NCT05879757 Real-world Usage of HyQvia in Multiple Myeloma Adults With Secondary Immunodeficiency
| NCT ID | NCT05879757 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Takeda |
| Condition | Multiple Myeloma |
| Study Type | OBSERVATIONAL |
| Enrollment | 75 participants |
| Start Date | 2023-10-17 |
| Primary Completion | 2027-02-16 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 75 participants in total. It began in 2023-10-17 with a primary completion date of 2027-02-16.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: Participants who meet all of the following criteria assessed at the time of enrollment are eligible for this study: 1. Ability and willingness to provide informed consent. For adult participants unable to provide informed consent, informed consent provided by the legally authorized representative (LAR). 2. Has a diagnosis of MM requiring systemic anti-myeloma therapy as per International Myeloma Working Group (IMWG) criteria. 3. 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). 4. Age \>=18 years old at the time of MM diagnosis. 5. Available medical history records starting from the diagnosis of MM requiring systemic anti-myeloma therapy as IMWG criteria. 6. Life expectancy \>6 months at the time of enrollment, per physician assessment. 7. Eastern Cooperative Oncology Group (ECOG) performance status score of \<=2. 8. Participants/LAR willing and able to comply with the requirements of the protocol. Exclusion Criteria: Participants who meet any of the following criteria assessed at the time of enrollment are not eligible for this study: 1. Known hypersensitivity to any of the components of HyQvia. 2. 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. 3. Prior use of Ig treatment or prophylaxis within 3 months from the date of enrollment. 4. Serious infection(s) requiring intravenous (IV) treatment at the time of enrollment into the study; except for participants on short-term oral antibiotic therapy. 5. 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. 6. 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. 7. 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). 8. 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.
Contact & Investigator
Study Director
STUDY DIRECTOR
Takeda
Frequently Asked Questions
Who can join the NCT05879757 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Multiple Myeloma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05879757 currently recruiting?
Yes, NCT05879757 is actively recruiting participants. Contact the research team at medinfoUS@takeda.com for enrollment information.
Where is the NCT05879757 trial being conducted?
This trial is being conducted at Córdoba, Argentina, Pilsen, Czechia, Prague, Czechia, Salouël, France and 11 additional locations.
Who is sponsoring the NCT05879757 clinical trial?
NCT05879757 is sponsored by Takeda. The principal investigator is Study Director at Takeda. The trial plans to enroll 75 participants.