Clinical trial · Observational
Quality Assurance of Secondary Immunodeficiencies (SID) in CLL/MM Patients
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)
NCT04172467CI-TRIAL-00055843QS-SIDcompletedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Secondary Immunodeficiencies (SID) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| non-interventional retrospective epidemiological observational study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Guideline Adherence (GLAD)
- timeFrame
- Median study observation period of 18.2 months
- description
- 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.
Secondary outcomes (1)
- measure
- Guideline Adherence and Susceptibility to Infection
- timeFrame
- Median study observation period of 18.2 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.