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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
ClinicalTrials.gov Identifier:
NCT00315757
First received: April 17, 2006
Last updated: October 29, 2012
Last verified: October 2012
History of Changes

April 17, 2006
October 29, 2012
May 2006
October 2010   (final data collection date for primary outcome measure)
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 ]
To evaluate disease response to mapatumumab in combination with bortezomib and bortezomib alone approximately every 6 weeks during treatment and every 3 months thereafter.
Complete list of historical versions of study NCT00315757 on ClinicalTrials.gov Archive Site
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 ]
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.
Not Provided
Not Provided
 
Study of Mapatumumab in Combination With Bortezomib (Velcade) and Bortezomib Alone in Subjects With Relapsed or Refractory Multiple Myeloma
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

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).
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma
  • 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.
  • 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.
    Other Name: Velcade
  • Active Comparator: A
    Bortezomib
    Intervention: Drug: Bortezomib
  • Experimental: B-10
    Bortezomib and Mapatumumab 10 mg/kg
    Interventions:
    • Biological: Mapatumumab
    • Drug: Bortezomib
  • Experimental: B-20
    Bortezomib and Mapatumumab 20 mg/kg
    Interventions:
    • Biological: Mapatumumab
    • Drug: Bortezomib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
105
October 2010
October 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   India
 
NCT00315757
HGS1012-C1055
No
GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
Human Genome Sciences Inc., a GSK Company
Not Provided
Study Chair: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP