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

February 16, 2026 updated by: Takeda

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Córdoba, Argentina, X5000AAW
        • Withdrawn
        • Instituto Privado de Investigaciones Clinicas de Cordoba
  • Czechia
      • Pilsen, Czechia, 30460
        • Recruiting
        • Fakultni nemocnice Plzen
        • Principal Investigator:
          • Alexandra Jungova
        • Contact:
      • Prague, Czechia, 128 08
        • Not yet recruiting
        • Vseobecna Fakultní Nemocnice
        • Principal Investigator:
          • Jan Straub
        • Contact:
  • France
      • Dijon, France, 21079
        • Not yet recruiting
        • Chu Dijon - Hopital Du Bocage
        • Principal Investigator:
          • Marie-Lorraine Chretien
        • Contact:
      • Nantes, France, 44 277
        • Recruiting
        • Hôpital Privé du Confluent
        • Principal Investigator:
          • Katell Le Du
        • Contact:
      • Orléans, France, 45067
        • Not yet recruiting
        • Hopital de la Source - CHR Orleans
        • Contact:
        • Principal Investigator:
          • Omar Benbrahim
      • Pessac, France, 33604
        • Not yet recruiting
        • CHU Bordeaux - Hôpital Haut-Lévêque
        • Contact:
        • Principal Investigator:
          • Jean-François Viallard
    • Somme
      • Salouël, Somme, France, 80480
        • Recruiting
        • CHU Amiens - Hopital Sud
        • Principal Investigator:
          • Clement Gourguechon
        • Contact:
  • Germany
      • Berlin, Germany, 10117
        • Not yet recruiting
        • MHP-Muenchner Haematologiepraxis
        • Principal Investigator:
          • Richard Schabath
        • Contact:
  • Greece
      • Athens, Greece, 11528
        • Recruiting
        • Alexandra General Hospital
        • Principal Investigator:
          • Efstathios Kastritis
        • Contact:
      • Thessaloniki, Greece, 57010
        • Recruiting
        • General Hospital of Thessaloniki "G. Papanikolaou"
        • Principal Investigator:
          • Ioanna Sakellari
        • Contact:
  • Italy
      • Bari, Italy, 70124
        • Recruiting
        • A.O.U.C Policlinico di Bari
        • Principal Investigator:
          • Angelo Vacca
        • Contact:
      • Catania, Italy, 95125
        • Recruiting
        • AOU Policlinico Rodolico San Marco
        • Principal Investigator:
          • Alessandra Romano
        • Contact:
      • Padua, Italy, 35128
        • Not yet recruiting
        • Azienda Ospedale Universita Padova
        • Principal Investigator:
          • Tamara Berno
        • Contact:
      • Treviso, Italy, 31122
        • Recruiting
        • University of Padova
        • Principal Investigator:
          • Francesco Cinetto
        • Contact:
  • Poland
      • Szczecin, Poland, 71252
        • Recruiting
        • Pomorski Uniwersytet Medyczny
        • Contact:
        • Principal Investigator:
          • Boguslaw Machalinski
  • Romania
      • Bucharest, Romania, 020125
        • Not yet recruiting
        • Spitalul Clinic Colentina
        • Contact:
        • Principal Investigator:
          • Mihaela Andreescu
      • Bucharest, Romania, 22328
        • Not yet recruiting
        • Institutul Clinic Fundeni
        • Contact:
        • Principal Investigator:
          • Sorina Badelita
      • Cluj-Napoca, Romania, 400015
        • Not yet recruiting
        • Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca
        • Contact:
        • Principal Investigator:
          • Ciprian Tomuleasa
      • Craiova, Romania, 200143
        • Not yet recruiting
        • Spitalul Clinic Municipal Filantropia Craiova
        • Contact:
        • Principal Investigator:
          • Luminita Ocroteala
  • Spain
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
        • Principal Investigator:
          • Joaquin Martinez-Lopez
        • Contact:
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Clinico San Carlos
        • Principal Investigator:
          • Silvia Sanchez-Ramon
        • Contact:
      • Palma, Spain, 70120
        • Recruiting
        • Hospital Universitari Son Espases
        • Principal Investigator:
          • Albert Perez-Montana
        • Contact:
  • Sweden
      • Lund, Sweden, SE-221 85
        • Not yet recruiting
        • Lund University Hospital
        • Contact:
        • Principal Investigator:
          • Goran Jonsson
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06100
        • Recruiting
        • Ankara University Medical Faculty
        • Principal Investigator:
          • Selami Toprak
        • Contact:
      • Antalya, Turkey (Türkiye), 7100
        • Recruiting
        • Antalya Training And Research Hospital
        • Principal Investigator:
          • Volkan Karakus
        • Contact:
      • Istanbul, Turkey (Türkiye), 34098
        • Not yet recruiting
        • Istanbul Universitesi
        • Principal Investigator:
          • Muhlis Cem Ar
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will include adult participants who suffer from MM, have a diagnosis of SID defined according to the European HyQvia label.

Description

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 unable to provide informed consent, informed consent provided by the legally authorized representative (LAR).
  2. Has a diagnosis of MM requiring systemic anti-myeloma therapy as per International Myeloma Working Group (IMWG) criteria.

  3. 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).

  4. Age >=18 years old at the time of MM diagnosis.
  5. Available medical history records starting from the diagnosis of MM requiring systemic 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 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 immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) and/or active hepatitis C and/or active hepatitis B infection.
  3. Prior use of Ig treatment or prophylaxis within 3 months from the date of enrollment.
  4. Serious infection(s) requiring intravenous (IV) treatment at the time of enrollment into the study; except for participants on short-term oral antibiotic therapy.

  5. 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.

  6. 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.
  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 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).
  8. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: No Intervention
As this is an observational study, no intervention will be administered in this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose of HyQvia per Kilogram of Body Weight
Time Frame: Up to 12 months
Dose of HyQvia will be calculated as grams per kilogram (g/kg) body weight per 4 weeks.
Up to 12 months
Infusion Volume per Site
Time Frame: Up to 12 months
Up to 12 months
Total Infusion Volume
Time Frame: Up to 12 months
Up to 12 months
Infusion Rate
Time Frame: Up to 12 months
Infusion rate will be reported in milliliters per hour (mL/h).
Up to 12 months
Duration of Infusion
Time Frame: Up to 12 months
The duration between start and end of infusion will be reported.
Up to 12 months
Location of Infusion Sites
Time Frame: Up to 12 months
Location of infusion sites will include right upper abdomen, left upper abdomen, right lower abdomen, left lower abdomen, right or left thigh, right or left arm, and other (specified).
Up to 12 months
Number of Infusion Sites
Time Frame: Up to 12 months
Up to 12 months
Number of Participants Characterized by Site of Care
Time Frame: Up to 12 months
Site of care will be categorized as home, hospital, doctor's office, other (specified).
Up to 12 months
Length and Diameter of Infusion Needles
Time Frame: Up to 12 months
Up to 12 months
Number of Participants per Type of Pump
Time Frame: Up to 12 months
Type of pump will include peristaltic infusion pump and syringe driver pump.
Up to 12 months
Number of Participants With Availability of Caregiver Support
Time Frame: Up to 12 months
Availability of caregiver support will be collected as yes, no, and unknown. If yes, caregiver relationship will be specified.
Up to 12 months
Number of Training Visits
Time Frame: Up to 12 months
Up to 12 months
Number of Participants With Infusions That are Discontinued, Slowed, or Interrupted
Time Frame: Up to 12 months
Up to 12 months
Number of Participants With Reasons of infusions Discontinued, Slowed, or Interrupted
Time Frame: Up to 12 months
Up to 12 months
Absolute Dose of HyQvia per Infusion
Time Frame: Up to 12 months
Absolute dose of HyQvia will be calculated as dose per infusion in milligrams (mg).
Up to 12 months
Treatment Interval
Time Frame: Up to 12 months
Treatment interval and ramp up dosing intervals will be reported as Weekly, every 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks and other administration according to the schedule defined by physician.
Up to 12 months
Number of Participants With Reasons for Discontinued, or Interrupted HyQvia Treatment or Switches to Other Treatment
Time Frame: Up to 12 months
Reasons for discontinued, or interrupted HyQvia treatment will include local adverse events (AE)/discomfort, systemic AE, administration complexity, insurance/reimbursement-related, low immunoglobulin (Ig) trough level, lack of effectiveness, inability to tolerate large volumes, death and other (specified). If switch, type of treatment after switch (example, antibiotic treatment, intravenous immunoglobulin [IVIg], subcutaneous immunoglobulin [SCIg], unknown) or switches to other treatment will be included.
Up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Characterized by Clinical Characteristics
Time Frame: Up to 12 months
Clinical characteristics of participants will include type of MM, and MM treatment/procedures, comorbidities, concomitant medications, laboratory tests and imaging.
Up to 12 months
Number of Participants With Multiple Myeloma (MM) Disease Status and Outcome at 12 Months
Time Frame: Month 12
MM disease status and outcome will include response and criteria used to assess response (if known).
Month 12
Overall Survival (OS)
Time Frame: Up to 12 months
OS will be summarized as the frequency and percentage of participants surviving to each follow-up visit. Additionally, time-to death, defined as the time from HyQvia initiation to death occurring before the end of the study period, will be assessed.
Up to 12 months
Number of Participants With Healthcare Resource Utilization (HCRU)
Time Frame: Up to 12 months
Number of participants with HCRU including annualized rates and emergency room visits, urgent care visits, outpatient visits, telemedicine visits, and other physician visits, with stratification of hospitalizations and visits due to infection, visit type and provider type.
Up to 12 months
Duration of Hospitalizations
Time Frame: Up to 12 months
Up to 12 months
Number of Participants With Related and Not Related Serious Adverse Events (SAEs)
Time Frame: Up to 12 months
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An SAE is defined as an untoward medical occurrence that at any dose is fatal, life-threatening, requires inpatient hospitalisation or results in prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a medically important event. AEs will be reported as local or systemic AEs.
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
Premedication use for HyQvia infusions will include start date, stop date and medication name. Technical problems with infusion will include problems with the handling of the pump, problems with the preparation of the infusion, problems with the infusion itself, infusion site leakage, and other (specified).
Up to 12 months
Time of Multiple Myeloma (MM) Diagnosis
Time Frame: At the time of baseline
At the time of baseline
Number of Participants Characterized With Type of Hemato-oncological Treatment
Time Frame: Baseline up to 12 months
Type of hemato-oncological treatment will list type, switches, interruptions and discontinuation with reasons of hemato-oncological treatment or procedure.
Baseline up to 12 months
Duration of Hemato-oncological Treatment
Time Frame: Baseline up to 12 months
Baseline 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
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. AEs will be reported as local or systemic AEs.
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Takeda

Investigators

  • Study Director: Study Director, Takeda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 17, 2023

Primary Completion (Estimated)

February 16, 2027

Study Completion (Estimated)

February 16, 2027

Study Registration Dates

First Submitted

May 19, 2023

First Submitted That Met QC Criteria

May 19, 2023

First Posted (Actual)

May 30, 2023

Study Record Updates

Last Update Posted (Actual)

February 18, 2026

Last Update Submitted That Met QC Criteria

February 16, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAK-771-5006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

IPD Sharing Access Criteria

IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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