A Prospective Phase II Study to Assess Immunophenotypic Remission After 3-drug Induction Followed by Randomized Stem Cell Mobilization, Autologous Stem Cell Transplantation (ASCT) and Lenalidomide Maintenance in Newly Diagnosed Multiple Myeloma
Overview
- Phase
- Phase 2
- Intervention
- Filgrastim
- Conditions
- Multiple Myeloma
- Sponsor
- Kuopio University Hospital
- Enrollment
- 80
- Locations
- 12
- Primary Endpoint
- Immunophenotypic response
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief 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.
Investigators
Eligibility 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
Arms & Interventions
B
Filgrastim
Intervention: Filgrastim
A
Cyclophosphamide plus filgrastim
Intervention: Cyclophosphamide
Outcomes
Primary Outcomes
Immunophenotypic response
Time Frame: Change from the start of induction treatment at 3 months, change from the start of induction at 6 months, at 9 months, at 12 months, at 16 months, at 20 months, at 24 moths
Response will be measured by International Myeloma Working Group (IMWG) guidelines, and if the response is stringent CR and immunophenotypic remission, those patients will be followed also by allele-spesific oligonucleotide-polymerase chain reaction assay (ASO-PCR) to find out molecular remission rate.
Secondary Outcomes
- Progression free survival(From date of inclusion until the date of first documented progression or date of death from any cause whatever come first assessed up to last patient 2 years on maintenance)