Study of Mapatumumab in Combination With Bortezomib (Velcade) and Bortezomib Alone in Subjects With Relapsed or Refractory Multiple Myeloma
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
1 other identifier
interventional
105
4 countries
20
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 multiple-myeloma
Started May 2006
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2006
CompletedFirst Posted
Study publicly available on registry
April 19, 2006
CompletedStudy Start
First participant enrolled
May 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedAugust 8, 2013
August 1, 2013
4.4 years
April 17, 2006
August 1, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
To evaluate disease response to mapatumumab in combination with bortezomib and bortezomib alone
17 cycles (up to a year)
Secondary Outcomes (1)
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
17 cycles (up to a year)
Study Arms (3)
A
ACTIVE COMPARATORBortezomib
B-10
EXPERIMENTALBortezomib and Mapatumumab 10 mg/kg
B-20
EXPERIMENTALBortezomib and Mapatumumab 20 mg/kg
Interventions
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.
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 Criteria
You may qualify if:
- 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
- years of age or older
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
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
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
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Department of Haematology, Royal North Shore Hospital
St Leonards, New South Wales, 2065, Australia
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
Tom Baker Cancer Center
Calgary, Alberta, T2N 4N2, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
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
Bharath Hospital & Institute of Oncology
Mysore, Karnataka, 570 017, India
Bangalore Institute of Oncology
Bangalore, 560027, India
All India Institute of Medical Sciences
New Delhi, 110 029, India
Rajiv Gandhi Cancer Institute & Research Center
New Delhi, 110 085, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2006
First Posted
April 19, 2006
Study Start
May 1, 2006
Primary Completion
October 1, 2010
Study Completion
October 1, 2010
Last Updated
August 8, 2013
Record last verified: 2013-08