Trial document




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  DRKS00010592

Trial Description

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Title

Einfluss von Prä-/Comedikation und Kombinationspartnern auf die
Verträglichkeit einer onkologischen Therapie mit Bendamustin

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Trial Acronym

BendaEVENTS

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The aim of this study is to collect data on treatment with bendamustine from the routine care of patients. We want to determine what impact other drugs have on the side effects of these therapies. The results of this study will be published after completion of this study and can thus contribute to our understanding of the side effects, e.g. how different combinations might help improve them.

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Brief Summary in Scientific Language

In this study, the role of supportive medication for reducing the side effects of Bendamustine will be examined in greater detail at a relatively large patient population. Older patients with many comorbidities receive appropriate therapy. To analyze possible correlations the following parameters are recorded:

cancer progress
therapy (dose and duration of chemotherapy)
combination partners of Bendamustine
type and degree of treatment-specific side effects
Dose shifts, dose reductions, hospitalization due to side effects
Pre- and co-medication to treat the side effects
Appropriate laboratory values ​​(especially various blood values)
Detection of comorbidities in Charlson comorbidity index

The aim is to improve the knowledge about the kinds of supportive medication and dosages, as they are carried out in the private practice routine. The role of the combination partners to the side effects of Bendamustine (increase / reduction) can be examined empirically so. A detailed analysis of this study allow to determine what factors may reduce the side effects continue.
Next to an possible increase in quality of life, the results could also lead to a reduced incidence of side effects related discontinuations, dose reductions and hospitalizations.
In addition, the objective of the non-interventional study will be the safety, tolerability and efficacy of bendamustine Ribosepharm under everyday conditions.

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Organizational Data

  •   DRKS00010592
  •   2016/06/01
  •   [---]*
  •   no
  •   Approved
  •   07/2016, Ethikkommission bei der Ärztekammer Niedersachsen
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   C91.1 -  Chronic lymphocytic leukaemia of B-cell type
  •   C85.9 -  Non-Hodgkin lymphoma, unspecified
  •   C90.0 -  Multiple myeloma
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Interventions/Observational Groups

  •   Doctor's will be asked about the patient therapy including pre-/comedication, primary diagnosis and other treatment related data
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   IV
  •   No
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Primary Outcome

Influence of premedication on the side effects of cancer therapy with bendamustine

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Secondary Outcome

Influence of combination partners on the side effects of cancer therapy with bendamustine

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2016/06/01
  •   750
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

adults (≥18 years), the doctor's decision for the prescribed therapy falls individually prior to inclusion in the NIS, Bendamustine Ribosepharm is used according to the prescribing information.

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Exclusion Criteria

<18 years (minors), patients not able to consent, pregnant patients

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Addresses

  • start of 1:1-Block address primary-sponsor
    • ribosepharm division - Hikma Pharma GmbH
    • Mr.  Dr. rer. nat.  Michael  Kübrich 
    • Lochhamer Straße 13
    • 82166  Gräfeling
    • Germany
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    •   089-45450302
    •   089-45450566
    •   [---]*
    •   [---]*
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    • GemeinschaftspraxisDr. med. Detlev Schröder und Dr. med. Haytham Kamal
    • Mr.  Dr. med.  Detlev  Schröder 
    • Karl-Wiechert-Allee 1A
    • 30625  Hannover
    • Germany
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    • NewConceptOncology GmbH
    • Mr.  Dr. rer. nat.  Hayssam  Zakaria 
    • Bödekerstr. 22
    • 30161  Hannover
    • Germany
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    •   0511 76355 123
    •   0511 76355 124
    •   zakaria at n-c-o.de
    •   [---]*
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Sources of Monetary or Material Support

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    • ribosepharm division - Hikma Pharma GmbH
    • Mr.  Dr. rer. nat.  Michael  Kübrich 
    • Lochhamer Straße 13
    • 82152  Martinsried
    • Germany
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    •   089-45450302
    •   089-45450566
    •   [---]*
    •   [---]*
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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.