Observes HyQvia use in adults with multiple myeloma and weakened immunity
Observes how HyQvia is given to adults with myeloma and secondary immunodeficiency.
Key facts
- Who runs it
- Takeda
- Where
- Ankara, Antalya, and Istanbul, TürkiyeSee the 3 sitesAlso in 10 other countries, 24 sites
- Trial code
- Registry title
- Real-world Usage of HyQvia in Multiple Myeloma Adults With Secondary Immunodeficiency
- Status
- Recruiting
- People taking part
- 75 people, planned
- Started
- 17 Oct 2023
- Expected to end
- 16 Feb 2027
- Type of study
- Observational
- Record updated
- 18 February 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with multiple myeloma who have secondary immunodeficiency and are starting HyQvia as part of routine care.
- Age
- 18 years or older at the time of multiple myeloma diagnosis
- Sex
- All sexes can join
- Disease stage
- Multiple myeloma that needs treatment with systemic anti-myeloma therapy; life expectancy over 6 months; ECOG performance status score of 2 or lower
- Earlier treatment
- Started HyQvia no more than 30 days before enrollment, or had no more than 2 doses, or will start within 30 days after enrollment. No immunoglobulin treatment in the 3 months before enrollment.
Main reasons for not taking part
- Known hypersensitivity to any component of HyQvia
- Primary immunodeficiency, HIV/AIDS, or active hepatitis B or C
- Serious infection needing intravenous treatment at enrollment
- Planned stem cell transplant, or a prior allogeneic transplant, or an autologous transplant within 3 months of enrollment
- Another cancer within 3 years before enrollment, with a few listed exceptions
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- Participants who meet all of the following criteria assessed at the time of enrollment are eligible for this study:
- 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; 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
- Participants/LAR willing and able to comply with the requirements of the protocol
Who cannot take part
- Prior use of Ig treatment or prophylaxis within 3 months from the date of enrollment
- 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; Note: Participants on investigational chimeric antigen receptor-T (CAR-T) cell therapies and/or bispecific antibodies may participate
- 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
- 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
- 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
- Serious infection(s) requiring intravenous (IV) treatment at the time of enrollment into the study; except for participants on short-term oral antibiotic therapy
- 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, is considered cured with minimal risk of recurrence within 3 years)
- Participants who meet any of the following criteria assessed at the time of enrollment are not eligible for this study:
Where in Türkiye
Also in 10 other countries, 24 sites
- Ankara University Medical FacultyAnkara, TürkiyeContact: Selami Toprak (principal investigator)Taking people
- Antalya Training and Research HospitalAntalya, TürkiyeContact: Volkan Karakus (principal investigator)Taking people
- Istanbul UniversitesiIstanbul, TürkiyeContact: Muhlis Cem Ar (principal investigator)Not yet recruiting
About the trial
What the trial wants to find out
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.
The group in the trial
- MM Participants With SID
Participants with MM diagnosed with SID will be treated with HyQvia as part of routine clinical care and will be followed prospectively from the date of starting HyQvia treatment through 12 months of follow-up.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Prospective, Observational Study to Assess the Real-World Usage and Outcomes of HyQvia in Patients With Multiple Myeloma (MM) Diagnosed With Secondary Immunodeficiency (SID)
- Plain-language title
- Observes HyQvia use in adults with multiple myeloma and weakened immunityGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 18 February 2026