Real-world Usage of HyQvia in Multiple Myeloma Adults With Secondary Immunodeficiency (NCT05879757) — Sweden Trial Details

Condition(s) studied

Multiple MyelomaSecondary Immunodeficiency (SID)

Investigational drug(s) / intervention(s)

No Intervention

No Intervention: As this is an observational study, no intervention will be administered in this study.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

No

Inclusion Criteria: Participants who meet all of the following criteria assessed at the time of enrollment are eligible for this study: 1. Ability and willingness to provide informed consent. For adult participants unable to provide informed consent, informed consent provided by the legally authorized representative (LAR). 2. Has a diagnosis of MM requiring systemic anti-myeloma therapy as per International Myeloma Working Group (IMWG) criteria. 3. 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). 4. Age \>=18 years old at the time of MM diagnosis. 5. Available medical history records starting from the diagnosis of MM requiring systemic anti-myeloma therapy as IMWG criteria. 6. Life expectancy \>6 months at the time of enrollment, per physician assessment. 7. Eastern Cooperative Oncology Group (ECOG) performance status score of \<=2. 8. Participants/LAR 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 (IV) 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. Note: Participants on investigational chimeric antigen receptor-T (CAR-T) cell therapies and/or bispecific antibodies may participate. 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, 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.

Primary outcome measure(s)

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 milligrams (mg).
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, 5 weeks, 6 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, 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.

Trial sites (27)

Facility	City	Region	Status
Instituto Privado de Investigaciones Clinicas de Cordoba	Córdoba	Argentina	Withdrawn
Fakultni nemocnice Plzen	Pilsen	Czechia	Recruiting
Vseobecna fakultni Nemocnice	Prague	Czechia	Not Yet Recruiting
CHU Amiens - Hopital Sud	Salouël	Somme	Recruiting
CHU Dijon - Hopital du Bocage	Dijon	France	Not Yet Recruiting
Hopital Prive du Confluent	Nantes	France	Recruiting
Hopital de la Source - CHR Orleans	Orléans	France	Not Yet Recruiting
CHU Bordeaux - Hopital Haut-Leveque	Pessac	France	Not Yet Recruiting
MHP-Muenchner Haematologiepraxis	Berlin	Germany	Not Yet Recruiting
Alexandra General Hospital	Athens	Greece	Recruiting
General Hospital of Thessaloniki "G. Papanikolaou"	Thessaloniki	Greece	Recruiting
A.O.U.C Policlinico di Bari	Bari	Italy	Recruiting
AOU Policlinico Rodolico San Marco	Catania	Italy	Recruiting
Azienda Ospedale Universita Padova	Padova	Italy	Not Yet Recruiting
University of Padova	Treviso	Italy	Recruiting
Pomorski Uniwersytet Medyczny	Szczecin	Poland	Recruiting
Spitalul Clinic Colentina	Bucharest	Romania	Not Yet Recruiting
Institutul Clinic Fundeni	Bucharest	Romania	Not Yet Recruiting
Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca	Cluj-Napoca	Romania	Not Yet Recruiting
Spitalul Clinic Municipal Filantropia Craiova	Craiova	Romania	Not Yet Recruiting
Hospital Clinico San Carlos	Madrid	Spain	Recruiting
Hospital Universitario 12 de Octubre	Madrid	Spain	Recruiting
Hospital Universitari Son Espases	Palma	Spain	Recruiting
Lund University Hospital	Lund	Sweden	Not Yet Recruiting
Ankara University Medical Faculty	Ankara	Turkey (Türkiye)	Recruiting
Antalya Training and Research Hospital	Antalya	Turkey (Türkiye)	Recruiting
Istanbul Universitesi	Istanbul	Turkey (Türkiye)	Not Yet Recruiting

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