Health Research Institute - General Campus, Ottawa, Ontario K1Y 4E9, Canada
Notre Dame Centre Hospitalier de l'Universite de Montreal, Montreal, Quebec H2L 4M1, Canada
Institute of Medical & Veterinary Science, Adelaide, South Australia 5000, Australia
Peter MacCallum Cancer Centre, East Melbourne, Victoria 3002, Australia
Clinical Haematology & BMT, Alfred Hospital, Melbourne, Victoria 3181, Australia
Additional Information
Starting date: May 2006
Ending date: October 2008
Last updated: March 18, 2008
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