drugset / Trial / NCT01215344
First Autologous Transplant on Minimal Residual Disease Markers in Previously Untreated Myeloma Undergoing Initial Treatment With Velcade
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to study the MRD status after VELCADE based induction therapy (VELCADE, lenalidomide, dexamethasone or VELCADE, liposomal doxorubicin, dexamethasone) in patients with previously untreated multiple myeloma and study the impact of HDC and ASCT on MRD status post-transplant. Our hypothesis is that MRD-status will continue to increase significantly at 3 months post-transplant and will validate that HDC and ASCT needs to be performed even when patients have achieved major response after induction therapy with novel agents.
Timeline
- Start
- 2010-11
- Primary completion
- 2015-11
- Completion
- 2018-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexamethasone | Small molecule | 20 mg | Oral |
| Subject | Dexamethasone | Small molecule | 40 mg | Oral |
| Subject | Doxorubicin | Other / unclassified | 30 mg/m2 | — |
| Subject | Lenalidomide | Other / unclassified | 25 mg | Oral |
| Background | Bortezomib | Small molecule | 1.3 mg/m2 | Intravenous |
| Background | Pamidronate | Small molecule | — | Intravenous |
| Background | Zoledronic acid | Other / unclassified | — | Other |