First Line Treatment Trial in Multiple Myeloma, Finnish Myeloma Group- Multiple Myeloma 02

• Status: Completed
• Trial end date: 2019-02-26
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kuopio University Hospital
• Collaborators: Celgene Corporation; Central Hospital of Kanta-Hame; Helsinki University Central Hospital; Jyväskylä Central Hospital; Kainuu and Länsi-Pohja Central Hospital; Kainuu Central Hospital, Kajaani; Kanta-Häme Central Hospital; Kymenlaakso Central Hospital Kotka Finland; Mikkeli Central Hospital; Oulu University Hospital; Satakunta Central Hospital; Tampere University Hospital; Turku University Hospital
• Treatments: Cyclophosphamide; Lenograstim

Criteria

Inclusion Criteria:

• written informed consent

• symptomatic, previously untreated International Stating System (ISS) 1-3 myeloma

• measurable disease

• WHO perf status 0-3

• eligible for ASCT

Exclusion Criteria:

• previously treated

• peripheral neuropathy gr >/= 2

• significant hepatic dysfunction

• severe cardiac dysfunction

• severe renal failure if not in dialysis