drugset / Trial / NCT01702831
Busulfan & Melphalan Conditioning for Autologous Stem Cell Transplant (ASCT) and Lenalidomide Maintenance
Phase 2
Completed
78 enrolled
University Health Network, Toronto
Celgene Corporation · collabOtsuka Pharmaceutical Development & Commercialization, Inc. · collabPrincess Margaret Hospital, Canada · collab
NaSingle-groupOpen-labelTreatment
Summary
A number of strategies have been proposed to improve the outcome of ASCT. The three main strategies are to incorporate novel agents into the induction regimen, using maintenance therapy following ASCT and the final strategy is to enhance conditioning regimens. Investigators would like to explore all these three strategies in this study: Investigators propose to take patients who have had standard novel agent (bortezomib) based induction regimens into this study and then use a dose-adjusted combination of busulfan and melphalan as conditioning regimen and finally Investigators would like to incorporate lenalidomide maintenance post ASCT until disease progression.
Timeline
- Start
- 2013-10-01
- Primary completion
- 2022-07-31
- Completion
- 2022-07-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Busulfan | Small molecule | 3.2 mg/kg | Intravenous |
| Subject | Lenalidomide | Other / unclassified | 15 mg | Oral |
| Subject | Melphalan | Small molecule | 140 mg/m2 | Intravenous |