Real-world Usage of HyQvia in Multiple Myeloma Adults With Secondary Immunodeficiency

Официальное название

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)

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Dose of HyQvia per Kilogram of Body Weight [Срок оценки: Up to 12 months]
• Absolute Dose of HyQvia per Infusion [Срок оценки: Up to 12 months]
• Treatment Interval [Срок оценки: Up to 12 months]
• Infusion Volume per Site [Срок оценки: Up to 12 months]
• Total Infusion Volume [Срок оценки: Up to 12 months]
• Infusion Rate [Срок оценки: Up to 12 months]
• Duration of Infusion [Срок оценки: Up to 12 months]
• Location of Infusion Sites [Срок оценки: Up to 12 months]
• Number of Infusion Sites [Срок оценки: Up to 12 months]
• Number of Participants Characterized by Site of Care [Срок оценки: Up to 12 months]

Вторичные конечные точки (11)

• Time of Multiple Myeloma (MM) Diagnosis [Срок оценки: At the time of baseline]
• Number of Participants Characterized by Clinical Characteristics [Срок оценки: Up to 12 months]
• Number of Participants Characterized With Type of Hemato-oncological Treatment [Срок оценки: Baseline up to 12 months]
• Duration of Hemato-oncological Treatment [Срок оценки: Baseline up to 12 months]
• Number of Participants With Multiple Myeloma (MM) Disease Status and Outcome at 12 Months [Срок оценки: Month 12]
• Overall Survival (OS) [Срок оценки: Up to 12 months]
• Number of Participants With Healthcare Resource Utilization (HCRU) [Срок оценки: Up to 12 months]
• Duration of Hospitalizations [Срок оценки: Up to 12 months]
• Number of Participants With Related and Not Related Serious Adverse Events (SAEs) [Срок оценки: Up to 12 months]
• Number of Participants With Non-serious Adverse Events (AEs) Causally or Temporally Related to HyQvia Treatment [Срок оценки: 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 [Срок оценки: Up to 12 months]

Критерии участия

Критерии включения

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 <=2.
• Participants/LAR willing and able to comply with the requirements of the protocol.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 5 центров

• CHU Amiens - Hopital Sud — Salouël
• CHU Dijon - Hopital du Bocage — Dijon
• Hopital Prive du Confluent — Nantes
• Hopital de la Source - CHR Orleans — Orléans
• CHU Bordeaux - Hopital Haut-Leveque — Pessac

Италия · 4 центра

• A.O.U.C Policlinico di Bari — Bari
• AOU Policlinico Rodolico San Marco — Catania
• Azienda Ospedale Universita Padova — Padova
• University of Padova — Treviso

Румыния · 4 центра

• Spitalul Clinic Colentina — Bucharest
• Institutul Clinic Fundeni — Bucharest
• Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca — Cluj-Napoca
• Spitalul Clinic Municipal Filantropia Craiova — Craiova

Испания · 3 центра

• Hospital Clinico San Carlos — Madrid
• Hospital Universitario 12 de Octubre — Madrid
• Hospital Universitari Son Espases — Palma

Turkey (Türkiye) · 3 центра

• Ankara University Medical Faculty — Ankara
• Antalya Training and Research Hospital — Antalya
• Istanbul Universitesi — Istanbul

Чехия · 2 центра

• Fakultni nemocnice Plzen — Pilsen
• Vseobecna fakultni Nemocnice — Prague

Греция · 2 центра

• Alexandra General Hospital — Athens
• General Hospital of Thessaloniki "G. Papanikolaou" — Thessaloniki

Аргентина · 1 центр

• Instituto Privado de Investigaciones Clinicas de Cordoba — Córdoba

Германия · 1 центр

• MHP-Muenchner Haematologiepraxis — Berlin

Польша · 1 центр

• Pomorski Uniwersytet Medyczny — Szczecin

Швеция · 1 центр

• Lund University Hospital — Lund

Идентификаторы

NCT: NCT05879757 · TAK-771-5006

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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