Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00004345

Trial Description

start of 1:1-Block title

Title

Symptom Experience of Multiple Myeloma Patients Treated with Autologous Stem Cell Transplantation Following High Dose Chemotherapy

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

Trial Acronym

syMMex

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

URL of the Trial

[---]*

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

Brief Summary in Lay Language

Aim of this study is to describe the symptoms of multiple myeloma patients during high-dosed chemotherapy and autologous stem cell transplantation. This is done at four time points: before the high dose, at the time of the greatest immuno defensive weakness, before discharge, and one month after discharge.

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

Brief Summary in Scientific Language

Background: Every year, about 1,300 autologous stem cell transplantations (ASCT) are performed in patients diagnosed with Multiple Myeloma (MM) in Germany. Symptoms related to this treatment are experienced as most severe by hematological patients. Most questionnaires used to assess symptom experience in this population offer a pre-selected choice of symptoms and do not measure all dimensions of symptom experience. Because of too heterogenous samples, little is known about the specific symptoms of patients with MM and ASCT. Aims of this study are to describe symptom experience of MM patients following high-dose chemotherapy (HD) and ASCT, to explore differences in symptom experience during HD and ASCT in patients with different induction and mobilization therapies, and to pilot-test the questionnaire of the “Patient Reported Outcomes in view of symptom experience of late effects and self-management of adult long-term survivors after allogeneic hematopoietic stem cell transplantation” (PROVIVO) study in an adapted version for the autologous transplant cohort.
Methods: In a descriptive, longitudinal study at the Department of Hematology/Oncology, University Medical Center, Freiburg, 40 patients with MM, HD and ASCT will be included and asked to answer the PROVIVO questionnaire at admission, nadir, discharge and 30 days after discharge between September 2012 and April 2013.
Data Analysis: Data will be analyzed using SPSS (German version 16.0 for Windows). The data analysis plan includes a descriptive trend analysis of symptom intensity and symptom distress at the four time points, repeated measure analyses of variance (ANOVA) of the variables nausea, vomiting, tiredness, diarrhea, mouth sores, and loss of appetite, to detect differences in symptom experience between the different induction regimens, and a descriptive analysis of the evaluation questions for the PROVIVO questionnaire.

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

Organizational Data

  •   DRKS00004345
  •   2013/01/30
  •   [---]*
  •   yes
  •   Approved
  •   339/12, 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
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   All Patients with multiple myeloma, 18 years of age and older admitted to one of the three transplant wards of the Department of Hematology/Oncology, University Medical Center, Freiburg, Germany, for HD and ASCT will be screened for inclusion criteria and consecutively included in the study. The criteria for inclusion are that the patients are able to read, understand, and answer the PROVIVO questionnaire and that HD and ASCT is part of the first treatment regimen after diagnosis. Patients have to answer the PROVIVO questionnaire at four timepoints:
    admission (day -4, calculated from day of ASCT), nadir (moment of lowest count of white blood cells, about day +7 to +10), discharge (about day +15) and one month after discharge of HD and ASCT (30 days after discharge).
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

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

Primary Outcome

Symptom experience of patients will be measured with the PROVIVO questionnaire at four timepoints: admission (day -4, calculated from day of ASCT), nadir (moment of lowest count of white blood cells, about day +7 to +10), discharge (about day +15) and one month after discharge of HD and ASCT (30 days after discharge).

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

Secondary Outcome

Evaluation of the PROVIVO questionnaire for the use with patients with multiple myeloma and HD and ASCT

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

Countries of Recruitment

  •   Germany
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
  •   2012/12/01
  •   40
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   75   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

All Patients with MM, and 18 years of age and older admitted to one of the three transplant wards of the Department of Hematology/Oncology, University Medical Center, Freiburg, Germany, for HD and ASCT will be screened for inclusion criteria and consecutively included in the study. The criteria for inclusion are that the patients are able to read, understand, and answer the PROVIVO questionnaire and that HD and ASCT is part of the first treatment regimen after diagnosis.

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

Exclusion Criteria

[---]*

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. 54
    • 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
    • Mr.  BScN  Matthias  Naegele 
    • Hugstetter Str. 54
    • 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
    • Mr.  BScN  Matthias  Naegele 
    • Hugstetter Str. 54
    • 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
    • Mr.  BScN  Matthias  Naegele 
    • Hugstetter Str. 54
    • 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 complete, follow-up complete
  •   2015/07/31
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.