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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01790737

Acronym

FMG-MM02

Enrollment

Registered

2013-02-13

Start date

2013-01-31

Completion date

2019-02-26

Last updated

2019-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Keywords

myeloma, stem cell mobilization, autologous stem cell transplantation, induction treatment, maintenance treatment

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

Interventions

DRUGCyclophosphamide

DRUGFilgrastim

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Immunophenotypic response	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	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.

Secondary

Measure	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

Other

Measure	Time frame
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)	Assessed up to 2 weeks from the start of mobilization

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026