Real-world Usage of HyQvia in Multiple Myeloma Adults With Secondary Immunodeficiency
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Other: No Intervention
As this is an observational study, no intervention will be administered in this study.
|
Outcome Measures
Primary Outcome Measures
- Dose of HyQvia per Kilogram of Body Weight [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 [Up to 12 months]
Absolute dose of HyQvia will be calculated as dose per infusion in milliliters (mL).
- Treatment Interval [Up to 12 months]
Treatment interval and ramp up dosing intervals will be reported as Weekly, every 2 weeks, 3 weeks, 4 weeks and other administration according to the schedule defined by physician.
- Infusion Volume per Site [Up to 12 months]
- Total Infusion Volume [Up to 12 months]
- Infusion Rate [Up to 12 months]
Infusion rate will be reported in milliliters per hour (mL/h).
- Duration of Infusion [Up to 12 months]
The duration between start and end of infusion will be reported.
- Location of Infusion Sites [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 [Up to 12 months]
- Number of Participants Characterized by Site of Care [Up to 12 months]
Site of care will be categorized as home, hospital, doctor's office, other (specified).
- Length and Diameter of Infusion Needles [Up to 12 months]
- Number of Participants per Type of Pump [Up to 12 months]
Type of pump will include peristaltic infusion pump and syringe driver pump.
- Number of Participants With Availability of Caregiver Support [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 [Up to 12 months]
- Number of Participants With Infusions That are Discontinued, Slowed, or Interrupted [Up to 12 months]
- Number of Participants With Reasons of infusions Discontinued, Slowed, or Interrupted [Up to 12 months]
- Number of Participants With Reasons for Discontinued, or Interrupted HyQvia Treatment or Switches to Other Treatment [Up to 12 months]
Reasons for discontinued, or interrupted HyQvia treatment will include local adverse events (AE)/discomfort, systemic AE, administration complexity, lack of efficacy, insurance/reimbursement-related, low immunoglobulin trough level, lack of effectiveness, inability to tolerate large volumes and other (specified). If switch, type of treatment after switch (e.g., antibiotic treatment, intravenous immunoglobulin [IVIg], subcutaneous immunoglobulin [SCIg], etc.) or switches to other treatment will be included.
Secondary Outcome Measures
- Time of Multiple Myeloma (MM) Diagnosis [Up to 12 months]
- Number of Participants Characterized by Clinical Characteristics [Up to 12 months]
Clinical characteristics of participants will include type of MM, and MM treatment/procedures, comorbidities, concomitant medications, laboratory tests and imaging.
- Number of Participants Characterized With Type of Hemato-oncological Treatment [Up to 12 months]
Type of hemato-oncological treatment will list type, switches, interruptions and discontinuation with reasons of hemato-oncological treatment or procedure.
- Duration of Hemato-oncological Treatment [Up to 12 months]
- Number of Participants With Multiple Myeloma (MM) Disease Status and Outcome at 12 Months [Month 12]
MM disease status and outcome will include response and criteria used to assess response (if known).
- Overall Survival (OS) [Up to 12 months]
OS will be summarized as the frequency and percentage of participants surviving to each follow-up visit. Additionally, time-to death, defined as the time from HyQvia initiation to death occurring before the end of the study period, will be assessed.
- Number of Participants With Healthcare Resource Utilization (HCRU) [Up to 12 months]
Number of participants with HCRU including annualized rates and emergency room visits, urgent care visits, outpatient visits, telemedicine visits, and other physician visits, with stratification of hospitalizations and visits due to infection, visit type and provider type.
- Duration of Hospitalizations [Up to 12 months]
- Number of Participants With Related and Not Related Serious Adverse Events (SAEs) [Up to 12 months]
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An SAE is defined as an untoward medical occurrence that at any dose is fatal, life-threatening, requires inpatient hospitalisation or results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event. AEs will be reported as local or systemic AEs.
- Number of Participants With Non-serious Adverse Events (AEs) Causally or Temporally Related to HyQvia Treatment [Up to 12 months]
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An SAE is defined as an untoward medical occurrence that at any dose is fatal, life-threatening, requires inpatient hospitalisation or results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event. AEs will be reported as local or systemic AEs.
- 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]
Premedication use for HyQvia infusions will include start date, stop date and medication name. Technical problems with infusion will include problems with the handling of the pump, problems with the preparation of the infusion, problems with the infusion itself, infusion site leakage, and other (specified).
Eligibility Criteria
Criteria
Inclusion Criteria:
Participants who meet all of the following criteria assessed at the time of enrollment are eligible for this study:
-
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
-
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:
-
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 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
-
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, with concurrence with the Sponsor's medical monitor, 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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Takeda
Investigators
- Study Director: Study Director, Takeda
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TAK-771-5006