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.
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.
Study Type
OBSERVATIONAL
Enrollment
75
As this is an observational study, no intervention will be administered in this study.
Dose of HyQvia per Kilogram of Body Weight
Dose of HyQvia will be calculated as grams per kilogram (g/kg) body weight per 4 weeks.
Time frame: Up to 12 months
Absolute Dose of HyQvia per Infusion
Absolute dose of HyQvia will be calculated as dose per infusion in milligrams (mg).
Time frame: Up to 12 months
Treatment Interval
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.
Time frame: Up to 12 months
Infusion Volume per Site
Time frame: Up to 12 months
Total Infusion Volume
Time frame: Up to 12 months
Infusion Rate
Infusion rate will be reported in milliliters per hour (mL/h).
Time frame: Up to 12 months
Duration of Infusion
The duration between start and end of infusion will be reported.
Time frame: Up to 12 months
Location of Infusion Sites
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).
Time frame: Up to 12 months
Number of Infusion Sites
Time frame: Up to 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Instituto Privado de Investigaciones Clinicas de Cordoba
Córdoba, Argentina
WITHDRAWNFakultni nemocnice Plzen
Pilsen, Czechia
RECRUITINGVseobecna fakultni Nemocnice
Prague, Czechia
NOT_YET_RECRUITINGCHU Amiens - Hopital Sud
Salouël, Somme, France
RECRUITINGCHU Dijon - Hopital du Bocage
Dijon, France
NOT_YET_RECRUITINGHopital Prive du Confluent
Nantes, France
RECRUITINGHopital de la Source - CHR Orleans
Orléans, France
NOT_YET_RECRUITINGCHU Bordeaux - Hopital Haut-Leveque
Pessac, France
NOT_YET_RECRUITINGMHP-Muenchner Haematologiepraxis
Berlin, Germany
NOT_YET_RECRUITINGAlexandra General Hospital
Athens, Greece
RECRUITING...and 17 more locations
Number of Participants Characterized by Site of Care
Site of care will be categorized as home, hospital, doctor's office, other (specified).
Time frame: Up to 12 months
Length and Diameter of Infusion Needles
Time frame: Up to 12 months
Number of Participants per Type of Pump
Type of pump will include peristaltic infusion pump and syringe driver pump.
Time frame: Up to 12 months
Number of Participants With Availability of Caregiver Support
Availability of caregiver support will be collected as yes, no, and unknown. If yes, caregiver relationship will be specified.
Time frame: Up to 12 months
Number of Training Visits
Time frame: Up to 12 months
Number of Participants With Infusions That are Discontinued, Slowed, or Interrupted
Time frame: Up to 12 months
Number of Participants With Reasons of infusions Discontinued, Slowed, or Interrupted
Time frame: Up to 12 months
Number of Participants With Reasons for Discontinued, or Interrupted HyQvia Treatment or Switches to Other Treatment
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.
Time frame: Up to 12 months
Time of Multiple Myeloma (MM) Diagnosis
Time frame: At the time of baseline
Number of Participants Characterized by Clinical Characteristics
Clinical characteristics of participants will include type of MM, and MM treatment/procedures, comorbidities, concomitant medications, laboratory tests and imaging.
Time frame: Up to 12 months
Number of Participants Characterized With Type of Hemato-oncological Treatment
Type of hemato-oncological treatment will list type, switches, interruptions and discontinuation with reasons of hemato-oncological treatment or procedure.
Time frame: Baseline up to 12 months
Duration of Hemato-oncological Treatment
Time frame: Baseline up to 12 months
Number of Participants With Multiple Myeloma (MM) Disease Status and Outcome at 12 Months
MM disease status and outcome will include response and criteria used to assess response (if known).
Time frame: Month 12
Overall Survival (OS)
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.
Time frame: Up to 12 months
Number of Participants With Healthcare Resource Utilization (HCRU)
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.
Time frame: Up to 12 months
Duration of Hospitalizations
Time frame: Up to 12 months
Number of Participants With Related and Not Related Serious Adverse Events (SAEs)
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.
Time frame: Up to 12 months
Number of Participants With Non-serious Adverse Events (AEs) Causally or Temporally Related to HyQvia Treatment
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. AEs will be reported as local or systemic AEs.
Time frame: 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
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).
Time frame: Up to 12 months