Clinical trial NCT00315757: Study of Mapatumumab in Combination With Bortezomib (Velcade) and Bortezomib Alone in Subjects With Relapsed or Refractory Multiple Myeloma
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Myeloma
Lead sponsor: Human Genome Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2006-04-19
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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

Primary outcomes:
measure: To evaluate disease response to mapatumumab in combination with bortezomib and bortezomib alone
timeFrame: 17 cycles (up to a year)
Secondary outcomes:
measure: 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
timeFrame: 17 cycles (up to a year)
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: La Jolla
country: United States
facility: Scripps Clinic Medical Group, Inc.
state: California
city: Lecanto
country: United States
facility: Cancer and Blood Disorders Center
state: Florida
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Bethesda
country: United States
facility: Center for Cancer and Blood Disorders
state: Maryland
city: Jefferson City
country: United States
facility: Capitol Comprehensive Cancer Care Clinic
state: Missouri
city: Omaha
country: United States
facility: Nebraska Methodist Cancer Center
state: Nebraska
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: St Leonards
country: Australia
facility: Department of Haematology, Royal North Shore Hospital
state: New South Wales
city: Adelaide
country: Australia
facility: Institute of Medical & Veterinary Science
state: South Australia
city: East Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Melbourne
country: Australia
facility: Clinical Haematology & BMT, Alfred Hospital
state: Victoria
city: Calgary
country: Canada
facility: Tom Baker Cancer Center
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Ottawa
country: Canada
facility: Ottawa Health Research Institute - General Campus
state: Ontario
city: Montreal
country: Canada
facility: Notre Dame Centre Hospitalier de l'Universite de Montreal
state: Quebec
city: Mysore
country: India
facility: Bharath Hospital & Institute of Oncology
state: Karnataka
city: Bangalore
country: India
facility: Bangalore Institute of Oncology
city: New Delhi
country: India
facility: All India Institute of Medical Sciences
city: New Delhi
country: India
facility: Rajiv Gandhi Cancer Institute & Research Center
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_CHAIR
References: