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Completed

NCT Number: NCT01790737

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

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kuopio University Hospital, Kuopio, Northern Savonia, Finland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cyclophosphamide

Drug

Filgrastim

Drug

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Kuopio University Hospital

Other

Collaborators

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

Registry information

Official study 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

Acronym: FMG-MM02

Important dates

Study start
2013
Primary completion
2018
Study completion
2019
First posted
Feb 13, 2013
Registry last updated
Mar 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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