Trial document




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  DRKS00022250

Trial Description

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Title

A Randomized, prospektivE pilot triAL on exercising during treatment in FItting TransplaNt Eligible patientS with Symptomatic multiple myeloma

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Trial Acronym

REAL-FITNESS

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URL of the Trial

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Brief Summary in Lay Language

Exercising in patients with mutliple myeloma, who received induction therapy (VCD).

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Brief Summary in Scientific Language

Symptomatic MM at Initial diagnosis and planned induction therapy VCD (Bortezomib, Cyclophosphamide, Dexamethasone). Two arms receiving/not receiving exercising.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00022250
  •   2020/10/05
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  •   yes
  •   Approved
  •   173/20, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   C90.0 -  Multiple myeloma
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Interventions/Observational Groups

  •   exersicing
  •   no exercising
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Control group receives no treatment
  •   Supportive care
  •   Parallel
  •   N/A
  •   No
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Primary Outcome

Feasibility with ist aim of a multicentric, randomised clinical trial.

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Secondary Outcome

(1) Evaluation of Revised Myeloma Comorbiditiy Index (R-MCI) due to differences in physical active vs. inactive MM-patients. (2) Event Free Survival (EFS).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2021/01/01
  •   30
  •   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

(1) Symptomatic MM at inital diagnosis. (2) Planned induction therapy with VCD followed by transplantation at UKF.

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Exclusion Criteria

(1) Spinal cord compression or unstable fractures. (2) Severe cardial diseases or arrythmia (NYHAE 3-4). (3) Chronic cardial diseases (NYHAE 3-4). (4) Other severe diseases not allowing physical activity and exercising (e. g. severe neurological disorder).

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Addresses

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    • Universitätsklinikum Freiburg
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • Germany
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    • Universitätaklinikum Freiburg
    • Ms.  Prof. Dr.  Monika  Engelhardt 
    • Hugstetter Str. 55
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg
    • Ms.  M. A.  Mandy-Deborah  Möller 
    • Breisacher Str. 115
    • 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 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.