Trials / Withdrawn
WithdrawnNCT02447055
Allogeneic Stem Cell Transplantation for Patients With Multiple Myeloma
Allogeneic Stem Cell Transplantation for Patients With Multiple Myeloma: a Pilot Feasibility Study Using a Novel Protocol
- Status
- Withdrawn
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Washington University School of Medicine · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Tocilizumab | |
| DRUG | Melphalan | |
| DRUG | Fludarabine | |
| DRUG | Cyclophosphamide | |
| DRUG | Tacrolimus | |
| DRUG | Mycophenolate mofetil | |
| DRUG | Filgrastim |
Timeline
- Start date
- 2015-12-01
- Primary completion
- 2016-06-01
- Completion
- 2016-06-01
- First posted
- 2015-05-18
- Last updated
- 2016-07-12
Source: ClinicalTrials.gov record NCT02447055. Inclusion in this directory is not an endorsement.