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

Sponsor:	Human Genome Sciences
Information provided by:	Human Genome Sciences
ClinicalTrials.gov Identifier:	NCT00315757

Purpose

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).

Condition	Intervention	Phase
Multiple Myeloma	Biological: Mapatumumab Drug: Bortezomib	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Active Control Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Multiple Myeloma

Drug Information available for: Bortezomib Mapatumumab

U.S. FDA Resources

Further study details as provided by Human Genome Sciences:

Primary Outcome Measures:

To evaluate disease response to mapatumumab in combination with bortezomib and bortezomib alone [ Time Frame: 17 cycles (up to a year) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 [ Time Frame: 17 cycles (up to a year) ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	100
Study Start Date:	May 2006
Estimated Study Completion Date:	October 2008
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator Bortezomib	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.
B-10: Experimental Bortezomib and Mapatumumab 10 mg/kg	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. 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.
B-20: Experimental Bortezomib and Mapatumumab 20 mg/kg	Biological: 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00315757

Show 20 Study Locations

Sponsors and Collaborators

Human Genome Sciences

Investigators

Study Chair:

David C Stump, MD

Human Genome Sciences, Inc

More Information

No publications provided

Responsible Party:	Human Genome Sciences, Inc ( Dan Odenheimer )
ClinicalTrials.gov Identifier:	NCT00315757 History of Changes
Other Study ID Numbers:	HGS1012-C1055
Study First Received:	April 17, 2006
Last Updated:	March 18, 2008
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada; Australia: Department of Health and Ageing Therapeutic Goods Administration; India: Drugs Controller General of India

Additional relevant MeSH terms:

Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders

Immunoproliferative Disorders
Immune System Diseases
Bortezomib
Antibodies, Monoclonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 01, 2010