drugset / Trial / NCT00861250
Assessment of Molecular Remission by ASO-qPCR After Bortezomib-dexamethasone (Vel/Dex) Followed by ASCT
Phase 2/3
Completed
47 enrolled
Tampere University Hospital
Helsinki University Central Hospital · collabJanssen-Cilag Ltd. · collabJyväskylä Central Hospital · collabKanta-Häme Central Hospital · collabKuopio University Hospital · collabOulu University Hospital · collabPäijänne Tavastia Central Hospital · collabSeinajoki Central Hospital · collabTurku University Hospital · collab
NaSingle-groupOpen-labelTreatment
Summary
The primary objective of this study is to determine the rate of molecular remissions (MolR) assessed by ASO-RQ-PCR technique after induction treatment with bortezomib and dexamethasone (Vel/Dex) prior to high-dose therapy with melphalan and autologous stem cell transplantation (HDT-ASCT), and after HDT-ASCT in patients with multiple myeloma.
Timeline
- Start
- 2009-03
- Primary completion
- 2014-12
- Completion
- 2015-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bortezomib | Small molecule | 1.3 mg/m2 | Intravenous |
| Subject | Dexamethasone | Small molecule | 40 mg | — |