Trial document





This trial has been registered retrospectively.
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  DRKS00003932

Trial Description

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Title

Association of multiple myeloma (MM) with different neoplasms (DN), including second primary malignancies (SPM): systematic analysis in consecutive patients

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

There are numerous innovations in treatment of multiple myeloma (MM), resulting in prolonged overall survival. Nevertheless, long-term complications may comprise the occurrence of different neoplasms (DNs). DNs after e.g. novel agent treatment (e.g. within MM015-study) have been reported, questioning whether specific risk factors predispose to DNs. Albeit previous analyses have focused on subsequent DNs, rather than prior or simultaneously (p/s) DNs (since the latter group needs to live long enough to acquire MM), we here assess both, since p/s DNs is even more pertinent, both phenomenons need to be known to MM experts and should allow to define host, MM- and/or therapy-related risks.

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Brief Summary in Scientific Language

Multiple myeloma (MM) has envisioned numerous innovations, resulting in prolonged overall survival. Nevertheless, long-term complications may comprise the occurrence of different neoplasms (DNs). DNs after e.g. novel agent treatment (e.g. within MM015-study) have been reported, questioning whether specific risk factors predispose to DNs. SEER and Swedish registry data on DNs have observed overall cumulative incidence rates of 5.1-5.5% in MM. Mailankody et al. showed standardized incidence ratios in MM- and MGUS-patients for AML/MDS of 11.51- and 8.01-fold, respectively. In a previous registry analysis (Hasskarl J. …Engelhardt M. 2011), we demonstrated an impaired prognosis in MM with subsequent DNs (HR 2.5; 95% CI 1.4-4.4) and that age >60 years was a confounding variable (HR 2.021; 95% CI 1.6-2.6).
Albeit previous analyses have focused on subsequent DNs, rather than prior or simultaneously (p/s) DNs (since the latter group needs to live long enough to acquire MM), we here assess both, since p/s DNs is even more pertinent, both phenomenons need to be known to MM experts and should allow to define host, MM- and/or therapy-related risks.

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Organizational Data

  •   DRKS00003932
  •   2015/05/28
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  •   yes
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  •   [---]*
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Secondary IDs

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

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

  •   There are numerous innovations in treatment of multiple myeloma (MM), resulting in prolonged overall survival. Nevertheless, long-term complications may comprise the occurrence of different neoplasms (DNs). DNs after e.g. novel agent treatment (e.g. within MM015-study) have been reported, questioning whether specific risk factors predispose to DNs. Albeit previous analyses have focused on subsequent DNs, rather than prior or simultaneously (p/s) DNs (since the latter group needs to live long enough to acquire MM), we here assess both, since p/s DNs is even more pertinent, both phenomenons need to be known to MM experts and should allow to define host, MM- and/or therapy-related risks.
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Characteristics

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

Prevalence of second malignancies in patients with multiple myeloma

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Secondary Outcome

Analysis of riskf factors and outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2011/12/01
  •   744
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Patients with mulrtiple myeloma

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Exclusion Criteria

none

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Addresses

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

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    • Universitätsklinikum Freiburg
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2012/04/30
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Trial Publications, Results and other Documents

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