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

Multiple Myeloma Clinical Trial

— FMG-MM02  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01790737
• Other study ID #: KUH5101424
• Secondary ID: 2012-001051-39
• Status: Completed
• Phase: Phase 2
• Start date: January 2013
• Est. completion date: February 26, 2019

Study information

• Verified date: February 2019
• Source: Kuopio University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 26, 2019
• Est. primary completion date: October 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Cyclophosphamide

• Filgrastim

Locations

Country	Name	City	State
Finland	Kanta-Häme Central Hospital	Hämeenlinna
Finland	Helsinki University Hospital	Helsinki
Finland	Jyväskylä Central Finland Central Hospital	Jyväskylä
Finland	Kainuu Kajaani Central Hospital	Kajaani
Finland	Länsi-Pohja Central Hospital	Kemi
Finland	Kymenlaakso Central Hospital	Kotka
Finland	Kuopio University Hospital	Kuopio	North Savo
Finland	Mikkeli Southern-Savo Central Hospital	Mikkeli
Finland	Oulu University Hospital	Oulu
Finland	Satakunta Central Hospital	Pori
Finland	Tampere University Hospital	Tampere	Pirkanmaa
Finland	Turku University Central Hospital	Turku

Sponsors (12)

Lead Sponsor	Collaborator
Kuopio University Hospital	Celgene Corporation, Central Hospital of Kanta-Hame, Helsinki University Central Hospital, Jyväskylä Central Hospital, Kainuu Central Hospital, Kajaani, Kymenlaakso Central Hospital Kotka Finland, Mikkeli Central Hospital, Oulu University Hospital, Satakunta Central Hospital, Tampere University Hospital, Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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