Hematologic DiseasesMULTISIMNCT03250845
Comparison of Multigam IV (5% vs. 10%) in Patients With an Immunodeficiency Secondary to a Hematological Disorder
An observational study of Hematologic Diseases and Secondary Immune Deficiency, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Diseases, Secondary Immune Deficiency
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 30 Jun 2017to 13 Dec 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 30 patients with an immunodeficiency secondary to a hematologic disorder
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Multigam IV (5% vs. 10%) as Substitution Therapy in Patients With an Immunodeficiency Secondary to a Hematological Disorder to Evaluate Infusion Time, Tolerance and Satisfaction. A Monocentric Observational Belgian Study
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.
Read the 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.
- Conditions
- Hematologic Diseases, Secondary Immune Deficiency
- Keywords
- Multigam, Immunoglobulin, Secondary immunodeficiency
- Medical subject headings
- Hematologic Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 1 month after Multigam 5% infusion
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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%.
Measured: End of study (after Multigam 10% infusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2017
- Study start30 Jun 2017
- Primary completion31 Oct 2017
- Study completion13 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hematologic DiseasesStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel Delforge, MD PhD, Principal investigator, UZ Leuven Gasthuisberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03250845
- Sponsor's protocol ID
- HEM-2017-001
- Acronym
- MULTISIM
- Status last verified
- Oct 2019
- First submitted
- 7 Aug 2017
- Last updated
- 15 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Multigam IV (5% vs. 10%) as Substitution Therapy in Patients With an Immunodeficiency Secondary to a Hematological Disorder to Evaluate Infusion Time, Tolerance and Satisfaction. A Monocentric Observational Belgian Study
- ClinicalTrials.gov ID
- NCT03250845
- Acronym / sponsor ID
- MULTISIM / HEM-2017-001
- Conditions
- Hematologic Diseases, Secondary Immune Deficiency
- Keywords
- Multigam, Immunoglobulin, Secondary immunodeficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 30 Jun 2017 (actual)
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 13 Dec 2017 (actual)
- First posted
- 16 Aug 2017 (actual)
- Results
- Posted 15 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 30 patients with an immunodeficiency secondary to a hematologic disorder
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Infusion Time of Multigam IV 5% and Multigam IV 10%
Time frame: 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.
4 secondary outcomes
Hospitalisation Time of Multigam IV 5% and Multigam IV 10%
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
Time frame: Up to 72 after each infusion
Nursing Actions Per Patient During Multigam IV 5% and Multigam IV 10% Administration
Time frame: During each infusion (up to 1 day)
Patient Satisfaction Questionnaire.
Time frame: End of study (after Multigam 10% infusion)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michel Delforge, MD PhD principal investigator
UZ Leuven Gasthuisberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematologic Diseases and Secondary Immune Deficiency, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infusion Time of Multigam IV 5% and Multigam IV 10% (time frame: Up to 1 month after Multigam 5% infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2019.