An observational study in Hematologic Diseases and Secondary Immune Deficiency, sponsored by Universitaire Ziekenhuizen KU Leuven. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-15.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Observational
The purpose of this observational study is to compare the administration of standard of care Multigam IV 5% and standard of care Multigam IV 10% in order to observe changes in infusion time and infusion related reactions. Patient satisfaction, number of actions taken by the nursing staff during infusion and satisfaction of the nursing staff will also be evaluated.
Given the growing number of patient contacts at our day-care center, there is a continuous search to further improve the flow and to shorten the time spent per patient at the day-care center, without loss of quality in care.
In order to achieve this goal, this study wants to compare the administration of Multigam IV 5% and Multigam IV 10%. Multigam 5% and Multigam 10% are immunoglobulin solutions that are administered to strengthen the body's natural defense system (immune system). In case of recurrent infections, patients with an immunodeficiency secondary to a hematologic disorder can be treated with immunoglobulin substitution therapy. Patients can receive Multigam IV 5% and Multigam IV 10% in daily clinical practice and will receive both formulations in the same manner and intensity, meaning their use is not limited to this study.
For this observational study, patients with an immunodeficiency secondary to a hematologic disorder will be evaluated for inclusion. Patient characteristics, infusion time, time spent at the day-care center, adverse events and number of actions taken by the nursing staff will be evaluated for Multigam 5% administration. After 3-4 weeks, patients will return for Multigam 10% administration and an identical evaluation will take place along with a questionnaire for the patient and nursing staff to assess their satisfaction. The results will be processed to compare and evaluate the administration of both immunoglobulin solutions.
476 studies on the registry are indexed under Hematologic Diseases; 109 are open to participants now.
This study's enrollment of 30 is below the median of 237 across 134 observational studies indexed under Hematologic Diseases.
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30 patients with an immunodeficiency secondary to a hematologic disorder
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Exclusion Criteria:
Infusion Time of Multigam IV 5% and Multigam IV 10%
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.
Time frame: Up to 1 month after Multigam 5% infusion
Hospitalisation Time of Multigam IV 5% and Multigam IV 10%
Comparison 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.
Time frame: Up to 1 month after Multigam 5% infusion
IVIg-related Adverse Events Per Patient During Multigam IV 5% and Multigam IV 10% Administration
Evaluation 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.
Time frame: Up to 72 after each infusion
Nursing Actions Per Patient During Multigam IV 5% and Multigam IV 10% Administration
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.
Time frame: During each infusion (up to 1 day)
Patient Satisfaction Questionnaire.
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%.
Time frame: End of study (after Multigam 10% infusion)
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.
| Milestone | All Study Participants |
|---|---|
| Started | 30 |
| Completed | 30 |
| Not completed | 0 |
| Milestone | All Study Participants |
|---|---|
| Started | 30 |
| Completed | 30 |
| Not completed | 0 |
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.
| hour | All Study Participants |
|---|---|
| Multigam 5% infusion | 4.92 (4.54 to 5.3) |
| Multigam 10% infusion | 2.29 (1.96 to 2.62) |
Comparison 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.
| hour | All Study Participants |
|---|---|
| Multigam 5% infusion | 5.87 (5.5 to 6.24) |
| Multigam 10% infusion | 4.56 (3.84 to 5.27) |
Evaluation 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.
| IVIg-related AEs per patient | All Study Participants |
|---|---|
| Multigam 5% infusion | 0 (0 to 0) |
| Multigam 10% infusion | 0.43 (0.12 to 0.74) |
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.
| Nursing actions per patient | All Study Participants |
|---|---|
| Multigam 5% infusion | 1.03 (0.97 to 1.1) |
| Multigam 10% infusion | 0.67 (0.3 to 1.04) |
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%.
| score on a scale | All Study Participants |
|---|---|
| Question 1 | 3 (1 to 5) |
| Question 2 | 5 (2 to 5) |
| Question 3 | 4 (1 to 5) |
| Question 4 | 5 (1 to 5) |
Collected over Up to 72 after each infusion. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Multigam 5% Infusion | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Multigam 10% Infusion | 0/30 (0%) | 0/30 (0%) | 8/30 (26.7%) |
| Event | Multigam 5% Infusion | Multigam 10% Infusion |
|---|---|---|
| HeadacheGeneral disorders | 0/30 | 4/30 |
| Infusion related reactionGeneral disorders | 0/30 | 3/30 |
| FatigueGeneral disorders | 0/30 | 2/30 |
| Infusion related reactionGeneral disorders | 0/30 | 2/30 |
| Back painMusculoskeletal and connective tissue disorders | 0/30 | 1/30 |
| Infusion related reactionGeneral disorders | 0/30 | 1/30 |
| Age, Continuous(years) | All Study Participants |
|---|---|
| Mean | 67.7 ± 10 |
| Sex: Female, Male(Participants) | All Study Participants |
|---|---|
| Female | 4 |
| Male | 26 |
| Race and Ethnicity Not Collected(Participants) | All Study Participants |
|---|
| Region of Enrollment(participants) | All Study Participants |
|---|---|
| Belgium | 30 |
| Haematological disorder(Participants) | All Study Participants |
|---|---|
| Plasma Cell Dyscrasia: Scleromyxedema | 1 |
| AL Amyloidosis | 2 |
| Multiple Myeloma | 12 |
| Chronic Lymphocytic Leukemia | 9 |
| Diffuse Large B-Cell Lymphoma | 2 |
| Follicular Lymphoma | 2 |
| Non-Hodgkin Lymphoma, Unclassifiable | 2 |
| Time between first IVIg infusion and start of study(years) | All Study Participants |
|---|---|
| Mean | 4.1 ± 4.3 |
| First Multigam Dosage(gram) | All Study Participants |
|---|---|
| Median | 30 (20 to 70) |
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