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

Kuopio University Hospital80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Multiple Myeloma

Interventions

CyclophosphamideDRUG

FilgrastimDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (12)

Kuopio University Hospital

Kuopio, Northern Savonia, Finland

Tampere University Hospital

Tampere, Pirkanmaa, Finland

Kanta-Häme Central Hospital

Hämeenlinna, Finland

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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