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

NCT04172467 | Completed Results

• 1 other identifier: AIO-SUP-0119ass (QS SID)
• Study Type: observational
• Target: 1,086
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Secondary Immunodeficiencies (SID)

Keywords

Secondary immunodeficiencies (SID); Chronic lymphocytic leukemia (CLL); Multiple myeloma (MM)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Guideline Adherence and Susceptibility to Infection

  Median study observation period of 18.2 months

Interventions

non-interventional retrospective epidemiological observational study OTHER

non-interventional retrospective epidemiological observational study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• AIO-Studien-gGmbH: lead
• Prof. Hartmut Link: collaborator
• Takeda: collaborator
• MMF GmbH: collaborator
• AIO AG Supportivtherapie: collaborator
• AG Supportive Maßnahmen in der Onkologie: collaborator

Study Sites (1)

Privatärztliche Praxis; Innere Medizin, Hämatologie, Internistische Onkologie

Kaiserslautern, 67655, Germany

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Multiple Myeloma

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders

Limitations and Caveats

The limitations of the retrospective study are that the information in the patient records cannot be verified and that the diagnosis and monitoring of the patients are not specified. In the case of infections, the classification was missing for a large number of patients.

Results Point of Contact

• Title: Prof. Hartmut Link
• Organization: Hematology Oncology Kaiserslautern

praxis-link@kabelmail.de

0631

Study Officials

• Hartmut Link, Prof. Dr.

  AIO AG Supportive Therapie

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2019
• First Posted: November 21, 2019
• Study Start: January 28, 2020
• Primary Completion: April 25, 2020
• Study Completion: August 3, 2020
• Last Updated: January 10, 2022
• Results First Posted: January 10, 2022

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)