First Line Treatment Trial in Multiple Myeloma, Finnish Myeloma Group- Multiple Myeloma 02 (FMG-MM02)
Primary Purpose
Multiple Myeloma
Status
Completed
Phase
Phase 2
Locations
Finland
Study Type
Interventional
Intervention
Cyclophosphamide
Filgrastim
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring myeloma, stem cell mobilization, autologous stem cell transplantation, induction treatment, maintenance treatment
Eligibility Criteria
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
Sites / Locations
- Kuopio University Hospital
- Tampere University Hospital
- Helsinki University Hospital
- Kanta-Häme Central Hospital
- Jyväskylä Central Finland Central Hospital
- Kainuu Kajaani Central Hospital
- Länsi-Pohja Central Hospital
- Kymenlaakso Central Hospital
- Mikkeli Southern-Savo Central Hospital
- Oulu University Hospital
- Satakunta Central Hospital
- Turku University Central Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
A
B
Arm Description
Cyclophosphamide plus filgrastim
Filgrastim
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Progression free survival
Full Information
NCT ID
NCT01790737
First Posted
February 4, 2013
Last Updated
February 27, 2019
Sponsor
Kuopio University Hospital
Collaborators
Helsinki University Central Hospital, Tampere University Hospital, Turku University Hospital, Oulu University Hospital, Mikkeli Central Hospital, Kymenlaakso Central Hospital Kotka Finland, Jyväskylä Central Hospital, Kanta-Häme Central Hospital, Satakunta Central Hospital, Kainuu Central Hospital, Kajaani, Celgene Corporation
1. Study Identification
Unique Protocol Identification Number
NCT01790737
Brief Title
First Line Treatment Trial in Multiple Myeloma, Finnish Myeloma Group- Multiple Myeloma 02
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
October 10, 2018 (Actual)
Study Completion Date
February 26, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kuopio University Hospital
Collaborators
Helsinki University Central Hospital, Tampere University Hospital, Turku University Hospital, Oulu University Hospital, Mikkeli Central Hospital, Kymenlaakso Central Hospital Kotka Finland, Jyväskylä Central Hospital, Kanta-Häme Central Hospital, Satakunta Central Hospital, Kainuu Central Hospital, Kajaani, Celgene Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
myeloma, stem cell mobilization, autologous stem cell transplantation, induction treatment, maintenance treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Description
Cyclophosphamide plus filgrastim
Arm Title
B
Arm Type
Active Comparator
Arm Description
Filgrastim
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
Filgrastim
Primary Outcome Measure Information:
Title
Immunophenotypic response
Description
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 Outcome Measure Information:
Title
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
Other Pre-specified Outcome Measures:
Title
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)
Time Frame
Assessed up to 2 weeks from the start of mobilization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raija Silvennoinen, MD
Organizational Affiliation
Kuopio University Hospital, Kuopio, FI
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kuopio University Hospital
City
Kuopio
State/Province
North Savo
ZIP/Postal Code
70200
Country
Finland
Facility Name
Tampere University Hospital
City
Tampere
State/Province
Pirkanmaa
ZIP/Postal Code
33100
Country
Finland
Facility Name
Helsinki University Hospital
City
Helsinki
Country
Finland
Facility Name
Kanta-Häme Central Hospital
City
Hämeenlinna
Country
Finland
Facility Name
Jyväskylä Central Finland Central Hospital
City
Jyväskylä
Country
Finland
Facility Name
Kainuu Kajaani Central Hospital
City
Kajaani
Country
Finland
Facility Name
Länsi-Pohja Central Hospital
City
Kemi
Country
Finland
Facility Name
Kymenlaakso Central Hospital
City
Kotka
Country
Finland
Facility Name
Mikkeli Southern-Savo Central Hospital
City
Mikkeli
Country
Finland
Facility Name
Oulu University Hospital
City
Oulu
Country
Finland
Facility Name
Satakunta Central Hospital
City
Pori
Country
Finland
Facility Name
Turku University Central Hospital
City
Turku
Country
Finland
12. IPD Sharing Statement
Learn more about this trial
First Line Treatment Trial in Multiple Myeloma, Finnish Myeloma Group- Multiple Myeloma 02
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