Trial Outcomes & Findings for Comparison of Multigam IV (5% vs. 10%) in Patients With an Immunodeficiency Secondary to a Hematological Disorder (NCT NCT03250845)
NCT ID: NCT03250845
Last Updated: 2019-11-15
Results Overview
Comparison of infusion time between Multigam (MG) IV 5% and Multigam IV 10%. Results will be assessed by Student's-t-test and 95% confidence interval.
COMPLETED
30 participants
Up to 1 month after Multigam 5% infusion
2019-11-15
Participant Flow
This study enrolled 30 patients with an immunodeficiency secondary to a hematologic disorder requiring immunoglobin substitution therapy from 1 academic center in Belgium. The last patient completed in December 2017.
Participant milestones
| Measure |
All Study Participants
30 participants who received Multigam 5% intravenous immunoglobulin (IVIg) and Multigam 10% intravenous immunoglobulin (IVIg) 3 to 4 weeks later.
Dosing was set at 0.4 g/kg for both infusions.
|
|---|---|
|
Multigam 5% Infusion (Baseline)
STARTED
|
30
|
|
Multigam 5% Infusion (Baseline)
COMPLETED
|
30
|
|
Multigam 5% Infusion (Baseline)
NOT COMPLETED
|
0
|
|
Multigam 10% Infusion (3-4 Weeks Later)
STARTED
|
30
|
|
Multigam 10% Infusion (3-4 Weeks Later)
COMPLETED
|
30
|
|
Multigam 10% Infusion (3-4 Weeks Later)
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
All Study Participants
n=30 Participants
Baseline characteristics of the study population (30 participants).
|
|---|---|
|
Age, Continuous
|
67.7 years
STANDARD_DEVIATION 10 • n=30 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=30 Participants
|
|
Region of Enrollment
Belgium
|
30 participants
n=30 Participants
|
|
Haematological disorder
Plasma Cell Dyscrasia: Scleromyxedema
|
1 Participants
n=30 Participants
|
|
Haematological disorder
AL Amyloidosis
|
2 Participants
n=30 Participants
|
|
Haematological disorder
Multiple Myeloma
|
12 Participants
n=30 Participants
|
|
Haematological disorder
Chronic Lymphocytic Leukemia
|
9 Participants
n=30 Participants
|
|
Haematological disorder
Diffuse Large B-Cell Lymphoma
|
2 Participants
n=30 Participants
|
|
Haematological disorder
Follicular Lymphoma
|
2 Participants
n=30 Participants
|
|
Haematological disorder
Non-Hodgkin Lymphoma, Unclassifiable
|
2 Participants
n=30 Participants
|
|
Time between first IVIg infusion and start of study
|
4.1 years
STANDARD_DEVIATION 4.3 • n=30 Participants
|
|
First Multigam Dosage
|
30 gram
n=30 Participants
|
PRIMARY outcome
Timeframe: Up to 1 month after Multigam 5% infusionComparison of infusion time between Multigam (MG) IV 5% and Multigam IV 10%. Results will be assessed by Student's-t-test and 95% confidence interval.
Outcome measures
| Measure |
All Study Participants
n=30 Participants
30 participants who received Multigam 5% intravenous immunoglobulin (IVIg) and Multigam 10% intravenous immunoglobulin (IVIg) 3 to 4 weeks later.
Dosing was set at 0.4 g/kg for both infusions.
|
|---|---|
|
Infusion Time of Multigam IV 5% and Multigam IV 10%
Multigam 5% infusion
|
4.92 hour
Interval 4.54 to 5.3
|
|
Infusion Time of Multigam IV 5% and Multigam IV 10%
Multigam 10% infusion
|
2.29 hour
Interval 1.96 to 2.62
|
SECONDARY outcome
Timeframe: Up to 1 month after Multigam 5% infusionComparison of hospitalisation time (time spent at day clinic) between Multigam IV 5% and Multigam IV 10%. Results will be assessed by Student's-t-test and 95% confidence interval.
Outcome measures
| Measure |
All Study Participants
n=30 Participants
30 participants who received Multigam 5% intravenous immunoglobulin (IVIg) and Multigam 10% intravenous immunoglobulin (IVIg) 3 to 4 weeks later.
Dosing was set at 0.4 g/kg for both infusions.
|
|---|---|
|
Hospitalisation Time of Multigam IV 5% and Multigam IV 10%
Multigam 10% infusion
|
4.56 hour
Interval 3.84 to 5.27
|
|
Hospitalisation Time of Multigam IV 5% and Multigam IV 10%
Multigam 5% infusion
|
5.87 hour
Interval 5.5 to 6.24
|
SECONDARY outcome
Timeframe: Up to 72 after each infusionEvaluation of the occurence of adverse events (AEs) for both administrations via CTCAE v4.03 criteria. Results are reported as the mean number of IVIg-related AEs per patient. Adverse events were actively monitored during infusion and patients could report adverse events up to 72h after infusion.
Outcome measures
| Measure |
All Study Participants
n=30 Participants
30 participants who received Multigam 5% intravenous immunoglobulin (IVIg) and Multigam 10% intravenous immunoglobulin (IVIg) 3 to 4 weeks later.
Dosing was set at 0.4 g/kg for both infusions.
|
|---|---|
|
IVIg-related Adverse Events Per Patient During Multigam IV 5% and Multigam IV 10% Administration
Multigam 5% infusion
|
0 IVIg-related AEs per patient
Interval 0.0 to 0.0
|
|
IVIg-related Adverse Events Per Patient During Multigam IV 5% and Multigam IV 10% Administration
Multigam 10% infusion
|
0.43 IVIg-related AEs per patient
Interval 0.12 to 0.74
|
SECONDARY outcome
Timeframe: During each infusion (up to 1 day)Evaluate the number of actions taken by the nursing staff during Multigam administration. Nursing actions were defined as the sum of actions required to increase the infusion rate (if needed) and any other action that had to be taken due to adverse effects during administration (e.g. lowering of infusion rate or supportive medication). Standard procedures like taking parameters were not accounted for this evaluation.
Outcome measures
| Measure |
All Study Participants
n=30 Participants
30 participants who received Multigam 5% intravenous immunoglobulin (IVIg) and Multigam 10% intravenous immunoglobulin (IVIg) 3 to 4 weeks later.
Dosing was set at 0.4 g/kg for both infusions.
|
|---|---|
|
Nursing Actions Per Patient During Multigam IV 5% and Multigam IV 10% Administration
Multigam 5% infusion
|
1.03 Nursing actions per patient
Interval 0.97 to 1.1
|
|
Nursing Actions Per Patient During Multigam IV 5% and Multigam IV 10% Administration
Multigam 10% infusion
|
0.67 Nursing actions per patient
Interval 0.3 to 1.04
|
SECONDARY outcome
Timeframe: End of study (after Multigam 10% infusion)Population: Row 3: 1 patient was unable to assess the question
Assess patient satisfaction via questionnaires. Questionnaires were taken at the end of MG 10% infusion and were validated by the principal investigator (PI) and head nurse. Patients could score following questions from 1 (strongly disagree) to 5 (strongly agree) \[Full scale: 1: strongly disagree; 2:disagree; 3: neutral; 4: agree; 5; strongly agree\]: Question 1: I experienced less side effects during Multigam 10% infusion. Question 2: I experienced time gain with Multigam 10%. Question 3: I had a more productive day with Multigam 10%. Question 4: I am in favor of of the use of Multigam 10%.
Outcome measures
| Measure |
All Study Participants
n=30 Participants
30 participants who received Multigam 5% intravenous immunoglobulin (IVIg) and Multigam 10% intravenous immunoglobulin (IVIg) 3 to 4 weeks later.
Dosing was set at 0.4 g/kg for both infusions.
|
|---|---|
|
Patient Satisfaction Questionnaire.
Question 1
|
3 score on a scale
Interval 1.0 to 5.0
|
|
Patient Satisfaction Questionnaire.
Question 2
|
5 score on a scale
Interval 2.0 to 5.0
|
|
Patient Satisfaction Questionnaire.
Question 3
|
4 score on a scale
Interval 1.0 to 5.0
|
|
Patient Satisfaction Questionnaire.
Question 4
|
5 score on a scale
Interval 1.0 to 5.0
|
Adverse Events
Multigam 5% Infusion
Multigam 10% Infusion
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Multigam 5% Infusion
n=30 participants at risk
30 participants who received Multigam 5% intravenous immunoglobulin (IVIg).
|
Multigam 10% Infusion
n=30 participants at risk
30 participants who received Multigam 10% intravenous immunoglobulin (IVIg) 3 to 4 weeks after their Multigam 5% infusion.
|
|---|---|---|
|
General disorders
Headache
|
0.00%
0/30 • Up to 72 after each infusion
|
13.3%
4/30 • Number of events 4 • Up to 72 after each infusion
|
|
General disorders
Fatigue
|
0.00%
0/30 • Up to 72 after each infusion
|
6.7%
2/30 • Number of events 2 • Up to 72 after each infusion
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/30 • Up to 72 after each infusion
|
3.3%
1/30 • Number of events 1 • Up to 72 after each infusion
|
|
General disorders
Infusion related reaction
|
0.00%
0/30 • Up to 72 after each infusion
|
6.7%
2/30 • Number of events 2 • Up to 72 after each infusion
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place