Phase
Condition
Neoplasm Metastasis
Multiple Myeloma
Cancer/tumors
Treatment
No Intervention
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 unableto provide informed consent, informed consent provided by the legally authorizedrepresentative (LAR).
Has a diagnosis of MM requiring systemic anti-myeloma therapy as per InternationalMyeloma Working Group (IMWG) criteria.
Initiated HyQvia treatment as part of routine clinical care no more than 30 daysbefore study enrollment or received no more than 2 doses of HyQvia treatment,whichever occurs first. Participants are also eligible if they newly start HyQviawithin 30 days after the enrollment visit. Note: Participants who do not start HyQvia treatment within 30 days of enrollmentwill 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 requiringsystemic 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
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 immunodeficiencyvirus/acquired immunodeficiency syndrome (HIV/AIDS) and/or active hepatitis C and/oractive hepatitis B infection.
Prior use of Ig treatment or prophylaxis within 3 months from the date ofenrollment.
Serious infection(s) requiring intravenous (IV) treatment at the time of enrollmentinto the study; except for participants on short-term oral antibiotic therapy.
Has participated in an interventional clinical study involving a medicinal productor device within 30 days prior to enrollment or is scheduled to participate in aninterventional clinical study involving a medical product or device during thisstudy. Note: Participants on investigational chimeric antigen receptor-T (CAR-T) celltherapies and/or bispecific antibodies may participate.
Planned stem cell transplant during the treatment period or had a prior stem celltransplant: allogeneic transplant at any time, autologous transplant within 3 monthsof 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 ofthe cervix or breast, localized prostate cancer or other non-invasive lesion that inthe opinion of the investigator, is considered cured with minimal risk of recurrencewithin 3 years).
Participant has had major surgery within 2 weeks before enrollment, or has not fullyrecovered from an earlier surgery, or has surgery planned during the time theparticipant 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.
Study Design
Study Description
Connect with a study center
Centro de investigaciones Clinicas Cordoba
Cordoba, X5000AAW
ArgentinaSite Not Available
Instituto Privado de Investigaciones Clinicas de Cordoba
Cordoba, X5000AAW
ArgentinaSite Not Available
Fakultni nemocnice Plzen
Pilsen, 30460
CzechiaActive - Recruiting
Vseobecna fakultni Nemocnice
Prague, 128 08
CzechiaSite Not Available
Vseobecna fakultni Nemocnice
Praha 2, 128 08
CzechiaSite Not Available
CHU Amiens - Hopital Sud
Salouel, Somme 80480
FranceActive - Recruiting
UH Amiens CEDEX 1
Amiens Cedex 1, 80054
FranceSite Not Available
CHU Dijon - Hopital du Bocage
Dijon, 21079
FranceSite Not Available
Hopital Prive du Confluent
Nantes, 44 277
FranceActive - Recruiting
Hopital de la Source - CHR Orleans
Orleans, 45067
FranceSite Not Available
CHU Bordeaux - Hopital Haut-Leveque
Pessac, 33604
FranceSite Not Available
MHP-Muenchner Haematologiepraxis
Berlin, 10117
GermanySite Not Available
Alexandra General Hospital
Athens, 11528
GreeceActive - Recruiting
G. Papanikolaou Hospital
Thessaloniki, 57010
GreeceSite Not Available
General Hospital of Thessaloniki "G. Papanikolaou"
Thessaloniki, 57010
GreeceActive - Recruiting
A.O.U.C Policlinico di Bari
Bari, 70124
ItalyActive - Recruiting
AOU Policlinico Rodolico San Marco
Catania, 95125
ItalyActive - Recruiting
Azienda Ospedale Universita Padova
Padova, 35128
ItalySite Not Available
University of Padova
Treviso, 31122
ItalyActive - Recruiting
Lubin Region St. Jana z Dukli
Lublin, 20-090
PolandSite Not Available
Pomorski Uniwersytet Medyczny
Szczecin, 71252
PolandActive - Recruiting
Institutul Clinic Fundeni
Bucharest, 22328
RomaniaSite Not Available
Spitalul Clinic Colentina
Bucuresti, 020125
RomaniaSite Not Available
Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca
Cluj Napoca, 400015
RomaniaSite Not Available
Ion Chiricuta Oncology Institute
Cluj Napoca, 400124
RomaniaSite Not Available
Spitalul Clinic Municipal Filantropia Craiova
Craiova, 200143
RomaniaSite Not Available
Clinical Emergency Hospital Sibiu
Sibiu, 550166
RomaniaSite Not Available
H12 de Octubre
Madrid, 28041
SpainSite Not Available
Hospital Clinico San Carlos
Madrid, 28040
SpainActive - Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
SpainActive - Recruiting
Hospital Universitari Son Espases
Palma, 70120
SpainActive - Recruiting
Lund University Hospital
Lund, SE-221 85
SwedenSite Not Available
SUS, Lund
Lund, SE-221 85
SwedenSite Not Available
Uppsala UH
Uppsala, 75185
SwedenSite Not Available
Ankara University
Ankara, 6620
TurkeySite Not Available
Ankara University Medical Faculty
Ankara, 06100
TurkeyActive - Recruiting
Antalya Training and Research Hospital
Antalya, 7100
TurkeyActive - Recruiting
Istanbul Universitesi
Istanbul, 34098
TurkeySite Not Available
Medipol Istanbul University
Istanbul, 34214
TurkeySite Not Available
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