drugset / Trial / NCT00903968
Combination Plerixafor (AMD3100)and Bortezomib in Relapsed or Relapsed/Refractory Multiple Myeloma
Phase 1/2
Completed
58 enrolled
Dana-Farber Cancer Institute
Brigham and Women's Hospital · collabGenzyme, a Sanofi Company · collabMillennium Pharmaceuticals, Inc. · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The purpose of this research study is to determine the safety of plerixafor and bortezomib, and the highest dose that can be given to people safely. Plerixafor appears to stop myeloma cells from attaching to bone marrow and has been used in other phase I studies for mobilization of stem cells for patients with myeloma and lymphoma. We have shown that the combination of plerixafor and bortezomib is very effective in killing myeloma cells in the laboratory more than the effect of each drug alone.
Timeline
- Start
- 2009-06-01
- Primary completion
- 2016-06
- Completion
- 2016-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bortezomib | Small molecule | 1 mg/m2 | Intravenous |
| Subject | Bortezomib | Small molecule | 1.3 mg/m2 | Intravenous |
| Subject | Dexamethasone | Small molecule | 40 mg | Oral |
| Subject | Plerixafor | Small molecule | 160 ug/kg | Other |
| Subject | Plerixafor | Small molecule | 240 ug/kg | Other |
| Subject | Plerixafor | Small molecule | 320 ug/kg | Other |
| Subject | Plerixafor | Small molecule | 400 ug/kg | Other |