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

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Mapatumumab
Mapatumumab
Bortezomib
Sponsored by
Human Genome Sciences Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic Arizona
  • Scripps Clinic Medical Group, Inc.
  • Cancer and Blood Disorders Center
  • University of Chicago
  • Center for Cancer and Blood Disorders
  • Capitol Comprehensive Cancer Care Clinic
  • Nebraska Methodist Cancer Center
  • Roswell Park Cancer Institute
  • Department of Haematology, Royal North Shore Hospital
  • Institute of Medical & Veterinary Science
  • Peter MacCallum Cancer Centre
  • Clinical Haematology & BMT, Alfred Hospital
  • Tom Baker Cancer Center
  • Cross Cancer Institute
  • Ottawa Health Research Institute - General Campus
  • Notre Dame Centre Hospitalier de l'Universite de Montreal
  • Bharath Hospital & Institute of Oncology
  • Bangalore Institute of Oncology
  • All India Institute of Medical Sciences
  • Rajiv Gandhi Cancer Institute & Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

A

B-10

B-20

Arm Description

Bortezomib

Bortezomib and Mapatumumab 10 mg/kg

Bortezomib and Mapatumumab 20 mg/kg

Outcomes

Primary Outcome Measures

To evaluate disease response to mapatumumab in combination with bortezomib and bortezomib alone

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

Full Information

First Posted
April 17, 2006
Last Updated
August 1, 2013
Sponsor
Human Genome Sciences Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00315757
Brief Title
Study of Mapatumumab in Combination With Bortezomib (Velcade) and Bortezomib Alone in Subjects With Relapsed or Refractory Multiple Myeloma
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Human Genome Sciences Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
Bortezomib
Arm Title
B-10
Arm Type
Experimental
Arm Description
Bortezomib and Mapatumumab 10 mg/kg
Arm Title
B-20
Arm Type
Experimental
Arm Description
Bortezomib and Mapatumumab 20 mg/kg
Intervention Type
Biological
Intervention Name(s)
Mapatumumab
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Mapatumumab
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Bortezomib
Other Intervention Name(s)
Velcade
Intervention Description
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.
Primary Outcome Measure Information:
Title
To evaluate disease response to mapatumumab in combination with bortezomib and bortezomib alone
Time Frame
17 cycles (up to a year)
Secondary Outcome Measure Information:
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Chair
Facility Information:
Facility Name
Mayo Clinic Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Scripps Clinic Medical Group, Inc.
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Cancer and Blood Disorders Center
City
Lecanto
State/Province
Florida
ZIP/Postal Code
34461
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Center for Cancer and Blood Disorders
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Capitol Comprehensive Cancer Care Clinic
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65109
Country
United States
Facility Name
Nebraska Methodist Cancer Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Department of Haematology, Royal North Shore Hospital
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Institute of Medical & Veterinary Science
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Peter MacCallum Cancer Centre
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
Clinical Haematology & BMT, Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3181
Country
Australia
Facility Name
Tom Baker Cancer Center
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Ottawa Health Research Institute - General Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4E9
Country
Canada
Facility Name
Notre Dame Centre Hospitalier de l'Universite de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
Bharath Hospital & Institute of Oncology
City
Mysore
State/Province
Karnataka
ZIP/Postal Code
570 017
Country
India
Facility Name
Bangalore Institute of Oncology
City
Bangalore
ZIP/Postal Code
560027
Country
India
Facility Name
All India Institute of Medical Sciences
City
New Delhi
ZIP/Postal Code
110 029
Country
India
Facility Name
Rajiv Gandhi Cancer Institute & Research Center
City
New Delhi
ZIP/Postal Code
110 085
Country
India

12. IPD Sharing Statement

Learn more about this trial

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

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