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

NCT01790737 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2019-03-01

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Cyclophosphamide

DRUG

Filgrastim

Sponsors & Collaborators

  • Helsinki University Central Hospital

    collaborator OTHER

  • Tampere University Hospital

    collaborator OTHER

  • Turku University Hospital

    collaborator OTHER_GOV

  • Oulu University Hospital

    collaborator OTHER

  • Mikkeli Central Hospital

    collaborator OTHER

  • Kymenlaakso Central Hospital Kotka Finland

    collaborator OTHER

  • Jyväskylä Central Hospital

    collaborator OTHER

  • Kanta-Häme Central Hospital

    collaborator OTHER_GOV

  • Satakunta Central Hospital

    collaborator OTHER

  • Kainuu Central Hospital, Kajaani

    collaborator OTHER

  • Celgene Corporation

    collaborator INDUSTRY

  • Kuopio University Hospital

    lead OTHER

Principal Investigators

  • Raija Silvennoinen, MD · Kuopio University Hospital, Kuopio, FI

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2018-10-10
Completion
2019-02-26

Countries

  • Finland

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01790737 on ClinicalTrials.gov