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)

Overview

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.

Interventions

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

Primary outcome measures

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

Secondary outcome measures (11)

• Time of Multiple Myeloma (MM) Diagnosis [Time frame: At the time of baseline]
• Number of Participants Characterized by Clinical Characteristics [Time frame: Up to 12 months]
• Number of Participants Characterized With Type of Hemato-oncological Treatment [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 [Time frame: Month 12]
• Overall Survival (OS) [Time frame: Up to 12 months]
• Number of Participants With Healthcare Resource Utilization (HCRU) [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) [Time frame: Up to 12 months]
• Number of Participants With Non-serious Adverse Events (AEs) Causally or Temporally Related to HyQvia Treatment [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 [Time frame: Up to 12 months]

Eligibility criteria

Inclusion criteria

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.

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 (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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

France · 5 centers

• 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

Italy · 4 centers

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

Romania · 4 centers

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

Spain · 3 centers

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

Turkey (Türkiye) · 3 centers

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

Czechia · 2 centers

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

Greece · 2 centers

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

Argentina · 1 center

• Instituto Privado de Investigaciones Clinicas de Cordoba — Córdoba

Germany · 1 center

• MHP-Muenchner Haematologiepraxis — Berlin

Poland · 1 center

• Pomorski Uniwersytet Medyczny — Szczecin

Sweden · 1 center

• Lund University Hospital — Lund

Identifiers

NCT: NCT05879757 · TAK-771-5006

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗