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

Phase 2

Completed

• Conditions: Multiple Myeloma
• Interventions: Biological: Mapatumumab; Drug: Bortezomib

• Registration Number: NCT00315757
• Lead Sponsor: Human Genome Sciences Inc.

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-04-17
• Study First Submitted QC: 2006-04-17
• Study First Posted: 2006-04-19
• Study Start: 2006-05
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Disposition First Submitted: 2011-03-30
• Disposition First Submitted QC: 2011-04-11
• Disposition First Posted: 2011-04-25
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-01
• Last Update Posted: 2013-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B-20	Mapatumumab	Bortezomib and Mapatumumab 20 mg/kg
B-20	Bortezomib	Bortezomib and Mapatumumab 20 mg/kg
A	Bortezomib	Bortezomib
B-10	Mapatumumab	Bortezomib and Mapatumumab 10 mg/kg
B-10	Bortezomib	Bortezomib and Mapatumumab 10 mg/kg

Primary Outcome Measures

Name	Time	Method
To evaluate disease response to mapatumumab in combination with bortezomib and bortezomib alone	17 cycles (up to a year)

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (20)

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

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