NCT06821880

Brief Summary

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:

  • 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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
2mo left

Started Feb 2025

Geographic Reach
2 countries

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Feb 2025Jul 2026

First Submitted

Initial submission to the registry

January 23, 2025

Completed
11 days until next milestone

Study Start

First participant enrolled

February 3, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 12, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

February 12, 2025

Status Verified

January 1, 2025

Enrollment Period

1.4 years

First QC Date

January 23, 2025

Last Update Submit

February 11, 2025

Conditions

Chronic Lymphocytic Leukaemia (CLL)Multiple Myeloma (MM)Secondary Immunodeficiency (SID)

Keywords

Chronic Lymphocytic Leukaemia (CLL)multiple myeloma (MM)Secondary immunodeficiency (SID)Infection-related symptomsInfectionsPRO measurePatient-reported outcomes

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy of the ePRO monitoring instrument for infection-related symptoms

    Evaluation of diagnostic accuracy of the daily ePRO screening measure to detect infections as diagnosed by a clinician (CTCAE).

    From enrollment until study discontinuation or up until study completion (day 365), which ever occurs first

Secondary Outcomes (3)

  • Changes in health-related quality of life measured with the EORTC QLQ-C30

    From enrollment until study discontinuation or up until study completion (day 365), which ever occurs first

  • Changes in health-related quality of life measured with the EORTC QLQ-MY20

    From enrollment until study discontinuation or up until study completion (day 365), which ever occurs first

  • 2. Changes in health-related quality of life measured with the EORTC QLQ-CLL17

    From enrollment until study discontinuation or up until study completion (day 365), which ever occurs first

Study Arms (1)

Patients with MM or CLL at risk of infectious complications due to SID

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population are subjects with MM or CLL and a SID who have recently started a anticancer therapy in Germany and Austria.

You may qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Medizinische Universität Innsbruck

Innsbruck, Tyrolia, 6020, Austria

RECRUITING

Medizinische Universität Graz

Graz, 8010, Austria

NOT YET RECRUITING

BKH Kufstein

Kufstein, 6330, Austria

NOT YET RECRUITING

Onkologischer Schwerpunkt am Oskar-Helene-Heim

Berlin, 14195, Germany

NOT YET RECRUITING

Klinikum Garmisch-Partenkirchen

Garmisch-Partenkirchen, 82467, Germany

NOT YET RECRUITING

MeSH Terms

Conditions

Leukemia, B-CellMultiple MyelomaInfections

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic Disorders

Central Study Contacts

Jens Lehmann, Ph.D.

CONTACT

+43 50 504 81551jens.lehmann@i-med.ac.at

Jan-Paul Bohn, Dr.

CONTACT

+43 50 504 82916jan-paul.bohn@i-med.ac.at

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2025

First Posted

February 12, 2025

Study Start

February 3, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

February 12, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share
Time Frame
Beginning with publication and ending 10 years after the publication of results
Access Criteria
Open access available

Locations

AU(3)DE(2)