A Phase 2 interventional study of Cyclophosphamide and Filgrastim in Multiple Myeloma, sponsored by Kuopio University Hospital. Completed at 12 sites in Finland. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-03-01.
Sponsored by Kuopio University Hospital · Phase 2, Interventional, and Treatment
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.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's enrollment of 80 is above the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Kuopio University Hospital is the lead sponsor of 132 studies on the registry; 23 are open to participants now.
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Exclusion Criteria:
Cyclophosphamide plus filgrastim
Drug: Cyclophosphamide
Filgrastim
Drug: Filgrastim
Immunophenotypic response
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.
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
Progression free survival
Time frame: 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
Proportion of pts collected with >/= 3 x 10e6/kg CD34+ with </= 2 apheresis after mobilization with CY 2g/m2 + filgrastim (group A) or filgrastim alone (group B)
Time frame: Assessed up to 2 weeks from the start of mobilization
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Kuopio University Hospital