Resumen

En este estudio, los participantes con mieloma múltiple e inmunodeficiencia secundaria (IDS) serán tratados con HyQvia según la práctica estándar de su centro. El objetivo principal del estudio es analizar los parámetros de infusión de la administración de HyQvia.

Descripción detallada

Este es un estudio prospectivo observacional de adultos con mieloma múltiple (MM) con IDS tratados con HyQvia como parte de la atención clínica de rutina. Este estudio caracterizará los parámetros de infusión de la administración de HyQvia en la práctica clínica real. El estudio incorporará aproximadamente 100 participantes. Los datos del estudio se obtendrán mediante las visitas de rutina al centro y los resultados reportados por el paciente (PRO) son voluntarios. Este ensayo multicéntrico se llevará a cabo en países seleccionados de Europa y América del Sur. La duración total de este estudio es de 38 meses. Los participantes realizarán múltiples visitas al centro durante los 12 meses posteriores a la inscripción para evaluaciones de seguimiento.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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.

Estudio prospectivo observacional para evaluar el uso en la práctica clínica real y los resultados de HyQvia en pacientes con mieloma múltiple (MM) con diagnóstico de inmunodeficiencia secundaria (IDS)

Resumen

Descripción detallada

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

No Intervention

Ubicaciones

Instituto Privado de Investigaciones Clinicas de Cordoba

Patrocinadores

Contactos

Takeda Contact