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)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 75
- 试验地点
- 27
- 主要终点
- Dose of HyQvia per Kilogram of Body Weight
研究概览
简要总结
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.
详细描述
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 South American countries. The overall time of this study is 38 months. Participants will make multiple visits to the clinic within 12 months after enrolment for follow-up assessments.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 <=
- •Participants/LAR willing and able to comply with the requirements of the protocol.
排除标准
- •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 (IV) 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.
- •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.
- •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).
- •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.
研究组 & 干预措施
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.
干预措施: No Intervention (Other)
结局指标
主要结局
Dose of HyQvia per Kilogram of Body Weight
时间窗: Up to 12 months
Dose of HyQvia will be calculated as grams per kilogram (g/kg) body weight per 4 weeks.
Absolute Dose of HyQvia per Infusion
时间窗: Up to 12 months
Absolute dose of HyQvia will be calculated as dose per infusion in milligrams (mg).
Treatment Interval
时间窗: Up to 12 months
Treatment interval and ramp up dosing intervals will be reported as Weekly, every 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks and other administration according to the schedule defined by physician.
Infusion Volume per Site
时间窗: Up to 12 months
Total Infusion Volume
时间窗: Up to 12 months
Infusion Rate
时间窗: Up to 12 months
Infusion rate will be reported in milliliters per hour (mL/h).
Duration of Infusion
时间窗: Up to 12 months
The duration between start and end of infusion will be reported.
Location of Infusion Sites
时间窗: Up to 12 months
Location of infusion sites will include right upper abdomen, left upper abdomen, right lower abdomen, left lower abdomen, right or left thigh, right or left arm, and other (specified).
Number of Infusion Sites
时间窗: Up to 12 months
Number of Participants Characterized by Site of Care
时间窗: Up to 12 months
Site of care will be categorized as home, hospital, doctor's office, other (specified).
Length and Diameter of Infusion Needles
时间窗: Up to 12 months
Number of Participants per Type of Pump
时间窗: Up to 12 months
Type of pump will include peristaltic infusion pump and syringe driver pump.
Number of Participants With Availability of Caregiver Support
时间窗: Up to 12 months
Availability of caregiver support will be collected as yes, no, and unknown. If yes, caregiver relationship will be specified.
Number of Training Visits
时间窗: Up to 12 months
Number of Participants With Infusions That are Discontinued, Slowed, or Interrupted
时间窗: Up to 12 months
Number of Participants With Reasons of infusions Discontinued, Slowed, or Interrupted
时间窗: Up to 12 months
Number of Participants With Reasons for Discontinued, or Interrupted HyQvia Treatment or Switches to Other Treatment
时间窗: Up to 12 months
Reasons for discontinued, or interrupted HyQvia treatment will include local adverse events (AE)/discomfort, systemic AE, administration complexity, insurance/reimbursement-related, low immunoglobulin (Ig) trough level, lack of effectiveness, inability to tolerate large volumes, death and other (specified). If switch, type of treatment after switch (example, antibiotic treatment, intravenous immunoglobulin \[IVIg\], subcutaneous immunoglobulin \[SCIg\], unknown) or switches to other treatment will be included.
次要结局
- Time of Multiple Myeloma (MM) Diagnosis(At the time of baseline)
- Number of Participants Characterized by Clinical Characteristics(Up to 12 months)
- Number of Participants Characterized With Type of Hemato-oncological Treatment(Baseline up to 12 months)
- Duration of Hemato-oncological Treatment(Baseline up to 12 months)
- Number of Participants With Multiple Myeloma (MM) Disease Status and Outcome at 12 Months(Month 12)
- Overall Survival (OS)(Up to 12 months)
- Number of Participants With Healthcare Resource Utilization (HCRU)(Up to 12 months)
- Duration of Hospitalizations(Up to 12 months)
- Number of Participants With Related and Not Related Serious Adverse Events (SAEs)(Up to 12 months)
- Number of Participants With Non-serious Adverse Events (AEs) Causally or Temporally Related to HyQvia Treatment(Up to 12 months)
- Number of Participants With Premedication use for HyQvia Infusions, any Technical Problems With the Infusion, and the Planned Versus Actual Dosing(Up to 12 months)