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)

Status: Recruiting
Location: See all (25) locations...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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.

Locations
Other Locations
Argentina
Instituto Privado de Investigaciones Clinicas de Cordoba
WITHDRAWN
Córdoba
France
CHU Dijon - Hopital du Bocage
NOT_YET_RECRUITING
Dijon
Hopital Prive du Confluent
RECRUITING
Nantes
Hopital de la Source - CHR Orleans
NOT_YET_RECRUITING
Orléans
CHU Bordeaux - Hopital Haut-Leveque
NOT_YET_RECRUITING
Pessac
CHU Amiens - Hopital Sud
RECRUITING
Salouël
Germany
MHP-Muenchner Haematologiepraxis
NOT_YET_RECRUITING
Berlin
Greece
Alexandra General Hospital
RECRUITING
Athens
General Hospital of Thessaloniki G. Papanikolaou
RECRUITING
Thessaloniki
Italy
A.O.U.C Policlinico di Bari
RECRUITING
Bari
AOU Policlinico Rodolico San Marco
RECRUITING
Catania
Azienda Ospedale Universita Padova
NOT_YET_RECRUITING
Padua
University of Padova
RECRUITING
Treviso
Poland
Pomorski Uniwersytet Medyczny
RECRUITING
Szczecin
Romania
Institutul Clinic Fundeni
NOT_YET_RECRUITING
Bucharest
Spitalul Clinic Colentina
NOT_YET_RECRUITING
Bucharest
Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca
NOT_YET_RECRUITING
Cluj-napoca
Spitalul Clinic Municipal Filantropia Craiova
NOT_YET_RECRUITING
Craiova
Spain
Hospital Clinico San Carlos
RECRUITING
Madrid
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitari Son Espases
RECRUITING
Palma
Sweden
Lund University Hospital
NOT_YET_RECRUITING
Lund
Turkey
Ankara University Medical Faculty
RECRUITING
Ankara
Antalya Training and Research Hospital
RECRUITING
Antalya
Istanbul Universitesi
NOT_YET_RECRUITING
Istanbul
Contact Information
Primary
Takeda Contact
medinfoUS@takeda.com
+1-877-825-3327
Time Frame
Start Date: 2023-10-17
Estimated Completion Date: 2027-02-16
Participants
Target number of participants: 75
Treatments
MM Participants With SID
Participants with MM diagnosed with SID will be treated with HyQvia as part of routine clinical care and will be followed prospectively from the date of starting HyQvia treatment through 12 months of follow-up.
Sponsors
Leads: Takeda

This content was sourced from clinicaltrials.gov