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Quality of Life in Patients With Multiple Myeloma

18 Years
Not Enrolling
Multiple Myeloma, Quality of Life

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Trial Information

Quality of Life in Patients With Multiple Myeloma

Multiple myeloma is a plasma cell tumor with an annual incidence of 6 pr. 100 000. In the
absence of curative treatment, the aim of the therapy is not only to induce an objective
response and a prolongation of survival but also to improve the patients quality of life.

This project will raise two problems which make QoL-data hard to interpret

1. In a clinical trial where many patients are included, statistically significant
differences are obtained. However, there is widespread agreement that p-values do not
indicate whether a particular finding has clinical significance because statistical
significance does not necessarily equate to a meaningful difference or change in QoL. A
crucial task for clinicians in interpreting trial-based QoL results is to determine if
the observed change is clinically important to the patient.

2. When measuring changes in QoL in a pretest-posttest design,response shift can affect
results. Patients with advanced disease can report surprisingly good QoL.Including
response shift into quality of life research would allow a better understanding of
changes in the QoL that patients report.

Inclusion Criteria:

- Multiple Myeloma

- Age > 18 years

- Informed consent

Exclusion Criteria:

- Terminal illness with life expectancy less than 3 months

- Unable to fill in a questionnaire in norwegian

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Principal Investigator

Finn Wisløff, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ullevål University Hospital, Norway


Norway:National Committee for Medical and Health Research Ethics

Study ID:




Start Date:

January 2006

Completion Date:

June 2008

Related Keywords:

  • Multiple Myeloma
  • Quality of Life
  • Multiple Myeloma
  • Quality of Life
  • Response Shift
  • Clinically Important Difference
  • Multiple Myeloma
  • Neoplasms, Plasma Cell