Clinical trial · Interventional
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
NCT00315757CI-TRIAL-00011668completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bortezomib | Drug | Bortezomib | ALIAS |
| Mapatumumab | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- A
- description
- Bortezomib
- interventionNames
- Drug: Bortezomib
- type
- EXPERIMENTAL
- label
- B-10
- description
- Bortezomib and Mapatumumab 10 mg/kg
- interventionNames
- Biological: Mapatumumab
- Drug: Bortezomib
- type
- EXPERIMENTAL
- label
- B-20
- description
- Bortezomib and Mapatumumab 20 mg/kg
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.