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

Completed · Phase 2

Conditions studied: Multiple Myeloma

In brief

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).

Key facts

Study ID

NCT00315757

Run by

Human Genome Sciences Inc.

People needed

105

Starts

2006-05-01

Expected to finish

2010-10-01

Last updated by the study team

2013-08-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• 18 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

Where it is running

• Mayo Clinic Arizona — Scottsdale, Arizona, United States
• Scripps Clinic Medical Group, Inc. — La Jolla, California, United States
• Cancer and Blood Disorders Center — Lecanto, Florida, United States
• University of Chicago — Chicago, Illinois, United States
• Center for Cancer and Blood Disorders — Bethesda, Maryland, United States
• Capitol Comprehensive Cancer Care Clinic — Jefferson City, Missouri, United States
• Nebraska Methodist Cancer Center — Omaha, Nebraska, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Department of Haematology, Royal North Shore Hospital — St Leonards, New South Wales, Australia
• Institute of Medical & Veterinary Science — Adelaide, South Australia, Australia
• Peter MacCallum Cancer Centre — East Melbourne, Victoria, Australia
• Clinical Haematology & BMT, Alfred Hospital — Melbourne, Victoria, Australia
• Tom Baker Cancer Center — Calgary, Alberta, Canada
• Cross Cancer Institute — Edmonton, Alberta, Canada
• Ottawa Health Research Institute - General Campus — Ottawa, Ontario, Canada
• Notre Dame Centre Hospitalier de l'Universite de Montreal — Montreal, Quebec, Canada
• Bharath Hospital & Institute of Oncology — Mysore, Karnataka, India
• Bangalore Institute of Oncology — Bangalore, India
• All India Institute of Medical Sciences — New Delhi, India
• Rajiv Gandhi Cancer Institute & Research Center — New Delhi, India

Full record on ClinicalTrials.gov

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