| April 17, 2006 |
| March 18, 2008 |
| May 2006 |
| October 2008 (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. |
| |
| 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). |
| |
| Phase II |
| Interventional |
| Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Multiple Myeloma |
- Biological: Mapatumumab
- Drug: Bortezomib
|
- Active Comparator: Bortezomib
- Experimental: Bortezomib and Mapatumumab 10 mg/kg
- Experimental: Bortezomib and Mapatumumab 20 mg/kg
|
| |
| |
| Active, not recruiting |
| 100 |
| October 2008 |
| October 2008 (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 |
| Dan Odenheimer, Human Genome Sciences, Inc |
| HGS1012-C1055 |
| Human Genome Sciences |
|
| Study Chair: |
David C Stump, MD |
Human Genome Sciences, Inc |
|
|
| Human Genome Sciences |
| March 2008 |
