Quality Assurance of Secondary Immunodeficiencies (SID) in CLL/MM Patients (QS-SID)

Quality Assurance on Diagnosis and Therapy of Secondary Immunodeficiencies (SID) in Patients With Chronic Lymphocytic Leukemia (CLL) or Multiple Myeloma (MM) in Germany (QS-SID)

Retrospective, representative registry for quality assurance on diagnosis and therapy of secondary immunodeficiencies (SID) in patients with chronic lymphocytic leukemia (CLL) or multiple myeloma (MM)

Study Overview

• Status: Completed
• Conditions: Secondary Immunodeficiencies (SID)
• Intervention / Treatment: Other: non-interventional retrospective epidemiological observational study

Detailed Description

Treatment structure analysis and recruitment (phase 1):

In a first step, data on care facilities, that treat patients with CLL or MM in Germany is obtained.

In phase 1 all centers in Germany that potentially treat patients with the CLL or MM are contacted and data of its facility care level and its number of treated patients is recorded using a one-sided pen-to-paper form. In addition, the willingness of care facilities to become involved in patients' documentation is elicited (phase 2).

Patient documentation (phase 2)

To achieve a reliable, representative sample of patients treated in Germany, the distribution of cases to be documented is specified in the individual indications amongst the facilities involved. This is done using the facilities' data on patient numbers and treatment structure obtained in phase I:

The participating centers are assigned to clusters based on key distinguishing features (facility type, care level and number of patients treated). This sample is modulated according to the previous treatment structure analysis. By taking this approach, the actual percentages of the various care facilities in an indication area can be reflected proportionally in the patient documentation sample.

In phase 2 a electronic case record form (eCRF) is completed in order to collect the original patient and treatment data, which are relevant to the purpose of the study. All data is gathered retrospectively and anonymously using the patient files. Patient and disease related variables (age, general condition according to the Eastern Cooperative Oncology Group (ECOG), relevant comorbidity, staging and relevant mutations), systemic antineoplastic treatment (chemotherapy, antibodies, kinase-inhibitors, relevant co-medication etc.) are recorded. Also, data on diagnosis of Ig-levels (IgG, IgA, IgM), therapy of secondary immunodeficiencies as well as the number and severity of occurred infections and their treatment is collected. Clusters for classification of infections will be developed (e.g. life-threatening, need for hospitalization).

In order to ensure data quality, the scientific project lead will provide training for two employees of the commissioned institute on matters regarding the content of the study. This knowledge will be incorporated into the programming of the user interface and the patient databases so that the program will check for completeness and, as far as possible, plausibility, on the basis of defined requirements and constraints. These checks accompany the process of entering data into the eCRF and allow for validating data instantly. If inconsistencies, mistakes or omissions are detected, data will be validated by an integrated query management system.

Physicians questionnaire (phase 3)

In an additional step and alongside the patient documentation, the attending physicians in participating centers will be surveyed (phase 3) on their competency profile, their assessment of guideline quality and their approach to avoid infections of CLL and MM patients.

• Study Type: Observational
• Enrollment (Actual): 1086

Contacts and Locations

Study Locations

• Germany
  • Kaiserslautern, Germany, 67655
    • Privatärztliche Praxis; Innere Medizin, Hämatologie, Internistische Onkologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic lymphocytic leukemia (CLL) or multiple myeloma (MM).

Description

Inclusion Criteria:

• patients with CLL or MM
• anti-neoplastic systemic therapy (all therapy lines) between July 1st 2017 and June 30th 2018

Exclusion Criteria:

- patient in terminal phase of the disease, life expectancy less than three months

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Guideline Adherence (GLAD)	For SID, immunoglobulin substitution (IgRT) is mandatory only for patients with an IgG level < 4g/l (or IgG subclass deficiency) and additionally more than 3 infections or a severe infection (≥ grade 3) and is optional (may be appropriate) if IgG level < 4g/l and/or 1-3 less severe infections (≤ grade 2). IgRT is not indicated if patients do not fulfil either condition. Scoring system: GLAD-Score 2: full guideline adherence GLAD-Score 1: deviations in dose or interval (+/- 10%) or a late start of IgRT (>28 days after a severe infection (≥ grade 3). GLAD-Score 0: IgRT without indication (overuse) or omitted IgRT despite recommendation (underuse). Likewise, 0 points were awarded if both the dose and the interval deviated from the GL recommendations (e.g. underdosed single dose) or if IgRT was not started until more than 3 months after hypogammaglobulinemia and at least one severe infection.	Median study observation period of 18.2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Guideline Adherence and Susceptibility to Infection	For the analysis of susceptibility to infection, the time to next infection was examined using the Andersen-Gill model for recurrent events. For effect estimation, hazard ratios are reported with 95% confidence interval in each case. GLAD-Score 2 is Reference, a higher hazard ratio means a higher susceptibility to infection.	Median study observation period of 18.2 months

Collaborators and Investigators

• Sponsor: AIO-Studien-gGmbH
• Collaborators: Takeda; Prof. Hartmut Link; MMF GmbH; AIO AG Supportivtherapie; AGSMO (Arbeitsgemeinschaft Supportive Maßnahmen in der Onkologie)
• Investigators: Principal Investigator: Hartmut Link, Prof. Dr., AIO AG Supportive Therapie

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2020
• Primary Completion (Actual): April 25, 2020
• Study Completion (Actual): August 3, 2020

Study Registration Dates

• First Submitted: November 19, 2019
• First Submitted That Met QC Criteria: November 19, 2019
• First Posted (Actual): November 21, 2019

Study Record Updates

• Last Update Posted (Actual): January 10, 2022
• Last Update Submitted That Met QC Criteria: November 10, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Chronic lymphocytic leukemia (CLL); Multiple myeloma (MM); Secondary immunodeficiencies (SID)
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Neoplasms; Neoplastic Processes; Neoplasm Metastasis; Immunologic Deficiency Syndromes
• Other Study ID Numbers: AIO-SUP-0119ass (QS SID)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

IPD Plan Description

Data is collected retrospectively and completely anonymously from patient records, no identifying characteris-tics (e.g. birth date, initial letters, pseudonym) will be collected.

It is hoped that these data will assist in creating new possibilities and ways to improve the quality of treatment through further training and enhancement of the availability and transparency of the guidelines.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No