drugset / Trial / NCT01790737
First Line Treatment Trial in Multiple Myeloma, Finnish Myeloma Group- Multiple Myeloma 02
Phase 2
Completed
80 enrolled
Kuopio University Hospital
Celgene Corporation · collabHelsinki University Central Hospital · collabJyväskylä Central Hospital · collabKainuu Central Hospital, Kajaani · collabKanta-Häme Central Hospital · collabKymenlaakso Central Hospital Kotka Finland · collabMikkeli Central Hospital · collabOulu University Hospital · collabSatakunta Central Hospital · collabTampere University Hospital · collabTurku University Hospital · collab
RandomizedSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to determinate the efficacy and safety of the 3-drug induction treatment (RVD; lenalidomide plus bortezomib plus dexamethasone)followed by randomized autologous stem cell mobilization, autologous stem cell transplantation and lenalidomide maintenance. Primary endpoint is the immunophenotypic remission rate.During the randomized mobilization phase two active comparator arms Cyclophosphamide (CY)2g/m2 + Granulocyte-colony stimulating factor(G-CSF) vrs G-CSF will be compared regarding efficacy, costs and safety.
Timeline
- Start
- 2013-01
- Primary completion
- 2018-10-10
- Completion
- 2019-02-26
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cyclophosphamide | Other / unclassified | 2 mg/m2 | — |
| Comparator | filgrastim | Protein / enzyme biologic | — | — |