Developing a tool to monitor infections and quality of life in patients with blood cancers and immune issues

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to create a patient-reported outcome (PRO) tool to effectively identify infections in adults with chronic lymphocytic leukemia (CLL) or multiple myeloma (MM) who have secondary immunodeficiency (SID). Participants will complete daily electronic questionnaires to report infection-related symptoms and health-related quality of life assessments every 1.5 months. The study will also evaluate the tool's diagnostic accuracy and its impact on treatment decisions, such as the initiation of immunoglobulin replacement therapy. Conducted across multiple centers in Germany and Austria, the study seeks to enroll 120 patients to gather comprehensive data over the treatment trajectory.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adult patient (\>=18 years of age)
* Access to an internet device (e.g., personal computer or tablet to use a web-based platform, or smartphone where the study app can be installed - all common iOS and Android systems)
* German-speaking
* Diagnosis of multiple myeloma or chronic lymphocytic leukemia
* Secondary immunodeficiency (defined as: recurrent infections, infections requiring inpatient treatment, hypogammaglobulinemia, neutropenia and/or lymphopenia on differential blood cell counts, deficit in lymphocyte subsets as assessed by flow cytometry)

Where it's running

• Medizinische Universität Innsbruck
  Innsbruck, Tyrolia, Austria Recruiting
• Medizinische Universität Graz
  Graz, Austria Not yet recruiting
• BKH Kufstein
  Kufstein, Austria Not yet recruiting
• Onkologischer Schwerpunkt am Oskar-Helene-Heim
  Berlin, Germany Not yet recruiting
• Klinikum Garmisch-Partenkirchen
  Garmisch-Partenkirchen, Germany Not yet recruiting

Study contacts

• Study coordinator: Jens Lehmann, Ph.D.
• Email: jens.lehmann@i-med.ac.at
• Phone: +43 50 504 81551

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.