Hematologic Diseases, Secondary Immune Deficiency
Conditions
Keywords
Multigam, Immunoglobulin, Secondary immunodeficiency
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age =\> 18 years * Immunodeficiency secondary to a hematologic disorder * Patient has received at least 2 Multigam IV 5% administrations * Patient may not have had any adverse events (grade 2 or higher according to CTCAE v4.03) during the last 2 Multigam IV 5% administrations * Patient needs at least 2 more immunoglobulin administrations * Signed informed consent
Exclusion criteria
* Patient has received less than 2 Multigam IV 5% administrations * Patient has had an adverse event (grade 2 or higher according to CTCAE v4.03) during the last 2 Multigam IV 5% administrations * Refusal to sign informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infusion Time of Multigam IV 5% and Multigam IV 10% | Up to 1 month after Multigam 5% infusion | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospitalisation Time of Multigam IV 5% and Multigam IV 10% | Up to 1 month after Multigam 5% infusion | 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. |
| IVIg-related Adverse Events Per Patient During Multigam IV 5% and Multigam IV 10% Administration | Up to 72 after each infusion | 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. |
| Nursing Actions Per Patient During Multigam IV 5% and Multigam IV 10% Administration | 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. |
| Patient Satisfaction Questionnaire. | End of study (after Multigam 10% infusion) | 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%. |
Countries
Belgium
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Baseline characteristics of the study population (30 participants). | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | All Study Participants | — |
|---|---|---|
| Age, Continuous | 67.7 years STANDARD_DEVIATION 10 | — |
| First Multigam Dosage | 30 gram | — |
| Haematological disorder AL Amyloidosis | 2 Participants | — |
| Haematological disorder Chronic Lymphocytic Leukemia | 9 Participants | — |
| Haematological disorder Diffuse Large B-Cell Lymphoma | 2 Participants | — |
| Haematological disorder Follicular Lymphoma | 2 Participants | — |
| Haematological disorder Multiple Myeloma | 12 Participants | — |
| Haematological disorder Non-Hodgkin Lymphoma, Unclassifiable | 2 Participants | — |
| Haematological disorder Plasma Cell Dyscrasia: Scleromyxedema | 1 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Belgium | 30 participants | — |
| Sex: Female, Male Female | 4 Participants | — |
| Sex: Female, Male Male | 26 Participants | — |
| Time between first IVIg infusion and start of study | 4.1 years STANDARD_DEVIATION 4.3 | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 8 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| All Study Participants | Infusion Time of Multigam IV 5% and Multigam IV 10% | Multigam 5% infusion | 4.92 hour |
| All Study Participants | Infusion Time of Multigam IV 5% and Multigam IV 10% | Multigam 10% infusion | 2.29 hour |
Comparison: H0: No difference between Multigam 5% and Multigam 10% infusion time Ha: Multigam 10% infusion time is significantly shorter than Multigam 5%p-value: <0.0001t-test, 1 sided
Secondary
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
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| All Study Participants | Hospitalisation Time of Multigam IV 5% and Multigam IV 10% | Multigam 5% infusion | 5.87 hour |
| All Study Participants | Hospitalisation Time of Multigam IV 5% and Multigam IV 10% | Multigam 10% infusion | 4.56 hour |
Comparison: H0: No difference in hospitalisation time between Multigam 5% and Multigam 10% infusion Ha: Hospitalisation time with Multigam 10% infusion is significantly shorter than with Multigam 5%p-value: <0.0005t-test, 1 sided
Secondary
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
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| All Study Participants | IVIg-related Adverse Events Per Patient During Multigam IV 5% and Multigam IV 10% Administration | Multigam 5% infusion | 0 IVIg-related AEs per patient |
| All Study Participants | 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 |
Secondary
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)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| All Study Participants | Nursing Actions Per Patient During Multigam IV 5% and Multigam IV 10% Administration | Multigam 5% infusion | 1.03 Nursing actions per patient |
| All Study Participants | Nursing Actions Per Patient During Multigam IV 5% and Multigam IV 10% Administration | Multigam 10% infusion | 0.67 Nursing actions per patient |
Comparison: H0: No difference in number of nursing actions per patient between Multigam 5% and Multigam 10% infusion Ha: Number of nursing actions per patient is smaller with Multigam 10% infusionp-value: 0.03t-test, 1 sided
Secondary
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)
Population: Row 3: 1 patient was unable to assess the question
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| All Study Participants | Patient Satisfaction Questionnaire. | Question 1 | 3 score on a scale |
| All Study Participants | Patient Satisfaction Questionnaire. | Question 2 | 5 score on a scale |
| All Study Participants | Patient Satisfaction Questionnaire. | Question 3 | 4 score on a scale |
| All Study Participants | Patient Satisfaction Questionnaire. | Question 4 | 5 score on a scale |