Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00003964

Trial Description

start of 1:1-Block title

Title

Non interventionel prospective study to develop a prognostic scoring system for outcome of autologous transplantation in multiple myeloma (MM).

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

EBMT

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

http://www.ebmt.org

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

In this study, data on the treatment of multiple myeloma are collected. The aim of the study is to determine the influence of certain prognostic factors on the outcome of your treatment. These prognostic factors include tumor burden at the time of diagnosis, the cytogenetics of multiple myeloma and the remission status of chemotherapy before transplantation. Based on these data, a so-called score system is created from which you want to determine the best treatment involving the above prognostic factors for future treatments.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

The study aims to prospectively audit autcomes of autologous stem cell
transplantations for Multiple Myeloma and validate the use of a prognostic score.
Data on tumour load at diagnosis will be gained from trephine biopsies (> or <
60% infiltration). Response to chemotherapy prior to autologous transplantation
will be assessed according to standard EBMT criteria. Data on ctyogenetic
aberrations will need to be more detailed than available through currently used
MED-B forms. A specifically designed questionnaire will be sent to collaborationg
centres to collect cytogenetic data. Details of chemotherapy prior to autologous
transplantation will be recorded. The ability of the prognostic score to predict
outcomes (EFS,OS) of autologous transplantation will be assessed in all patients
and analysed in comparison to the International Staging Sysyem( ISS). The impact
of novel therapies on transplant outcomes will be analysed and the predictive power
of the scoring sytem validated for patients treated on those therapy regimes.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00003964
  •   2015/05/12
  •   [---]*
  •   yes
  •   Approved
  •   248/11, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   C90 -  Multiple myeloma and malignant plasma cell neoplasms
  •   C90 -  Multiple myeloma and malignant plasma cell neoplasms
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   The study aims to prospectively audit autcomes of autologous stem cell
    transplantations for Multiple Myeloma and validate the use of a prognostic score.
    Data on tumour load at diagnosis will be gained from trephine biopsies (> or <
    60% infiltration). Response to chemotherapy prior to autologous transplantation
    will be assessed according to standard EBMT criteria. Data on ctyogenetic
    aberrations will need to be more detailed than available through currently used
    MED-B forms. A specifically designed questionnaire will be sent to collaborationg
    centres to collect cytogenetic data. Details of chemotherapy prior to autologous
    transplantation will be recorded. The ability of the prognostic score to predict
    outcomes (EFS,OS) of autologous transplantation will be assessed in all patients
    and analysed in comparison to the International Staging Sysyem( ISS). The impact
    of novel therapies on transplant outcomes will be analysed and the predictive power
    of the scoring sytem validated for patients treated on those therapy regimes.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

The aim o the study is to prospectively validate a prognostic scoring sytem for
outcomes (EFS,OS) of autologous transplantation in Multiple Myeloma, developed
retrospectively at Hammersmith Hospital, London, based on tumour load at
diagnosis (Plasmacell% on trephine),cytogenetic aberrations (FISH and metaphase
cytogenetics) and treatment responses to chemotherapy prior to autologous
transplant.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Test the predictive power of the score to identify a subgroup of high risk patients
who currently profit least from autologous stem cell transplantion and may be
candidates for therapeutic trials of novel agents.
Develop the prognostic score as a tool for such risk adapted therapies.
Validate the scoring sytem in patients treated with novel agents/drug combinations
Further definition of cytogenetic risk groups

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
  •   Netherlands
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2012/03/01
  •   50
  •   Multicenter trial
  •   International
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

MM-patients.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

none

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Freiburg
    • Ms.  Prof. Dr.  Monika  Engelhardt 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Universitätsklinikum Freiburg
    • Ms.  Prof. Dr.  Monika  Engelhardt 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Universitätsklinikum Freiburg
    • Ms.  Prof. Dr.  Monika  Engelhardt 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Universitätsklinikum Freiburg
    • Ms.  Prof. Dr.  Monika  Engelhardt 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.