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

Last updated: March 18, 2025
Sponsor: Takeda
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neoplasm Metastasis

Multiple Myeloma

Cancer/tumors

Treatment

No Intervention

Clinical Study ID

NCT05879757
TAK-771-5006
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

Participants who meet all of the following criteria assessed at the time of enrollment are eligible for this study:

  1. Ability and willingness to provide informed consent. For adult participants unableto provide informed consent, informed consent provided by the legally authorizedrepresentative (LAR).

  2. Has a diagnosis of MM requiring systemic anti-myeloma therapy as per InternationalMyeloma Working Group (IMWG) criteria.

  3. 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).

  4. Age >=18 years old at the time of MM diagnosis.

  5. Available medical history records starting from the diagnosis of MM requiringsystemic anti-myeloma therapy as IMWG criteria.

  6. Life expectancy >6 months at the time of enrollment, per physician assessment.

  7. Eastern Cooperative Oncology Group (ECOG) performance status score of <=2.

  8. 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:

  1. Known hypersensitivity to any of the components of HyQvia.

  2. Primary immunodeficiency (PID) or diagnosed with human immunodeficiencyvirus/acquired immunodeficiency syndrome (HIV/AIDS) and/or active hepatitis C and/oractive hepatitis B infection.

  3. Prior use of Ig treatment or prophylaxis within 3 months from the date ofenrollment.

  4. Serious infection(s) requiring intravenous (IV) treatment at the time of enrollmentinto the study; except for participants on short-term oral antibiotic therapy.

  5. 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.

  6. 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.

  7. 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).

  8. 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

Total Participants: 75
Treatment Group(s): 1
Primary Treatment: No Intervention
Phase:
Study Start date:
October 17, 2023
Estimated Completion Date:
February 16, 2027

Study 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.

Connect with a study center

  • Centro de investigaciones Clinicas Cordoba

    Cordoba, X5000AAW
    Argentina

    Site Not Available

  • Instituto Privado de Investigaciones Clinicas de Cordoba

    Cordoba, X5000AAW
    Argentina

    Site Not Available

  • Fakultni nemocnice Plzen

    Pilsen, 30460
    Czechia

    Active - Recruiting

  • Vseobecna fakultni Nemocnice

    Prague, 128 08
    Czechia

    Site Not Available

  • Vseobecna fakultni Nemocnice

    Praha 2, 128 08
    Czechia

    Site Not Available

  • CHU Amiens - Hopital Sud

    Salouel, Somme 80480
    France

    Active - Recruiting

  • UH Amiens CEDEX 1

    Amiens Cedex 1, 80054
    France

    Site Not Available

  • CHU Dijon - Hopital du Bocage

    Dijon, 21079
    France

    Site Not Available

  • Hopital Prive du Confluent

    Nantes, 44 277
    France

    Active - Recruiting

  • Hopital de la Source - CHR Orleans

    Orleans, 45067
    France

    Site Not Available

  • CHU Bordeaux - Hopital Haut-Leveque

    Pessac, 33604
    France

    Site Not Available

  • MHP-Muenchner Haematologiepraxis

    Berlin, 10117
    Germany

    Site Not Available

  • Alexandra General Hospital

    Athens, 11528
    Greece

    Active - Recruiting

  • G. Papanikolaou Hospital

    Thessaloniki, 57010
    Greece

    Site Not Available

  • General Hospital of Thessaloniki "G. Papanikolaou"

    Thessaloniki, 57010
    Greece

    Active - Recruiting

  • A.O.U.C Policlinico di Bari

    Bari, 70124
    Italy

    Active - Recruiting

  • AOU Policlinico Rodolico San Marco

    Catania, 95125
    Italy

    Active - Recruiting

  • Azienda Ospedale Universita Padova

    Padova, 35128
    Italy

    Site Not Available

  • University of Padova

    Treviso, 31122
    Italy

    Active - Recruiting

  • Lubin Region St. Jana z Dukli

    Lublin, 20-090
    Poland

    Site Not Available

  • Pomorski Uniwersytet Medyczny

    Szczecin, 71252
    Poland

    Active - Recruiting

  • Institutul Clinic Fundeni

    Bucharest, 22328
    Romania

    Site Not Available

  • Spitalul Clinic Colentina

    Bucuresti, 020125
    Romania

    Site Not Available

  • Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca

    Cluj Napoca, 400015
    Romania

    Site Not Available

  • Ion Chiricuta Oncology Institute

    Cluj Napoca, 400124
    Romania

    Site Not Available

  • Spitalul Clinic Municipal Filantropia Craiova

    Craiova, 200143
    Romania

    Site Not Available

  • Clinical Emergency Hospital Sibiu

    Sibiu, 550166
    Romania

    Site Not Available

  • H12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital Clinico San Carlos

    Madrid, 28040
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hospital Universitari Son Espases

    Palma, 70120
    Spain

    Active - Recruiting

  • Lund University Hospital

    Lund, SE-221 85
    Sweden

    Site Not Available

  • SUS, Lund

    Lund, SE-221 85
    Sweden

    Site Not Available

  • Uppsala UH

    Uppsala, 75185
    Sweden

    Site Not Available

  • Ankara University

    Ankara, 6620
    Turkey

    Site Not Available

  • Ankara University Medical Faculty

    Ankara, 06100
    Turkey

    Active - Recruiting

  • Antalya Training and Research Hospital

    Antalya, 7100
    Turkey

    Active - Recruiting

  • Istanbul Universitesi

    Istanbul, 34098
    Turkey

    Site Not Available

  • Medipol Istanbul University

    Istanbul, 34214
    Turkey

    Site Not Available

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