First Line Treatment Trial in Multiple Myeloma, Finnish Myeloma Group- Multiple Myeloma 02 (FMG-MM02)

Kuopio University Hospital

Status and phase: Completed; Phase 2

Conditions: Multiple Myeloma

Treatments: Drug: Cyclophosphamide; Drug: Filgrastim

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01790737

KUH5101424

2012-001051-39 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

A

Active Comparator group

Description:

Cyclophosphamide plus filgrastim

Treatment:

Drug: Cyclophosphamide

B

Active Comparator group

Description:

Filgrastim

Treatment:

Drug: Filgrastim