Overview

This trial is active, not recruiting.

Condition multiple myeloma
Treatments cyclophosphamide, filgrastim
Phase phase 2
Sponsor Kuopio University Hospital
Collaborator Helsinki University Central Hospital
Start date January 2013
End date December 2017
Trial size 80 participants
Trial identifier NCT01790737, 2012-001051-39, KUH5101424

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 + Granylocyte-colony stimulating factor)G-CSF vrs G-CSF will be compared regarding efficacy, costs and safety.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Cyclophosphamide plus filgrastim
cyclophosphamide
(Active Comparator)
Filgrastim
filgrastim

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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 laste patient 2 years on maintenance

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

Official title 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
Principal investigator Raija Silvennoinen, MD
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Kuopio University Hospital.