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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Drug: Cyclophosphamide
* Drug: Filgrastim


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Cyclophosphamide plus filgrastim | Drug: Cyclophosphamide<br> <br> |
| Active Comparator: B<br>Filgrastim | Drug: Filgrastim<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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myeloma, stem cell mobilization, autologous stem cell transplantation, induction treatment, maintenance treatment