Real-world Usage of HyQvia in Multiple Myeloma Adults With Secondary Immunodeficiency
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
Participants who meet all of the following criteria assessed at the time of enrollment are eligible for this study:
- 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.
- Note: Participants who do not start HyQvia treatment within 30 days of enrollment will be considered as screen failures (and replaced).
- Age ≥18 years old at the time of MM diagnosis
- Available medical history records starting from the diagnosis of MM requiring systemic anti-myeloma therapy as IMWG criteria
- Life expectancy >6 months at the time of enrollment, per physician assessment
- Eastern Cooperative Oncology Group (ECOG) performance status score of ≤2
- Willing and able to comply with the requirements of the protocol
EXCLUSION CRITERIA
Exclusion Criteria:
Participants who meet any of the following criteria assessed at the time of enrollment are not eligible for this study:
- 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 treatment at the time of enrollment into the study; except for participants on short-term oral antibiotic therapy
- Has participated in an interventional clinical study involving a medicinal product or device within 30 days prior to enrollment or is scheduled to participate in an interventional clinical study involving a medical product or device during this study
- Planned stem cell transplant during the treatment period, or had a prior stem cell transplant: allogeneic transplant at any time, autologous transplant within 3 months of enrollment
- History of malignancy (other than MM) within 3 years before the date of enrollment (exceptions are squamous and basal cell carcinomas of the skin, carcinoma in situ of the cervix or breast, localized prostate cancer or other non-invasive lesion that in the opinion of the investigator, with concurrence with the Sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years)
- Participant has had major surgery within 2 weeks before enrollment, or has not fully recovered from an earlier surgery, or has surgery planned during the time the participant is expected to participate in the study Note: Participants with planned surgical procedures to be conducted under local anesthesia may participate. Kyphoplasty or vertebroplasty are not considered major surgery.
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Multiple Myeloma,Secondary Immunodeficiency (SID)
Age
18+
Participants Needed
100
Est. Completion Date
Mar 1, 2026
Treatment Type
OBSERVATIONAL
Sponsor
Takeda
ClinicalTrials.gov NCT Identifier
NCT05879757
Study Number
TAK-771-5006
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