Overview
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.
Description
This is a prospective, observational study of adults having multiple myeloma (MM) with SID treated with HyQvia as part of routine clinical care. This study will characterize the real-world infusion parameters of HyQvia administration.
The study will enroll approximately 100 participants.
Study data will be requested through participants' routine clinic visits and patient-reported outcome (PRO)s are voluntary.
This multi-center trial will be conducted in selected European and Latin American countries. The overall time of this study is 38 months. Participants will make multiple visits to the clinic 12 days after last dose of study drug for a follow-up assessment.
Eligibility
Inclusion Criteria:
Participants who meet all of the following criteria assessed at the time of enrollment are
eligible for this study:
1. Has a diagnosis of MM requiring systemic anti-myeloma therapy as per International
Myeloma Working Group (IMWG) criteria
2. 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).
3. Age ≥18 years old at the time of MM diagnosis
4. Available medical history records starting from the diagnosis of MM requiring systemic
anti-myeloma therapy as IMWG criteria
5. Life expectancy >6 months at the time of enrollment, per physician assessment
6. Eastern Cooperative Oncology Group (ECOG) performance status score of ≤2
7. 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 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
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, with concurrence with the Sponsor's medical monitor,
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.