Real-world Usage of HyQvia in Multiple Myeloma Adults With Secondary Immunodeficiency

Korábbi kezelés

• 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.

Más betegség

• 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).

Egyéb

• Participants who meet any of the following criteria assessed at the time of enrollment are not eligible for this study:

• 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.