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Tracking infections and quality of life in blood cancer patients with weakened immunity

Develops a patient questionnaire for infection symptoms in adults with leukemia or myeloma.

Plain-language title generated from the registry record
Registry title: Developing a Patient-Reported Outcome (PRO) Screening Measure for Infections and Measuring Quality of Life in Hematological Patients With Secondary Immunodeficiency (SID) Across the Treatment Trajectory - The PRO SID Project

Key facts

Where
Berlin and Garmisch-Partenkirchen, GermanySee the 2 sites

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with multiple myeloma or chronic lymphocytic leukemia who also have secondary immunodeficiency. Participants fill in daily symptom questionnaires online.

Age
18 years or older
Sex
All sexes can join
Disease stage
Multiple myeloma or chronic lymphocytic leukemia with secondary immunodeficiency (for example recurrent infections, infections needing hospital treatment, low antibody levels, or low white blood cell counts)

Main reasons for not taking part

  • Cannot join without access to an internet device such as a computer, tablet or smartphone
  • Cannot join if not German-speaking

Read by machine on 12 November 2026.

Where in Germany

  • Onkologischer Schwerpunkt am Oskar-Helene-HeimBerlin, GermanyContact: Markus Schuler, Priv.-Doz. Dr. med.Not yet recruiting
  • Klinikum Garmisch-PartenkirchenGarmisch-Partenkirchen, GermanyContact: Till Seiler, Dr. med.Not yet recruiting

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
Medical University Innsbruck
Trial code
NCT06821880
Record updated
12 February 2025
Original description
The goal of this observational study is to improve the treatment of hematological patients with secondary immunodeficiency (SID) by developing a patient-reported outcome (PRO) instrument to detect clinically diagnosed infections. The study focuses on adults diagnosed with chronic lymphocytic leukemia (CLL) or multiple myeloma (MM) who are at increased risk of infections due to SID.Read full original descriptionShow less

Developing a Patient-Reported Outcome (PRO) Screening Measure for Infections and Measuring Quality of Life in Hematological Patients With Secondary Immunodeficiency (SID) Across the Treatment Trajectory - The PRO SID Project

The goal of this observational study is to improve the treatment of hematological patients with secondary immunodeficiency (SID) by developing a patient-reported outcome (PRO) instrument to detect clinically diagnosed infections. The study focuses on adults diagnosed with chronic lymphocytic leukemia (CLL) or multiple myeloma (MM) who are at increased risk of infections due to SID.

The main questions it aims to answer are:

1. Can a newly developed PRO screening tool for infection-related symptoms reliably detect infections in patients with SID? 2. How does the health-related quality of life change over the treatment course

Participants will:

* Complete daily electronic PRO questionnaires (ePRO) to monitor infection-related symptoms * Complete ePRO health-related quality of life questionnaires every 1.5 months * Participate in study visits every three months to ensure documentation of clinical data

Inclusion: 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).

ClinicalTrials.gov NCT06821880