Clinical trial NCT05879757: Real-world Usage of HyQvia in Multiple Myeloma Adults With Secondary Immunodeficiency
Official title: 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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Myeloma
Secondary Immunodeficiency (SID)
Keywords: Drug Therapy
Supportive Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2023-05-30
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include adult participants who suffer from MM, have a diagnosis of SID defined according to the European HyQvia label.

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.

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 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.

Eligibility criteria: 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 outcomes:
measure: Dose of HyQvia per Kilogram of Body Weight
timeFrame: Up to 12 months
measure: Absolute Dose of HyQvia per Infusion
timeFrame: Up to 12 months
measure: Treatment Interval
timeFrame: Up to 12 months
measure: Infusion Volume per Site
timeFrame: Up to 12 months
measure: Total Infusion Volume
timeFrame: Up to 12 months
measure: Infusion Rate
timeFrame: Up to 12 months
measure: Duration of Infusion
timeFrame: Up to 12 months
measure: Location of Infusion Sites
timeFrame: Up to 12 months
measure: Number of Infusion Sites
timeFrame: Up to 12 months
measure: Number of Participants Characterized by Site of Care
timeFrame: Up to 12 months
measure: Length and Diameter of Infusion Needles
timeFrame: Up to 12 months
measure: Number of Participants per Type of Pump
timeFrame: Up to 12 months
measure: Number of Participants With Availability of Caregiver Support
timeFrame: Up to 12 months
measure: Number of Training Visits
timeFrame: Up to 12 months
measure: Number of Participants With Infusions That are Discontinued, Slowed, or Interrupted
timeFrame: Up to 12 months
measure: Number of Participants With Reasons of infusions Discontinued, Slowed, or Interrupted
timeFrame: Up to 12 months
measure: Number of Participants With Reasons for Discontinued, or Interrupted HyQvia Treatment or Switches to Other Treatment
timeFrame: Up to 12 months
Secondary outcomes:
measure: Time of Multiple Myeloma (MM) Diagnosis
timeFrame: At the time of baseline
measure: Number of Participants Characterized by Clinical Characteristics
timeFrame: Up to 12 months
measure: Number of Participants Characterized With Type of Hemato-oncological Treatment
timeFrame: Baseline up to 12 months
measure: Duration of Hemato-oncological Treatment
timeFrame: Baseline up to 12 months
measure: Number of Participants With Multiple Myeloma (MM) Disease Status and Outcome at 12 Months
timeFrame: Month 12
measure: Overall Survival (OS)
timeFrame: Up to 12 months
measure: Number of Participants With Healthcare Resource Utilization (HCRU)
timeFrame: Up to 12 months
measure: Duration of Hospitalizations
timeFrame: Up to 12 months
measure: Number of Participants With Related and Not Related Serious Adverse Events (SAEs)
timeFrame: Up to 12 months
measure: Number of Participants With Non-serious Adverse Events (AEs) Causally or Temporally Related to HyQvia Treatment
timeFrame: Up to 12 months
measure: Number of Participants With Premedication use for HyQvia Infusions, any Technical Problems With the Infusion, and the Planned Versus Actual Dosing
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Cordoba
country: Argentina
facility: Instituto Privado de Investigaciones Clinicas de Cordoba
city: Pilsen
country: Czechia
facility: Fakultni nemocnice Plzen
city: Prague
country: Czechia
facility: Vseobecna fakultni Nemocnice
city: Salouel
country: France
facility: CHU Amiens - Hopital Sud
state: Somme
city: Dijon
country: France
facility: CHU Dijon - Hopital du Bocage
city: Nantes
country: France
facility: Hopital Prive du Confluent
city: Orleans
country: France
facility: Hopital de la Source - CHR Orleans
city: Pessac
country: France
facility: CHU Bordeaux - Hopital Haut-Leveque
city: Berlin
country: Germany
facility: MHP-Muenchner Haematologiepraxis
city: Athens
country: Greece
facility: Alexandra General Hospital
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki "G. Papanikolaou"
city: Bari
country: Italy
facility: A.O.U.C Policlinico di Bari
city: Catania
country: Italy
facility: AOU Policlinico Rodolico San Marco
city: Padova
country: Italy
facility: Azienda Ospedale Universita Padova
city: Treviso
country: Italy
facility: University of Padova
city: Szczecin
country: Poland
facility: Pomorski Uniwersytet Medyczny
city: Bucharest
country: Romania
facility: Institutul Clinic Fundeni
city: Bucuresti
country: Romania
facility: Spitalul Clinic Colentina
city: Cluj Napoca
country: Romania
facility: Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca
city: Craiova
country: Romania
facility: Spitalul Clinic Municipal Filantropia Craiova
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Palma
country: Spain
facility: Hospital Universitari Son Espases
city: Lund
country: Sweden
facility: Lund University Hospital
city: Ankara
country: Turkey
facility: Ankara University Medical Faculty
city: Antalya
country: Turkey
facility: Antalya Training and Research Hospital
city: Istanbul
country: Turkey
facility: Istanbul Universitesi
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: