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

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00315757
• Other study ID #: HGS1012-C1055
• Status: Completed
• Phase: Phase 2
• First received: April 17, 2006
• Last updated: August 1, 2013
• Start date: May 2006
• Est. completion date: October 2010

Study information

• Verified date: August 2013
• Source: Human Genome Sciences Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaAustralia: Department of Health and Ageing Therapeutic Goods AdministrationIndia: Drugs Controller General of India
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Biological:
• Mapatumumab
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.
• Mapatumumab
20 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.

Drug:
• Bortezomib
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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Human Genome Sciences Inc.

Countries where clinical trial is conducted

United States,  Australia,  Canada,  India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate disease response to mapatumumab in combination with bortezomib and bortezomib alone		17 cycles (up to a year)	No
Secondary	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)	Yes