Real-world Usage of HyQvia in Multiple Myeloma Adults With Secondary Immunodeficiency
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTakeda
About this trial
In this study, multiple myeloma participants with secondary immunodeficiency (SID) will be treated with HyQvia according to their clinic's standard practice. The study's main aim is to look into infusion parameters of HyQvia administration.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ability and willingness to provide informed consent. For adult participants unable to provide informed consent, informed consent provided by the legally authorized representative (LAR).
Has a diagnosis of MM requiring systemic anti-myeloma therapy as per International Myeloma Working Group (IMWG) criteria.
Initiated HyQvia treatment as part of routine clinical care no more than 30 days before study enrollment or received no more than 2 doses of HyQvia treatment, whichever occurs first. Participants are also eligible if they newly start HyQvia within 30 days after the enrollment visit.
Age >=18 years old at the time of MM diagnosis.
Disqualifiers
Known hypersensitivity to any of the components of HyQvia.
Primary immunodeficiency (PID) or diagnosed with human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) and/or active hepatitis C and/or active hepatitis B infection.
Prior use of Ig treatment or prophylaxis within 3 months from the date of enrollment.
Serious infection(s) requiring intravenous (IV) treatment at the time of enrollment into the study; except for participants on short-term oral antibiotic therapy.
Trial population
The study population will include adult participants who suffer from MM, have a diagnosis of SID defined according to the European HyQvia label.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
No Intervention
Other interventionAs this is an observational study, no intervention will be administered in this study.
Treatment groups
75 Participants
are divided into 1 treatment groupGroup A: MM Participants With SID1 intervention
Trial outcomes
Primary outcomes
1
Dose of HyQvia per Kilogram of Body Weight
Dose of HyQvia will be calculated as grams per kilogram (g/kg) body weight per 4 weeks.
Time frame
Up to 12 months2
Absolute Dose of HyQvia per Infusion
Absolute dose of HyQvia will be calculated as dose per infusion in milligrams (mg).
Time frame
Up to 12 months3
Treatment Interval
Treatment interval and ramp up dosing intervals will be reported as Weekly, every 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks and other administration according to the schedule defined by physician.
Time frame
Up to 12 months4
Infusion Volume per Site
Time frame
Up to 12 monthsSecondary outcomes
1
Time of Multiple Myeloma (MM) Diagnosis
Time frame
At the time of baseline2
Number of Participants Characterized by Clinical Characteristics
Clinical characteristics of participants will include type of MM, and MM treatment/procedures, comorbidities, concomitant medications, laboratory tests and imaging.
Time frame
Up to 12 months3
Number of Participants Characterized With Type of Hemato-oncological Treatment
Type of hemato-oncological treatment will list type, switches, interruptions and discontinuation with reasons of hemato-oncological treatment or procedure.
Time frame
Baseline up to 12 months4
Duration of Hemato-oncological Treatment
Time frame
Baseline up to 12 months Source ClinicalTrials.gov