Trial document





This trial has been registered retrospectively.
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  DRKS00003868

Trial Description

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Title

Analysis of organ function and comrbidity parameters, as well as established multiple myelom prognosis factors as structured, sysematic aquisition of age-associated concomitant factors and their prognostic relevance for evidence based assertions concerning therapy tolerance and survival in myelom patients.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Myeloma patients are generally older and often very fragile patients who are on average 70 years old. Patients present with regard to their general health , their physical fitness and physical endurance very different; most have multiple co-morbidities ( comorbidities ) , can vary in severity and number considerably . Comorbidity explain why significant individual differences in treatment tolerability exist - such variation - so far not systematically recorded . The importance of detecting comorbidities systematically is impressive for MDS and AML patients and for patients from intensive therapy measures , as has been allogeneic ( " from family or unrelated donor - derived ) stem cell transplantation demonstrated. Increasingly , the urgency of the systematic collection recognized existing comorbidities also in diseases other than MDS / AML in order to achieve the best possible therapeutic success. This is therefore crucial as myeloma patients today a wide variety of treatment options are available , such as a) new drug combinations , b ) stem cell transplantation in clinical trials or c ) standard therapies. For the objective assessment of the best therapy in myeloma patients thus the statement of an existing comorbidity and assessment of treatment tolerance appears to be significant . the assessment of the ' fitness ' of a myeloma patients is so far mostly ' instinctively ' recorded in the history and examination of myeloma patients appear but for the currently available therapies significantly intensive systematic required.
In this research project , therefore, should prognostic factors , such as organ function , comorbidities , and known prognostic factors in myeloma patients with multiple myeloma , are widely studied independently and depending on the treatment assignment. We postulate that our analysis will provide an in-depth , independent Komorbiditätsassessment age ( survey), the scientific statements about the compatibility of individual therapy and overall survival in myeloma patients now enables reliable and will provide an essential decision support for treatment decisions .

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Brief Summary in Scientific Language

The effort to capture co-morbidities in myeloma patients , partly the result of the realization that myeloma patients is a typically older patients clientele with an average of 69 years ( at the University Hospital Freiburg: 62 years , in Olmstedt county and Mayo clinic : 69 years and in Sweden: 72 years , personal communication Kyle RA , Mayo Clinic, USA), which differs significantly in its general condition, in its twill union fitness, strength, weight and number of comorbidities and thus the treatment tolerability. The importance of comorbidity systematically capture is impressive to MDS and AML patients ( Deschler B , 2006) and before intensive therapy measures, such as allogeneic stem cell transplantation ( Sorror ML , 2009) , has been demonstrated. Since today is no longer melphalan / prednisone ( MP) alone are open , but various treatment options myeloma patients, eg a) new drug combinations , b ) an autologous or allogeneic stem cell transplantation in studies or c ) conventional standard therapies , objective assessment of comorbidity and treatment tolerability for patients with myeloma seems essential and indispensable for the correct choice of treatment . The study aims to test the prognostic factors organ function , comorbidities , as well as the usual myeloma prognostic factors in a large myeloma patients clientele (> 400 patients) , which is characterized excellent in Freiburg based on a data and myeloma database to verify preliminary analysis and these results prospectively subsequently further to validate .

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Forwarding of patient-related data:

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00003868
  •   2015/01/28
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  •   yes
  •   Approved
  •   81/10, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   DRKS00003927 (DRKS-ID Studienteil 1/study part 1) 
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Health Condition or Problem studied

  •   C90 -  Multiple myeloma and malignant plasma cell neoplasms
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Interventions/Observational Groups

  •   The effort to capture co-morbidities in myeloma patients , partly the result of the realization that myeloma patients is a typically older patients clientele with an average of 69 years ( at the University Hospital Freiburg: 62 years , in Olmstedt county and Mayo clinic : 69 years and in Sweden: 72 years , personal communication Kyle RA , Mayo Clinic, USA), which differs significantly in its general condition, in its twill union fitness, strength, weight and number of comorbidities and thus the treatment tolerability. The importance of comorbidity systematically capture is impressive to MDS and AML patients ( Deschler B , 2006) and before intensive therapy measures, such as allogeneic stem cell transplantation ( Sorror ML , 2009) , has been demonstrated. Since today is no longer melphalan / prednisone ( MP) alone are open , but various treatment options myeloma patients, eg a) new drug combinations , b ) an autologous or allogeneic stem cell transplantation in studies or c ) conventional standard therapies , objective assessment of comorbidity and treatment tolerability for patients with myeloma seems essential and indispensable for the correct choice of treatment . The study aims to test the prognostic factors organ function , comorbidities , as well as the usual myeloma prognostic factors in a large myeloma patients clientele (> 400 patients) , which is characterized excellent in Freiburg based on a data and myeloma database to verify preliminary analysis and these results prospectively subsequently further to validate .
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Detection of comorbidities (MM -specific factors , organ function, function assessment) in patients with multiple myeloma and their influence on the Ereignisfreie- and overall survival.

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Secondary Outcome

1. Detection of already established comorbidity scores ( HCT -CI , Kaplan- Feinstein ) and compared with a newly developed myeloma- specific score.
2.Evaluation a weighted vs. unweighted MM specific comorbidity score.
3.Evaluation of comorbidity scores to make a prediction regarding . Therapy tolerability / toxicity of chemotherapy can .
4. Influence of therapy concepts retrospectively in the period 1997-2003 compared with new Therapieagentien in time from 2003 to 2009 on the Ereignisfreie- and overall survival in patients with multiple myeloma.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2011/10/03
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   90   Years
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Additional Inclusion Criteria

Patients with newly diagnosed or recurrent requiring therapy for multiple myeloma

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Exclusion Criteria

No need of therapy of multiple myeloma

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Addresses

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    • Universitätsklinikum Freiburg
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg
    • Ms.  Prof. Dr.  Monika  Engelhardt 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg
    • Ms.  Prof. Dr.  Monika  Engelhardt 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Freiburg
    • Ms.  Prof. Dr.  Monika  Engelhardt 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.