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

February 27, 2019 updated by: Kuopio University Hospital

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland
        • Helsinki University Hospital
      • Hämeenlinna, Finland
        • Kanta-Häme Central Hospital
      • Jyväskylä, Finland
        • Jyväskylä Central Finland Central Hospital
      • Kajaani, Finland
        • Kainuu Kajaani Central Hospital
      • Kemi, Finland
        • Länsi-Pohja Central Hospital
      • Kotka, Finland
        • Kymenlaakso Central Hospital
      • Mikkeli, Finland
        • Mikkeli Southern-Savo Central Hospital
      • Oulu, Finland
        • Oulu University Hospital
      • Pori, Finland
        • Satakunta Central Hospital
      • Turku, Finland
        • Turku University Central Hospital
    • North Savo
      • Kuopio, North Savo, Finland, 70200
        • Kuopio University Hospital
    • Pirkanmaa
      • Tampere, Pirkanmaa, Finland, 33100
        • Tampere University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
Cyclophosphamide plus filgrastim
Drug: Cyclophosphamide
Active Comparator: B
Filgrastim
Drug: Filgrastim

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunophenotypic response
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
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 Outcome Measures

Outcome Measure
Time Frame
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
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 Outcome Measures

Outcome 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)
Time Frame: Assessed up to 2 weeks from the start of mobilization
Assessed up to 2 weeks from the start of mobilization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kuopio University Hospital

Collaborators

Turku University Hospital
Helsinki University Central Hospital
Oulu University Hospital
Celgene Corporation
Tampere University Hospital
Satakunta Central Hospital
Jyväskylä Central Hospital
Kanta-Häme Central Hospital
Kymenlaakso Central Hospital Kotka Finland
Mikkeli Central Hospital
Kainuu Central Hospital, Kajaani

Investigators

  • Principal Investigator: Raija Silvennoinen, MD, Kuopio University Hospital, Kuopio, FI

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

October 10, 2018

Study Completion (Actual)

February 26, 2019

Study Registration Dates

First Submitted

February 4, 2013

First Submitted That Met QC Criteria

February 11, 2013

First Posted (Estimate)

February 13, 2013

Study Record Updates

Last Update Posted (Actual)

March 1, 2019

Last Update Submitted That Met QC Criteria

February 27, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KUH5101424
  • 2012-001051-39 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Multiple Myeloma

Clinical Trials on Filgrastim

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cambodia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe