drugset / Trial / NCT02447055
Allogeneic Stem Cell Transplantation for Patients With Multiple Myeloma
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to develop a novel platform for allo-SCT in multiple myeloma (MM) with the idea of maximizing anti-myeloma effect with conditioning and minimizing GvHD (graft versus host disease). Specifically, the investigators will use the Flu/Mel (fludarabine and melphalan) regimen. For GvHD prophylaxis, the investigators use the Hopkins PT-Cy (post-transplant cyclophosphamide) platform with the novelty of adding tocilizumab as both an anti-myeloma therapy and as a method to reduce GvHD. IL-6 has an important role in promoting the growth of myeloma cells and progression of disease.
Timeline
- Start
- 2015-12
- Primary completion
- 2016-06
- Completion
- 2016-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tocilizumab | Monoclonal antibody | 8 mg/m2 | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 50 mg/kg | Intravenous |
| Background | Fludarabine | Small molecule | 30 mg/m2 | Intravenous |
| Background | Melphalan | Small molecule | 140 mg/m2 | Intravenous |
| Background | Mycophenolate Mofetil | Small molecule | 15 mg/kg | Oral |
| Background | Tacrolimus | Small molecule | 1 mg | Intravenous |
| Background | filgrastim | Protein / enzyme biologic | 10 ug/kg | Subcutaneous |