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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00315757
Recruitment Status : Completed
First Posted : April 19, 2006
Last Update Posted : August 8, 2013
Sponsor:
Information provided by (Responsible Party):
Human Genome Sciences Inc.

Tracking Information
First Submitted Date  ICMJE April 17, 2006
First Posted Date  ICMJE April 19, 2006
Last Update Posted Date August 8, 2013
Study Start Date  ICMJE May 2006
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2007)
To evaluate disease response to mapatumumab in combination with bortezomib and bortezomib alone [ Time Frame: 17 cycles (up to a year) ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 17, 2006)
To evaluate disease response to mapatumumab in combination with bortezomib and bortezomib alone approximately every 6 weeks during treatment and every 3 months thereafter.
Change History Complete list of historical versions of study NCT00315757 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2007)
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) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2006)
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Mapatumumab in Combination With Bortezomib (Velcade) and Bortezomib Alone in Subjects With Relapsed or Refractory Multiple Myeloma
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Myeloma
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 17, 2011)
105
Original Enrollment  ICMJE
 (submitted: April 17, 2006)
100
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   India,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00315757
Other Study ID Numbers  ICMJE HGS1012-C1055
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Human Genome Sciences Inc.
Study Sponsor  ICMJE Human Genome Sciences Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: GSK Clinical Trials GlaxoSmithKline
PRS Account Human Genome Sciences Inc.
Verification Date August 2013

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