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Trial Outcomes & Findings for Quality Assurance of Secondary Immunodeficiencies (SID) in CLL/MM Patients (NCT NCT04172467)

NCT ID: NCT04172467

Last Updated: 2022-01-10

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

1086 participants

Primary outcome timeframe

Median study observation period of 18.2 months

Results posted on

2022-01-10

Participant Flow

This is a retrospective sample analysis of patients from practices and hospitals in Germany who were representatively screened using previously collected care parameters of the participating institutions. Previous and current treatment and infection data were collected from patients who received a line of therapy for the treatment of CLL or MM started in 2018 (1st, 2nd and 3rd or higher line).

The time period was chosen to ensure that patients have been followed up for at least 12 months in order to collect data on susceptibility to infection and possible secondary immunodeficiencies

Participant milestones

Participant milestones
Measure
Not Applicable. Non-interventional Retropspective Observational Study.
This was a retrospective sample analysis representative for practices and hospitals in Germany. The treatments and infection data were collected from patients with chronic lymphocytic leukaemia (CLL) and multiple myeloma (MM). GL adherence (GLAD) was analysed.
Overall Study
STARTED
1086
Overall Study
COMPLETED
1086
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Non-interventional Retrospective Observational Study.
n=1086 Participants
This was a retrospective sample analysis representative for practices and hospitals in Germany. The treatments and infection data were collected from patients with chronic lymphocytic leukaemia (CLL) and multiple myeloma (MM). GL adherence (GLAD) was analysed.
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
267 Participants
n=5 Participants
Age, Categorical
>=65 years
819 Participants
n=5 Participants
Age, Continuous
73 years
n=5 Participants
Sex: Female, Male
Female
475 Participants
n=5 Participants
Sex: Female, Male
Male
611 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
Race (NIH/OMB)
White
0 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
1086 Participants
n=5 Participants
Region of Enrollment
Germany
1086 Participants
n=5 Participants
Therapy Line
1st line
539 Participants
n=5 Participants
Therapy Line
2nd line
317 Participants
n=5 Participants
Therapy Line
3rd line
230 Participants
n=5 Participants
Disease
Chronic Lymphocytic Leukaemia (CLL)
490 Participants
n=5 Participants
Disease
Multiple Myeloma (MM)
596 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Median study observation period of 18.2 months

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.

Outcome measures

Outcome measures
Measure
Non-interventional Retrospective Observational Study.
n=1086 Participants
This was a retrospective sample analysis representative for practices and hospitals in Germany. The treatments and infection data were collected from patients with chronic lymphocytic leukaemia (CLL) and multiple myeloma (MM). GL adherence (GLAD) was analysed.
GLAD-Score 1
1 point for deviations in dose or interval (+/- 10%) or a late start of IgRT (\>28 days after a severe infection (≥ grade 3)
GLAD-Score 0
0 points for 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
Guideline Adherence (GLAD)
GLAD-Score 2
889 Participants
—
—
Guideline Adherence (GLAD)
GLAD-Score 1
75 Participants
—
—
Guideline Adherence (GLAD)
GLAD-Score 0
122 Participants
—
—

SECONDARY outcome

Timeframe: Median study observation period of 18.2 months

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.

Outcome measures

Outcome measures
Measure
Non-interventional Retrospective Observational Study.
n=889 Participants
This was a retrospective sample analysis representative for practices and hospitals in Germany. The treatments and infection data were collected from patients with chronic lymphocytic leukaemia (CLL) and multiple myeloma (MM). GL adherence (GLAD) was analysed.
GLAD-Score 1
n=75 Participants
1 point for deviations in dose or interval (+/- 10%) or a late start of IgRT (\>28 days after a severe infection (≥ grade 3)
GLAD-Score 0
n=122 Participants
0 points for 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
Guideline Adherence and Susceptibility to Infection
250 Number of infectious events
63 Number of infectious events
221 Number of infectious events

Adverse Events

Non-interventional Retropspective Observational Study.

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof. Hartmut Link

Hematology Oncology Kaiserslautern

Phone: 0631

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place