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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

17 cycles (up to a year)

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Chair

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

HGS1012-C1055

NCT ID:

NCT00315757

Start Date:

May 2006

Completion Date:

October 2010

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Roswell Park Cancer Institute Buffalo, New York  14263
Capitol Comprehensive Cancer Care Clinic Jefferson City, Missouri  65109
University of Chicago Chicago, Illinois  60637
Center for Cancer and Blood Disorders Bethesda, Maryland  20817
Mayo Clinic Arizona Scottsdale, Arizona  85259
Nebraska Methodist Cancer Center Omaha, Nebraska  68114
Scripps Clinic Medical Group, Inc. La Jolla, California  92037
Cancer and Blood Disorders Center Lecanto, Florida  34461